MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'generics'. Sat, 03 Sep 2011 02:01:58 +0100 http://www.medworm.com/index.php?rid=5182313&cid=t_114929_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F09%2Fbrando-pharma-makes-offer-generic.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5182313 Thu, 01 Sep 2011 14:54:00 +0100 5182313 http://www.medworm.com/index.php?rid=5182322&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSXrWAMrwa34%2F In an effort to thwart generic competition, brand-name drugmakers are promising not to launch so-called authorized generics if their generic rivals promise not to market copycat versions of the brand-name drugs, according to a new report from the US Federal Trade Commission. The findings, released in a 270-page report, explore a twist on the controversial practice of pay-to-delay in which brand-name drugmakers settle patent litigation with an agreement that involves a payment and a commitment by a generic drugmaker not to launch a rival med for a specified period of time. The FTC has called these deals anti-competitive and cost consumers $3.5 billion annually. Now, the agency, which has been urging Congress to pass legislation to restrict these deals (see here), is turning its attention to... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5182322 Thu, 01 Sep 2011 12:51:07 +0100 5182322 http://www.medworm.com/index.php?rid=5182315&cid=t_114929_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F08%2Fshould-us-government-step-in-to-ease.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5182315 Tue, 30 Aug 2011 12:20:00 +0100 5182315 http://www.medworm.com/index.php?rid=5140307&cid=t_114929_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F08%2Fdouble-dip-viagra-patent-means-no.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5140307 Tue, 16 Aug 2011 12:15:00 +0100 5140307 http://www.medworm.com/index.php?rid=5130724&cid=t_114929_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FvhZooslpidM%2F Raising Questions: The debate over whether antibiotics should be used less frequently in livestock has been revived by the recent recall of ground turkey tainted by salmonella bacteria that is resistant to many of the drugs, the WSJ reports. Food-safety experts say that routine use of antibiotics in feed as a preventive can promote antibiotic-resistant bacteria and threaten human health, while industry groups counter that the practice reduces animal diseases, promotes growth and keeps meat prices low, the paper says. Crop Inspections: Mushrooms grown about 25 miles away from the Japanese nuclear plant damaged in the March earthquake and tsunami have been found to be contaminated by radiation, Bloomberg News reports. Rice is also a concern, with about half of the country’s crop grown ... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5130724 Mon, 15 Aug 2011 12:43:25 +0100 5130724 http://www.medworm.com/index.php?rid=5118990&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FwbuuG2ELBEc%2F As Washington looks to shrink overwhelming deficits, the pharmaceutical industry is gearing up to fight any plan to seek more discounts and rebates for Medicare. Having contributed $112 billion to health care reform last year, drugmakers are bolstering their lobbying efforts and are warning that any move to extract more money will cost them a collective $20 billion and jeopardize 260,000 jobs. “We made a contribution to the Affordable Care Act that was substantial and fundamental,” Pfizer ceo Ian Read tells Bloomberg News. “We are only 10 percent of the health-care spend in the United States, and we are the most efficient part of that.” And he adds that Pfizer will “oppose any further changes” to Medicare. The industry is centering on the Medicare Part D drug benefit, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5118990 Thu, 11 Aug 2011 17:43:43 +0100 5118990 http://www.medworm.com/index.php?rid=5107899&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRkVSK5_Bu9Y%2F Good morning, everyone, and nice to see you again. We hope the weekend was invigorating. Now, of course, the time has come to resume the routine of meetings and deadlines, even if it is a slow time of year. To get started, yes, we are brewing that mandatory cup of stimulation, so feel free to join us. Meanwhile, here are some tidibts from around the world. Hope your day goes well and stay in touch… Pfizer And UCSD Collaborate On Early Drug Discovery (San Diego Union Tribune) China’s Healthcare Push May Curb Sales For Brand-Name Pharma (Bloomberg News) Nestle Eyes Pfizer Formula Milk Powder Business (Business China) EU Approves Botox For Treating Urinary Incontinence (Reuters) Takeda Pharmaceuticals Faces Rising Number Of Actos Lawsuits (Associated Press) Bayer Is Eyeing Pfizer ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5107899 Mon, 08 Aug 2011 11:50:32 +0100 5107899 http://www.medworm.com/index.php?rid=5086559&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fo0atlcygBx4%2F Three years after a dispute erupted over the seizure by EU authorities of Indian-made generics as they were being shipped through Europe, India and the European Commission have struck an interim deal that restricts the 27 member EU states from seizing meds unless there is evidence that drugs will be diverted in the European Union, according to a statement from the Prime Minister’s office in India. The seizures were made after EU authorities in various countries, starting with The Netherlands, maintained the generics violated intellectual property rights and were, therefore, counterfeit. The actions infuriated Indian generic drugmakers, because exporters would be forced to find alternative routes to send shipments, which would increase costs and hurt competitiveness (back story). Pati... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5086559 Mon, 01 Aug 2011 12:36:50 +0100 5086559 http://www.medworm.com/index.php?rid=5078029&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FErKoEEBgvYc%2F A group of 40 members of the House of Representatives have written President Obama urging the Trans Pacific Partnership talks currently under way should include a requirement that countries offer 12 years of data exclusivity for new biologics. The missive is the latest move by the pharmaceutical industry to create what it calls parity with US law. “The US-led biopharmaceutical industry would be disadvantaged if the US does not ensure consistency with US law as part of the TPP, because foreign countries do not provide the same type of protection rules,” according to the July 27 letter, which PhRMA is circulating. The trade group has also distributed this document as part of its lobbying campaign. You may recall that brand-name drugmakers won a 12-year exclusivity period as part of a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5078029 Fri, 29 Jul 2011 15:16:56 +0100 5078029 http://www.medworm.com/index.php?rid=5062216&cid=t_114929_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FFHR0zj2kkIs%2F The dividing line between the big generic and brand-name drug makers is increasingly fuzzy. Let’s hope each industry knows what it’s getting into. It used to be that the sides were clear. Big Pharma developed new drugs, while generic companies like Teva copied these medicines once their patent protection expired. Each industry had its own trade group, lawyers and PR teams. Disputes were common. Yet as today’s WSJ reports, the industries are converging. Teva is defending a brand-name multiple-sclerosis drug, Copaxone, from rivals seeking to sell a generic version. Among those rivals is the Sandoz generic unit of Swiss drug giant Novartis, in partnership with Momenta. There’s a host of reasons why the two types of drug makers are treading on each others’ turf, i... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5062216 Mon, 25 Jul 2011 18:03:06 +0100 5062216 http://www.medworm.com/index.php?rid=5062218&cid=t_114929_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FO-b9eVJqNos%2F Tables are Turned: Teva Pharmaceutical Industries mostly makes generic drugs, but now finds itself acting like Big Pharma — defending the patent for a brand-name drug in order to stave off the threat of generic competition, the WSJ reports. Mylan and Momenta are challenging the validity of Teva’s patents for the multiple-sclerosis drug Copaxone, hoping to sell generic copies before the patents expire in 2014 and 2015, the paper says. So far, the FDA hasn’t granted Teva’s requests to require separate clinical trials of the proposed generic versions. Radiation Threat: The Japanese food supply is being threatened by radiation from the nuclear power-plant disaster earlier this year, with more than 2,600 cattle contaminated and some tainted meat put on sale, Bloomberg Ne... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5062218 Mon, 25 Jul 2011 12:31:36 +0100 5062218 http://www.medworm.com/index.php?rid=5062451&cid=t_114929_136_f&fid=39026&url=http%3A%2F%2Fcarolinemfr.blogspot.com%2F2011%2F07%2Fgood-news-for-patients.html There occasionally actually is good news for patients. This time its financial. Many brand name drugs will have their patents expire in 2011 and 2012. In the Boston Globe today was an article "Drug Prices Will Fall Sharply As Patents Expire" (A poor title that I read first as 'patients expire'.) The article mostly talks about Lipitor, Protonix, Plavix and other medications I don't take the but the point is there. All these expensive drugs that came out in the early 1990s or so, now will lose their patent protection and generics will take over.I get my Femara by mail order - simply because I can't afford it at the local pharmacy. It cost me over $100 for a copy for a single month (OUCH!) so I switched to my insurance mail order and it cost me $70 for a three month supply. Then my last refil... Caroline's Breast Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=5062451 Mon, 25 Jul 2011 10:04:00 +0100 5062451 http://www.medworm.com/index.php?rid=5051240&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ff0rmi8u5dV8%2F The US Senate Judiciary Committee has approved a bipartisan bill that would limit pay-to-delay settlements that are designed to keep lower-cost generic drugs off the market for extended periods. The move comes after the US Supreme Court declined to review one hotly contested deal (see this) amid repeated cries from the US Federal Trade Commission that settlements are anticompetitive and costly to consumers. Under the bill, which is called the Preserve Access to Affordable Generic Drugs Act, brand-name drugmakers would be deterred from settling patent disputes by paying generic rivals in exchange for promises that a copycat version of its drug will be kept off the market. The deals would be considered illegal and the FTC would be given the authority to stop the agreements (read the legislat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5051240 Thu, 21 Jul 2011 20:04:25 +0100 5051240 http://www.medworm.com/index.php?rid=5029206&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9bl9WpBKcU8%2F In a bid to help federal and state governments save money, a bipartisan trio of US Senators has introduced a bill to promote the use of generics in the Medicaid program. The move comes as brand-name drugmakers are also fighting on Capitol Hill to fend off a proposal that would restore rebates for drugs taken by seniors who are eligible for both Medicaid and Medicare (see this). Called the Affordable Medicines Utilization Act of 2011, the bill would give states incentives to increase generic drug use by letting them keep part of the difference that the federal government receives between the cost of a generic and its brand-name counterpart (here is the bill). In making their case, the pols cite a recent study by the American Enterprise Institute that maintained Medicaid needlessly spent app... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5029206 Fri, 15 Jul 2011 14:43:12 +0100 5029206 http://www.medworm.com/index.php?rid=5029201&cid=t_114929_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F07%2Fbranded-pharma-wages-war-against.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5029201 Thu, 14 Jul 2011 11:53:00 +0100 5029201 http://www.medworm.com/index.php?rid=5008660&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FoGHMXqJ1AYw%2F India has promised not to link a proposed trade deal with the European Union to any limits on making generic AIDS drugs, according to a joint statement from India’s Commerce Minister Anand Sharma and the Joint United Nations Programme on HIV/AIDS. The declaration came in response to growing criticism that pharma was pushing provisions in trade talks that would limit the availability of AIDS meds. The EU and India began talks in 2007 on a free-trade agreement that would be worth an estimated $134 billion in commerce. But a report last year in the Journal of the International AIDS Society suggested provisions could raise prices delay access to improved meds, and recommended that “inappropriate” trade deals should not be pursued unless new policies are created (see here). A key poin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5008660 Fri, 08 Jul 2011 13:20:18 +0100 5008660 http://www.medworm.com/index.php?rid=5008666&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fb0Td2mZIFjs%2F European Union antitrust regulators have ended a four-year probe into charges that Boehringer Ingelheim abused the patent system to thwart rivals from launching versions of the best-selling Spiriva med for treating chronic obstructive pulmonary disease, or COPD. To settle the investigation, the German drugmaker agreed to make changes in its intellectual property protections. As the EU noted, Boehringer is the market leader in COPD meds thanks to its Spiriva inhalers, which generated nearly $4.3 billion in sales last year. The fracas began, though, in 2003, when Boehringer filed patent applications for new treatments involving combinations of three categories of active substances, including a new active substance that was discovered by Almirall, a Spanish drugmaker. Almirall objected to the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5008666 Thu, 07 Jul 2011 12:15:21 +0100 5008666 http://www.medworm.com/index.php?rid=4984693&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIkIZCh14KuA%2F After years of embarrassment, lobbying and litigation, The Medicines Company last week finally succeeded in convincing Congress to support what has been derisively called the ‘Dog Ate My Homework Act.’ In reality, this was not a separate bill, but an amendment to the patent reform legislation known as the America Invents Act. The amendment was designed to compensate for a mistake that occurred a decade ago, when the drugmaker sought a patent extension for its Angiomax anti-coagulant, but its lawyers missed the filing deadline by one day, a contentious point that the law firm denies (see comment below). And so the amendment, which was introduced by four members of the House, would retroactively alter the process used to review filings - and grant an additional day (read the amen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4984693 Wed, 29 Jun 2011 14:35:16 +0100 4984693 http://www.medworm.com/index.php?rid=4976207&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-30La5fXibE%2F The US Supreme Court has agreed to review a complicated and controversial case that may alter the way brand-name drugmakers use patent law to delay generic competition (see this). At issue is the ability of generic drugmakers to seek FDA approval under a provision of the Hatch-Waxman Act to market a drug for uses not covered by patents held by brand-name drugmakers. The case has generated considerable interest and, in fact, the US Solicitor General urged the court to conduct a review. Wall Street, meanwhile, has signaled that, if the status quo continues, brand-name drugmakers will have a new means of fending off unwanted generic rivals. The Generic Pharmaceutical Association says the review is needed because a Federal Circuit ruling “threatens to eliminate a critical check on brand-name... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4976207 Mon, 27 Jun 2011 20:53:16 +0100 4976207 http://www.medworm.com/index.php?rid=4976210&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Frveg3vLj9MY%2F The UK government has filed a lawsuit seeking about $351 million in damages against Servier Laboratories over charges the French drugmaker “abused” its dominant position by delaying rivals from launching generic versions of a blood pressure drug, The Financial Times writes. Health Secretary Andrew Lansley and more than 150 primary care trusts claim that between July 2001 and July 2007, Servier schemed to prevent a generic form of Aceon, or perindopril, from reaching the market, the paper continues. Consequently, the National Health Service paid “elevated prices.” The Servier patent on Aceon expired in 2003, but a generic did not appear in the UK until July 2007. The lawsuit cites documents showing Servier applied to the European Patent Office for another patent during t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4976210 Mon, 27 Jun 2011 15:07:38 +0100 4976210 http://www.medworm.com/index.php?rid=4968912&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FK90Sx9ix8RI%2F In a closely watched case, the US Supreme Court has ruled that generic drugmakers are not required to strengthen product labeling if alerted to side effects, even when the same change has not been made to the labeling for the branded med. However, the court was divided with a 5-to-4 majority deciding in favor of the argument made by the generic industry. The decision came in response to a pair of lawsuits by two women who claimed such changes could have been made under state law and without FDA approval for such changes. They argued generic drugmakers would create uncertainty about safety if they are not held liable under state laws and update labeling in the face of evidence of serious side effects. Generic drugmakers, including Actavis and Pliva, argued they would have been required to p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4968912 Thu, 23 Jun 2011 15:16:43 +0100 4968912 http://www.medworm.com/index.php?rid=4921757&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FC0tblUFA4DY%2F In what some say would be a highly unusual move, the US Federal Trade Commission is considering using its rule-making power to stop pay-to-delay deals between brand-name drugmakers and their generic rivals, after failing to convince Congress or the courts to act, Bloomberg News reports. A rule to block the deals would involve antitrust issues, rather than consumer protection, and could be made on the agency’s own initiative under its basic statutory authority rather than at the direction of Congress, Bert Foer, president of the American Antitrust Institute, tells the news service. “Any potential attempt by the FTC to move forward unilaterally with such a rulemaking would be unprecedented,” Sean Heather, executive director of the global regulatory cooperation project at the US Cha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4921757 Thu, 09 Jun 2011 15:10:23 +0100 4921757 http://www.medworm.com/index.php?rid=4911817&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FscuNG8BkIgY%2F To settle a bitter dispute over seizures of generic meds at a Dutch airport, Eli Lilly is about to make an undisclosed payment to several Indian generic drugmakers, The Financial Times writes. Several big drugmakers, in fact, benefited when the lower-cost drugs were impounded, since the move thwarted distribution of the generics throughout the European Union. The seizures in 2008 and 2009 were made in response to claims that the meds violated intellectual property rules protecting patents within the EU. But the move also prompted fierce criticism from health activists and non-governmental organizations that argued the generics were simply being shipped through the EU to developing countries where the patent laws did not apply, the FT notes. The seizures were only the latest struggle in a l... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4911817 Wed, 08 Jun 2011 13:00:39 +0100 4911817 http://www.medworm.com/index.php?rid=4911820&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWRej8NgksWI%2F Good morning, everyone, and how are you today? A scorcher is predicted to envelope the Pharmalot corporate campus. We plan to keep cool by perusing interesting documents and chatting up interesting people. We will also break later to appear on a PhRMA panel on social media. To prepare, we are downing a few cups of stimulation - our flavor today is Southern Pecan. Meanwhile, here are some nifty tidbits from around your world. Watch out for the heat and see you soon… Pfizer Teams With Harvard In $100M Drug Discovery Deal (Bloomberg News) Merck Ends Trial Of Intercell Vaccine For MRSA (Reuters) Covidien Seeks A Buyer For Its Pharma Unit (Bloomberg News) Orphan Drug Development Success Remains Elusive (Gen New) US Seeks Prison Sentences For Device Execs (Associated Press) Glaxo Faces Adv... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4911820 Wed, 08 Jun 2011 12:00:08 +0100 4911820 http://www.medworm.com/index.php?rid=4893916&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_PKuBogHIcg%2F And so, another working week will soon draw to a close. This is, of course, our signal to daydream about the weekend. Our agenda includes some therapeutic swimming, catching up on our reading and taking in a soccer match with the short people. And you? How about enjoying the weather with a nice bike ride? Or spending time with someone special? Perhaps thinking big thoughts is in order. Whatever you do, have a wonderful time. And be safe. See you soon… Pfizer And Hisun Pharmaceuticals Plan Generic Venture (Bloomberg News) Tianjin Tasly Pharmaceutical To Build A Factory In Maryland (CapitalVue) Drugmakers Bolster US Corporate Philanthropy (Reuters) The New Pricing Game In Germany (Business Week) Endo Sales Reps Granted Class-Action Lawsuit For Overtime (Reuters) Teva Gives Big Golden P... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4893916 Fri, 03 Jun 2011 12:03:23 +0100 4893916 http://www.medworm.com/index.php?rid=4872472&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FadgmeRx2WXw%2F The Obama administration is urging the US Supreme Court to review a complicated and controversial case that may alter the way brand-name drugmakers use patent law to delay generic competition. At issue is the ability of generic drugmakers to seek FDA approval under a provision of the Hatch-Waxman Act to market a drug for uses not covered by patents held by brand-name drugmakers. Not surprisingly, the case has generated considerable interest in the generic industry, as a quick peek at the Supreme Court docket makes clear (see here to see who has filed a brief). Wall Street, for instance, has signaled that, if the status quo continues, brand-name drugmakers will have found a new means of fending off unwanted generic rivals. In a statement, the Generic Pharmaceutical Association says the Supr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4872472 Fri, 27 May 2011 13:08:59 +0100 4872472 http://www.medworm.com/index.php?rid=4872478&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNiLoxnKRUDE%2F The Duke University researcher who consulted for Sanofi at the same he implored the FDA not to approve a med from a rival drugmaker is now being investigated for failing to disclose his financial ties. Last March, thrombosis expert Victor Tapson wrote the agency to argue that generic versions of Lovenox may not be as safe as the brand-name med, but he did not mention his relationship to Sanofi. His work on behalf of Sanofi was disclosed yesterday in a US Senate Finance Committee report that detailed how Sanofi also engaged two medical societies to encourage the FDA to delay approval of a rival med the drugmaker feared would undercut its blockbuster Lovenox bloodthinner. Sanofi paid more than $5 million to the two medical societies, including $260,600 to Duke’s Tapson (back story). And no... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4872478 Thu, 26 May 2011 14:46:08 +0100 4872478 http://www.medworm.com/index.php?rid=4862920&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FwIP6GVupYbw%2F Sanofi contributed more than $5 million to two medical groups and a Duke University researcher that encouraged the FDA to delay approval of a medicine the drugmaker feared would undercut its blockbuster Lovenox bloodthinner, according to a US Senate Finance Committee report released this morning. The Society of Hospital Medicine, the North American Thrombosis Forum and Duke University thrombosis expert Victor Tapson wrote to the FDA to argue that generic versions of Lovenox may not be as safe as Lovenox, but the letters did not mention any ties to Sanofi, according to the Senate findings, which were first reported by The Wall Street Journal. Just the same, the FDA last summer approved a generic from Momenta Pharmaceuticals and Sandoz, the Novartis generics unit (back story here and here).... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862920 Wed, 25 May 2011 12:55:52 +0100 4862920 http://www.medworm.com/index.php?rid=4862924&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPY8LOK5kv_0%2F Once again, the US Federal Trade Commission is trying to thwart pay-to-delays deals and its latest effort is a brief in which the agency has asked an appeals court to reverse a lower court ruling that sanctioned a settlement between Schering-Plough and two generic drugmakers - Upsher Smith and ESI, which was a division of Pfizer’s Wyeth - over the K-Dur blood pressure med. The background: In 1995, the two generic drugmakers sought FDA approval to sell versions of K-Dur, but Schering-Plough, now owned by Merck, filed suit for patent infringement. Just before the trial, Schering-Plough agreed to pay Upsher $60 million not to sell a generic until 2001, and the FTC filed suit (read here). Separately, Schering-Plough agreed to pay ESI up to $15 million to agree not to sell a generic until... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862924 Wed, 25 May 2011 12:02:39 +0100 4862924 http://www.medworm.com/index.php?rid=4862918&cid=t_114929_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F05%2Fsanofis-strategic-use-ie-bribery-of.html In a report titled "Sanofi's Strategic Use of Third Parties to Influence the FDA," the Senate Finance Committee said Sanofi SA "contributed more than $5 million to two medical groups and a medical researcher that encouraged U.S. regulators to delay approval" of the generic version of Levenox, a bloodthinner that had global sales exceeding $4 billion in 2009.According a WSJ article (see "Sanofi Pays Doctors to Dis Generic Version of Lovenox"), "between 2007 and 2010, the company contributed more than $2.6 million to the Society of Hospital Medicine; more than $2.3 million to the North American Thrombosis Foundation, which studies blood clots; and more than $260,000" to Dr. Victor Tapson, thrombosis specialist and faculty member in the Pulmonary, Allergy and Critical Care Medicine division o... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4862918 Wed, 25 May 2011 11:04:00 +0100 4862918 http://www.medworm.com/index.php?rid=4848148&cid=t_114929_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F05%2Fend-is-nigh-judgment-day-for-low-cost.html Some people think "Judgment Day" will come tomorrow, May 21, 2011, at 2 a.m. Eastern Daylight Time at which time will begin the "rapture" where "all the graves will be opened and all of the dead bodies will come out" and only the true believers will be saved.I don't believe in that particular fantasy, but I do believe the end is near for so-called low cost generic drugs.Several recent signs suggest that the stars are aligned against low cost generic drugs. Here's my summary of these signs.For quite some time we've heard about "Big Pharma’s Record Drug Shortages" (see "The nation is facing an unprecedented drug shortage" and "What’s Behind Big Pharma’s Record Drug Shortages?"). Shortages might be caused by "too many mergers and acquisitions" that have reduced the number of suppliers.T... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4848148 Fri, 20 May 2011 12:27:00 +0100 4848148 http://www.medworm.com/index.php?rid=4848154&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkTurjNnKuyc%2F And so another working week will soon draw to a close. This is, of course, our signal to daydream about weekend plans. Our modest agenda includes yardwork, hanging with assorted short people and another installment in the ‘Let’s-see-them-before-they-die‘ concert series. And you? Anything special in the pipeline? How about curling up with a good e-book? Or a dinner with a favorite someone? Or maybe just a walk in the park? Whatever you do, have a great time and be safe. See you soon… FDA Approves J&J HIV Med For Combo Use (Reuters) EU OKs Bloodthinner From Pfizer And Bristol (Associated Press) EMA Approves Glaxo And Human Genome’s Benlysta For Lupus (Reuters) Pfizer Truck Robbed On Way To CVS (Securing Pharma) AstraZeneca To Eliminate 135 Jobs In Massachus... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4848154 Fri, 20 May 2011 11:39:57 +0100 4848154 http://www.medworm.com/index.php?rid=4813672&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUGg3_Y9s14U%2F Hello and top of the morning to you. A sparkly sun is warming the Pharmalot corporate campus this morning, where we are scrambling to cope with a growing assortment of meetings and deadlines. We know you can relate. So please join us for a cup of stimulation - our flavor today is Cinnamon Cream Swirl - as you ready yourself. Meanwhile, here are some tidbits from around the world. Dig in and have a productive day… Arena Plans Shorter Study For Rejected Diet Pill (San Diego Union-Tribune) Medco CEO Sees A Biotech M&A Blitz (Reuters) FDA Asks Hip Makers For Patient Data On Metal Levels In Blood (Bloomberg News) Roche Will Seek Approval For New Skin Cancer Med (Reuters) Sanofi Plans To Revamp Animal Health Unit (Financial Times) Teva Reports A Decline In US Generic Drug Sales (Bloom... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4813672 Wed, 11 May 2011 12:09:24 +0100 4813672 http://www.medworm.com/index.php?rid=4803138&cid=t_114929_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fwhat-are-the-most-popular-and-most-expensive-drugs-in-america%2F2011.05.09 The top 10 prescribed drugs in the U.S. for 2010 in order of prescriptions written are: Hydrocodone (combined with acetaminophen) — 131.2 million prescriptions Generic Zocor (simvastatin), a cholesterol-lowering statin drug — 94.1 million prescriptions Lisinopril (brand names include Prinivil and Zestril), a blood pressure drug — 87.4 million prescriptions Generic Synthroid (levothyroxine sodium), synthetic thyroid hormone — 70.5 million prescriptions Generic Norvasc (amlodipine besylate), an angina/blood pressure drug — 57.2 million prescriptions Generic Prilosec (omeprazole), an antacid drug — 53.4 million prescriptions (does not include over-the-counter sales) Azithromycin (brand names include Z-Pak and Zithromax), an antibiotic — 52.6 million ... Better Health blogs http://www.medworm.com/rss/comments.php?id=4803138 Mon, 09 May 2011 21:00:00 +0100 4803138 http://www.medworm.com/index.php?rid=4789641&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F919qtSMsjE4%2F Despite setbacks in courts and Congress, the Federal Trade Commission continues to hammer away at pay-to-delay deals involving patent settlements between brand-name and generic drugmakers. The agency views these deals as anti-competitive, arguing they rob consumers of lower-cost meds that might otherwise arrive much sooner in pharmacies. And so the FTC chair Jon Leibowitz has released yet another report that he hopes will generate some momentum in Congress toward restricting these agreements. The report found there 31 deals in fiscal year 2010, a 63 percent increase from fiscal year 2009. The deals reached in the last year involved 22 different brand-name meds with combined annual US sales of about $9.3 billion. Of the 31 settlements, 26 involved generics that were “first filers,” whic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4789641 Wed, 04 May 2011 12:39:30 +0100 4789641 http://www.medworm.com/index.php?rid=4780484&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkIDXexTtgK8%2F File this under nice try, but you have no standing, none at all. A federal judge yesterday tossed a lawsuit filed by Mylan Laboratories, which hoped to force the FDA to act on an application by Ranbaxy Laboratories to sell a generic version of the best-selling Lipitor cholesterol med. The ruling is not unexpected, but for the moment, raises the prospect that consumers may bear the brunt. Here’s the background: Back in 2002, Ranbaxy was the first to file an application with the FDA for clearance to sell generic Lipitor, which is made by Pfizer. The two drugmakers had previously reached a deal three years ago allowing Ranbaxy to sell its pill as of this coming November. Ranbaxy believes it is entitled to six months of exclusivity for successfully challenging Pfizer patents. However, M... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4780484 Tue, 03 May 2011 14:49:08 +0100 4780484 http://www.medworm.com/index.php?rid=4768250&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEKnIm6NQuKw%2F Another working week is about to draw to a close. And not a moment too soon. This is, of course, the signal to daydream about weekend plans. Our modest agenda includes a family gathering, mowing the lawn (wish us luck) and promenading with the official Pharmalot mascots. What about you? Does spring cleaning beckon? How about finding recession-era bargains at a garage sale? Or maybe take a moment to think big thoughts? Whatever you do, have a great time. And see you soon… Merck Profits Top Estimates (Bloomberg News) Woman Severely Hurt By Abbott Labs Truck (Lake County News-Sun) Johnson & Johnson Prostate Cancer Drug Approved By FDA (Bloomberg News) Generic Lipitor Ruling Expected Next Week (Dow Jones) FDA Panel Recommends Vertex Hepatitis C Drug (Boston Globe) Wolter Kluwers Buy... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4768250 Fri, 29 Apr 2011 11:48:24 +0100 4768250 http://www.medworm.com/index.php?rid=4762933&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRHai_my_1TA%2F In the latest move by European antitrust regulators to probe patent settlements, the European Union disclosed this morning that an investigation is under way into whether Teva Pharmaceuticals and Cephalon struck an illegal deal to keep a generic version of the Provigil sleep disorder drug off the market (read the statement). Like the US Federal Trade Commission, the EU has been probing so-called pay-to-delay deals in the belief that they stifle competition and, therefore, delay entry to the marketplace of lower-cost medicines (read about the FTC efforts here). The interest among European antitrust regulators followed a report from the European Union competition commissioner saying that delays in bringing generic drugs to the market had cost consumers and healthcare providers billions. Rece... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4762933 Thu, 28 Apr 2011 17:28:46 +0100 4762933 http://www.medworm.com/index.php?rid=4762937&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fhg7QGCQONN0%2F Hello, everyone. Another busy day is about to unfold here on the Pharmalot corporate campus, as we prepare for a round of meetings and deadlines. To cope, we are our brewing our mandatory cup of stimulation - we continue to favor Wild Mountain Blueberry this week. Meanwhile, here are some items to help you get started. Hope your day goes well and stay in touch… Par Pharma Pays $153M To Settle Pricing Lawsuits (Reuters) Sanofi-Aventis Profit Falls Due To Generics (Bloomberg News) More US Women Are Using The Morning After Pill (Reuters) Roche Wins FDA Approval For HPV Diagnostics Test (Bloomberg News) AstraZeneca Profits Get A Lift From Tax Breaks (Pharma Times) Merck Hepatitis C Drug Wins FDA Panel Backing (Boston Globe) Australia Delays Subsidies For Some Medicines (Australian Broadc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4762937 Thu, 28 Apr 2011 11:49:06 +0100 4762937 http://www.medworm.com/index.php?rid=4753972&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fb_qg-ukLNv0%2F The ongoing refusal by Johnson & Johnson to partipicate in the Medicines Patent Pool, which is an initiative designed to streamline patent licensing for producing generics of patented HIV meds and offering lower prices in poor countries, has now generated a scolding from Doctors Without Borders, the international humanitarian organization. In a statement, the group accuses the health care giant of turning its corporate back on HIV patients by undermining access to key AIDS drugs. J&J holds patents on rilpivirine, which is being developed as a first-line HIV treatment, as well as darunavir and etravirine, two meds that treat HIV patients who have become resistent to other drugs. The missive appears carefully timed. Later this week, J&J will hold it annual shareholder meeting,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4753972 Tue, 26 Apr 2011 12:28:30 +0100 4753972 http://www.medworm.com/index.php?rid=4715023&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3EmIsWhgxuY%2F Late last month, the US Supreme Court asked the Obama administration for its views on a complicated and controversial spat that has the potential to alter the way brand-name drugmakers use patent law to delay generic competition (look here). Whether the Supremes choose to review the case is unclear, but by asking the US Solicitor General to comment, the court has signaled a hearing is, indeed, a possibility. The case, meanwhile, is being closely watched, as one might imagine. A growing number of generic drugmakers have begun filing briefs with the Supreme Court, explaining why a review is warranted. And Wall Street has signaled that, if the status quo continues, brand-name drugmakers will have hit on a new means of fending off unwanted generic rivals. Here is the background: In 2005, Novo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4715023 Thu, 14 Apr 2011 12:00:05 +0100 4715023 http://www.medworm.com/index.php?rid=4696954&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3Eb37NoKR6k%2F Hello, everyone, and nice to see you again. We hope the weekend was refreshing and enjoyable. Now, though, the routine of meetings and deadlines has returned. To cope, yes, we are brewing that mandatory cup of stimulation. Meanwhile, here are some tidbits to get you going. Let us know if you hear anything interesting and have a great, productive day… Endo Pharma Buying American Medical For $2.6 Billion (Associated Press) Intercell Suspends Trial For MRSA Vaccine (Bloomberg News) Actress Sues Lilly For Using Her Face In Prozac Ad (New York Post) Novartis Stops Tasigna Trial In Patients With GIST (Reuters) Inspiration Pharma Eyes Plant In Ireland And 500 Jobs (Irish Post) Merck KGgA Considers Job Cuts At Serono Unit (Reuters) Merck And Sun Pharma Near Generics Deal (LiveMint) British M... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4696954 Mon, 11 Apr 2011 11:51:13 +0100 4696954 http://www.medworm.com/index.php?rid=4684759&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FinwJ4AHbem4%2F And the answer is…. 82 percent. At least according to the latest annual report on prescription drug spending released by Express Scripts, the pharmacy benefits manager. Of course, such a finding is not surprising, given that the cost of generics fell by 10.2 percent compared with a rise in brand-name meds by 9.7 percent. Rising drug prices have caused a stir on several fronts in recent weeks, in fact. The manufacturer of an injectable drug to prevent premature births, KV Pharmaceuticals, last week slashed the price after coming under pressure (see this) and an order of Catholic nuns successfully placed shareholder proposals over rising drug prices (look here). Nonetheless, the overall growth in spending on prescription drugs - including specialty medications, such as biologics, was c... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4684759 Thu, 07 Apr 2011 13:29:15 +0100 4684759 http://www.medworm.com/index.php?rid=4684760&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fd_j1yofCUbQ%2F Five of the world’s biggest drugmakers failed to comply with mandatory disclosure laws for their patented medicines in India, which means they are vulnerable not only to fines, but also competition in the form of compulsory licenses that could be issued to generic drugmakers, which would then have the right to sell lower-cost versions of the patented drugs. The breach was uncovered by Shamnad Basheer, a professor of intellectual property law at the National University of Juridicial Sciences in New Delhi, India, and a contributor to the Spicy IP patent blog. He led a group of lawyers who collected information on patent disclosures made by foreign drugmakers to regulators under what is known as a Right to Information, or RTI, request. At issue is a requirement that drugmakers share in... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4684760 Thu, 07 Apr 2011 12:54:41 +0100 4684760 http://www.medworm.com/index.php?rid=4684761&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7VtbjQj12Pw%2F Good morning, everyone. Another brand new day is on the way. Of course, this calls for a hearty cup of stimluation - our flavor today is Cinnamon Cream Swirl. Feel free to grab one yourself, or a bottle of water if you prefer, and join us as we peruse the news of the world. As always, we appreciate tips and hints and allegations. So send them our way. Meanwhile, have a great day and see you soon… J&J May Do $10B Deals To Bolster Growth (Bloomberg News) Synthetic Drugs Send Thousands To Emergency Rooms (Associated Press) Merck’s Dutch R&D Unit To Keep Some Jobs After All (Reuters) The Valent Pharma CEO And His Acquisition Binge (Bloomberg News) Where Are The ImClone Alumni? (Xconomy) FDA Approves Restless Legs Syndrome Med (Reuters) AstraZeneca Wins FDA Approval Of Thy... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4684761 Thu, 07 Apr 2011 12:03:32 +0100 4684761 http://www.medworm.com/index.php?rid=4658359&cid=t_114929_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FJUldICkQw3Y%2F FDA V. Food Colors: For the first time, the FDA is assessing whether or not foods like Jell-O, Lucky Charms and Minute Maid Lemonade should carry warnings that their artificial colors could worsen behavioral problems in kids, the New York Times reports. The FDA has previously decided that there is not a link between the colors and behavior or health problems, but the NYT says that it will ask a panel of experts on Wednesday and Thursday to review the evidence. More and more studies have suggested a link, the Times says. Drug  Deal: Valeant Pharmaceuticals of Canada last night made a hostile bid for Cephalon for $5.7 billion, the WSJ reports. The all-cash offer is a 24.5% premium, and Valeant CEO J. Michael Pearson said he would be willing to increase it “somewhat.” Cephalon sa... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4658359 Wed, 30 Mar 2011 11:44:14 +0100 4658359 http://www.medworm.com/index.php?rid=4653608&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fer8yKF-x980%2F Good morning, everyone. Another shiny day is unfolding here on the Pharmalot corporate campus, where we are, once again, hustling the short people off to the schoolhouse. We are also preparing for a podcast later today, so wish us luck. Meanwhile, please join us for the much-needed cup of stimulation and a quick scan of the news of the world. Hope your day is productive. See you soon… FDA Asks Maker Of Tainted Wipes To Stop Production (MSNBC) Medicaid Spent Extra $329M On Brand-Name Drugs: Report (Bloomberg News) Cephalon To Make Takeover Bid For ChemGenex (Associated Press) Closing Arguments Set In Merck Contamination Case (Sacramento Bee) None Hurt At Catalent Packaging Facility Fire In The UK (Outsourcing Pharma) Florida Gov To Hunt Down Pill Mills (Florida Times-Union) High-Dose ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4653608 Tue, 29 Mar 2011 11:50:43 +0100 4653608 http://www.medworm.com/index.php?rid=4642995&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuZGC-ukK-wc%2F Should generic drugmakers be required to strengthen product labeling if alerted to side effects, even when the same change has not been made to the labeling for the branded med? This question goes to the heart of a pair of state lawsuits filed by two women, who claim generic drugmakers should be held liable for failing to warn of serious side effects. However, the drugmakers, which include Actavis and Pliva, claim federal law preempts the lawsuits, because they would be required to offer labeling that is different from what appears on the label of the brand-name drug. The generic drugmakers further maintain that permitting such lawsuits to proceed in state courts would raise their costs, which would, ultimately, be passed on to consumers. This complicated issue will be heard this coming We... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4642995 Mon, 28 Mar 2011 13:12:39 +0100 4642995 http://www.medworm.com/index.php?rid=4636662&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FlYLOC-LmD10%2F And so another working week soon draws to a close. This is, of course, the signal to dream about weekend plans. Our agenda calls for spending time with the short people and cleaning up around the Pharmalot corporate campus. And you? Will you catch up on some sleep? Read an e-book? Take a walk in the park? Have a good time, whatever you do. And be safe. Meanwhile, here are some tidbits. Catch you soon, everyone… Medical Marijuana Sales Rival Viagra (Time) Cephalon Wins Ruling Over Generic Copy Of Watson’s Fentora (Reuters) Martin Sheen Testifies In Accutane Trial (ABA Journal) Branded Discounts Save Seniors $38M In Two Months (Pharma Times) Prevanar Vaccine To Resume In Japan (Bloomberg News) Pfizer Drugs Shrinks Pancreatic Tumors In Research (Bloomberg News) FDA OKs Merck Shing... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4636662 Fri, 25 Mar 2011 12:10:36 +0100 4636662 http://www.medworm.com/index.php?rid=4615430&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEl6Lh_WvNNM%2F Welcome to the working week. We hope the weekend was relaxing and fruitful. Now, of course, the time has come to resume the routine of meetings and deadlines. Doing so under rainy skies does this make this a challenge, though, yes? So reach for that cup of stimulation - our flavor today is chocolate raspberry truffle - to lift your spirits. Meanwhile, here are some tidbits to help you along. Have a good day, everyone, and stay in touch… Novartis Wins EU Approval For Gilenya MS Pill (Reuters) FDA Not Ready To Act On Tainted Wipes (MSNBC) Glaxo CEO Says Drugmakers Should Not Leave UK Over Taxes (The Guardian) Xenoport Ends Development Of Heart Drug (Reuters) Mylan Sues FDA Over Ranbaxy Lipitor Generic (Bloomberg News) FDA And EMA Form QBD Pilot Plan (Outsourcing Pharma) Inovio Receives... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4615430 Mon, 21 Mar 2011 11:52:14 +0100 4615430 http://www.medworm.com/index.php?rid=4605851&cid=t_114929_97_f&fid=35606&url=http%3A%2F%2Fwww.theangriestpharmacist.com%2F2011%2F03%2F17%2Funfortunately-this-is-a-true-story%2F I swear on the life of my unborn children that the following conversation is almost 100% exactly as it happened. Right as it concluded, I went and recorded a "note" on my iPhone to help me remember this idiocy... ---------------------------- "I was wondering, if I brought a list of my medicines up here, could you tell me how much each of them would cost?" "Are you on file here? And do you have insurance?" "I've never been here before, but I have Paid insurance." "Well then, unfortunately, I cannot. Your best be would be to look on the back of your card and call the Member Services or Customer Service number listed there. They can tell you exactly how much each prescription will cost. All I can give you here is the cash price which doesn't do you any good when your insurance will foot the b... The Angriest Pharmacist blogs http://www.medworm.com/rss/comments.php?id=4605851 Fri, 18 Mar 2011 03:37:20 +0100 4605851 http://www.medworm.com/index.php?rid=4600798&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNPe3p37WgVo%2F Hello, everyone, and nice to see you again. A spot of rain is falling on the Pharmalot corporate campus, but our spirits remain sunny. Of course, a cup or two of stimulation can help - our flavor this morning is Rain Forest Nut. Meanwhile, there are meetings and deadlines that await. So here are some interesting items to help you along. Have a great day and do stay in touch… Pfizer To Move Antibacterials Research To Shanghai (The Day) Abbott CEO Compensation Fell 2.5 Percent Last Year (Dow Jones) DEA Seizes Execution Drug In Georgia (Associated Press) Japan Nuclear Catastrophe Spurs Debate Over Radiation Pills (Bloomberg News) Those $4 Rx Programs Can Save US Billions (Reuters) Cephalon Sues US Over Fentora Generic Approval (Bloomberg News) Aegerion Receives Orphan Status For Lipid D... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4600798 Wed, 16 Mar 2011 11:53:04 +0100 4600798 http://www.medworm.com/index.php?rid=4592691&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5cPetg5jHnI%2F For those wondering about the difficulties confronting the FDA as the agency attempts to monitor the supply chain, the chart offers some insight. From roughly 1,200 foreign manufacturing plants in 2001, the number grew to more than 3,500 in 2008 - a 185 percent increase. Yet the number of FDA inspections rose 23 percent, leading to a 57 percent drop in the inspection rate. [UPDATE: In 2001, 20.7 percent of facilities were inspected, but only 8.9 percent in fiscal year 2008]. In China alone, the problem is daunting. There are nearly 1,000 manufacturers of drug substances eligible for FDA inspection. And for 89 percent of audited Chinese-made drug substances, US and European pharmaceutical purchasers fail to demand the mandatory Chinese license and certificate, according to Philippe André o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4592691 Tue, 15 Mar 2011 12:15:33 +0100 4592691 http://www.medworm.com/index.php?rid=4592694&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fw63z2G8UvTM%2F After spending more than a decade growing into a behemoth by single-mindedly pursuing big acquisitions - think Warner-Lambert, Pharmacia and Wyeth - Pfizer is now signaling a change of heart. To wit, the drugmaker is said to considering the spin off or sale of all four non-pharma units, including nutritionals, consumer health, animal health and a business that makes capsules. Moreover, Pfizer may even shed what it calls the Established Products division, a $10 billion operation that includes off-patent meds, the Greenstone generics unit and biosimilars, according to an investor note from Sanford Bernstein analyst Tim Anderson. He writes that such moves would trim Pfizer nearly in half - from about $67 billion in annual revenue to between $35 billion and $40 billion. “If we hadn&#8217... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4592694 Mon, 14 Mar 2011 14:39:05 +0100 4592694 http://www.medworm.com/index.php?rid=4570761&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzGaMvXkB8L0%2F After weeks of anticipation and furious lobbying, Canada’s House of Commons passed a bill called C-393, which was designed to allow generic versions of patented AIDS meds to be sent to developing countries. The bill was conceived to amend a 2004 law called Canada’s Access to Medicines Regime, which proved ineffective. Since its passage six years ago, only one license was ever issued and this involved exporting just one order of an AIDS med to Rwanda. However, the legislation, which the pharmaceutical industry has fought over concerns that intellectual property rights would be undermined, still has another hurdle to clear, because it must still be approved by the Senate before becoming law. And the Senate is controlled by the Conservative Party, and supporters are now ramping up th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4570761 Thu, 10 Mar 2011 14:01:41 +0100 4570761 http://www.medworm.com/index.php?rid=4560597&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FC7Wu-i1zM6o%2F Hello, everyone, and top of the morning to you. Another shiny day is unfolding here on the Pharmalot corporate campus, where we are hustling the short people off to their various school houses for some learning. And this marathon calls for a much needed cup of stimulation - our flavor today is Cinnamon Cream Swirl. Please join us as we also peruse the news for interesting developments. As always, we encourage you to contact us if you hear of something noteworthy. Meanwhile, have a great day… FDA Warns About Abbott HIV Med In Premature Babies (Reuters) Teva Says Docs Contacted For Generic Copaxone Study (Bloomberg News) FDA Accepts Application For Astra & Bristol Diabetes Drug (Associated Press) Japan Finds No Direct Link To Vaccines And Deaths (Reuters) FTC Takes Aim At Patent T... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4560597 Tue, 08 Mar 2011 12:53:17 +0100 4560597 http://www.medworm.com/index.php?rid=4560598&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDDJwXnTTp4M%2F The Supreme Court rejected a challenge to a pay-to-delay deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop a patent lawsuit over the Cipro antibiotic (see this). The move is a blow to the Federal Trade Commission, which calls the deals anticompetitive and had been hoping the Supreme Court would review a case in the face of legislative inactivity. The issue has divided lower courts around the country for years. A wholesaler and three retailers, including CVS and Rite-Aid, asked the Supreme Court to review the settlement, arguing the deals choke off competition by stifling the arrival of lower-cost generics on their shelves. In the case they cited, Barr challenged the Cipro patent in October 1991 and struck a deal with Bayer in January 1997 tw... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4560598 Mon, 07 Mar 2011 22:44:07 +0100 4560598 http://www.medworm.com/index.php?rid=4522286&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fc4iwc7RTeus%2F Two years ago, Pfizer trumpted a deal in which Aurobindo, a large supplier of active pharmaceutical ingredients that is based in India, would make a few dozen generic meds for the brand-name drugmaker. The move was part of a grand plan to expand into generics with lower manufacturing costs and revive growth as patents on big-selling, brand-name meds began expiring. “These agreements represent solid, measurable progress, and a strong commitment to achieve our growth objectives,” said David Simmons, who heads the drugmaker’s emerging markets and established products units, in a statement. Established products is a Pfizer euphemism for generics and branded generics. “We will dramatically change Pfizer’s Established Products portfolio to an engine of positive growth.” Since... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4522286 Fri, 25 Feb 2011 15:51:21 +0100 4522286 http://www.medworm.com/index.php?rid=4512612&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQuxCL-HX5SA%2F If you live in the US and search Google for a prescription drug, you’re likely to be directed to the web site run by the National Library of Medicine. But Canadians will be directed to Wikipedia for generic meds or sites run by drugmakers when scouring for a brand-name treatment, according to a study published in the Annals of Pharmacotherapy (here is the abstract). Why? One reason is a partnership between Google and the National Institutes of Health, which returns NIH-sponsored drug info pages more prominently for searches in the US. The study found that US patients using Google would most often encounter NIH-sponsored pages, hosted by the National Library of Medicine, as the top result. But US residents using Bing and Yahoo, or Canadian residents using Google for searches were led... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4512612 Wed, 23 Feb 2011 17:04:14 +0100 4512612 http://www.medworm.com/index.php?rid=4507582&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fjhk8uLvM9QY%2F Call it congressional deja vu. Last week, a pair of bills that previously went nowhere were again introduced and both take aim at brand-name drugmakers. The first, called the Say No to Drug Ads Act, would eliminate tax breaks for direct-to-consumer advertising and was introduced by Jerry Nadler, a Democratic Congressman from New York who failed to enlist any co-sponsors. The rationale for his repeat effort is that DTC ads allow drugmakers to “keep prices artificially high, steering consumers – and physicians – away from generics…It’s bad enough that TV drug ads mislead consumers and tout benefits of high-priced drugs without properly conveying the risks, but the drug companies don’t need extra subsidies to do so,” he says in a statement. (You can read the bill her... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4507582 Tue, 22 Feb 2011 13:27:06 +0100 4507582 http://www.medworm.com/index.php?rid=4495432&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhzVMM9bdJ8U%2F A handful of Senate Democrats have revived a bill that would restrict brand-name drugmakers from being able to market an authorized generic during the 180-day exclusivity period that follows the first successful challenge to a patent by a generic rival. Known as the Fair Prescription Drug Competition Act, the bill was first introduced by US Senator Jay Rockefeller, a West Virginia Democrat, in 2007. Authorized generics, as you know, may be sold by brand-name drugmakers after a patent expires, although marketed differently. However, a 2009 report by the US Federal Trade Commission found that consumers are harmed by deals between brand-name and generic drugmakers in which a generic entry is delayed. The FTC noted that the arrival of an authorized generic during that 180-day exclusivity perio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4495432 Fri, 18 Feb 2011 17:10:06 +0100 4495432 http://www.medworm.com/index.php?rid=4489633&cid=t_114929_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FrVgcYbhWuRk%2F The Generic Pharmaceutical Association meets this week;expect a lot of chatter about what a future FDA user-fee system might look like. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4489633 Wed, 16 Feb 2011 17:47:24 +0100 4489633 http://www.medworm.com/index.php?rid=4482972&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTPwrSwUNAKo%2F Good morning, everyone. Nice to see you again. A sunny day is unfolding here on the Pharmalot corporate campus, where we are happily quaffing our mandatory cup of stimulation. This will be an especially busy day as we must break for a personal matter, but we will endeavor, nonethless, to hunt about for interesting items. Meanwhile, we would like to remind you that we are hosting a webinar on requirements for disclosing payments to physicians (look here). See you soon… Sanofi-Aventis To Buy Genzyme For $20 Billion (Bloomberg News) Sanofi-Aventis Will Withdraw Anzement From Five Countries (Dow Jones) Merck No Longer Has Buyer For Dutch R&D Unit (Reuters) Takeda Strikes Deal With Covance And Quintiles (Outsourcing Pharma) Generic Drugmakers To Support FDA User Fees (Wall Street Jou... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4482972 Wed, 16 Feb 2011 12:56:39 +0100 4482972 http://www.medworm.com/index.php?rid=4477686&cid=t_114929_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FqEkQvkntccE%2F Also: doc fix in 2012 budget is criticized; budget also includes provisions on generics; health apps. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4477686 Tue, 15 Feb 2011 13:55:23 +0100 4477686 http://www.medworm.com/index.php?rid=4478156&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9oaO7W1OaAM%2F Federal budgets always make interesting reading and, this year, the Obama White House does not disappoint. Tucked into the section reserved for the US Department of Health and Human Services is a section that focuses on generics and how these can save an estimated $11.1 billion over 10 years - or roughly $1 billion a year (look here). Not small change, yes? But how? There are two proposals. One would shrink exclusivity for biologics to seven years from 12 years, a move that would roll back a provision in health care reform. You may recall that brand-name drugmakers won a 12-year exclusivity period last year as part of an effort to create a so-called FDA approval pathway for biosimilars. Generic drugmakers, of course, wanted a shorter term. At issue is the balancing act between protecting R... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4478156 Mon, 14 Feb 2011 20:27:44 +0100 4478156 http://www.medworm.com/index.php?rid=4446032&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqZDR45Q5V5o%2F A trade deal being negotiated between Canada and the European Union could cost Canadians another $2.8 billion annually in drug costs - notably, by delaying the availability of lower-cost generics in Canada by about 3.5 years - if certain proposals are cemented, according to a new report commissioned by generic drugmakers. During the talks, the EU has sought various changes in Canadian laws and regulations governing intellectual property concerning brand-name meds. These include extending the term of patent protection by up to five years if drugs are bogged down in the regulatory approval process; lengthening the period of data exclusivity from eight years to 10 years or more; and strengthening notice of compliance regulations by adding an appeals process. The upshot is that Canadian payers... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4446032 Mon, 07 Feb 2011 16:24:19 +0100 4446032 http://www.medworm.com/index.php?rid=4433330&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZnvAWxo_J08%2F Rise and shine, everyone. Another day is on the way. And here on the frosty Pharmalot corporate campus we are bounding with energy thanks to the ritual cup of stimulation, or three. The special flavor today is Golden French Toast. Of course, this makes it all the more possible to hunt down those interesting tidbits. Here are a few to help you get started. Hope your day goes well and do stay in touch… Komen Advocacy Group Is Cautious On Avastin (Wall Street Journal) Merck 2011 Misses Estimate And Takes $1.7M Drug Write-Off (Bloomberg News) Teva Receives FDA Warning Letter For Jerusalem Plant (Reuters) Merck’s Gardasil Prevents HPV And Genital Warts In Men (Bloomberg News) Glaxo Profits Slump On Legal Costs And Avandia Slowdown (PharmaTimes) Painkiller Prescription Errors Due To ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4433330 Thu, 03 Feb 2011 13:12:59 +0100 4433330 http://www.medworm.com/index.php?rid=4429224&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1F3Beuifq9s%2F Certainly, at hospitals. In fact, the shortage of injectable generics for cancer and other serious diseases is forcing many hospitals to scramble to locate meds or find alternatives. In some cases, the FDA has allowed imports, but the agency approval process has also meant fewer new available generics. “We think this is near a crisis situation,” Bona Benjamin, a director at the American Society of Health-System Pharmacists, a pharmacist trade group, tells The Wall Street Journal. Numbers, of course, help tell the story. The FDA reports a record 178 drug shortages in 2010, up from 157 the year earlier and 55 five years ago. And here is the latest list. You’ll notice this is much shorter than the list indicating shortages that have been resolved (take a peek). The problem,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4429224 Wed, 02 Feb 2011 18:03:31 +0100 4429224 http://www.medworm.com/index.php?rid=4429228&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fl411FQvaYHI%2F Good morning, everyone. How are you today? Here on the Pharmalot corporate campus, the Iceman Cometh, but we are keeping warm with our traditional cup of stimulation. Please join us as we dig in, so to speak, for the usual routine of deadlines and the like. And as always, feel free to share interesting stories. By the way, we would like to note that we are co-sponsoring an upcoming conference on patient adherence. We hope you will join us. Meanwhile, here are a few tidbits to help you along. Have a great day… Lilly & Bristol End Enrollment For Lung Cancer Trial Over Safety (Reuters) Sanofi Fails To Block Generic Taxotere In Australia (Bloomberg News) Glaxo Sells Quest Stake For $1.7 Billion (Reuters) Anti-Counterfeit Rules Will Limit Access To Meds: Oxfam (The Guardian) S&P... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4429228 Wed, 02 Feb 2011 13:05:31 +0100 4429228 http://www.medworm.com/index.php?rid=4419451&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvXrdzviin2U%2F A closely watched debate will get under way in Canada today over a bill, called C-393, which was designed to allow generic versions of patented AIDS meds to be sent to developing countries. The bill was conceived to amend a 2004 law called Canada’s Access to Medicines Regime, which proved ineffective. Since its passage six years ago, only one license was ever issued and this involved exporting just one order of an AIDS med to Rwanda. Two months ago, however, a Canadian House of Commons committee eliminated a key reform, notably the one-license solution. This would provide a generic drugmaker with a single compulsory license to export lower-cost meds to developing countries covered by the law, rather than requiring a separate negotiation and licensing process for every single order f... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4419451 Mon, 31 Jan 2011 14:30:55 +0100 4419451 http://www.medworm.com/index.php?rid=4399818&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVytK4mo5a_A%2F A pair of US Senators have reintroduced legislation that would limit the so-called pay-to-delay deals that remain one of the hottest controversies enveloping the pharmaceutical industry. The move comes after the House and Senate last month failed to agree on an appropriations bill, which included pay-to-delay restrictions. You may recall that pay-to-delay settlements involve agreements in which brand-name and generic drugmakers settle patent disputes by exchanging a payment for a commitment to refrain from marketing a generic off the market for a set period of time. However, the Federal Trade Commission calls these deals anti-competitive and force consumers and government healthcare programs to pay high prices. A Congressional Budget Office report estimated the federal government could sav... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4399818 Wed, 26 Jan 2011 18:11:24 +0100 4399818 http://www.medworm.com/index.php?rid=4399827&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWajKqxyDcWc%2F Once again, a generic drugmaker has lost a case over preemption. In the latest instance, the US Court of Appeals for the Ninth Circuit ruled against Perrigo Pharmaceuticals, which argued that federal law preempted a state lawsuit that brought a failure-to-warn claim. This continues a string of such preemption rulings in courts around the country (back story). For those unfamiliar, preemption is the notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA unsuccessfully argued two years ago before the US Supreme Court that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. At issue was whether patients can sue a drugmaker through state law when a product has already b... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4399827 Tue, 25 Jan 2011 15:59:42 +0100 4399827 http://www.medworm.com/index.php?rid=4382949&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbWRWTVXZO5M%2F Another nasty lobbying battle has broken out over biosimilars. And the latest involves a group of generic drugmakers, insurers and pharmacy benefit managers, which are pushing back against a recent effort by brand-name drugmakers to weaken a part of healthcare reform that is supposed to create competition for expensive biologics. The provision says generics can enter the market after a brand-name biologic has had exclusivity for 12 years. But earlier this month, a bipartisan group of four US Senators - including Orrin Hatch, Kay Hagan, Michael Enzi and John Kerry - wrote FDA commish Margaret Hamburg to urge a different interpretation that would favor brand-name drugmakers and biotechs. Their letter was circulated on and beyond Capitol Hill by, among others, the BIO trade group. At issue is... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4382949 Fri, 21 Jan 2011 14:25:26 +0100 4382949 http://www.medworm.com/index.php?rid=4377787&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcjCmn3mBJKE%2F Two years ago, the US Federal Trade Commission filed a highly publicized lawsuit against Cephalon over pay-to-delay deals worth an estimated $200 million with some generic drugmakers - Ranbaxy Labs, Mylan Labs and Teva Pharmaceuticals - to keep a copycat version of its Provigil sleep-disorder pill off the market until 2012 (read this). Now, though, more than three dozen other drugmakers have raced to court to try to keep details of their own deals from being disclosed as a result of this battle. In a motion filed in federal court in Philadelphia this week, no fewer than 37 drugmakers - including Abbott Laboratories, Merck, Novartis, Bristol-Myers Squibb, Sanofi-Aventis, GlaxoSmithKline, Pfizer, Bayer, AstraZeneca, Johnson & Johnson, Actavis, Waston Pharmaceuticals, Dr. Reddy’s, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4377787 Thu, 20 Jan 2011 20:48:02 +0100 4377787 http://www.medworm.com/index.php?rid=4372247&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fsb2Jltl930U%2F At a time when the national deficit is a growing problem, Medicare could have saved $111 million on more than a dozen Part B outpatient drugs, but its system for identifying prices for lower-cost generics is inefficient, according to a new report from the Office of Inspector General at the US Department of Health and Human Services. Here’s how it works: Drugmakers must submit average sales price (ASP) data to the Centers for Medicare & Medicaid Services within 30 days after the close of each quarter, and the data are used to calculate amounts to be paid for the following quarter. But this causes a two-quarter lag between when sales occur and payments reflect the sales, which the OIG says is “especially problematic.” That’s because the OIG found Medicare paid ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4372247 Wed, 19 Jan 2011 14:14:27 +0100 4372247 http://www.medworm.com/index.php?rid=4361306&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUuhSDJneggs%2F One month after yet again raiding offices of various drugmakers (back story), the European Commission is now taking a more polite approach and telling several companies - including Bayer and Roche - to submit details of their settlements over patent disputes. The EC asked a “selected number of originator and generic companies” to submit a copy of all patent settlement agreements relevant to the 27-member EU region and which were concluded between Jan. 1, 2010 and Dec. 31, 2010, according to an EC statement. Like the US Federal Trade Commission, the EC has been probing these pay-to-delay deals in the belief that they stifle competition and, therefore, delay entry to the marketplace of lower-cost medicines (read about the FTC efforts here). This followed a report from the Europe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4361306 Tue, 18 Jan 2011 14:20:42 +0100 4361306 http://www.medworm.com/index.php?rid=4343334&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCgLvWskDCNk%2F Hello, everyone, and top of the morning to you. A steely, wintry sky hovers over the Pharmalot corporate campus this morning, where we are enduring the usual routine of hustling short people to this or that school house. As we cope - where is that cup of stimulation? - please join us in perusing the news of the world. Meanwhile, feel free to pass along interesting tidbits. Have a good one… AstraZeneca And Cancer Charity Strike Drug Testing Deal (Bloomberg News) FDA Warns Of Acetaminophen Risks Of Liver Toxicity (Drug Store News) Drug Shortages Persist With No End In Sight (Daily Finance) Biotechs And Generics Spar Over Biologic Exclusivity (The Wall Street Journal) FDA Says Sanofi-Aventis’ Lantus Link To Cancer Is Unclear (Reuters) US Cancer Costs Are Expected To Soar (Los Ange... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4343334 Thu, 13 Jan 2011 13:02:18 +0100 4343334 http://www.medworm.com/index.php?rid=4331236&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FED0DYDEIm1U%2F The controversy over so-called pay-to-delay settlements between brand-name and generic drugmakers has prompted attorneys general from 32 states to file an amicus, or friend-of-the-court brief urging the US Supreme Court to review the deals, which the states say thwart competition and block needed access to lower-cost medications. The move comes less than a month after three pharmacy chains and a wholesaler petitioned the court to rule on the issue, which has divided other federal courts (see this) and spurred the Federal Trade Commission into a Quixotic quest to urge Congress to pass a law to restrict these deals (back story). The case that precipitated these filings involved a deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop its patent cha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331236 Tue, 11 Jan 2011 13:26:37 +0100 4331236 http://www.medworm.com/index.php?rid=4331240&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ffs_tQgfFVm0%2F Nothing like a trade off between generations. A new study suggests that extending data exclusivity for small molecule brand-name drugs will lead to higher drug costs in the short term, but down the road, more than 200 additional drugs would be approved as a result of the increased revenue generated, offering increased industry incentives. And this would also boost life expetancy for future generations. In other words, today’s patients pay more, but tomorrow’s patients can get a better deal. Data exclusivity, you may recall, refers to the exclusive access to clinical trial data and, right now, brand-name drugmakers are granted five years for data submitted during the FDA approval process. There’s also an extra three years for supplemental applications and six months more f... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331240 Mon, 10 Jan 2011 14:55:34 +0100 4331240 http://www.medworm.com/index.php?rid=4281552&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXw5i4ajxIVo%2F Hello, everyone, and top of the morning to you. Another shiny day is unfolding here on the Pharmalot corporate campus, where we are scrambling to do too many things at once. Sounds familiar, yes? To cope, we are quaffing yet another cup of stimulation. Meanwhile, here are some tidbits to help you along. Hope your day is productive and do stay in touch… Arena To Refile Obesity Drug By End Of 2011 (Reuters) Biogen And Elan Want To Update Tysabri Label (Bloomberg News) J&J Shareholders File Suit Over Manufacturing Gaffes (Bloomberg News) Novo Sales Rep Sues For Wrongful Termination (West Virginia Record) Teva And Takeda Settle Actos Patent Lawsuit (Reuters) Vertex Ends Part Of Telaprevir Study For Hepatitis C (Bloomberg News) Pharmacist Jailed For Mail Fraud (Standard Speaker) (Sou... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4281552 Wed, 22 Dec 2010 13:17:56 +0100 4281552 http://www.medworm.com/index.php?rid=4272601&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpAmBhLecykw%2F The controversy over the so-called pay-to-delay settlements is bubbling up to the US Supreme Court. Three pharmacy chains and a wholesaler have asked the court to review the issue because they maintain the deals choke off competition by stifling the arrival of lower-cost generics on their shelves. The issue has become a cause celebre for the US Federal Trade Commission (look here), which has been lobbying Congress to enact legislation to restrict the settlements, and has also divided courts across the country, which is why the Supreme Court was asked to review the topic and settle the matter. The case cited by the retailers and wholesaler involved a deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop its patent challenge to the Cipro antibiot... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4272601 Mon, 20 Dec 2010 15:41:59 +0100 4272601 http://www.medworm.com/index.php?rid=4241949&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU1IRA4muioM%2F Generally, trade agreements are discussed behind closed doors, but a New Zealand talk paper was leaked the other day and contains ideas that run counter to suggestions being pushed by US and the global pharmaceutical industry. In fact, the Public Citizen advocacy group, which publicized the leak, calls it a “direct challenge to the monopoly interests of major pharmaceutical corporations.” The disclosure comes amid negotiations that are being held this week in New Zealand among eight countries and the US that are participating in the Trans Pacific Partnership free trade agreement, or FTA. At issue is the extent to which the FTA would move beyond intellectual property standards in the World Trade Organization’s Trade Related Aspects of Intellectual Property, or TRIPS agreem... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4241949 Wed, 08 Dec 2010 16:45:36 +0100 4241949 http://www.medworm.com/index.php?rid=4225655&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FF-sSQsuvSc0%2F As more big-selling, brand-name meds fall off the patent cliff, lower-cost generics are destined to become more popular, yes? And a known side effect of this development is that more insurers are using this transformation to force doctors and patients to switch to generics. But to what extent? A new survey of 10,842 patients by the non-profit advocacy group shows that up to 70 percent of prescriptions written by doctors are forcibly changed by health insurers. Complete results have not yet been released, but Global Healthy Living Foundation says that, since sometimes generics are not identical to brand-name meds, the findings suggest some patients with chronic conditions are being placed at risk because they relapse after being switched to a cheaper drug. “This disturbing finding is ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4225655 Fri, 03 Dec 2010 14:36:41 +0100 4225655 http://www.medworm.com/index.php?rid=4225657&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FdczYYLlP0h4%2F Once again, European Commission antitrust regulators have raided the offices of several drugmakers seeking evidence that they struck anticompetitive deals or used their dominant market positions to squeeze rivals. So far, though, only AstraZeneca has confirmed that it received a visit. “The Commission has reason to believe that the companies concerned may have acted individually or jointly, notably to delay generic entry for a particular medicine,” the commission says in a statement. This could be a potential violation of EU antitrust rules.” The focus of the raid on AstraZeneca was its Nexium heartburn med, which is a $5 billion global seller but faces generic competition across Europe. “Earlier this week, competition authorities commenced inspections at a small numbe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4225657 Fri, 03 Dec 2010 13:18:40 +0100 4225657 http://www.medworm.com/index.php?rid=4214483&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZvMCwRENZ_o%2F Over the next few days, countless grandmothers - and so-called ‘grand-others’ - will hold vigils across Canada in hopes of convincing Parliament to revive a recently gutted bill, which was designed to amend a controversial 2004 law that was supposed to allow generic versions of patented AIDS meds to be exported to developing countries. Earlier this month, the Canadian House of Commons Standing Committee on Industry, Science and Technology eliminated key reforms proposed for the bill. Known as C-393, the bill was supposed to fix the Access to Medicines Regime (CAMR). But the law proved ineffective - since passage six years ago, only one license was ever issued and this involved exporting just one order of an AIDS med to Rwanda. “There are further opportunities to amend and... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4214483 Tue, 30 Nov 2010 13:29:36 +0100 4214483 http://www.medworm.com/index.php?rid=4197358&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7souxMLZV4g%2F Earlier this year, a bill was introduced in New Jersey that would prevent pharmacists from switching anti-epilepsy pills over concerns that some patients have reacted poorly to generics that are deemed bioequivalent (read here). This has been a long-standing issue with epileptics, some of whom say the slightest difference can cause serious reactions, including seizures. Pfizer, for instance, encountered such complaints after it began marketing a new version of its venerable Dilantin drug and stopped selling Dilantin Kapseals in favor of new Dilantin capsules two years ago. In fact, a Maryland couple filed a wrongful death lawsuit against the drugmaker for switching its products after their son took the new version and later died of a grand mal seizure (back story). And so a New Jersey stat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4197358 Wed, 24 Nov 2010 14:43:04 +0100 4197358 http://www.medworm.com/index.php?rid=4190525&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8S4VgXuJzVE%2F Welcome back, everyone. We hope your weekend was refreshing and put to good use. Now, of course, the routine returns, although this is a short week on this side of the pond. Nonetheless, meetings and deadlines loom, if only for a little while. So please join us as we brew the mandatory cup of stimulation and peruse the news of the world. Hope your day goes well and stay in touch… Bayer & Regeneron Eye Drugs Show Good Results (Bloomberg News) Genzyme Considers New Sanofi Deal Structure (TheStreet) FDA Approves 2nd Human Study Of Embryonic Stem Cells (Associated Press) Merck Wins Fosamax Trial (The New York Times) VR Labs To Build HQ In Florida (Fort Myers News-Press) Advair Poses Generic Hurdles (The Wall Street Journal) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4190525 Mon, 22 Nov 2010 13:04:07 +0100 4190525 http://www.medworm.com/index.php?rid=4159504&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FmZpXjtw7NXc%2F When the going gets tough, the FDA pays consultants for get-tough lessons. No kidding. Turns out the agency has been forking over tens of millions of dollars to such firms as McKinsey to help the Office of Generic Drugs, which has a huge backlog of 2,000 applications, make tough decisions, The Wall Street Journal writes. There is a touch of drama here. One consultant, Leadership Performance Solutions, holds classes at a Civil War battlefield - specifically, the Battle of Antietam in Maryland for leadership lessons. Dan Feldman, a psychologist and the firm’s president, tells the paper the setting is a good tool for teaching government and business leaders about the perils of backing away from “tough decisions.” What does this cost? McKinsey has signed contracts for more t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4159504 Fri, 12 Nov 2010 13:14:30 +0100 4159504 http://www.medworm.com/index.php?rid=4155402&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FB8VV4pLwrP4%2F Good morning, everyone. Another brand new day is under way here on the Pharmalot corporate campus, where the short people are showing signs of arriving at the local school house on time. This calls for a celebratory cup of stimulation and we invite you to join us. While you indulge, the news of the world awaits you. Have a great day and do stay in touch… J&J Holds Talks To Resolve Risperdal Probe (Dow Jones) Former Pfizer Exec Leaves CEO Job At Cellceutix (Xconomy) Novartis Halts Cancer Drug Trial (TheStreet) Medicare Chief To Make First Appearance Before Congress (Bloomberg News) Hawaii Sues McKesson And First DataBank Over Pricing (Honolulu Star-Advertiser) Activists Lobby India To Reject Obama Lobbying On IP And Meds (Pharmabiz) One Million More Kids Are Diagnoses With ADHD (... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4155402 Thu, 11 Nov 2010 13:08:24 +0100 4155402 http://www.medworm.com/index.php?rid=4155226&cid=t_114929_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F70L2mY2flJ4%2F When consumers pay $4 cash for a prescription, there's no incentive for pharmacies to go through the hassle of submitting the claim. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4155226 Wed, 10 Nov 2010 22:37:44 +0100 4155226 http://www.medworm.com/index.php?rid=4119717&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMG3RQRES24g%2F Will Congress ever pass a bill that limits pay-to-delay deals? The Federal Trade Commission has been trying to convince Congress for months to do so, but opposition is mounting. Five Democratic Senators are objecting to a bill recently passed by the Senate Appropriations Committee because it contains a provision that would restrict these patent settlements (see this). In a letter to Senate Majority Leader Harry Reid, the endangered Nevada Democrat, and Appropriations Committee chairman Daniel Inouye, a Democrat from Hawaii, the Democrats say they have “substantive concerns with the content” of the provision and that the decision to include it in the appropriations bill “contradicts both the spirit and the letter of the Senate rules” (see the letter). Why bother to ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4119717 Thu, 28 Oct 2010 21:34:10 +0100 4119717 http://www.medworm.com/index.php?rid=4106055&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWTWwWrCyCEM%2F The bitter contest over bringing a generic Lovenox bloodthinner to market took another unusual turn yesterday when Amphastar Pharmaceuticals filed a lawsuit against the FDA, charging the agency with unlawfully detaining two shipments of raw materials need to make its version of the widely used drug. The move comes three months after the FDA approved a generic developed by Momenta Pharmaceuticals, which has a marketing deal with the Sandoz generic unit of Novartis (back story). This is only the latest instance in which Amphastar has railed against the FDA’s handling of the Lovenox wars. Last year, Amphastar charged there was a conflict of interest at the agency, because Janet Woodcock, who oversees the agency’s Center for Drug Evaluation and Research, had an alleged working rela... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106055 Tue, 26 Oct 2010 13:32:19 +0100 4106055 http://www.medworm.com/index.php?rid=4086518&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FijNS9kKsegA%2F Hello, everyone, nice to see you again. Another shiny day is emerging here on the Pharmalot corporate campus, where we are hustling to deliver one of the short people to the local schoolhouse. Busy, busy, busy. Meanwhile, those meetings and deadlines loom. We know you relate. So here are a few interesting items to help you along. Have a wonderful day and stay in touch… Pfizer Pays $240M For Stake In Brazil’s Teuto (Reuters) Vioxx Lawyers Who Led Settlement Will Get $315M (Bloomberg News) Boehringer’s Pradaxa Bloodthinner Wins FDA Approval (Reuters) Amylin’s Diabetes Drug Debacle (TheStreet) McKesson To Pay $15M To Connecticut For Inflating Prices (CTNow) Sanofi Wins $442M Judgment Over Plavix Patent (Bloomberg News) Anti-Counterfeiting Effort Nabs 1M Pills (InPharma... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4086518 Wed, 20 Oct 2010 11:41:18 +0100 4086518 http://www.medworm.com/index.php?rid=4077592&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyEG2mI_la8Y%2F For those who like to keep track of the revolving door between industry and regulators, it is worth noting that Gary Buehler, who for many years ran the FDA’s Office of Generic Drugs, is joining Teva Pharmaceuticals as vp for regulatory strategic operations. Teva, of course, is the world’s biggest supplier of generics. The move comes just a few months after Buehler was reassigned to run the FDA’s Office of Pharmaceutical Science after FDA commish Margaret Hamburg complained publicly about a backlog of generic drug approvals (back story). The backlog went from 891 in fiscal year 2005 to 1,912 in fiscal year 2010, although Buehler was known inside the FDA to battle for funding for reviewers. To cope, the agency continues to explore the notion of imposing user fees on generi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4077592 Mon, 18 Oct 2010 12:54:18 +0100 4077592 http://www.medworm.com/index.php?rid=4077593&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbVC-Yw-XyJ0%2F This should not come as a surprise, but the Great Recession continues to take a toll on prescription fill rates. In the first six months of this year, the so-called abandonment rate has inched up still more - reaching almost 10 percent of all new prescriptions for brand-name meds, according to the latest data provided by Wolters Kluwer, a market research firm. That’s up from slightly higher than 9 percent during the second half of 2009, and significantly higher than the 7.5 percent notched during the second half of 2008, when the recession took off and the stock market plummeted. The current rate is almost double what was seen in 2006. But abandonment rates for generics held steady at about 5 percent, reflecting the lower costs for copycat meds (see the write up for the last six-mont... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4077593 Mon, 18 Oct 2010 12:26:53 +0100 4077593 http://www.medworm.com/index.php?rid=4077595&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7pZyAG5Y9VM%2F Welcome back, everyone. We hope your weekend was restful and refreshing. Now, of course, the time has come to brace yourself for the usual routine of meetings and deadlines. We are no different. So please join us for the mandatory cup of stimulation as we peruse the news of the world. Meanwhile, we hope today brings you new insights and rewards. Catch you later… Pfizer Pays Up To $350M To License Biocon Diabetes Drugs (Dow Jones) Lilly To Close Singapore Drug Discovery Center (Dow Jones) Roche Seeks To Broaden Actemra Indications (Reuters) Lilly Osteoporosis Drug Regrows Jawbone: Study (Reuters) How An Arizona Town Landed 500 Roche Jobs (Inside Tucson Business) Man Charged With Stealing From Glaxo (Raleigh News & Observer) Wyeth Fined Over Hazardous Waste (Irish Times) Canadians... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4077595 Mon, 18 Oct 2010 12:05:11 +0100 4077595 http://www.medworm.com/index.php?rid=4055956&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtsVcPs4lKRU%2F The proposed Anti-Counterfeiting Trade Agreement has been causing a ruckus for nearly two years as consumer activists object to provisions that may allow European nations to seize low-cost generics under the guise of counterfeit products. The talks are designed to uphold intellectual property standards, according to this statement from US Trade Rep: “ACTA…will include state-of-the-art provisions on the enforcement of intellectual property rights, including provisions on civil, criminal, and border enforcement measures, robust cooperation mechanisms among ACTA Parties to assist in their enforcement efforts, and establishment of best practices for effective (intellectual property rights) enforcement.” But critics say the initiative goes too far and, with a final deal expect... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4055956 Mon, 11 Oct 2010 16:15:33 +0100 4055956 http://www.medworm.com/index.php?rid=4023135&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxdkBOsxfVuk%2F The National Institutes of Health is joining an international patent pool in hopes of increasing the availability of medicines to treat HIV and AIDS in developing countries. By licensing a patent for darunavir, the agency becomes the first patent holder to take such a step, which was lauded by patient activist groups that, simultaneously, called on the pharmaceutical industry to quickly follow suit. The Medicines Patent Pool is a new initiative designed to streamline patent licensing for producing generic versions of patented HIV treatments and lower prices for meds in countries where people are unable to afford the drugs. The patent pool was launched recently by UNITAID, which has previously indicated several major drugmakers, including Merck and Gilead Sciences, have discussed signing up... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4023135 Fri, 01 Oct 2010 12:24:21 +0100 4023135 http://www.medworm.com/index.php?rid=3994341&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFSDEMvk3Izg%2F Last week, the FDA held its first open meeting about user fees for generic drug makers, an issue that has been around nearly 20 years. The session came as generics continue to grow in popularity – nearly 75 percent of prescription drug volume was generic last year – and the FDA grapples with an inability to approve drugs fast enough. However, the backlog appears to be less of a priority to the agency than having funds to conduct overseas plant inspections. Meanwhile, the generic industry is split – the usual trade group was there along with a new coalition representing a few big players, but Mylan Laboratories spoke for itself. And so we spoke with Ramsey Baghdadi of Provision Policy, a healthcare analysis firm that provides insights to Concept Capital and The RPM Report, about his i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3994341 Thu, 23 Sep 2010 13:24:17 +0100 3994341 http://www.medworm.com/index.php?rid=3987232&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWUMM2W1zUeE%2F Want to know what the FDA thinks about biosimilars and how to gauge immunogenecitiy or when bioequivalence studies will be needed? Then you may want to attend the two-day hearing the agency has scheduled on Nov. 2 and 3 at its Silver Spring, Maryland campus. Although not formally announced, a draft notice has been circulating for the past few days. “Because negotiations of new and reauthorized user fee programs, historically, have largely been conducted by trade associations representing the affected companies, FDA also seeks to identify which existing industry trade associations represent such companies,” according to the FDA notice. UPDATE: The FDA will not comment officially until the notice appears in the Federal Register. The meeting is the latest signal that the FDA is formul... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3987232 Mon, 20 Sep 2010 17:36:32 +0100 3987232 http://www.medworm.com/index.php?rid=3987236&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcB0AB5jloI4%2F Welcome back, everyone. We hope you had a pleasant weekend and feel refreshed. Now, of course, the routine resumes as meetings and deadlines approach. To steel ourselves, we are preparing the mandatory cup of simulation. So please join us as we indulge and scan the news of the world. Hope your day goes well and do stay in touch… Bristol-Myers And Astra Tout Diabetes Study Results (Dow Jones) Roche’s Avastin Fails In Late-State Colon Cancer Study (Bloomberg News) India May Separate Approvals From Patent Status (LiveMint) Drugmakers Protest New Prices In Greece (PharmaTimes) Some African Nations Side With India Over Generics Debate (Economic Times) Genentech Exec Looks Ahead To Rockefeller University (Nature) Novartis Pulls European Application For Blood Pressure Pill (PharmaTime... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3987236 Mon, 20 Sep 2010 11:35:40 +0100 3987236 http://www.medworm.com/index.php?rid=3981014&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FwaAb5QlVs3Q%2F A Florida hospital has filed a lawsuit against Astellas Pharma over Adenoscan, a med given to people who unable to run on a treadmill during cardiac stress tests, because the drugmaker argues hospitals would violate a method-of-use patent if they fail to sign licensing agreements and purchase its brand-name injectable instead of lower-cost generics. According to the lawsuit, Astellas associate general counsel Catherine Leavitt sent threatening letters to Lakeland Regional Medical Center saying that “Astellas is the only party that can authorize the patented use of adenosine infusion for MPI studies. Such permission is only granted when Adenoscan is purchased from Astellas.” MPI, or myocardial perfusion imaging, is a test used to determine cardiac artery disease. And so, Lakela... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3981014 Fri, 17 Sep 2010 14:57:30 +0100 3981014 http://www.medworm.com/index.php?rid=3981015&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhFvpmaAFRys%2F Want to hinder the supply of low-cost, accessible AIDS/HIV meds to poor countries? One way is to continue to implement free-trade agreements between India, which is an increasingly important supplier of these meds, and the European Union, according to a new report co-authored by an official from UNITAID, the United Nations relief organization that supplies the drugs to such nations. How so? Trade talks currently taking place between India and the European Union include proposals that could delay or restrict Indian generic drug makers by extending patent terms for brand-name meds, requiring data exclusivity and imposing tighter rules on enforcing borders. The report, which appears in the Journal of the International AIDS Society, suggests prices could rise and access delayed to improved med... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3981015 Fri, 17 Sep 2010 13:48:27 +0100 3981015 http://www.medworm.com/index.php?rid=3981018&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFhfKaF5_N6U%2F And so another week will soon draw to a close. And not a moment too soon, yes? After all, this has been a busy stretch. What will you do this weekend? A drive in the country to pick apples? Take in a new movie? Spend time with someone special? For our part, we will reflect on the year past and the year ahead. And then take the official Pharmalot mascots for a brisk stroll. Meanwhile, the news of the world awaits. Whatever you do, we hope all goes well. See you soon… New Russian Law Eases Red Tape For Drugmakers (The Economist Intelligence) J&J Wants To Buy The Rest Of Crucell Vaccine Maker (Reuters) FDA Panel OKs Wider Use For Alkermes Drug (Reuters) Bayer Sees Huge Market For Its Bloodthinner (Bloomberg News) Childhood Vaccination Rates Remain High (The Los Angeles Times) Settl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3981018 Fri, 17 Sep 2010 11:55:07 +0100 3981018 http://www.medworm.com/index.php?rid=3946687&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FT2IYaC17BMc%2F In yet another blow to the US Federal Trade Commission, a federal appeals court has refused to reconsider its ruling last April that upheld the legality of so-called pay-for-delay deals that thwart the introduction of generic rivals (here is the order). However, in a dissenting opinion, Justice Rosemary Pooler writes that the issue must ultimately be decided by the US Supreme Court, given the conflicting outcomes in various cases. The initial ruling by the US Second Circuit Court of Appeals was made after reviewing a deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop its patent challenge to the Cipro antibiotic. Barr challenged the Cipro patent in October 1991 and struck a deal with Bayer in January 1997, about two weeks before the case was s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3946687 Wed, 08 Sep 2010 12:03:05 +0100 3946687 http://www.medworm.com/index.php?rid=3907784&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FafNQrW4XcCs%2F This is hardly surprising. A federal judge late yesterday refused to issue a preliminary injunction to block Sandoz and Momenta Pharmaceutical from proceeding with sales of their generic Lovenox bloodthinner, which was recently approved by the FDA (see this). Sanofi-Aventis, which sells the $4 billion treatment, quickly filed a lawsuit, claiming the FDA acted arbitrarily and capriciously, because the generic is not exactly the same as its own med, and that the move would cause it irreparable harm (look here). But US District Court Judge Emmet Sullivan ruled the FDA had not acted inappropriately. “Just because the FDA…reached a conclusion at odds with the position advanced by Sanofi does not mean that the FDA’s decision was arbitrary and capricious,” he wrote in a 33... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3907784 Thu, 26 Aug 2010 11:59:09 +0100 3907784 http://www.medworm.com/index.php?rid=3903130&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ftv9Dj06babs%2F The retail prices for the 217 most widely used brand-name drugs rose an average of 8.3 percent last year, despite a drop in inflation, according to a new survey by AARP. And for the most popular meds, prices rose 41.5 percent, outpacing a 13.3 percent rise in the Consumer Price Index. The results were first reported in The New York Times and here is the complete survey. However, the findings may not match reality for many Americans who take lower-cost generics, according to John Vernon, an assistant professor of health policy at the University of North Carolina who consults for drugmakers. “It can easily be shown that branded prices are higher here than they are in other countries, but we have the lowest and the most competitively priced generic drugs in the world, and the generic share ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3903130 Wed, 25 Aug 2010 13:16:57 +0100 3903130 http://www.medworm.com/index.php?rid=3899635&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3bEXiAzSrD0%2F What do Americans think about when they think about prescription drugs? A new survey finds that cost, safety and industry influence over physicians are on a lot of minds. The overall picture suggests many Americans want cheaper generics; they worry about side effects and drug interactions, and believe docs are more concerned with newer, expensive meds than what is affordable. The survey was conducted last May by Consumer Reports of 1,154 adults who currently take prescription meds. To be more specific, 46 percent of those surveyed currently take a prescription med, and the average number they regularly take is 4.1. But nearly 90 percent expressed concern about physician prescribing habits - 69 percent agreed completely or somewhat that drugmakers have too much influence. Fifty percent say ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3899635 Tue, 24 Aug 2010 12:55:36 +0100 3899635 http://www.medworm.com/index.php?rid=3896098&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPyHmKCZ3g8s%2F Hello, everyone. Nice to see you again. As promised, we have returned. We trust you had a pleasant and productive week while we were away. And we want to say thanks for the nice send-off notes so many of you posted. Much appreciated. As always, though, the time has now come to reach for that favored cup of stimulation as we gear up for another week. Here goes… Glaxo Starts Final Clinical Trials For Shingles Vaccine (Reuters) Roche Buys Imaging Company For $100 Million (SwissInfo) Pfizer Tries To Remediate Former Upjohn Site (North Haven Citizen) Archimedes Pharma Sets Up Shop (The Star-Ledger of NJ) Genzyme Shareholder Sues To Block Deal That Hasn’t Happened (Boston Globe) Taiwan Seeks To Remove Non-Tariff Barriers To China (Focus Taiwan) Jailed Psychiatrist Pleads Guilty Over ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3896098 Mon, 23 Aug 2010 11:34:15 +0100 3896098 http://www.medworm.com/index.php?rid=3865456&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVdgbM3QaGSA%2F For months, US Federal Trade Commission commish Jon Leibowitz has argued that passing legislation to restrict pay-for-delay deals between brand name and generic drugmakers will save consumers billions of dollars over the next decade (back story). He has pointed to a Congressional Budget Office study forecasting nearly $2 billion in savings over 10 years and an FTC study that estimates savings of $3.5 billion annually. And he has maintained restrictions would speed the arrival of low-cost generics by more than a year onto pharmacy shelves. Now, a new study claims the CBO report “is flawed and likely substantially overestimates the budgetary savings,” and also claims that restrictions may have the opposite effect. “Under many circumstances, reverse payment patent settlemen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3865456 Fri, 13 Aug 2010 15:28:09 +0100 3865456 http://www.medworm.com/index.php?rid=3806022&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fs3_divSIb8U%2F Last week, the FDA issued one of those surprise product approvals by giving a thumbs up to a generic version of Lovenox, a widely used bloodthinner sold by Sanofi-Aventis, much sooner than most people expected (see here and here). The move is something of a game-changer for the pharmaceutical industry and so we spoke briefly with Jonathan Pan, a senior associate at the Scientia Advisors consulting firm, about the implications… Pharmalot: Why is this approval such an important development? Pan: Well, it’s a $4 billion product for Sanofi-Aventis. That’s one reason it’s important. The second reason is the active ingredient is an extremely complicated molecule – a macro molecular that wraps around itself – which means it’s hard to characterize and hard to manufacture. So it r... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3806022 Fri, 30 Jul 2010 14:35:24 +0100 3806022 http://www.medworm.com/index.php?rid=3806023&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7SvmpDcngfs%2F In yet another legislative bid to tackle pay-to-delay deals, the US Senate Appropriations Committee voted yesterday to pass the Preserve Access to Affordable Generic Drugs Act, which was included in the Financial Services and General Government Appropriations bill reported out of the committee. A companion House bill was recently passed as part of the Supplemental Appropriations Act of 2010. The Congressional Budget Office estimates the House bill would save the federal government $2.6 billion over 10 years by reducing drug costs. “The cost of brand-name drugs rose nearly ten percent last year. In contrast, the cost of generic drugs fell by nearly ten percent. At this time of spiraling health care costs, we cannot turn a blind eye to these anticompetitive backroom deals that deny consume... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3806023 Fri, 30 Jul 2010 13:06:17 +0100 3806023 http://www.medworm.com/index.php?rid=3802587&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsYwntWuqtGs%2F Despite various legislative and courtroom setbacks, FTC commish Jon Leibowitz insists there is reason to be optimistic that so-called pay-to-delay deals may soon be a thing of the past. In testimony this week before the House Committee on the Judiciary’s Subcommittee on Courts and Competition Policy, he appeared to see blue skies on his horizon and went so far as to say the ‘tide may be turning.’ For instance, he cited a recent ruling by the US Second Circuirt Court of Appeals, which actually upheld the legality of pay-for-delay deals, but at the same time, took the unusual step of inviting entities that purchase drugs and had challenged a particular deal to ask for that case to be reviewed by the full circuit, citing the “exceptional importance” of the antitrust impl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3802587 Thu, 29 Jul 2010 12:47:40 +0100 3802587 http://www.medworm.com/index.php?rid=3798821&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPPqBtajCQRY%2F Most people know generics are less expensive than brand-name meds. But what about the folks who administer Medicaid programs? A new report argues that roughly $271 million could have been saved last year if more generics had been substituted for brand-name drugs. Of course, this assumes such substitution would not cause unforseen side effects that can ring up overall healthcare costs. In any event, the report examined 20 brand-name meds for which generics were available in the identical dosage form, strength, package type and package size. These included the Risperdal antipsychotic, the Zithromax antibiotic, the Wellbutrin antidepressant, the Lamictal epilepsy drug and the Toprol XL antihypertensive. The report, by the way, was written by Alex Brill, a research fellow at the American Enter... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3798821 Wed, 28 Jul 2010 16:04:25 +0100 3798821 http://www.medworm.com/index.php?rid=3795054&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-ypN_wd8wVc%2F Stunned by the FDA approval of a generic version of its best-selling Lovenox blood thinner, Sanofi-Aventis has filed a lawsuit in federal court, charging the agency with exceeding its authority, and acted arbitrarily and capriciously in granting Momenta Pharmaceuticals the right to market a drug (see background here). In arguing its case, Sanofi claims the FDA is allowing a generic to be sold that is not similar in safety or efficacy to Lovenox, which generated $4 billion in sales last year. And so Sanofi is seeking a temporary restraining order to force the FDA to withdraw approval, which would prevent Momenta and its partner, the Sandoz generic unit of Novartis, from moving forward. Sanofi has moved aggressively before to thwart generic Lovenox, filing a citizen’s petition with the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3795054 Tue, 27 Jul 2010 13:05:42 +0100 3795054 http://www.medworm.com/index.php?rid=3795055&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_tKJw58uuGI%2F Here’s a question for you: if a company wants to convince regulators that it did nothing wrong in connection with an investigation, should the company cooperate or should the company provide misleading info in hopes of throwing them off any perceived scent? The European Commission says Servier somehow made the wrong choice. And so the EC has charged Servier and Les Laboratoires Servier with providing bad info to the agency, which is seeking evidence that drugmakers in several countries struck anticompetitive deals to stall cheaper generic versions of their own meds after patents had expired or used their dominant market positions to squeeze rivals. EU regulators have said they suspected that Servier did deals with generic rivals Krka, Lupin, Matrix, Niche Generics and Teva to thwart ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3795055 Tue, 27 Jul 2010 12:45:04 +0100 3795055 http://www.medworm.com/index.php?rid=3795028&cid=t_114929_136_f&fid=39026&url=http%3A%2F%2Fcarolinemfr.blogspot.com%2F2010%2F07%2Fgenerics-and-prescriptions.html Living here in Massachusetts, there is a state law which mandates the use of prescriptions unless the doctor specifies 'no substitutions'. (I could be wrong, this could be a federal law but since I have no brain I'll just say state law.) All of my prescriptions, of which there are many - they cover the top of my bedside table, are generics except one - Femara which was released just a few years ago.A recent study says that generics are just as effective as the brand name drugs. But we need to remember a generic is not an identical drug but (as the fancy word implies) are biosimilars - meaning they are close but not quite. Now there is a movement to shorten the 12 years in which drugs are protected from generics in the US. Basically biotech companies say they need the 12 years to recoup the... Caroline's Breast Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=3795028 Tue, 27 Jul 2010 10:17:00 +0100 3795028 http://www.medworm.com/index.php?rid=3790678&cid=t_114929_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FRYRU8509ddE%2F The trade group for generic drug makers also says the U.S. health-care system saved nearly $140 billion last year through using generics. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3790678 Mon, 26 Jul 2010 16:46:59 +0100 3790678 http://www.medworm.com/index.php?rid=3790925&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFPKkiqBmLug%2F Hello, everyone, and welcome back. We hope your weekend was relaxing. Now, of course, the routine returns as meetings and deadlines loom. At least the heat wave has broken, as measured by a rare, cool breeze now wafting through the Pharmalot corporate campus. So please join us for the mandatory cup of stimulation as we prepare for another day. One note: we will be speaking later on an industry panel, so please excuse the interruption in our usual schedule. Meanwhile, have a good one and stay in touch…. Onyx Posts Positive Results For Cancer Drug (Associated Press) Sanofi Cuts Forecast After FDA Approves Generic Lovenox (Bloomberg News) The Brilinta Guessing Game As FDA Panel Nears (Reuters) Eisai Gets Boost From FDA OK For Higher-Dose Aricept (PharmaTimes) Genzyme Is Seen As More Att... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3790925 Mon, 26 Jul 2010 12:00:41 +0100 3790925 http://www.medworm.com/index.php?rid=3780565&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhUrAUHm71Bo%2F With all those patent expirations under way, brand-name drugmakers, of course, are desperate to wring as much money as possible out of their products. So how do they counter the generic onslaught? There are several tricks and every company employs multiple strategies, although patent challenges were the most popular choice over the past three years, according to a new survey. Patent litigation, in fact, was pursued by 60 percent of those queried by Cutting Edge Information, followed closely by defensive pricing, which was popular among 57 percent of the respondents. Half of those surveyed also like to concoct new formulations or a next-generation drug, with new indications clocking in at 45 percent. Only 29 percent pointed to an authorized generic or generics subsidiary. Over the next thre... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3780565 Thu, 22 Jul 2010 14:42:20 +0100 3780565 http://www.medworm.com/index.php?rid=3772469&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjPagjNQJtdw%2F Top of the morning to you. A relatively balmy day here on the Pharmalot corporate campus, where we are preparing for some important events. What about you? Are significant meetings on the horizon? And what about those deadlines? As always, a cup of stimulation is brewing. So please join us in surveying a few interesting tidbits. Have a great day and stay in touch… Advil Ad Account Is Shopped Around (AdWeek) WHO May Declare End To Swine Flu Pandemic (Bloomberg News) Reglan Lawsuits, Generics And Preemption (New Orleans City Business) Pfizer Halts Another Tanezumab Study (Associated Press) Ireland Plans Global Pharma Center Of Excellence (Irish Examiner) People Receiving HIV Treatment Rose 30 Percent In 2009 (Bloomberg News) Paxil Lawsuit Over Heart Birth Defect Is Settled (Associated ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3772469 Tue, 20 Jul 2010 11:35:42 +0100 3772469 http://www.medworm.com/index.php?rid=3767314&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVAkuw91uRH4%2F Two months ago, Paul Bisaro, the ceo of Watson Pharmaceuticals, made a sensational charge against the Federal Trade Commission - in court papers, he accused the agency of abusing its power in attempting to stop pay-for-delay deals. Bisaro claimed the FTC harassed his company and used confidential FDA info to force Watson to strike a deal with Apotex, another generic drugmaker, to sell a version of Cephalon’s Provigil, a sleep-disorder drug. The FTC is challenging a 2005 deal between Cephalon and several generic drugmakers that were paid $300 million by arguing the payments bought market exclusivity. The FTC issued a subpoena last year and sought to compel Bisaro to respond to questions in connection with an investigation into that deal, although he refused to testify. Bisaro claims the F... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3767314 Mon, 19 Jul 2010 12:23:08 +0100 3767314 http://www.medworm.com/index.php?rid=3746989&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWwA5LUh4guc%2F Welcome back. We hope you had a refreshing weekend and feel recharged. Now, of course, the routine returns with those meetings and deadlines. As you might expect, we are brewing the mandatory cup of stimulation. Please join us as we indulge and scan the news of the world. Hope your day goes well and do stay in touch… Russia Approves Merck KGgA’s MS Pill (Reuters) Sanofi May Sell EU Research Sites To Covance (OutsourcingPharma) J&J Sued Over Pediatric OTC Med Recalls (Reuters) Another Canadian Province Cuts Generic Prices (PharmaTimes) FDA To Review First Of Three New Diet Pills (Associated Press) Sigma Pharma Wants Better Deal From Aspen (International Business Times) Abbott Warns Against Further Healthcare Cuts (Irish Examiner) Pfizer Works To Clean Contaminants From Mich... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3746989 Mon, 12 Jul 2010 12:09:04 +0100 3746989 http://www.medworm.com/index.php?rid=3730096&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLnS1R8Akp9w%2F That’s the implication of a new survey released by the European Union, whose antitrust regulators have been raiding drugmakers in several countries seeking evidence they struck anticompetitive deals or used their dominant market positions to squeeze rivals. Last year, EU competition commissioner Neelie Kroes issued a report saying delays in bringing generic drugs to market cost consumers and healthcare providers billions (back story here and here). Now, the EU says the number of patent settlements that are “potentially problematic” under EU antitrust rules fell to 9, or 10 percent of 93 such deals between July 2008 and December 2009 compared with 45, or 22 percent of the 207 deals in the period covered in last year’s inquiry, which was January 2000 to June 2008. And... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3730096 Tue, 06 Jul 2010 13:46:31 +0100 3730096 http://www.medworm.com/index.php?rid=3718698&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fh68KkPeH3gU%2F Rise and shine, everyone. Another day is on the way. This means, of course, that meetings and deadlines beckon. Never mind that a holiday weekend is just around the corner. To cope, we are brewing the mandatory cup of stimulation, and enjoying an unexpectedly cool breeze. So please join us as we peruse the news of the world. Good luck today and catch you soon… AstraZeneca Loses Bid To Overturn Antitrust Fine (Dow Jones) Biogen Names Exelisis’ George Scangos As CEO (Bloomberg News) Recession Hurts Funding For AIDS Drug Program (New York Times) FDA Issues Latest List Of Drug With Possible Risks (Reuters) Quebec To Cut Generic Drug Prices (PharmaTimes) USPTO Denies Request To Re-Examine Plavix Patent (Dow Jones) Michigan Grows CROs (Xconomy) Calistoga Raises $40M To Fund Drug Tria... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718698 Thu, 01 Jul 2010 11:56:22 +0100 3718698 http://www.medworm.com/index.php?rid=3710790&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-b8gjxRZsWE%2F A federal judge has struck down litigation brought by several generic drugmakers, which sought to prove that AstraZeneca’s key patent on its Crestrol cholesterol pill was invalid. The outcome had been expected, but nonetheless, removed a potentially huge problem for the drugmaker, which racked up $4.5 billion in global Crestor sales last year. In reaching his decision, US District Court Judge Joseph Farnan ruled that the generic drugmakers, a group that included Apotex, Aurobindo Pharma, Cobalt Laboratories, Mylan Laboratories, Par Pharmaceuticals, Sandoz, Sun Pharmaceuticals and Teva Pharmaceuticals, failed to prove the AstraZeneca patent was invalid because it was an obvious invention. He also decided Apotex may be held liable for infringing the patent (read the ruling). In an inve... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3710790 Tue, 29 Jun 2010 21:31:33 +0100 3710790 http://www.medworm.com/index.php?rid=3714124&cid=t_114929_87_f&fid=34470&url=http%3A%2F%2Fwww.thehealthcareblog.com%2Fthe_health_care_blog%2F2010%2F06%2Ftop-10-generic-bargains.html By ED PULLEN, MD Many of the breakthrough drugs of the 1980-1990′s are now available as generics, and pharmacy competition has led to great bargains for patients needing these drugs. The 1980’s and 1990’s were a golden age in the... (Source: The Health Care Blog) The Health Care Blog blogs http://www.medworm.com/rss/comments.php?id=3714124 Mon, 28 Jun 2010 23:00:00 +0100 3714124 http://www.medworm.com/index.php?rid=3679914&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMXgDoWb_u_s%2F A sunny day here on the Pharmalot corporate campus, where we are using some spare moments to catch up on our reading. And of course, we are leisurely quaffing a few cups of stimulation. Later, we plan to grab a bite with Mrs. Pharmalot and The Pharmalittles in honor of you-know-what day. Whatever your plans, we hope the day is enjoyable. Meanwhile, here are a few stray items to keep you fresh. And remember to say hi to your dad. Have a great time… Patents on blockbusters are expiring. The human genome is not delivering. And the low-hanging fruit was long ago picked from the orchard of obvious follow-ups. Adrian Ivinson, director of Harvard’s NeuroDiscovery Center, is reminded of the shifts underway in the industry every time he looks out of his Cambridge, Ma., window at the “... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3679914 Sun, 20 Jun 2010 14:13:01 +0100 3679914 http://www.medworm.com/index.php?rid=3676899&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZRxrE7wS55A%2F Good morning, everyone. How are you today? The weekend is just around the corner, of course, and that means looking ahead to…. what? We expect to frolic with some industry types at a soiree and, otherwise, lounge around the Pharmalot corporate campus to catch up on some reading. As for you, we hope your plans are exciting. Meanwhile, here are a few news items of the world. Have a great time and, by the way, do remember to call Dad… Sanofi-Aventis Prostate Cancer Drugs Wins FDA Approval (Reuters) UK’s NICE Approves Amgen’s Prolia (Bloomberg News) Walgreens Launches Mobile Prescription Reminders (EWeek) Malaysia Forecast To Lead Generics Growth In Asia (PharmaTimes) Pharma Urged To Develop More Orphan Drugs (Bloomberg News) Pfizer Biotech Drug Tops Placebo In Knee Pai... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3676899 Fri, 18 Jun 2010 11:48:30 +0100 3676899 http://www.medworm.com/index.php?rid=3672035&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FN1LYwKfnai4%2F Does government intervention help Canadians obtain lower drug prices compared with the free market in the US? Not according to a new report from the Fraser Institute, a libertarian think tank in Calgary, which examined per-capita spending on meds by both Canadians and Americans last year. The results indicate that everyone is spending the same 1.7 percent of their income on a per-capita basis. As a percentage of after-tax income, per capita spending in Canada was 2.6 percent, compared to 2.3 percent in the US. Meanwhile, the number of scrips dispensed per person was 14.2 in Canada and 12.7 in the US. While per capita incomes are higher in the US, the study argues one main reason spending is so similar is because Canadians pay more than twice as much for generics than Americans. In absolute... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3672035 Thu, 17 Jun 2010 11:55:41 +0100 3672035 http://www.medworm.com/index.php?rid=3665947&cid=t_114929_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F9dHnQFue9NA%2F Also: HHS wants more authority to boot Medicare cheats; companies worry a fund to help pay for retiree benefits will run out; being obese may be bad for your sex life. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3665947 Wed, 16 Jun 2010 12:37:46 +0100 3665947 http://www.medworm.com/index.php?rid=3610513&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_T4eW80uKvA%2F A generic drug may be bioequivalent with a brand-name med and approved by the FDA, but that doesn’t mean a generic drugmaker is shielded from a product-liability lawsuit. That’s what a federal judge ruled in refusing to dismiss a lawsuit by consumers who allege two generic drugmakers failed to warn about side effects caused by differences in their versions of the Wellbutrin XL antidepressant. In a 29-page decision, US District Judge Berle Schiller cited the US Supreme Court’s decision in Wyeth vs. Levine, which determined FDA approval does not shield drugmakers from state lawsuits, and concluded that generic drugmakers also have a duty to warn about any new side effects that may occur after the FDA has approved their medicines. Several generic drugmakers recently petition... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3610513 Fri, 28 May 2010 16:59:53 +0100 3610513 http://www.medworm.com/index.php?rid=3599738&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOgrZm0fTE7A%2F Rise and shine. Another day awaits. And who knows what lies ahead? Meetings? Deadlines? Unexpected tidbits of information? We can relate. So grab a cup of stimulation - or perhaps, a bottle of water, since it will be rather sticky today in the greater Pharmalot metropolitan region - and dive in. As always, here are some items to ease the process. Have a great day everyone and stay in touch… UK’s NICE Won’t Cover Bayer Liver Cancer Drug (Bloomberg News) AMRI Cuts US Workforce 10% And Shifts Jobs To Asia (OutsourcingPharma) FTC Commish Remains Bullish On Ending Pay-To-Delay Deals (PharmaTimes) Dennis Quaid Sues Baxter Over Heparin Overdose (USA Today) Merck Will Not Raise Its Dividend (Associated Press) Sanofi-Aventis Will Reassign Global Media Ad Duties (MM&M) Photo t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3599738 Wed, 26 May 2010 11:48:29 +0100 3599738 http://www.medworm.com/index.php?rid=3588859&cid=t_114929_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FP9foj31tWZo%2F Abbott says the Piramal deal will catapult it into the leading position in the fastest-growing segment of India's pharmaceutical business: branded generics. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3588859 Fri, 21 May 2010 15:58:56 +0100 3588859 http://www.medworm.com/index.php?rid=3581836&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fx3xcHLRFS7Y%2F The French Competition Authority is investigating allegations made by Teva Sante, a unit of Teva Pharmaceuticals, that Sanofi-Aventis disparaged generic versions of its best-selling Plavix bloodthinner, and deliberately attempted to restrict generic access to the marketplace. In its November 2009 complaint, Teva charged that Sanofi’s communications with doctors and pharmacists emphasized differences between Plavix and generics, including Teva’s 75mg version, without revealing the differences. However, Sanofi failed to say the differences have no therapeutic significance or effect on safety or efficacy (see the statement). Sanofi’s communications with scientists and practitioners emphasised differences between Plavix and competing generics, including Teva’s clopidogrel 7... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3581836 Thu, 20 May 2010 15:22:58 +0100 3581836 http://www.medworm.com/index.php?rid=3585836&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fx3xcHLRFS7Y%2F The French Competition Authority is investigating allegations made by Teva Sante, a unit of Teva Pharmaceuticals, that Sanofi-Aventis disparaged generic versions of its best-selling Plavix bloodthinner, and deliberately attempted to restrict generic access to the marketplace. In its November 2009 complaint, Teva charged that Sanofi’s communications with doctors and pharmacists emphasized differences between Plavix and generics, including Teva’s 75mg version, without revealing the differences. However, Sanofi failed to say the differences have no therapeutic significance or effect on safety or efficacy (see the statement). Sanofi’s communications with scientists and practitioners emphasised differences between Plavix and competing generics, including Teva’s clopidogrel 7... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3585836 Thu, 20 May 2010 15:22:03 +0100 3585836 http://www.medworm.com/index.php?rid=3577626&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fh_IpIo82H4Y%2F A federal appeals court last month may have upheld the legality of pay-for-delay deals that thwart the introduction of generics, but the issue isn’t dead yet. A group of consumers, union health and welfare funds, which have been certified as a class, are asking a California appeals court to review the same set of circumstances involving Bayer, Barr Pharmaceuticals and the Cipro antibiotic. At issue in both cases is a deal in which Bayer paid Barr, now owed by Teva Pharmaceuticals, to drop its 1991 patent challenge to Cipro. In 1997, Barr struck a deal with Bayer just two weeks before a lawsuit was set to go to trial, delaying the entrance of a generic version. The US Second Circuirt Court of Appeals ruled the deal was kosher (see here), although the Federal Trade Commission continues... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3577626 Wed, 19 May 2010 12:11:47 +0100 3577626 http://www.medworm.com/index.php?rid=3573939&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fzo7NBIKNNso%2F How gloomy is the outlook among pharma execs? A new survey finds 82 percent predict big drugmakers won’t be able to innovate sufficiently internally to replenish their dwindling pipelines. And this deperation will lead to still more acquisitions - 68 percent believe substantial acquisition activity will occur within the next two years and 19 percent anticipating “major activity” within the next year. Those who believe the glass is half full think the improved economic situation means pharma should have confidence to proceed with mergers - 63 per cent think the climate for doing business and access to funding have improved in the past year. The survey of 381 pharma execs was just released by Marks & Clerk, a large patent law firm in the UK, so it’s hard to know ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3573939 Tue, 18 May 2010 15:55:58 +0100 3573939 http://www.medworm.com/index.php?rid=3573944&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyWRw6FKi8nc%2F Prices for the most widely used brand-name meds jumped 9.7 during the 12-month period ending in March, according to AARP, which called the increase the largest since the organization began tracking this sort of thing in 2002. Specialty drug prices rose 9.2 percent and generics fell by 9.7 percent. AARP notes that general inflation climbed 0.3 percent during the same period. AARP then makes another comparison - the average annual cost for three generic meds declined by $51 during this period, while there was a $706 increase for three brand name drugs. “The life-saving drugs Americans need are out of reach for many because of unjustifiable price hikes,” AARP Executive Vice President John Rother says in a statement. “Consumers desperately need a competitive prescription drug market that... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3573944 Tue, 18 May 2010 12:23:54 +0100 3573944 http://www.medworm.com/index.php?rid=3549567&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FI_HEEGxSij0%2F Welcome to the working week. We hope your weekend was pleasant and gave you a chance to refresh. Now, of course, the routine resumes, which means those meetings and deadlines loom once again. To prepare, we have assembled a few interesting items to jumpstart what is, so far, a sunny day. Meanwhile, we will brew yet another cup of stimulation. Have a good one and do stay in touch… NiCox Painkiller Heads For FDA Panel Review (PharmaTimes) Sandoz Building In Denver Catches Fire (The Denver Post) Teva And Baxter To Fight $500M Damages In Propofol Case (Bloomberg News) Spain Should Encourage Docs To Prescribe Generics (PharmaTimes) Cipla Revenue Forecast Misses Target (Bloomberg News) Boehringer Ingelheim To Accelerate M&A In China (Global Times) Merck To Shift India Office To Mumbai... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3549567 Mon, 10 May 2010 11:33:24 +0100 3549567 http://www.medworm.com/index.php?rid=3549568&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTPxQQJprgls%2F A blustery day here on the Pharmalot corporate campus, where we are using the opportunity to catch up on some reading and, of course, quaffing a cup or three of needed stimulation. Later, we hope to take Mrs. Pharmalot and the Pharmalittles to one of her favorite eateries in honor of you-know-what day. Whatever you do today, we hope it is enjoyable. Meanwhile, here are a few items to keep you fresh. And remember to say hi to your mom. Have a great time… Teva Pharmaceuticals is really just a bunch of kibbutzniks. So says Bill Marth, who runs the US arm of the Israeli drugmaker, which is moving aggressively to become one of the biggest suppliers of medicines in America. “We are aggressive and not everybody likes us. But we are doing something every day that lowers health care costs and ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3549568 Sun, 09 May 2010 15:49:54 +0100 3549568 http://www.medworm.com/index.php?rid=3538387&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8SmLptd4QEY%2F The industry cutbacks continue. Of course, 70 positions is relatively modest compared with the thousands announced at various times. Just the same these do add up. Sanofi-Aventis, which recently eliminated another 70 jobs at its US headquarters in Bridgewater, New Jersey, (see here), cites decaying patent protection as a key reason for deteriorating business conditions and, by extention, the job cuts. In announcing the cuts, Sanofi-Aventis complains that brand-name drugmakers in Canada have “no effective right of appeal” when facing patent challenges and, as a result, generics can appear before patents expires. Using rather pointed language, the drugmaker says the “lack of government policy leadership” threatens its ability to maintain R&D investments, capital ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3538387 Wed, 05 May 2010 22:55:07 +0100 3538387 http://www.medworm.com/index.php?rid=3534102&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1zp-ai1enLI%2F The proposed Free Trade Agreement between India and the European Union will stipulate that “there should be no limit on India’s capacity to produce and export life-saving medicines,” an EU official tells PharmaTimes. Moreover, an internal EU customs regulation will be changed to ensure there are no further seizures by EU customs officials of drugs made in India that pass through Europe on their way to Africa and Latin America, according to Daniele Smadja, Ambassador of the EU Delegation to India. “We are committed that what had happened a year and a half ago doesn’t happen again,” the EU official adds, referring to 18 seizures of Indian-made meds at EU ports, which were made based on claims by drugmakers that the meds contravened their EU patents. However, Indian drugmakers... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3534102 Wed, 05 May 2010 12:09:58 +0100 3534102 http://www.medworm.com/index.php?rid=3534106&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqgrdiktVbGc%2F Kathleen Jaeger, who has been one of the industry’s more visible and vocal personalities for more than a decade, is leaving the Generic Pharmaceutical Association, where she has been the chief executive and president since 2002. Her last day is June 30. She joined the GPhA after it was formed as the result of a merger between three other trade associations (here is the GPhA statement). During her tenure, Jaeger was prominent in the various debates over health care reform and the pay-to-delay issue, in particular; Medicare Part D (see here); user fees and generic drugmakers (see here); and, of course, a pathway for biosimilars (see this). (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3534106 Tue, 04 May 2010 17:09:29 +0100 3534106 http://www.medworm.com/index.php?rid=3501514&cid=t_114929_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F_XEJZSdrEWo%2F Kathleen Jaeger, president and chief executive of the lobbying group, says the GPhA is working to address Teva's concerns and "come up with an appropriate resolution" to hopefully get the company to change its mind. (Source: WSJ.com: Health Blog) WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3501514 Fri, 23 Apr 2010 18:51:21 +0100 3501514 http://www.medworm.com/index.php?rid=3499309&cid=t_114929_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLz3zbR0ti1A%2F Drugmakers lost a legal battle against programs promoted by the UK’s National Health Service that encourage docs to prescribe cheaper meds. The Association of the British Pharmaceutical Industry had argued NHS incentives were an illegal inducement under strict European rules on promotion. But the European Court of Justice ruled they complied with European Union advertising legislation (see the ABPI statement). Under the programs, UK medical practices are rewarded for switching patients to generics or prescribing them to new patients who would otherwise get more expensive patented meds. Individual docs who share in the profits of medical practices could ultimately benefit from the incentives, prompting drugmakers to argue they breached an EU ban on incentives for prescribing, Reuters ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3499309 Fri, 23 Apr 2010 11:44:44 +0100 3499309