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 'abbott laboratories'. Sat, 03 Sep 2011 02:30:45 +0100 http://www.medworm.com/index.php?rid=5159834&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOa5-_YVQ_fM%2F And so another working week is about to draw to a close. This is, of course, our signal to daydream about weekend plans. Our modest agenda includes shuttling one of our short people off to an institution of higher learning, catching up on some reading and then bracing for a hurricane. Big fun, as they say. And what about you? Will you be boarding windows? Evacuating the homestead? For those of you in other locales, perhaps this slow time of the year is ripe for a pleasant drive or an outdoor event. Whatever you do, enjoy and be safe. See you soon… UK Probes How Medications Were Switched (BBC) Cipla Seeks Partners, Not Divestitures (Pharma Times) Shire Wins Approval Of Anti-Swelling Drug (Bloomberg News) Surgical Mesh Devices Should Be Banned: Watchdog Group (Star-Ledger of NJ) FDA Ap... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159834 Fri, 26 Aug 2011 12:09:55 +0100 5159834 http://www.medworm.com/index.php?rid=5159840&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0qGTbAcfmZ0%2F Six months after a federal appeals court decided a pair of GlaxoSmithKline sales reps are not eligible for overtime pay, they are now asking the US Supreme Court to review their case. And the implications for the pharmaceutical industry are likely to be far-reaching, given that drugmakers have been laying off thousands of sales reps as part of a massive wave of cost cutting in recent years. The petition, however, is not surprising, because there has been a split among appeals courts over this issue. Last year, the US Court of Appeals for the Second Circuit ruled that Novartis reps are entitled to overtime (back story), and the Supreme Court earlier this year declined to review the decision (see here). That ruling came just two weeks after the US Court of Appeals for the Ninth Circuit ruled... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159840 Thu, 25 Aug 2011 12:07:40 +0100 5159840 http://www.medworm.com/index.php?rid=5008657&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzvMEtESvnWs%2F File this under ‘Only In Your Dreams.’ To promote its Zolfresh sleeping pill in India, Abbott Laboratories has embarked on an advertising campaign that is being harshly criticized for using unproven data and old-fashioned fear in the guise of educating consumers about insomnia. Moreover, critics say the ads may prompt some people to buy potentially harmful pills that are not really needed, Reuters writes in an interesting expose. To wit, a newspaper ad featuring an attractive Bollywood actress warns that “Hard Work Never Kills. Lack of Sleep Can.” The message then says that “Research shows that sleeping less than 6 hours at night leads to (a) 48 percent increase in developing or dying from heart disease.” But the research cited only demonstrates an assoc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5008657 Fri, 08 Jul 2011 17:12:36 +0100 5008657 http://www.medworm.com/index.php?rid=4992994&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQp-xlA4Oic4%2F Few topics are more contentious than ghostwriting - the mysterious practice in which an article lands in a medical journal with the names of various authors who, as it turns out, had little or nothing to do with the substance of the publication. The issue has caused several scandals for several drugmakers and medical journals, causing embarrassment and turmoil. However, keeping track can be difficult. So the Project On Government Oversight, a watchdog group that regularly probes the topic, has compiled a handy primer on recent episodes (read here, here, here, here and here), as well as the steps taken by various universities and government agencies to cope with the problem. In case you were wondering, though, allegations have been reported for the following journals: The American Journal ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992994 Fri, 01 Jul 2011 12:30:53 +0100 4992994 http://www.medworm.com/index.php?rid=4992997&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FlsjDsYTX5tA%2F For the second time in less than two years, the FDA has issued a sobering warning about the Depakote epilepsy med sold by Abbott Laboratories. This time, the agency says that children born to mothers who take the anti-seizure drug or related products during pregnancy have an increased risk of lower cognitive test scores than children exposed to other such drugs (read here). The conclusion was reached after the agency reviewed epidemiologic studies. In the primary study upon which the FDA based its conclusion, cognitive tests were performed at age three; in other studies, testing was done on children 5 to 16 years old. The problem, the FDA says, is that long-term effects on cognitive development are unknown and it remains unclear whether the effects occur when fetal exposure is limited to l... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992997 Thu, 30 Jun 2011 21:19:37 +0100 4992997 http://www.medworm.com/index.php?rid=4984689&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEygW_voyKzU%2F Rise and shine. Another glorious day is unfolding here on the Pharmalot corporate campus, where we are moving along like a cool breeze. Of course, there is much to be done - phone calls, meetings, reading documents. You name it. And we know you can related. So grab that cup of stimulation - no excuses, please - and pick up your to-do list. Meanwhile, here are some tidbits from around your world. Have a good one… US Court Orders Seizure Of Cipla Pet Drug For Patent Violation (Dow Jones) Lilly Plans 10 Drug In Final-Stage Trials By End Of 2011 (Bloomberg News) Niaspan Prescriptions Fall After Negative Study Results (Dow Jones) Pfizer Signs Deal With Russian Venture Capital Firm For R&D (Associated Press) Forest Files COPD Drug For FDA Approval (Pharma Times) ‘Neurontin Kille... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4984689 Thu, 30 Jun 2011 11:53:38 +0100 4984689 http://www.medworm.com/index.php?rid=4976203&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIws0xix-Znw%2F A group of two dozen academics has lodged a formal complaint with the independent Pharmaceutical Advertising Advisory Board in Canada over a promotional campaign that Abbott Laboratories is running to promote its AndroGel testosterone gel, which was approved to treat hypogonadism. They cite a newspaper ad campaign, emails sent to physicians and the ‘Low-T‘ web site. In their letter, the academics charge that Abbott is promoting AndroGel for unapproved uses, exaggerating implied effectiveness, potentially harming public health due to cardiovascular side effects associated with the gel and violating Canadian law by failing to disclose that the drugmaker is sponsoring various ads and communications aimed at consumers and physicians. The ad “has serious potential to lead to h... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4976203 Tue, 28 Jun 2011 13:42:15 +0100 4976203 http://www.medworm.com/index.php?rid=4960328&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBKp9JbQ2S5I%2F Good morning, everyone. How are you today? Getting ready for those meetings and deadlines? We relate. There is much to do here on the Pharmalot corporate campus - reading, writing, chasing down interesting people. To prepare, we are brewing that reliable cup of stimulation - our flavor today is Rain Forest Nut. Feel free to join us. And to get things started, here are some tidbits. Have a good one and stay in touch… Bristol And Astra Diabetes Pill Faces Safety Hurdles (Bloomberg News) Biotechs Want Faster Drug Approvals (Boston Globe) Lilly CEO Blames Tax Laws And Immigration For Slower Innovation (Bloomberg News) Glaxo Ordered To Give Plaintiff Lists To United Health (Legal Intelligencer) Too Many UK Patients Are Prescribed Risky Drugs (Pharma Times) Abbott Labs Plant Closure Delaye... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4960328 Thu, 23 Jun 2011 11:54:26 +0100 4960328 http://www.medworm.com/index.php?rid=4872477&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FgXmYGKYgYhk%2F A study run by the National Institutes of Health was ended 18 months early after finding that adding Niaspan to a statin in people with heart disease did not reduce the risk of cardiovascular events, including heart attacks and strokes. Moreover, Niaspan may have boosted the risk of ischemic events, raising questions about the benefit of raising HDL, or so-called good cholesterol, to fight heart disease. The 3,414-person study, which added the Abbott Laboratories pill to Merck’s Zocor, found the combination was linked to stroke in 1.6 percent of patients, compared with 0.7 percent among those given a placebo. The combo failed to reduce heart attacks, heart-related hospitalizations and the need for procedures to reduce chest pain and restore strong blood flow to the heart. “The... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4872477 Thu, 26 May 2011 16:07:59 +0100 4872477 http://www.medworm.com/index.php?rid=4848154&cid=t_132556_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=4829300&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjslS28kfTmI%2F Will Abbott Laboratories lose what was to have been a big money maker? The answer should be known on Thursday, when an FDA advisory committee meets to decide the fate of Trilipix, a so-called fenofibrate pill that was approved in 2008 for lowering cholesterol but, more recently, was linked to a higher rate of heart problems among women who combined the drug with a statin. However, the clinical significance of the finding, which was disclosed in a study known as ACCORD, is not entirely certain, which is why the FDA panel is meeting. However, one question to be addressed is whether the FDA should withdraw approval for using the med in conjunction with a statin or, instead, revise the labeling and possibly include study results. Another option is to require another study (see this). The ACCOR... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4829300 Tue, 17 May 2011 12:51:04 +0100 4829300 http://www.medworm.com/index.php?rid=4803524&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FL8HlrImotBE%2F Hello, everyone, and how are you today? A shiny day is unfolding on the Pharmalot corporate campus where, once again, we are scrambling to deliver the short people to the local school house. And, of course, we are quaffing our mandatory cup of stimulation. This will be a particularly busy day as we tend to podcast matters. Meanwhile, here is the news of the world. Hope your day goes well… Drugmakers Replace Reps With Digital Tools (Wall Street Journal) Pfizer’s Chantix Blamed For Murder-Suicide In Lawsuit (Pittsburgh Post-Gazette) Sanofi Wins FDA OK For Short Needle Flu Vaccine (Reuters) NSAIDs May Raise Risks After Heart Attack (Health Day) MannKind Narrow Quarterly Loss While Awaiting FDA OK (Associated Press) Aurobindo Pharma Considers Spin Offs (Wall Street Journal) US Atta... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4803524 Tue, 10 May 2011 12:02:42 +0100 4803524 http://www.medworm.com/index.php?rid=4768245&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOKIB4C-4crU%2F The big drugmaker yesterday released results from two eagerly awaited Phase III clinical trials for tofacitinib, a rheumatoid arthritis treatment that Wall Street bets will become a big seller and, significantly, compensate for a string of laboratory failures, not to mention a growing number of meds losing patent protection. However, the results failed to answer a few key questions, at least according to one analyst. “Although the press release states that both studies met all their primary endpoints (beat placebo) at both doses of tofacitinib (5mg and 10mg), the press release doesn’t give us the critical pieces of information we are interested in, ” writes Wachovia Securities analyst Larry Biegelsen, in an investor note. “Unfortunately, the press releases did not i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4768245 Fri, 29 Apr 2011 15:13:08 +0100 4768245 http://www.medworm.com/index.php?rid=4768250&cid=t_132556_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=4759043&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FF7d0dGHppWA%2F Top of the morning to you. Gray skies are hovering over the Pharmalot corporate campus, but our spirits remain sunny. And why not? This inspires us to trot out one of our favorite sayings, courtesy of the morning mayor: ‘Every brand new day should be unwrapped like a precious gift.’ So while you tug on the ribbon, here are a few items to get you started. Have a great day, everyone, and smile… Merck To Buy Back Up To $5 Billion In Stock (Reuters) Teva Resumes Manufacturing At California Site (Orange County Business Journal) J&J Agrees To Buy Synthes For $21.3 Billion (Bloomberg News) Supreme Court Skeptical About Vermont Data Mining Law (Bellingham Herald) Lupin May Wait To Sell Birth Control Pills In The US (Bloomberg News) Merck And Biogen Expand Facilities In North... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4759043 Wed, 27 Apr 2011 11:54:02 +0100 4759043 http://www.medworm.com/index.php?rid=4724262&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeHY6DN5Y0og%2F Hard to believe, yes? But even we take a break now and then. While we have our laptop and Blackberry with us and will, periodically, check on interesting developments, regular posting will not occur this week. We apologize for any inconvenience, but we promised Mrs. Pharmalot and The Short People (that famous, non-existent ’60’s group) that we would focus on their desires. Meanwhile, we hope you enjoy any holidays that you may celebrate. Have a great time, everyone, and see you in a few days… Synthes Confirms Aquisition Talks With Johnson & Johnson (Bloomberg News) Will Amgen Declare A Dividend On Thursday? (Reuters) EU Proceeds With Plan To Cut Patent Costs By 80 Percent (Pharma Times) Merck Scientist Sees Potential HIV Vaccine As Distant Goal (Dow Jones) FDA Warns Patients Ove... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4724262 Mon, 18 Apr 2011 13:00:40 +0100 4724262 http://www.medworm.com/index.php?rid=4684757&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4DW4f4lkHe8%2F Whenever shareholders bemoan the fate of their investment in this or that drugmaker, invariably someone mentions that Fred Hassan should become ceo. Why? Fred has a brief, but if controversial track record of running companies and then selling to others. This happened when he ran Pharmacia, which was sold to Pfizer, and more recently with Schering-Plough, which is now part of Merck. But Fred is not the only one who knows how to flip a drugmaker. Let us introduce you to - or remind you of the existence of - Adrian Adams. Earlier this week, he notched a deal to sell Inspire Pharmaceuticals, where he is ceo, to Merck for $430 million, or $5 a share, a 26 percent premium at the time of the announcement. However, the stock was about $6 when he was hired in February 2010. For months after his a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4684757 Thu, 07 Apr 2011 15:46:48 +0100 4684757 http://www.medworm.com/index.php?rid=4664473&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCFkCzxDEPE8%2F File this under praying for relief. Several religious groups - including an order of Catholic nuns and a chain of Catholic hospitals - are pressuring a few big drugmakers to exercise some price restraint and have placed proposals that will be voted on during upcoming annual shareholder meetings. Such efforts are not new, but the latest attempt comes after one Wall Street analyst reported that prices for 130 best-selling brand-name drugs rose 6.9 last year, which was the biggest increase in a decade. For instance, a shareholder proposal in the Pfizer proxy from The Sisters of Charity of Saint Elizabeth, which is based in New Jersey, states that the cost of medicines has “skyrocketed in this country in recent years” and the “failure to control costs could undermine the goal... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4664473 Fri, 01 Apr 2011 12:37:46 +0100 4664473 http://www.medworm.com/index.php?rid=4658618&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZAJe68L6mfg%2F A federal jury rejected charges by GlaxoSmithKline that Abbott Laboratories with stifling competition and creating an illegal monopoly after more than quadrupling the price of its Norvir med, which is used in AIDS cocktails. However, Abbott was ordered to pay $3.4 million for breaching licensing contracts. This is a far cry from the $571 million that Glaxo sought in damages, though. Here’s the background: Abbott sells a combo pill called Kaletra that includes Norvir and its own protease inhibitor. Glaxo claims Abbott raised Norvir’s price - but not the Kaletra price - in 2003 in order to boost Kaletra sales at the expense of other protease inhibitors that require Norvir as a booster. In other words, Abbott allegedly tried to use Norvir to create an illegal monopoly (back story). Gl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658618 Wed, 30 Mar 2011 23:27:47 +0100 4658618 http://www.medworm.com/index.php?rid=4658624&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ft-aVCoVtrjA%2F Hard to believe, but that is the word from Challenger, Gray & Christmas, the outplacement consultants that track monthly changes in each industry. Their latest tally finds that job cuts in the pharmaceutical industry have fallen 87 percent, from 26,165 job cuts a year ago to 3,385 so far this year. This includes 960 planned layoffs announced in March. Consequently, the pharma biz no longer ranks near the top among industries that are laying off gobs and gobs of employees. For most of last year, the pharmaceutical industry had the unpleasant distinction of being the industy sector to consistently shed the largest number of people each month, trailing only the government sector. This time around, pharma did not even make the Challenger top ten (see the rankings here). Of course, jobs a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658624 Wed, 30 Mar 2011 12:52:37 +0100 4658624 http://www.medworm.com/index.php?rid=4653607&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVId4_w7jKkA%2F Yesterday, we wrote that California State Controller John Chiang sent a letter to Gilead Sciences to ask the drugmaker for a reduction in the price of Atripla, a key AIDS med. As it turns out, Chiang actually sent letters to a total of nine drugmakers, asking each of them to lower the prices on their AIDS meds and also extend supplemental agreements that were reached last year to relieve financial pressure on the AIDS Drug Assistance Programs around the country. The other drugmakers he wrote were Abbott Laboratories, Merck, Boehringer Ingelheim, Genentech, Bristol-Myers Squibb, Merck, Johnson & Johnson’s Tibotec unit and ViiV Healthcare, a joint venture between Pfizer and GlaxoSmithKline. In each case, Chiang wrote that California’s ADAP program has experienced a 257 percent ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4653607 Tue, 29 Mar 2011 11:51:03 +0100 4653607 http://www.medworm.com/index.php?rid=4636660&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_LncIHegHag%2F Normally, a high price for a medication prompts outrage and accusations from consumers, politicians, doctors and insurers. Now, though, there is the courtroom spectacle of an attorney for GlaxoSmithKline charging Abbott Labs with being greedy, stifling competition and creating an illegal monopoly after more than quadrupling the price of its Norvir med. The pill is used in AIDS cocktails. The background: Abbott sells a combo pill called Kaletra that includes Norvir and its own protease inhibitor. Glaxo claims Abbott raised Norvir’s price - but not the Kaletra price - in 2003 in order to boost Kaletra sales at the expense of other protease inhibitors that require Norvir as a booster. In other words, Abbott allegedly tried to use Norvir to create an illegal monopoly. A Glaxo lawyer told a ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4636660 Fri, 25 Mar 2011 13:27:32 +0100 4636660 http://www.medworm.com/index.php?rid=4631648&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLb25IzA8q8M%2F Good morning, everyone, and how are you today? Gloomy skies are hovering over the Pharmalot corporate campus again. Nonetheless, our spirits remain sunny. You know the refrain: ‘Every brand new day should be unwrapped like a precious gift.’ In other words, those meetings and deadlines may loom, but you will persevere. Meanwhile, please join us for, yes, that mandatory cup of stimulation and get ready to conquer the world. Have a good one and stay in touch… Merck Returns Blood Clot Drug to Portola (Reuters) Bayer Launches Melt-In-The-Mouth Impotence Pill In UK (Pharma Times) Abbott Settles HIV Drug Price Lawsuit With Pharmacies (Reuters) No Fracture Warnings Needed On OTC Heartburn Meds (Reuters) Canadian Access To Medicines Bill Stalls In Senate (Bridges Weekly) Amgen Say... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4631648 Thu, 24 Mar 2011 11:59:01 +0100 4631648 http://www.medworm.com/index.php?rid=4592694&cid=t_132556_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=4575245&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9SFnI_wDtgA%2F If music soothes the savage beast, what could music do for doctors? Back in the 1960’s, at least two drugmakers decided music was a good way to sell their meds to the prescription pad crowd. But there had to be a hook. And so both Merck and Abbott Labs had RCA Victor create custom-made LP’s featuring mood music, and the albums were given to docs in order to promote…mood-altering drugs. Get it? The other day, we wrote about a 1966 Merck LP, which was called ‘Symposium in Blues’ and featured songs by several blues artists in order to pitch the Elavil antidepressant (look here). As it turns out, three years earlier, there was ‘Music to Nudge You to Sleep,’ which featured Arthur Fiedler conducting the Boston Pops Orchestra. This collection was used to ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4575245 Fri, 11 Mar 2011 12:43:02 +0100 4575245 http://www.medworm.com/index.php?rid=4536448&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ffv2Jsa06fpQ%2F Some of the biggest drugmakers do not have a good track record when it comes time for FDA inspectors to visit their plants. Overall, the FDA found violations at 54 percent of plants inspected last year, up 20 percent from a decade low in 2007, according to data obtained from the agency by Bloomberg News. And 80 drugmakers failed more than half of their inspections. Who led the pack? Pacira Pharmaceuticals, which makes painkillers sold in hospitals, was the worst offender among publicly traded drugmakers with an 82 percent failure rate during 11 inspections. Abbott Labs failed 59 percent of 111 inspections; Pfizer flunked 57 percent of 202 inspections; Merck bombed out on 52 percent of 134 visits and Johnson & Johnson failed 48 percent of 161 inspections. By contrast Mylan passed 79 pe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4536448 Wed, 02 Mar 2011 15:14:42 +0100 4536448 http://www.medworm.com/index.php?rid=4536451&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FF1tWDgOPbVU%2F Hello, everyone, and nice to see you again. A mild and sunny day is unfolding here on the Pharmalot corporate campus, where the dogs are barking and a needed cup of stimulation is brewing. What does today hold in store? Meetings and deadlines, no doubt. We relate. So to help you along, we have gathered a few tidbits. Let us know if you come across something noteworthy yourselves. Meanwhile, have a good one… FDA Rejects MS Pill From Merck KGgA (Reuters) Roche Gets EU Backing For Avastin For Breast Cancer (MarketWatch) Celgene Discloses Fed Probe Of Cancer Drug Marketing (Dow Jones) Glaxo Offer To Pay Trainee Tuition Fees (BBC News) Glaxo HIV Drugs Not Tied To Heart Risks (Bloomberg News) Judge Rules Patent Settlement Documents To Remain Sealed (Dow Jones) Poor Health Literacy Leads To... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4536451 Wed, 02 Mar 2011 12:40:14 +0100 4536451 http://www.medworm.com/index.php?rid=4532568&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0FTiBAYhJQY%2F In December 2003, Abbott Labs raised the price of its Norvir AIDS drug, which is commonly used in HIV drug cocktails, by 400 percent, infuriating the AIDS community. But patients were not the only ones who were angered - GlaxoSmithKline, the Rite-Aid pharmacy chain and several wholesalers claim Abbott wanted to crowd them out of the market and a trial has just begun over $1.5 billion in damages. Abbott sells a combo pill called Kaletra that includes Norvir and its own protease inhibitor. The lawsuit claims Abbott raised Norvir’s price - but not the Kaletra price - in order to boost Kaletra sales at the expense of other protease inhibitors that require Norvir as a booster. In other words, Abbott allegedly tried to use Norvir to create an illegal monopoly over the market for protease inhib... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4532568 Tue, 01 Mar 2011 13:39:15 +0100 4532568 http://www.medworm.com/index.php?rid=4532571&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3ON0OinTH9Q%2F In what is being hailed as a victory for sales reps, the US Supreme Court has decided not to review lawsuits in which a lower court decided that Novartis and Schering-Plough should have paid overtime to its sales teams. The move means that still other lawsuits filed against several other drugmakers are likely to yield the same outcome, possibly prompting changes in the way sales reps are compensated (see the court denials here and here). Here’s the background: a federal appeals court last July ruled Novartis reps are not exempt from overtime provisions of the Fair Labor Standards Act and, therefore, should be paid overtime. The same court also upheld a similar decision reached two years ago against Schering-Plough by a federal court, which denied a motion to dismiss a case brought ag... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4532571 Mon, 28 Feb 2011 17:17:56 +0100 4532571 http://www.medworm.com/index.php?rid=4532574&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fbz21nVunmHE%2F Abbott Laboratories and its marketing of the Similac infant formula is again under a microscope. The latest episode involves a new mobile phone app that offers a plethora of tidbits and tools for tracking feeding schedules for babies (see this). And the app is getting some favorable reviews from some mommy bloggers (look here and here), but what is not evidently clear is that these moms were paid by a company doing work for Abbott. Now, not all of the reviews are entirely favorable, and the mom bloggers do appear to disclose that payment was received from a firm called Collective Bias, which describes itself as “an emerging media firm focused on the intersection of mobile/social media and social shopper marketing” (read here), although the moms insist their thoughts are their o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4532574 Mon, 28 Feb 2011 13:57:12 +0100 4532574 http://www.medworm.com/index.php?rid=4532575&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8ZP2dAScsyI%2F Good morning, everyone, and nice to see you again. We hope your weekend was refreshing. Now, of course, the time has come to resume the routine of meetings and deadlines. So please join us as we reach for our mandatory cup of stimulation and scan the news of the world. We hope your day goes well and do let us know if you come across anything interesting. Have a good one… Merck And Sanofi Animal Joint Venture Closing Delayed (Dow Jones) Fujifilm To Buy Merck’s Biotech Makers (AFP) Bayer Reports Loss On Schering Brand Writedown (Bloomberg News) Lilly Pays $337K Fine For Hazardous Emissions (Indianapolis Star) J&J Must Defend Kickback Lawsuit, Judge Rules (Bloomberg News) Congress Takes Up Major Changes In Patent Law (Associated Press) Teva Expects FDA To Reject Merck MS Drug... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4532575 Mon, 28 Feb 2011 12:57:40 +0100 4532575 http://www.medworm.com/index.php?rid=4512611&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCMkq7oeoOAY%2F A US appeals court has reversed a two-year-old jury verdict that found Abbott Labs had to pay $1.67 billion to Johnson & Johnson for infringing a patent on the Remicade arthritis treatment. The spat began when J&J’s Centocor Ortho Biotech unit and New York University filed a lawsuit in 2007, alleging Abbott’s rival Humira med infringed a patent relating to antibodies for treating rheumatoid arthritis. The appeals court, however, decided the Centocor patent was invalid and lacked an adequate written description. The patent “at best, describes a plan for making fully-human antibodies and then identifying those that satisfy the claim limitation,” the court wrote. “But a ‘mere wish or plan’ for obtaining the claimed invention is not sufficie... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4512611 Wed, 23 Feb 2011 17:39:28 +0100 4512611 http://www.medworm.com/index.php?rid=4512615&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuxeJeGTt4U8%2F Less than a month after announcing plans to eliminate 1,900 jobs, Abbott Labs is reorganizing its pharmaceutical unit and the head of the operation, Donald Patton, will retire next week. The reorg combines domestic and international pharma businesses into a “proprietary” division focusing on patented brand meds, and will be run by Carlos Alban, a senior vp for international pharma. Patton, 59, has been senior vp of US pharma biz since January 2010, but the unit has run into difficulties, such as the recent failure to win FDA approval for the Certriad cholesterol pill, which would have combined its own TriLipix with AstraZeneca’s Crestor. Development was then discontinued. And last month, Abbott disclosed plans to delay seeking FDA approval for a psoriasis med after receiving ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4512615 Wed, 23 Feb 2011 14:06:27 +0100 4512615 http://www.medworm.com/index.php?rid=4512617&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3sAMB9LDD1o%2F Rise and shine, everyone. Another day is on the way. And as usual, we are preparing by quaffing the mandatory cup of stimulation - our flavor today is Golden French Toast. We would also like to remind your that we are hosting a webinar on requirements for disclosing payments to physicians (please look here). Meanwhile, here are a few items of interest to help you on your way. We hope today is productive and you achieve your goals. Have a good one… Texas AG Wants Actos Marketing Documents From Lilly (Dow Jones) US Protests Canadian Drugmaker Insolvency Case (Dow Jones) Vertex Reports Significant Data For Cystic Fibrosis Drug (The Street) India Begins Review Of Foreign Takeovers Of Drugmakers (Economic Times) Takeda Pulls Pain Drug That Is Now Called Useless (Japan Times) CMO Consolida... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4512617 Wed, 23 Feb 2011 12:48:46 +0100 4512617 http://www.medworm.com/index.php?rid=4446034&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSZss_ZM6lJg%2F For the past few years, Abbott Laboratories has regularly mailed a survey to new moms about breastfeeding and the use of infant formula. The marketing move reflects a vested interest, since Abbott sells the Similac baby formula, which recently made headlines after beetles were discovered in one of its factories, prompting a recall (see this). The survey, however, comes from the National Institute for Infant Nutrition, a non-existent entity, which has caused a few quizzical moms to post questions and skeptical remarks on chat boards (look here and here). Not surprisingly, a few suspected the source was, in fact, an infant formula maker. “I think this is a front for the formula companies. They should just be honest about it, imo, and offer to send you free coupons,” wrote one mom... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4446034 Mon, 07 Feb 2011 14:29:48 +0100 4446034 http://www.medworm.com/index.php?rid=4436941&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpgW5SMkd_Ws%2F The US Department of Justice has decided to intervene - or join - a whistleblower lawsuit that was filed in late 2008 by three former Abbott Laboratories sales reps, who accused the drugmaker of concocting an illegal scheme to promote its Depakote seizure med. The charges include paying kickbacks to docs to boost prescriptions and, subsequently, defrauding Medicare and Medicaid. The fact that the feds are interested is not a surprise. In late 2009, Abbott disclosed in a Securities and Exchange Commission filed that the Justice Department ws investigating Abbott’s sales and marketing activities of the pill, which is used to treat bipolar disorder, seizures and migraines. The probe centers on possible violations of the Federal False Claims Act, the Food and Drug Cosmetic Act and the Anti-K... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4436941 Fri, 04 Feb 2011 13:35:45 +0100 4436941 http://www.medworm.com/index.php?rid=4429226&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHxI8Pbg08wY%2F What a difference a day can make. This morning, the latest employment tally issued by Challenger Gray & Christmas indicates the number of layoffs undertaken in January by drugmakers was eclipsed by a few other industries, such as finance, construction, aerospace and retail. For the first time in quite a while, the pharmaceutical industry did not make the top five among employers issuing pink slips. To be specific, the outplacement consultants counted 2,090 jobs cut last month, which is down from the roughly 3,500 positions eliminated in December and 4,900 cut in November, for instance. To some, this downtick may have been viewed as mildly heartening news. But then, of course, we recall the plans announced yesterday by Pfizer, which will elminate up to 3,500 jobs, including 1,100 at f... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4429226 Wed, 02 Feb 2011 14:11:45 +0100 4429226 http://www.medworm.com/index.php?rid=4424448&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4AV-BeRptIw%2F Once again affirming ongoing safety concerns about the anticipated widespread use of diet pills, the FDA issued a so-called Complete Response Letter for Contrave, a drug developed by Orexigen Therapeutics. The move comes less than two months after an FDA advisory panel recommended the pill for approval, but also voted in favor of requiring additional studies to gauge cardiovascular risks (back story). In disclosing the rejection, Orexigen ceo Michael Narachi disclosed the agency wants the drugmaker to conduct a randomized, double-blind, placebo-controlled trial. “We are surprised and extremely disappointed,” he says in a statement. Had the FDA approved Contrave, the pill would become the first new prescription diet drug to reach US consumers since 1999, when the FDA endorsed Ro... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4424448 Tue, 01 Feb 2011 13:30:49 +0100 4424448 http://www.medworm.com/index.php?rid=4419453&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXql_GCjRfw8%2F Welcome to the working week. We hope your weekend was refreshing and relaxing. Now, of course, the time has come to resume the routine of meetings and deadlines. To cope, we are, once again, armed with a cup of stimulation - our flavor today is chocolate raspberry truffle - and invite you to join us. Meanwhile, here are some interesting tidbits to begin the day. Hope your day goes well and do stay in touch. We enjoy hearing what goes on in your world… FDA OKs Novartis Meningitis Vaccine In Children, No Infants (Bloomberg News) Radiologist Wins $482M In Stent Patent Suit Against J&J (Star-Ledger of NJ) Pfizer Order To Pay $142M Over Neurontin Marketing Is Upheld (MarketWatch) Glaxo Settles Avandia Suit On Eve Of Trial (Bloomberg News) Dr. Reddy’s Gets Court Approval To Sell... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4419453 Mon, 31 Jan 2011 12:51:11 +0100 4419453 http://www.medworm.com/index.php?rid=4406034&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-seOemh4OKc%2F Once again, Maryland lawmakers are considering legislation that would ban drug and device makers from giving gifts to docs and other healthcare providers. The move comes after a sensational scandal in which a Baltimore cardiologist was allegedly influenced by Abbott Laboratories to perform numerous unnecessary stent procedures (see this and this about the parties at his house). Such laws already exist in Vermont and Massachusetts (read here and here), where payments to docs must also be disclosed. However, the bills caused considerable controversy, pitting drugmakers, doctors and restauranteurs against consumer and patient advocacy groups. Most likely, such a battle will play out in Maryland, as well. Maryland has considered this sort of legislation before, but without any results, as The... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4406034 Thu, 27 Jan 2011 13:42:27 +0100 4406034 http://www.medworm.com/index.php?rid=4406036&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQi1kO4OIQZc%2F Hello, everyone. And how are you today? Yet another pile of snow has descended on the Pharmalot corporate campus, where we have a shovel in one hand and a cup of stimulation in the other. Nonetheless, we will not be deterred from foraging for interesting news and assorted developments. And so here are a few tidbits to get us all started. Enjoy, and we hope your day goes well… AstraZeneca To Double Stock Buybacks Amid Drug Setbacks (Bloomberg News) Lilly Profit And Sales Beat Wall Street Forecasts (Reuters) Off-Label Prescribing To Children Is Widespread In Europe (PharmaTimes) FDA Denies Additional Indication For Glaxo’s Avodart (Reuters) Data Exclusivity Remains Hurdle To EU-India Free Trade Deal (Business Standard) Novartis Profit Falls And Vaccine Sales Slide (Bloomberg News... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4406036 Thu, 27 Jan 2011 12:56:53 +0100 4406036 http://www.medworm.com/index.php?rid=4399821&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpNBNg2yf5XM%2F Yet another big drugmaker is contracting its workforce. This time, Abbott Laboratories is cutting about 1,900 positions - or 6 percent of its US workforce - following a series of pipeline setbacks and what the drugmaker called a “challenging regulatory environment,” a reference to its inability to win FDA approval for various meds. The move is expected to save $200 million over the next few years (see statement). Last week, for instance, Abbott disclosed plans to delay seeking FDA approval for a psoriasis med after receiving word from agency staffers about safety concerns. There was also a disappointment last month when the FDA issued a Complete Response Letter for the Certriad cholesterol pill, which would have combined its own TriLipix with AstraZeneca’s Crestor. Develo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4399821 Wed, 26 Jan 2011 14:25:53 +0100 4399821 http://www.medworm.com/index.php?rid=4377787&cid=t_132556_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=4372244&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FR_sG6y_tNSQ%2F Once again, the FDA has issued a complete response letter for the controversial inhaled insulin device being developed by MannKind. Last March, the agency requested more safety data and, this time, is seeking info from two new trials - one with Type 1 diabetes patients and another with Type 2 diabetes patients. MannKind says the trials are already under way, but this could mean a two-year delay. The move is only the latest setback for MannKind, which some say is on a Quixotic quest to market a whistle-sized device called Afrezza. Along the way, the company with the not-so-modest name has also irritated some investors with a degree of hyperbole concerning interactions with potential partners and the FDA (see this). Nonetheless, elderly Los Angeles billionaire and philanthropist Alfred Mann... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4372244 Wed, 19 Jan 2011 22:14:12 +0100 4372244 http://www.medworm.com/index.php?rid=4372248&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fs5qKDqpGsjg%2F Drugmakers quarrel all the time, but generally, the choice language and harsh tones are saved for board meetings or court motions. Depomed ceo Carl Pelzel, however, is not shy about his feelings for Abbott Laboratories, which he accuses of reneging on a North American marketing deal to sell its drug to treat neuropathic pain. “We are perplexed by Abbott’s reluctance to adhere to their contract obligations given the in-depth market research previously undertaken regarding this product,” Pelzel complains. “We are disappointed that the product does not appear to fit into the Abbott commercial portfolio and that they have chosen to contest what we believe are clear and unambiguous contractual terms.” What are those terms? Depomed gets a milestone payment of between $3... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4372248 Wed, 19 Jan 2011 13:21:08 +0100 4372248 http://www.medworm.com/index.php?rid=4343328&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fy_nfZpM3GEM%2F A whistleblower lawsuit filed in 2002 has been unsealed and reveals that nearly two dozen drugmakers have been accused of selling unapproved prescription meds for years. Of course, such charges must still be proven, but the US Department of Justice did get involved in pursuing three other companies - Forest Laboratories (read here), Schwarz Pharma and Eon Laboratories - originally named in the lawsuit and reached settlements. What will happen from here is unclear. But for one other company, the DOJ has declined to intervene, or join, the lawsuit in pursuit of the rest of the drugmakers, including Abbott Laboratories, Actavis, Mylan Laboratories, Shire Pharmaceuticals, Watson Pharmaceuticals and Teva Laboratories. Nonetheless, the lawsuit offers some disturbing details in so far as that una... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4343328 Thu, 13 Jan 2011 23:30:41 +0100 4343328 http://www.medworm.com/index.php?rid=4343333&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxFzUNrUH_lU%2F In February 2005, a Houston hospital employee named Gayathri Murthy went to see a rheumatologist because she suffered from rheumatoid arthritis and signed up for a clinical trial in which she was given Humira, a widely used, big-selling biologic marketed by Abbott Laboratories. However, Murthy subsequently developed lymphoma, and has now filed a lawsuit against the drugmaker because she claims the warnings were inadequate. She contends that the information about side effects on the informed consent form she was provided was incomplete and misleading. And a video shown her painted a “rosy picture” and “lacked fair balance,” according to her lawsuit. In arguing her case, Murthy’s lawyer, Andy Vickery, maintains the Humira warning label noted that, in July 2004, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4343333 Thu, 13 Jan 2011 13:47:53 +0100 4343333 http://www.medworm.com/index.php?rid=4338267&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8rf99O1NZL4%2F Rise and shine, everyone. Another brand new day is on the way. And, not surprisingly, a spot of snow has descended on the Pharmalot corporate campus. But we were warned, after all. While we search for ways to dig out, here are a few items of interest. And of course, we hope your day is pleasant, even if you work from home. Enjoy and do stay in touch… Merck And Parexel To Develop Biosimilars (Reuters) Sanofi CEO Committed To Buying Genzyme (Boston Herald) Painkillers May Increase Risk Of Heart Attacks And Strokes (Bloomberg News) Lilly Alzheimer’s Med Study Has Patient With Brain Swelling (Reuters) Drugmakers Sue Czech Government Over Pricing (Pharma Times) Shingles Vaccine Lowers Risk By 55 Percent (Agence France Presse) Bayer To Enforce Property Rights After Humira Ruling (Blo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4338267 Wed, 12 Jan 2011 13:05:06 +0100 4338267 http://www.medworm.com/index.php?rid=4309852&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6G2WLJ5CltI%2F In a move hailed by consumer advocates, India has rejected a patent for an HIV med sold by Abbott Laboratories, because it was not deemed to be a novel invention (the Indian Patent Act does not permit patenting of incremental innovations). The decision is expected to give a significant boost to domestic generic drugmakers that are willing to make and sell lower-cost versions of the Kaletra protease inhibitor, which combines lopinavir and ritonavir, in India and developing countries. “The impact of the case is tremendous,” writes Tahir Amin, co-founder and director of the Intellectual Property Initiative for Medicines, Access & Knowledge in a note to us. His group fought to reject the Indian patent and he complained that Abbott has been “gaming the patent system&#8221... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4309852 Tue, 04 Jan 2011 13:04:39 +0100 4309852 http://www.medworm.com/index.php?rid=4285351&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsM8mIx_spwY%2F After meeting with FDA officials to review the recent rejection of its Lorqess diet pill, Arena Pharmaceuticals now plans to refile its application by the end of 2011. This means, of course, its drug probably not become available until 2012 and, by then, could well be the last of a new round of diet pills to arrive in pharmacies. Hardly a competitive advantage. You may recall that an FDA advisory panel voted 9-to-5 last September not to recommend approval for Lorqess over concerns the drug may cause tumors in rats and efficacy was marginal. Meanwhile, Vivus failed to win agency approval for its Qnexa pill over side effect issues (look here), although the same FDA panel more recently did endorse the Contrave drug from Orexigen Therapeutics (read this). The three-way race is being closely w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4285351 Thu, 23 Dec 2010 14:20:57 +0100 4285351 http://www.medworm.com/index.php?rid=4285352&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWExP1Mt3GvU%2F Normally, glucose test strips don’t land on many radar screens in a big way, but when a company recalls 359 million of them - that’s right, 359 million - it’s hard not to notice. But that’s exactly what Abbott Laboratories has done because its strips may give false low blood glucose readings. This, of course, can have serious implications, because false results may lead patients to try to raise their blood glucose unnecessarily, or fail to treat elevated blood glucose. The strips are marketed under such brand names as Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima, which were distributed in the US and Puerto Rico. How much this will cost Abbott is not yet clear. But the drug and device maker is still suffering from the fall... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4285352 Thu, 23 Dec 2010 13:16:11 +0100 4285352 http://www.medworm.com/index.php?rid=4285353&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fj_8GX6iXEFk%2F The holiday weekend may be in the offing, but the Pharmalot corporate campus is still humming. And why not? The world has not stopped spinning, after all, and there is always something interesting going on. So while you prepare for a celebration or simply slow down the usual pace, here are a few items to help you along. Meanwhile, we pass along holiday greetings and hope everyone has a chance to catch up on some fun things and enjoy life. See you soon… Cephalon Names Kevin Buchi As CEO (statement) Lundbeck Alcoholism Pill May Be A Goldmine (Bloomberg News) Novartis To Build Vaccine Plant In North Carolina (Raleigh News & Observer) FDA Reviews Safety Of Human Growth Hormone Drugs (Reuters) Pfizer And Bristol Bloodthiners Beats Sanofi Drug In Study (Bloomberg News) Massachusetts Award... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4285353 Thu, 23 Dec 2010 12:54:53 +0100 4285353 http://www.medworm.com/index.php?rid=4238144&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4Sh8Pl_eSsA%2F Could this be a record? Earlier today, Abbott Laboratories agreed to pay $126.5 million to settle charges of deliberately misreporting pricing info in order to hike reimbursements from Medicare and Medicaid (see this). A few hours later, Abbott agreed to pay $41 million to resolve criminal and civil charges that its Kos Pharmaceuticals unit engaged in kickbacks and off-label marketing; the deal also involves a deferred prosecution agreement. More than $38 million will cover civil allegations that Kos offered and paid illegal kickbacks to doc, other medical professionals, physician groups and managed care companies in the form of money, free travel, grants, honoraria and other goodies to persuade them to prescribe or recommend the Niaspan and Advicor cholesterol drugs. For instance, two do... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4238144 Tue, 07 Dec 2010 23:39:15 +0100 4238144 http://www.medworm.com/index.php?rid=4238145&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGuLviF9y5LA%2F In a surprise move, the FDA’s Endocrinologic and Metabolic Advisory committee voted 13-to-7 to recommend that Orexigen Therapeutics’ Contrave diet pill be allowed on the market. If the agency follows the advice, which is not guaranteed, Contrave would become the first new prescription diet drug to reach US consumers since 1999, when the FDA approved Roche’s Xenical. The panel, however, also voted 11-to-8 that additional studies are needed to ascertain cardiovascular risks. Nonetheless, the recommendation has the potential to drastically change the weight-loss market and, perhaps, put a dent in the burgeoning population of obese people, which has become a public health issue. Despite the clamoring for new diet tools, the same FDA panel earlier this year bounced two other n... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4238145 Tue, 07 Dec 2010 21:49:42 +0100 4238145 http://www.medworm.com/index.php?rid=4238146&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuW_5HEPTvp0%2F In the latest instance of pharmaceutical fraud, three companies - Abbott Laboratories, Boehringer Ingelheim’s Roxane Labs unit and B. Braun Medical - have collectively agreed to pay $421 million to settle charges that they deliberately misreported pricing info in order to hike reimbursements from Medicare and Medicaid. This is only the latest instance in which drugmakers have been tagged for rigging the average wholesale price charged federal healthcare systems. Numerous lawsuits and charges have been brought against nearly every large drugmaker by the feds and many states in recent years. With these settlements, the US Department of Justice has recovered more than $1.8 billion from drugmakers over pricing fraud. “By offering their customers one price and then falsely reporting... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4238146 Tue, 07 Dec 2010 17:40:50 +0100 4238146 http://www.medworm.com/index.php?rid=4233419&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfM8YgL3QPgc%2F By now, you may have heard how Abbott Laboratories celebrated the unusual achievements involving Mark Midei, a Baltimore cardiologist who two years ago managed to place 30 stents made by the drug and device maker in patients in just one day. This was a feat worthy of recognition - after all, how many docs can race from operating table to operating table as if they are playing speed pool? Never mind that, cumulatively, Midei placed stents in hundreds of patients who did not need them, which helped explain why he was setting records in the Baltimore area for such procedures. Last year, in fact, he was tossed from St. Joseph Medical Center in Towson, Md., where he headed cardiac catherization. He is now suing the hospital. But today, the US Senate Finance Committee released a report indicatin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4233419 Mon, 06 Dec 2010 16:58:34 +0100 4233419 http://www.medworm.com/index.php?rid=4233420&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FD4Bf0b4VGAE%2F Back in August 2008, a Baltimore cardiologist named Mark Midei reached new heights - he placed 30 stents made by Abbott Laboratories in patients in just one day. This was cause for celebration at the drug and device maker. Execs wrote laudatory e-mails. A sales rep spent $2,159 on a pig roast party at his home. And Midei later became a well-compensated consultant for Abbott. But there was a catch - he placed stents in hundreds of patients who did not need them, which helped explain why he was setting records in the Baltimore area for such procedures. Patient complaints prompted an internal investigation the St. Joseph Medical Center, which is located in Towson, Md., where Midei headed cardiac catheterization. These were followed by a series of articles in The Baltimore Sun (look here and h... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4233420 Mon, 06 Dec 2010 16:31:29 +0100 4233420 http://www.medworm.com/index.php?rid=4183538&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyBd3vLakqQw%2F First, some drugmakers caught the transparency bug. Now, a big regulator has been infected. As of next week, the European Medicines Agency will provide clinical trial data on request for every drug that has been reviewed, and hopes to publish reports on its web site within five years, according to Bloomberg News. The move came in response to a long-standing request from researchers at the Nordic Cochrane Centre for trial reports on three obesity drugs - Roche’s Xenical, Abbott Lab’s Meridia and Sanofi-Aventis’ Acomplia - in hopes of determining whether published data corresponded with the detailed reports submitted to the EMA, the news service continues. The researchers sought the reports in June 2007, just after an FDA panel rejected Acomplia over suicide concerns (see this). Th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4183538 Fri, 19 Nov 2010 14:01:16 +0100 4183538 http://www.medworm.com/index.php?rid=4119716&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_uKvTFMX99I%2F Rise and shine, everyone. Another day beckons. And this is a special one here on the Pharmalot corporate campus as the shortest of short people celebrates a birthday. An especially large cup of stimulation is in order…among other things. While we fuss, please enjoy these items and, of course, we hope your weekend is wonderful. Whether you pick a pumpkin, rake some leaves, read a book or enjoy a walk, do enjoy yourselves. See you soon… Glaxo Licenses Amicus Therapeutics’ Fabry Drug (Reuters) Sanofi-Aventis Buys A Chinese OTC Maker (Associated Press) Glaxo Cuts Prices In Indonesia By Up To 50 Percent (Reuters) Hepatitis C Is Fertile Field For Blockbusters (The Wall Street Journal) Supreme Court To Review Roche And Stanford Dispute Today (The Tech) AstraZeneca And Daiichi Sign $... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4119716 Fri, 29 Oct 2010 11:35:14 +0100 4119716 http://www.medworm.com/index.php?rid=4098462&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FofgMWGHYZdw%2F Today is the day that countless people - from the overweight to those overweighted in Arena Pharmaceutical stock - may learn whether the FDA will approve the drugmaker’s diet pill. Not every agency deadline is so closely watched, but this one is generating enormous attention for two reasons - diet pills have not fared well despite the rising rate of obesity and an unusual push by angry investors who believe the FDA unfairly reviewed the drug - which we were the first to report (see this). Last month, you may recall, an FDA advisory committee voted 9-to-5 that the risks of the Lorqess diet drug developed by Arena outweighed the benefits. The decision came after concerns about valvulopathy and, in particular, links to malignancies in rats at higher doses, which were revealed in FDA bri... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4098462 Fri, 22 Oct 2010 12:57:50 +0100 4098462 http://www.medworm.com/index.php?rid=4098464&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIAF1KmZPK2w%2F Good morning, everyone. The end of the week is rapidly approaching and that usually means one thing - daydreaming about weekend plans. We expect to catch up on a few chores, but will spend most of our time entertaining the shortest of short people with a little bowling and ice cream, and a trip to the book store. What about you? A drive in the country to watch the leaves change? Toss a football? Pick a pumpkin? Walk your own official mascots? Whatever you do, have a good time and be safe. See you soon… EMA Revises Stance On Genzyme’s Fabrazyme (Reuters) Wyeth Must Disclose Earlier Effexor XR Patent Settlements (New Jersey Law Journal) Amgen Exec Retires And Gets $400K Consulting Deal (SEC filing) FDA Adds Heart Warning To HIV Drug Combo (Associated Press) Roche And Biogen End D... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4098464 Fri, 22 Oct 2010 12:06:06 +0100 4098464 http://www.medworm.com/index.php?rid=4082333&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FmXWFiEHhuFU%2F Good morning, everyone. Nice to see you again. A spot of rain is falling here on the Pharmalot corporate campus, but our spirits are sunny just the same. After all, as the Morning Mayor used to say: Every brand new day should be unwrapped like a precious gift. So while you tug on the ribbon, please join us for a cup of stimulation and a bit of news. Hope your day goes well… Statins May Lower Colon Cancer Risk: Study (Associated Press) FDA Panel Rejects Dosing Restrictions On Anemia Meds (Bloomberg News) Mom Sues Abbott Over Beetles In Similac (Chicaco Business) Glaxo Strikes Alliance For Rare Disease Research (Dow Jones) Sanofi-Aventis Signs Reseach Deal With Harvard (PharmaTimes) UK Scraps Generic Substitution Plan (PharmaTimes) FDA Expands Use of Bristol-Myers’ Baraclude (Ass... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4082333 Tue, 19 Oct 2010 12:13:44 +0100 4082333 http://www.medworm.com/index.php?rid=4065613&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7xnycViW3MI%2F John Ziegler says the answer is no, but he believes Abbott Laboratories fired him in February 2006 from his job as a sales rep due to his age. At the time, he was 54 years old and so he subsequently filed a complaint with the US Equal Employment Opportunity Commission, which recently filed a lawsuit against the drugmaker. The complaint charges Abbott with “unfairly disciplining” Ziegler and “failing to properly acknowledge his successful sales performance.” And the drugmaker, the lawsuit goes on to claim, ultimately replaced Ziegler “with a less-experienced, less-educated, but much younger (then 34) sales representative who was not subjected to the same discipline and lack of acknowledgement as Ziegler.” We will update you with any reply from Abbott. UPD... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4065613 Wed, 13 Oct 2010 10:51:47 +0100 4065613 http://www.medworm.com/index.php?rid=4065614&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3ieT7tccico%2F No, AARP did not file a lawsuit. But the age-old advocacy group has signed on as co-counsel in an existing whistleblower lawsuit that was filed against Abbott Laboratories, Johnson & Johnson and Boston Scientific for allegedly off-label marketing of metal biliary stents. The suit was filed in 2006 by Kevin Colquitt, a former sales rep and manager for Guidant, which was bought by Abbott. In his suit, Colquitt charged the stents were incorrectly placed in older patients to treat vascular disease, but were not approved by the FDA for that purpose. The suit also contends the device makers made false statements to the FDA that the stents were intended for cancer patients with biliary blockages, and were marketed to docs as vascular stents, also without FDA approval (read the lawsuit here).... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4065614 Wed, 13 Oct 2010 10:51:34 +0100 4065614 http://www.medworm.com/index.php?rid=4055957&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAN4d2O3u9_g%2F The decision late last week by the FDA to encourage Abbott Laboratories to withdraw its Meridia diet pill has obvious implications for other drugmakers seeking approval for obesity drugs. But will those companies gain or lose? The answer will depend on the extent to which the FDA sees the need to offer more options to fight fat while weighing (pun intended) pressing safety concerns. On one hand, there are few options available to overweight Americans: Roche’s Xenical, which is also sold over-the-counter by GlaxoSmithKline as Alli, and phentermine, the surviving half of the infamous fen-phen weight-loss cocktail (the other half, fenfleuramine, along with a chemically related pill were both recalled in 1997 due to serious heart and lung side effects). But these are only modestly effect... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4055957 Mon, 11 Oct 2010 12:53:29 +0100 4055957 http://www.medworm.com/index.php?rid=4045395&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FB2c40euP3Jc%2F And so another work week will soon draw to a close. Not a moment too soon, yes? Any special plans in the offing? A weekend drive in the country? Think of all the apples waiting to be picked. For our part, we hope to catch up on some chores and spend time with our short people; they shouldn’t feel neglected. Whatever you do, have a nice time. Meanwhile, here are a few items of interest to help you round out the week. Enjoy… Who Kidnapped The Pharmaceutical Delivery Driver? (The Los Angeles Times) Sanofi Denies Offering Genzyme A Takeover Price Range (The Street) Abbott Pulls Meridia From Australia (Sydney Morning Herald) Targacept ADHD Drug Fails In Study (Associated Press) Novartis Unveils Pricing For New MS Drug (Dow Jones) apple pic thx to muffet on flickr creative commons (S... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4045395 Fri, 08 Oct 2010 12:12:38 +0100 4045395 http://www.medworm.com/index.php?rid=4040793&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMkF6JZmLfI8%2F There is no shock that layoffs continue, is there? In the past few months, several drugmakers disclosed plans to reduce staff or continued with previously announced cuts. Among them has been Abbott Laboratories, Bristol-Myers Squibb, Endo Pharmaceuticals, Lundbeck, Lonza, and Johnson & Johnson, among many others. And so the latest monthly tally of pharma layoffs amounts to 6.069 industry jobs lost in September, compared with just 200 in August, according to Challenger, Gray & Christmas, the outplacement consulting. Nonetheless, the industry has shed 43,334 jobs this year, which appears on track to nearly match the 58,583 that were eliminated last year (you can read the latest report here and the last monthly survey here). The only sectors to throw more people overboard so far th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4040793 Thu, 07 Oct 2010 12:07:33 +0100 4040793 http://www.medworm.com/index.php?rid=4036950&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FoXA-DZUmgEk%2F Hello, everyone. It is truly a pleasure to see you again. We apologize for the service disruption of the past two days. Unfortunately, there were those proverbial technical difficulties that were well beyond our control. Now, though, we have returned and hope to provide you with the usual flow of tidbits that will feed your habit. Meanwhile, have a nice evening… UK’s NICE To End Curbs On Alzheimer’s Drug (Reuters) The Incredible Shrinking US Biotech Sector (Bloomberg News) Bayer Bets On Sex Drug For Older Women (Agence France Presse) Pfizer Reviews Alternatives For Capsule Unit (Associated Press) Merck To Investo $30M In Netherlands Production Line (Dutch News) InterMune Sells Hepatitis C Drug Rights To Roche (Dow Jones) Novartis Jury Decides Whether Novartis Hid Bone-Dru... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4036950 Wed, 06 Oct 2010 23:51:13 +0100 4036950 http://www.medworm.com/index.php?rid=4003437&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLo0iD8kmVyw%2F What a difference a week can make. That’s the point of a letter written to Abbott Laboratories by Tom Harkin, an Iowa Democrat, who chairs the Senate Health, Education, Labor and Pensions Committee, after it was learned the drugmaker discovered beetles in a Michigan factory where its Similac powdered infant formula is made,, but took a week to launch a recall. Last week, Abbott began recalling 5 million units after reports by two consumers of contamination. Supposedly, extensive testing found 99.8 percent of products did not show signs of contamination, but Abbott bolstered its call centers and expanded the bandwidth of its websites to contend with an outpouring of consumer concern. The recall will cost Abbott about $100 million in lost sales. Meanwhile, Saudi Arabia’s Food and... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4003437 Mon, 27 Sep 2010 12:26:58 +0100 4003437 http://www.medworm.com/index.php?rid=3999296&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fj1je8kub4nc%2F And the job cuts just keep on coming. Less than two years after slashing 10 percent of its workforce, Bristol-Myers Squibb now plans to eliminate 3 percent of its headcount in the next few months, according to an email that Bristol-Myers ceo Lamberto Andreotti wrote to employees this morning. “We’ve initiated a streamlining project,” a spokeswoman confirms, who says the reduction is not targeted at any one area or country. “This is something we’ve just begun undertaking. It’s a global initiative.” The drugmaker employs about 28,000 currrently, which means 840 or so jobs will go. This is only the latest in an ongoing series of cutbacks by major drugmakers. In the past year, Merck, Pfizer, Sanofi-Aventis, Eli Lilly and Abbott Laboratories have all a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3999296 Thu, 23 Sep 2010 21:03:54 +0100 3999296 http://www.medworm.com/index.php?rid=3994343&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJSN3QSy3_u0%2F Good morning, folks. Another shiny day is emerging as we hustle the short people off to the local schoolhouse and busy ourselves with the news of the world. Speaking of which, the House passed a bill that would ban corporate execs from doing business with Medicare and Medicaid if their companies were convicted of fraud (take a peek). Now, though, the time has come for a cup of stimulation. Please join us, and have a great day… Merck Will Review Planned Facility Closing (Radio Netherlands) Perils For Pill Pushers (The Financial Times) FDA Finds Risk In Glaxo Rotarix Vaccine Data (Reuters) European Parliament Endorses Drug Monitoring Rules (PharmaTimes) Clinical Trials In Russia & Eastern Europe Fell In 2009 (OutsourcingPharma) Fake Avastin Hurts 61 People (Shanghai Daily) Abbott ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3994343 Thu, 23 Sep 2010 12:03:27 +0100 3994343 http://www.medworm.com/index.php?rid=3981016&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnhV0EShxyos%2F After an especially nasty boardroom spat spilled into public view this month, Elan has reached a deal with a pair of dissident board members, who wanted to conduct their own corporate governance audit and threatened a lawsuit that the beleaguered biotech had to race to court to block (back story here). At issue were several transactions that raised questions about undisclosed financial conflicts of interest among Kelly Martin, the embattled Elan ceo, and still other board members. The revelations were not a secret - they were publicized by a dissident shareholder who went so far as to create a web site this year for agitators called Save Elan (read more here). In response to these developments, Martin earlier this month issued an extraordinary, 18-page letter touting his accomplishments an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3981016 Fri, 17 Sep 2010 12:43:15 +0100 3981016 http://www.medworm.com/index.php?rid=3976710&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FT-EWnRbXh7I%2F At first blush, diet pills appear to be all the rage these days. There are no fewer than three new obesity drugs that have generated enormous interest - among investors and patients - this year. And for awhile, the anticipation has suggested this troubled market - which has been littered with recalls, litigation and limited effectiveness - may finally generate real progress. Recently, though, there has been as much concern as optimism. Two months ago, an FDA advisory panel voted against marketing approval for Vivus’ Qnexa pill over worries about usage by pregnant women and psychiatric side effects (back story). [Yesterday, another panel couldn't decide whether to yank Abbott Labs' much older Meridia drug, which is linked to cardiovascular risk, or issue stronger warnings]. Today, an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3976710 Thu, 16 Sep 2010 14:00:06 +0100 3976710 http://www.medworm.com/index.php?rid=3973108&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeGtWp6_IEtQ%2F Don’t you hate it when someone can’t made up their mind? How about an entire FDA advisory panel? That’s exactly what happened this afternoon when an FDA committee voted 8-to-8 after being confronted with the thorny question of what to do about Abbott Labs’ Meridia diet pill. Even though a recent trial called SCOUT showed Meridia patients with heart disease had a 16 percent higher chance of developing cardiovascular risks compared with those on a placebo, the Endocrinologic and Metabolic Drugs committee was, ultimately, unable to muster enough votes to decide whether the drug should be allowed to remain on the market or recommend withdrawal. The breakdown: eight members voted to keep Meridia on the market, although they also 8 agreed the pill should have a boxed warn... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973108 Wed, 15 Sep 2010 23:18:09 +0100 3973108 http://www.medworm.com/index.php?rid=3973111&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsNp0T-pISJQ%2F Since working dad best describes our place in the world, we do not pretend to know what all working moms want from their employers. So we dutifully glanced at Working Mother magazine to learn that several drugmakers - 11, in fact - made the latest list of the 100 best employers in the land. Which ones? Abbott Labs, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Genentech, Johnson & Johnson, Merck, Novo Nordisk, Pfizer and Sanofi-Aventis. A notable exception is Novartis, which made the 2009 list (see here), but has since gained some notoriety for agreeing to pay a combined $402 million to settle a pair of embarassing class-action lawsuits brought by female employees who claimed the drugmaker engaged in a pattern of discrimination involving pay, promotion and pregna... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973111 Wed, 15 Sep 2010 15:33:26 +0100 3973111 http://www.medworm.com/index.php?rid=3973117&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fb2h0UB6N-As%2F Rise and shine, everyone. Another day is upon us. But this is a good thing. As one of our favorite sages, the Morning Mayor, used to say: Every brand new day should be unwrapped like a precious gift. While you tug on the ribbon, we will brew the mandatory cup of stimulation and poke around for interesting items. Here, in fact, are a few to help you get started. Have a good one and stay in touch… Roche Rules Out Merging R&D With Genentech (Reuters) Abbott To Close Canadian Baby Formula Plant (Brockville Recorder & Times) China’s BGI And Merck Form Alliance (Bio-IT World) Abbott Fights To Keep Meridia Diet Pill On The Market (Reuters) K-V Pharmaceutical Secures A $20M Loan (Fox Business) Genentech CEO Resigns From Dendreon Board (Xconomy) Cell Therapeutics Appeals FDA R... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973117 Wed, 15 Sep 2010 11:51:18 +0100 3973117 http://www.medworm.com/index.php?rid=3965695&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrIq-yS7snsQ%2F In response to US pricing of the Norvir AIDS drug sold by Abbott Laboratories, an advocacy group plans to petition the National Institutes of Health this month to break several patents on the drug. The forthcoming move by Knowledge Ecology International comes six years after the group failed at a similar attempt to convince the agency to override patents held by the drugmaker on the grounds that a recent 400 percent price hike was unreasonable, anticompetitive and threatened the health and safety of people with AIDS (here is the 2004 petition and the NIH denial). In a recent report, however, KEI notes that for patients without some form of government assistance or insurance, Norvir continues to cost much more than in other countries, both those are that considered developed and less-devel... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965695 Tue, 14 Sep 2010 12:13:13 +0100 3965695 http://www.medworm.com/index.php?rid=3965699&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU6W3fLZnEss%2F Eight months after their European counterparts told doctors to stop prescribing Abbott Labs’ Meridia diet pill, the FDA will now ask an advisory panel meeting this Wednesday whether the drug should be withdrawn from the US market. At issue are cardiovascular risks highlighted in a trial called SCOUT that was released last November, which showed Meridida patients with heart disease had a more than 11 percent risk of cardiovascular risks compared with 10 percent of those on a placebo. Since then, the FDA has been criticized for not moving faster, although the agency had preferred to wait for full results to be issued. And so the advisory committee can now choose among four options: besides recommending withdrawal, the experts can urge continued marketing with the same labeling; continu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965699 Mon, 13 Sep 2010 16:40:54 +0100 3965699 http://www.medworm.com/index.php?rid=3965704&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0BKEg-uDqt0%2F Hello, everyone. Nice to see you again. We hope you enjoyed the weekend, which amounted to an extended break, in our case. In any event, the routine has now returned and, of course, we are brewing the mandatory cup of stimulation to help us along. Please join us with a cup of your own, or a water bottle, perhaps, we scan the news of the world. Have a great day and stay in touch… IRB Delays Frustrate Investigators (OutsourcingPharma) India Becomes A Hub For Counterfeit Meds (The Washington Post) Genzyme Sells Genetics Unit For $925M To LabCorp (Associated Press) An Eli Lilly Scout Discusses Social Media (140conf) AstraZeneca And UCL Sign Stem Cell Deal (The Guardian) Hopes Fade For Roche And Ipsen Diabetes Drug (Reuters) Mcgarrybowen Wins Creative Duties On Pfizer Advil Account (AdWee... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965704 Mon, 13 Sep 2010 11:56:12 +0100 3965704 http://www.medworm.com/index.php?rid=3946685&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUaWD5R0p9l4%2F Earlier this week, a behind-the-scenes brawl between at least two Elan board members and the rest of the directors, including CEO Kelly Martin, erupted into public view. At issue is corporate governance, but more specifically, a series of deals in which accusations of undisclosed conflicts of interests were raised concerning Martin and several board members. The dissident board members - Vaughn Bryson, a former Eli Lilly ceo, and Jack Schuler, a former president at Abbott Laboratories - hired their own law firm to conduct an independent review, but Elan raced to court and received a one-week injunction to stop them. Elan claims the separate review will undermine its own examination, a curiosu position because it contradicts the role of independent board members. Bryson and Schuler could no... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3946685 Wed, 08 Sep 2010 15:32:35 +0100 3946685 http://www.medworm.com/index.php?rid=3943030&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3hInnF9Llts%2F Welcome back, everyone. We hope your weekend was splendid and you had a chance to recharge. The weather, after all, was magnificent. Now, of course, the time has come to return to the routine. So as you brace for those meetings and deadlines, please join us as we reach for our treasured cup of stimulation and dig in for another day. Hope yours goes well. And do stay in touch… Glaxo Will Not Bid For Genzyme (Reuters) The Problem With Gardasil (Fortune) Abbott Signs R&D Deal With Israeli Science Office (Globes) A Painful Summer For J&J CEO Bill Weldon (Fortune) Actus And Sequoia To Sell Stake In Paras (Bloomberg News) Genzyme Job Cuts To Follow Takeover (The Boston Globe) Roche Strikes Deal For Alzheimer’s And Parkinson’s Drugs (Reuters) AstraZeneca Signs Emerging... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3943030 Tue, 07 Sep 2010 11:52:27 +0100 3943030 http://www.medworm.com/index.php?rid=3933265&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaKrQUrCNzEU%2F Good morning, everyone. How are you today? Slowing down just a bit, perhaps? Here in the states, of course, a three-day weekend is fast approaching. And so we will pull in the sidewalks early. We hope you have the opportunity to do the same. Meanwhile, here are a few nuggets to help you close out the week. Whatever you do over the next few days, may it be enjoyable. Cheers… Celldex Says Pfizer Ends Cancer Vaccine Deal (Reuters) Allergan Steps Up Overseas Clinical Trials (CBS News) Novartis Experimental Malaria Drug May Be First In 30 Years (Bloomberg News) Abbott Cancels Sale Of Solvay Vaccines Unit (The Wall Street Journal) Accenture And ICRI Partner On Indian Clinical Research Training (Outsourcing Pharma) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3933265 Fri, 03 Sep 2010 12:02:08 +0100 3933265 http://www.medworm.com/index.php?rid=3929457&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDY75SsEr9v8%2F After months of waiting, the final and complete results from a study about the Meridia diet pill are now available in The New England Journal of Medicine and the findings are as bad as what was suggested by the preliminary data released last November. The SCOUT study, which was financed by Abbott Labs, the company that sells the pill, shows Meridia raised heart attack and stroke risk in patients with pre-existing heart disease (read the abstract). The study examined nearly 10,000 people 55 and older with pre-existing cardiovascular disease, type 2 diabetes or both, who were given Meridia or a placebo. They also participated in a diet and exercise program. On average, Meridia was taken for more than three years and the risk of a heart attack or stroke was 16 percent higher. Those taking the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3929457 Thu, 02 Sep 2010 12:17:27 +0100 3929457 http://www.medworm.com/index.php?rid=3831556&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7PdyP6SApPE%2F Eight months after their counterparts in Europe told doctors to stop prescribing the Meridia diet pill, the FDA has finally scheduled an advisory committee meeting to review safety risks. A spokesman for Abbott Labs, which sells the drug, confirmed the Endocrinologic and Metabolic Drugs advisory committee will review Meridia on Sept. 15, a day before Arena Pharmaceuticals’ lorcaserin is reviewed. The move comes in the wake of a trial known as SCOUT, which emerged last November and showed an increased risk of serious, non-fatal cardiovascular events, such as stroke or heart attack, when comparing the drug with a placebo among nearly 10,000 patients. The trial was designed to assess the impact of weight loss on cardiovascular problems in a large group of overweight people taking the pi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3831556 Fri, 06 Aug 2010 20:00:39 +0100 3831556 http://www.medworm.com/index.php?rid=3758106&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDjg7tRYJ3HQ%2F What will it take to convince a panel of experts that a diet pill is safe, not just effective? Vivus is the latest company to fail to come up with an answer. An FDA advisory committee today voted 9 to 7 to reject its Qnexa pill, which was effective in clinical trials, but worried panelists about usage by pregnant women and psychiatric side effects. These concerns were raised by agency medical reviewers (look here), given that diet drugs are widely expected to be used on a long-term basis. The outcome contradicts what some Wall Street analysts were cautiously predicting - a vote in favor of recommending approval, albeit with labeling and marketing restrictions, which would have made Qnexa the first new prescription diet pill in more than a decade. However, this has been a three-way race. Tw... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3758106 Fri, 16 Jul 2010 02:14:15 +0100 3758106 http://www.medworm.com/index.php?rid=3750275&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQ3eBZlyjWkI%2F The California Supreme Court has overturned a lower court decision that dismissed a price-fixing lawsuit brought by a group of pharmacies. They had charged the largest drugmakers agreed to set artificially high prices, and acted in concert to restrain reimportation of their lower-priced foreign drugs into the US and restrict price competition from generics. As a result, the drugmakers were able to maintain prices 50 to 400 percent higher than for the same drugs sold outside the US. The drugmakers - which included Abbott Labs; AstraZeneca; Novartis; Allergan; Boehringer Ingelheim; Eli Lilly; Johnson & Johnson; Janssen Pharmaceutica; Ortho McNeil; Ortho Biotech; GlaxoSmithKline; Pfizer; Hoffman-LaRoche; Aventis Pharmaceuticals; Amgen; Purdue Pharma; Merck; Bristol-Myers-Squibb, and Wyeth - a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3750275 Tue, 13 Jul 2010 12:03:55 +0100 3750275 http://www.medworm.com/index.php?rid=3746989&cid=t_132556_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=3740825&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7g1p0YcWa0c%2F Some companies will overwhelm you with documents during litigation. Others destroy them. Glenmark Pharmaceuticals, one of India’s large generic drugmakers, is in that second category. We know because the company was sanctioned by a federal judge for destroying more than a year’s worth of potential evidence that could have factored into patent litigation with Abbott Laboratories and Sanofi-Aventis over plans to introduce a generic version of a blood pressure med known as Tarka. In fact, Glenmark produced just three e-mails in response to discovery requests for an entire year’s worth of material and allegedly engaged in a “systematic document destruction policy,” in which documents and e-mails were retained on company servers for only one month. The ruling, whic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3740825 Fri, 09 Jul 2010 12:46:39 +0100 3740825 http://www.medworm.com/index.php?rid=3733296&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKt1cB4vPm9Q%2F Last week, the American Journal of Cardiology published a paper that carried a curious title: “Linguistic Analysis of In-Office Dialogue Among Cardiologists, Primary Care Physicians, and Patients With Mixed Dyslipidemia.” In short, this examined the discussions between 24 doctors - 12 cardiologists and 12 primary care physicians - and 45 patients who were diagnosed with high cholsterol. The subject of their chat? Treatment with Niaspan, a drug sold by Abbott Labs. The paper found docs didn’t do well discussing the problem and their patients are poor listeners. And the study made an interesting observation - that only one doc noted Niaspan will improve HDL and offer protection from heart blockages or development of plaque in the arteries. However, as CardioBrief pointed ou... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3733296 Wed, 07 Jul 2010 12:55:19 +0100 3733296 http://www.medworm.com/index.php?rid=3721962&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcFjj9pHrjGk%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is something that’s become a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Datatrial promoted Scott Vogelsberg to communications manager, giving him responsibility for the company’s marketing, public relations and social media efforts. Before joining Datatrial, he was senior creative strategi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3721962 Fri, 02 Jul 2010 12:09:32 +0100 3721962 http://www.medworm.com/index.php?rid=3721963&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvbID8-KEIdg%2F And so another working week will soon draw to a close. Although this will be a long holiday weekend here in the states. Have anything special planned? So many choices, yes? Perhaps a drive in the country or a day at the beach is in order. As for us, we expect to attend a backyard soiree or two, tune up the treadmill, catch up on some reading and quaffe a beverage with Mrs. Pharmalot. Whatever you do, have a great time and stay safe. See you soon… Lilly To Acquire Alnara Pharmaceuticals (see statement) Sanofi-Aventis Plans A Big US Acquisition (Bloomberg News) Ranbaxy Shifts Discovery Operations To Daiichi (Dow Jones) UK’s NICE Rejects Novartis Kidney Cancer Drug (Reuters) UK Criticized Over Glaxo Flu Vaccine Deal (The Mirror) Abbott’s Top Pharma Exec Resigns (Crain’... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3721963 Fri, 02 Jul 2010 11:54:25 +0100 3721963 http://www.medworm.com/index.php?rid=3718695&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRnVigrnX3FU%2F Since the passage of the False Claims Act in 1986, the federal government has recovered about $22 billion through qui tam, or whistleblower lawsuits and a fair number of these have emanated from the pharmaceutical industry. An untold number of such lawsuits are always in the wings, as people who work with or for drugmakers attempt to expose alleged wrongdoing. There have been accusations that some whistleblowers are only in it for the money (see this), but life as a whistleblower has its challenges (see here). And so concerned that the pharmaceutical industry may not be doing enough to educate employees about whistleblowing protection, US Senator Chuck Grassley has written 16 big drugmakers to provide information about their programs. The letters went to Abbott Labs, Amgen, AstraZeneca, Br... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718695 Thu, 01 Jul 2010 14:34:30 +0100 3718695 http://www.medworm.com/index.php?rid=3710798&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPlw3NtaReH4%2F Top of the morning to you. Another balmy day here on the Pharmalot corporate campus, where an usual quiet has set in now that the short people are busy with their summer activities. We are keeping busy, of course, sifting through documents. And you? Projects and meetings beckon, no doubt. To cope, please join us for a cup of stimulation and a peek at a few interesting items. Have a nice day, everyone… Bayer Drops One Patent Infringement Case Over Yaz (Reuters) Novartis Can’t Force Alcon Merger (PharmaTimes) Teva Gets FDA OK For Generic Effexor XR (Reuters) UK’s NICE Reverses Decision On Rheumatoid Arthritis Meds (PharmaTimes) Speeding Clinical Trial Recruitment With E-records (Outsourcing Pharm) Abbott Puts Solvay Flu Biz Up For Sale (The Wall Street Journal) Taro Pharma ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3710798 Tue, 29 Jun 2010 11:45:35 +0100 3710798 http://www.medworm.com/index.php?rid=3691111&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FabPp1SIe2UY%2F A new study that finds low testosterone is much less common in older men than previously thought - and is closely identified with just nine specific symptoms - may cause physicians and patients to rethink their use of various elixirs. Take AndroGel, for instance. The salve is cleverly promoted on an unbranded web site called ‘Is It Low T?,’ which features a quiz. The site lists various symptoms and risks purported to be associated with the condition, although some do not match what was noted in the study, which was published last week in The New England Journal of Medicine. The study found that only 2 percent of men aged 40 to 80 suffer from the condition, which is also called male menopause, andropause or late-onset hypogonadism. The researchers measured testosterone levels in... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3691111 Wed, 23 Jun 2010 19:20:49 +0100 3691111 http://www.medworm.com/index.php?rid=3691115&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FgQcbNg-vDTc%2F Hello, everyone. Nice to see you again. Another sunny day here on the Pharmalot corporate campus and this can mean just one thing - a celebration with a deserved cup of stimulation. We invite you to join us. And as you do, please enjoy the smattering of world news accumulated below. Have a great day and stay in touch… Connecticut Subpoenas CVS Over Drug Program (Reuters) Dr. Reddy’s Expects Orders From Merck And Abbott (Economic Times) Sanofi Fights Counterfeiting In Egypt (InPharma-Technologist) Genentech Wins Another Approval For Lucentis (San Francisco Business Times) A Closer Look At The Biovail-Valeant Merger (Seeking Alpha) Piramal To Share Abbott Payout With Employees (Economic Times) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3691115 Wed, 23 Jun 2010 12:01:01 +0100 3691115 http://www.medworm.com/index.php?rid=3683872&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEPyViqp86VU%2F And the answer is…. GlaxoSmithKline, which led its counterparts in a host of variables that formed the second-ever Access to Medicine Index. European drugmakers, in fact, bested US rivals in making medicines available to people in developing countries, although the foundation that runs the project says this lead is shrinking. The index is designed to offer investors a way to compare pharma’s social responsibility records by measuring 106 indicators that examined activities across seven criteria such as philanthropy, patents, pricing and management (see more here). The latest report - the first was issued in 2008 - covers 27 companies, including 20 brand-name drugmakers and seven generics manufacturers, which have their own list and was topped by Ranbaxy Labs, now owned by Daiic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3683872 Mon, 21 Jun 2010 12:45:18 +0100 3683872 http://www.medworm.com/index.php?rid=3666225&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPxIkfIQXUvo%2F Good morning, everyone. Nice to see you again. Another shiny day here on the Pharmalot corporate campus, where we are recovering from the latest installment in our ‘Let’s See Them Before They Die‘ concert series. Accordingly, we are brewing multiple cups of stimulation. Meanwhile, here are a few items to help you get started yourselves. Hope your day goes well and catch you later… Sanofi-Aventis To Cut More Costs, Sales Force (Bloomberg News) Abbott And Neurocrine Sign Deal For Endometriosis Drug (Reuters) Cipla Signs Chinese Partner To Make Biosimilars (Bloomberg News) Sanofi-Aventis Buys Canderm Pharma (Montreal Gazette) The New World Order In R&D (InPharm) USDA Approves Vaccine For Dog Flu (Los Angeles Times) Amylin Stock Hit On Bydureon Data (Reuters) Pfize... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3666225 Wed, 16 Jun 2010 12:03:56 +0100 3666225 http://www.medworm.com/index.php?rid=3662932&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FioCvk6N5dh4%2F In a victory for sales reps, a federal court judge has ruled Abbott Lab reps are not exempt from overtime provisions of the Fair Labor Standards Act and, therefore, should be paid overtime. The ruling, which came in the form of a summary judgment and is now headed to trial to determine damages for about 80 Abbott reps, is the latest in a highly contentious decision that has divided courts across the country and, some lawyers speculate, could eventually reach the US Supreme Court. The FLSA’s overtime compensation requirement doesn’t apply to employees who work as outside salespeople, but the law does require employers to pay overtime for hours worked beyond 40 hours a week, unless a FLSA exemption applies. What are those exemptions? If an employee’s primary duty is to obtain orders or... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3662932 Mon, 14 Jun 2010 19:17:28 +0100 3662932 http://www.medworm.com/index.php?rid=3659158&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNM47jZabUxw%2F Welcome to the working week. We hope the weekend was refreshing and restful. Now, of course, the time has come to resume the usual routine of meetings and deadlines and what-not. Are you ready? If not, grab a cup of something stimulating and scan the news of the world. What better way to get started? So dig in and have a good day, everyone. Catch you soon… Human Genome Concedes Hep C Drug Approval Is Unlikely (TheStreet) Bayer’s Nexavar Fails Phase III Lung Cancer Trial (Reuters) Glaxo Gets Complete Response Letter For MenHibrix (PharmaTimes) Debating Anti-Counterfeiting Technology In Nigeria (234Next) Dr. Reddy’s Blocked From Launching Version Of Allegra (Business Standard) Abbott Lays Off 120 Workers In California (North County Times) New KV Pharma Board Ousts CEO (St. ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3659158 Mon, 14 Jun 2010 11:41:48 +0100 3659158 http://www.medworm.com/index.php?rid=3629870&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuuoSiaC2UfA%2F And so another working week is about to draw to a close. And not a moment too soon, yes? What are your plans this weekend? A trip to the beach? A stroll in the park? Running around with your own short people? As for us, we have a full menu that includes yet another lacrosse tournament and showing off the newest Pharmalot mascot. Time is also alotted for the official Pharmalot nap. Whatever you do, have a great time and see you soon… Ranbaxy Recalls Painkillers In The UK (Bloomberg News) Hormone Patch May Be Safer For Women: Study (Reuters) Pfizer Recalls Products Made By Claris (Dow Jones) J&J Misled Pennsylvania On Risperdal Risks (Bloomberg News) Abbott Wins FDA Approval For Ovarian Cancer Test (Medill Reports) Merck Creates Collaboration For Cancer Research (The Star-Ledger) ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3629870 Fri, 04 Jun 2010 11:20:55 +0100 3629870 http://www.medworm.com/index.php?rid=3595895&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyacNMhGx7xk%2F Hello, again. A shiny day here on the Pharmalot corporate campus, where we expect a busy day. How about you? Much to do? We look forward to shortening our to-do list. To get started, we are quaffing the usual cup of stimulation and rummaging through the news of the world. Hope your day goes well and drop us a line if you hear anything interesting…. Astellas Hires 300 Reps In China (Bloomberg News) FDA Extends Review Of Novartis MS Drug (PharmaTimes) Abbott Labs Plans To Sell $3B In Debt (BioValley) Genzyme Agrees To $175M Consent Decree (Bloomberg News) Execs Worry About FDA’s BadAd Program (Advertising Age) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3595895 Tue, 25 May 2010 11:48:01 +0100 3595895 http://www.medworm.com/index.php?rid=3526947&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGcH7rZ8YJbU%2F Another month, another list. Once again, there is speculation about which medications will generate the most revenue over the next few years. Interestingly, the latest conclusion mirrors another recent list that suggests conventional pills will easily be eclipsed. Only two small molecules make this newest ranking, which was compiled by EvaluatePharma. Not surprisingly, one of them is AstraZeneca’s Crestor cholesterol fighter, although the newest list differs slightly from this list. And so once again, there are myriad implications raised, including the strategic direction pursued by the biggest drugmakers and the costs for patients. The percentage figure refers to sales growth from 2009 to 2016… 1. Humira (arthritis) Abbott Labs/Eisai - $10.1b; 9 percent 2. Avastin (cancer) Roc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3526947 Mon, 03 May 2010 12:47:00 +0100 3526947 http://www.medworm.com/index.php?rid=3508448&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fnf6jcSWzpi8%2F Rise and shine. Another day lies ahead. And no doubt, it will be a busy one. As always, there is much to do - meetings and deadlines beckon. While we attempt to hustle one of the short people off to the local schoolhouse, here are a few items to jumpstart your day. We hope it is a good one. And once again, do stay in touch… AstraZeneca Wins Wider EU Crestor Labeling (Reuters) Novo Nordisk Raises Forecasts (Bloomberg News) Irish Reference Pricing Could Cause Shortages (PharmaTimes) Abbott Court Loss Prompts Review Of Patent Standards (Daily Herald) ACRO To Fund CRO Academic Research (OutsourcingPharma) J&J Unit Denied Appeal Of Patent Decision (MarketWatch) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3508448 Tue, 27 Apr 2010 11:31:24 +0100 3508448 http://www.medworm.com/index.php?rid=3468018&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZbwVlkKVymw%2F And the winner is…. Roche’s Avastin, which is used to treat various cancers. Everyone loves a list, of course, so Reuters compiled this ranking and the most interesting finding is there seems to be just one pill that will be among the biggest sellers in 2014. In other words, injectables will dominate. Assuming this is reasonably accurate, what might it say about big drugmakers? Will they spend more in the lab or strike still more deals with smaller prey developing the next big thing? Will pills become passe? And what will it mean for patient costs? Consensus sales forecasts for world’s top 10 drugs in 2014: 1. Avastin (cancer) Roche - $8.9b 2. Humira (arthritis) Abbott - $8.5b 3. Enbrel (arthritis) Pfizer - $8b 4. Crestor (cholestero... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3468018 Wed, 14 Apr 2010 15:58:25 +0100 3468018 http://www.medworm.com/index.php?rid=3463858&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJPDzW8C-sqc%2F A federal judge ordered Abbott Laboratories to give prosecutors some of ceo Miles White’s emails as part of a federal probe into whether the drugmaker improperly marketed its Depakote pill, which is used to treat bipolar disorder, seizures and migraines. Emails sent or received between 1996 and 2008 by two other execs - William Dempsey and Jeff Leiden - must also be turned over. The US Attorney for the Western District of Virginia is investigating Abbott for “potential federal violations arising out of Abbott’s impermissible off-label marketing of Depakote as a treatment for agitation and aggression in the elderly, and health-care fraud arising out of that allegedly improper use,” US District Judge Samuel Wilson wrote in a recent opinion (see here). Abbott allegedl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3463858 Tue, 13 Apr 2010 12:19:31 +0100 3463858 http://www.medworm.com/index.php?rid=3420758&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3siamx0eDUw%2F This is a list of the top 20 drugmakers, ranked by global prescription drug sales for the 12 months ended Sept. 30, 2009, according to IMS Health, which prepared this for Reuters. The dollar sales are in billions and, next to that, is the percent change from the year-over-year period. As you can see, though, the results don’t include the mergers between Merck and Schering-Plough, and Pfizer and Wyeth, since these weren’t consummated until later in the year. 1 - Pfizer - $41.7 billion - (0.8) 2 - Novartis - $36.7 billion - 7.0 3 - Sanofi-Aventis - $35.1 billion - 3.3 4 - GlaxoSmithKline - $34.3 billion - (3.4) 5 - AstraZeneca - $33.2 billion - 7.8 6 - Roche - $31.3 billion - 8.6 7 - Johnson & Johnson - $26.9 bi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3420758 Mon, 29 Mar 2010 16:43:51 +0100 3420758 http://www.medworm.com/index.php?rid=3374375&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJHNZMyRf0k8%2F A new research collaboration involving the National Institutes of Health, the FDA and three drugmakers will be launched today in hopes of getting cancer drugs to the market faster, and test five experimental breast cancer medsReuters writes. The $26 million, five-year study will be called Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis, or I-SPY2, and use DNA to match the best drug to each patient, and more quickly toss approaches that don’t work or are too toxic. The companies - Amgen, Abbott Labs and Pfizer - agreed to share info on using genes to predict how well patients respond as part of The Biomarkers Consortium, which includes the FDA, the NIH and PhRMA, the industry trade group. “I think it is the theme for the f... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3374375 Wed, 17 Mar 2010 12:56:09 +0100 3374375 http://www.medworm.com/index.php?rid=3350567&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDBJkyxf0FEQ%2F Three years ago, Thailand made waves by threatening to issue compulsory licenses for several best-selling meds, including Abbott Labs’ Kaletra AIDS drug. The Thai government argued needed meds were priced too high for most of it citizens and it had the right to override patents under provisions of a World Trade Organization agreement. In March 2007, Abbott took a hard-line stance by yanking registration applications in Thailand for seven drugs (background). An activist group, KEI, which supported the Thai move to issue compulsory licenses, recently obtained a cable written by Ralph Boyce, who at the time was US Ambassador to Thailand, indicating the US was aware of the health consequences of Abbott’s move and that the hardball tactic could strengthen the industry’s hand i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3350567 Wed, 10 Mar 2010 13:10:35 +0100 3350567 http://www.medworm.com/index.php?rid=3350568&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWd4iws7642I%2F A pleasant morning here on the Pharmalot corporate campus. After a recent spell of snow, spring appears to have finally bloomed. And that makes it a bit easier to cope with those mid-week deadlines and meetings, yes? So grab a cup of something stimulating and dig in for another day. Here are a few interesting items to help you on your way. Cheers, everyone… Abbott Bests Biogen With Bid For Facet Biotech (Bloomberg) Bristol-Myers’ CEO 2009 Pay Was Down 22 Percent (Associated Press) Sandoz Names Don DeGolyer To Heads US Ops (Chain Drug Review) Novartis Takes Option On Transgene Cancer Vaccine (Reuters) Lilly, Amylin Diabetes Drug Await FDA OK (The Wall Street Journal) Teva Pharmaceuticals Names Phillip Frost As Chairman (Associated Press) Coffee pix thx to chichcacha flickr creat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3350568 Wed, 10 Mar 2010 12:24:03 +0100 3350568 http://www.medworm.com/index.php?rid=3302634&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fk55qOTJU1vI%2F A federal judge dismissed an antitrust lawsuit filed by the Federal Trade Commission against Abbott Labs’s Solvay Pharmaceuticals unit for allegedly conspiring with several generic drug makers to delay competition for its AndroGel testosterone-replacement med (here is the ruling). The ruling is a setback for the agency, which has been pushing aggressively to end so-called pay-to-delay deals (look here). The White House, in fact, included a proposal to make these agreements illegal as part of its health care reform package (see here). The FTC alleged Solvay entered into illegal deals with Watson Pharmaceuticals, Par Pharmaceutical and Paddock Labs to delay introduction of a generic AndroGel. The generics sought FDA approval and, in their submissions, noted their copycats wouldn’... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3302634 Wed, 24 Feb 2010 12:45:00 +0100 3302634 http://www.medworm.com/index.php?rid=3259189&cid=t_132556_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2010%2F02%2F09%2Fabbott-labs-seeks-fda-510k-clearance-for-new-automated-ovarian-cancer-detection-test%2F A new diagnostic tool physicians can use to monitor patients for the most common form of ovarian cancer may soon be available in the United States. A new diagnostic tool physicians can use to monitor patients for the most common form of ovarian cancer may soon be available in the United States.  Abbott Laboratories’ (Abbott’s) ARCHITECT [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=3259189 Tue, 09 Feb 2010 22:24:31 +0100 3259189 http://www.medworm.com/index.php?rid=3236088&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJS4E6W84DIk%2F A snowy day here on the Pharmalot corporate campus, but it is winter, after all. So what better way to greet such weather than with a warm cup of stimulation? The water is boiling as we write. Meanwhile, here are a few items to help you slog through the day. Hope it’s a good one… Pfizer Profits Misses Estimates (Reuters) Roche Profits Hurt By Genentech Deal (PharmaTimes) FDA Approves Drug For Hand Disorder (Bloomberg News) Indian Court Stays Decision To Revoke Humira Patent (Business Standard) Takeda Profit Falls Due To Acquisitions (Bloomberg News) Ironwood IPO Price Gets A Haircut (Bloomberg News) Suit Against J&J Over Baby Bath Can Proceed (NJ Law Journal) Snowman courtesy of Flickr Creative Commons LD (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3236088 Wed, 03 Feb 2010 12:39:24 +0100 3236088 http://www.medworm.com/index.php?rid=3223488&cid=t_132556_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FfCvv5EjMt-c%2Fwill-you-be-taking-one-of-final-seats.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3223488 Fri, 29 Jan 2010 20:31:00 +0100 3223488 http://www.medworm.com/index.php?rid=3212602&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcQggzcNsI9w%2F Hello, everyone. ‘Tis a sunny day here on the Pharmalot corporate campus, the perfect elixir to the middle-of-the-week hurdles. What will today bring? We can only guess, but to steel ourselves, we have brewed our usual ritual - a cup of stimulation. Pour one yourself or grab a water bottle and dig in. Hope your day goes well… Merck To Appeal Temodar Patent Loss To Teva (Philly.com) Abbott Labs’ 2010 Forecast Exceeds Expectations (Reuters) Pain Pumps Linked To Chondrolysis (The New York Times) Virginia Gov Proposes Biotech Funding (Washington Business Journal) Pfizer Compensates Nigerian Trovan Victims (AllAfrica) Gilead Sciences Profit Rises 43 Percent (Bloomberg News) Class Decertification In Neurontin Case Upheld (Legal Intelligencer) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3212602 Wed, 27 Jan 2010 13:20:12 +0100 3212602 http://www.medworm.com/index.php?rid=3197884&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTfQz4yrm1BU%2F Two regulators, two different approaches to risk. Yesterday, the European Medicines Agency told docs to stop prescribing Abbott’s Meridia diet pill, because the risks outweigh the benefits, and decided Abbott’s license to market the pill should be suspended (look here). At the same time, the FDA added new warnings highlighting increased risks for patients with heart problems but reserves further action until full results arrive in March and a committee meeting is held (see here). The varying decisions were made after reviewing data from a trial known as SCOUT, which emerged last November and showed an increased risk of serious, non-fatal cardiovascular events, such as stroke or heart attack, when comparing the drug with a placebo among nearly 10,000 patients. The trial was desi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3197884 Fri, 22 Jan 2010 14:48:41 +0100 3197884 http://www.medworm.com/index.php?rid=3176119&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_3q_NgS2GHQ%2F Once again, the end of a long week approaches. We hope you survived so far. What are your weekend plans? Catching up on reading or with friends? We will tend to the short and not-so-short people. Before we get ahead of ourselves, however, another day lies ahead. So let’s all grab our cup of stimulation and get started. Meanwhile, have a great weekend, everyone, and see you soon… Pfizer Hit With Chantix Lawsuits (Reuters) Wockhardt And Abbott Deal May Be Blocked (LiveMint) Xenoport Says Restless Legs Drug Won’t Need Panel (Bloomberg News) FDA: No Heart Risk With Spiriva Inhaler (Associated Press) Amgen’s Denosumab And Bone Cancer (BusinessWeek) photo thx to tipiro on Flickr creative commons (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3176119 Fri, 15 Jan 2010 13:07:54 +0100 3176119 http://www.medworm.com/index.php?rid=3153629&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5kDsqoxwlBY%2F The drugmaker was accused of conspiring to block generics of its TriCor cholesterol med - a $1 billion seller - from becoming available by making minor changes in formulation. Lawsuits were previously filed by a group of generic drugmakers, retailers and wholesalers, including Teva Pharmaceuticals, Walgreen and Rite-Aid, which Abbott settled for $184 million in November 2008 (see here). The multi-state lawsuit, which was filed in March 2008, alleged Abbott and Laboratoires Fournier, which discovered the drug, made the changes to TriCor knowing there was no clinical benefit, but didso in order to prevent pharmacists from dispensing less-expensive generic versions. The states also charged the drugmakers thwarted generics by filing baseless patent-infringement lawsuits against generic rivals ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3153629 Thu, 07 Jan 2010 21:00:42 +0100 3153629 http://www.medworm.com/index.php?rid=3075767&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXR9H6iErs0s%2F Rise and shine, everyone. Another day awaits. And a busy one is predicted. We will be attending a lengthy meeting ourselves, in fact. While you ponder your own schedules and what-not, here are a few items to help you get started. Hope the day is pleasant and productive…. SEC Probes Drug Mergers For Insider Trading (Wall Street Journal) AstraZeneca Explores Alliances With Competitors (Bloomberg News) Roche Invests Another $71M In China (China Post) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3075767 Thu, 10 Dec 2009 11:25:23 +0100 3075767 http://www.medworm.com/index.php?rid=3056883&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDs60YIKgPgg%2F Good morning again and nice to see you. A busy day is expected and so we are studying our to-do list as another deadline looms. Meanwhile, we are also looking ahead to the weekend. Our leaves are finally gone, which means there will be more time to cavort with the short and not-so-short people. And we look forward to catching up on some reading. What about you? While you ponder, here are a few items to jumpstart the day. Whatever you decide, have a great weekend, everyone… AstraZeneca Wins Partial FDA Approval For Seroquel XR (Associated Press) ZymoGenetics Axes Jobs, Quits Immunology Drugs (Xconomy.com) FDA Staff Suggests Liver Warning On Merck’s Cancidas (Reuters) Abbott Lays Off 80 Temp Workers (North County Times) Biogen Boosts Offer For Facet Biotech (Bloomberg News) FDA ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3056883 Fri, 04 Dec 2009 13:18:15 +0100 3056883 http://www.medworm.com/index.php?rid=3056884&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjpT-v-IGEXs%2F The agency says the epilepsy can cause an increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies. And the FDA warns that women of childbearing potential should only use valproate if it is essential to manage their medical condition (here is the FDA statement). The drug has a sordid profile: it already carries a strong “black box” warning that it may cause birth defects (prescribing info) and a study in The New England Journal of Medicine linked it to lower IQs in the children of women who took the drug. In June, the FDA recommended added study of delayed development reported in children whose moms took Depakote. The warning comes just one month after Abbott Labs disclosed the US Department ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3056884 Thu, 03 Dec 2009 23:38:26 +0100 3056884 http://www.medworm.com/index.php?rid=3052386&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQYFGBiP13pw%2F Public Citizen has written the agency to urge an outright ban, citing preliminary results from the 10,000-patient SCOUT study called that showed a slightly higher risk of heart attack, stroke and death in patients taking Meridia compared with a placebo. At the time the study, which was conducted in patients who were older than 55, overweight with a history of heart disease or diabetes, was released last month, the FDA was “making no conclusions” about the findings. Both the FDA and the European Medicines Agency’s Committee for Medicinal Products for Human Use has started a safety review (see the FDA statement here, the EMEA statement here and the Public Citizen petition here). “We would hope that the science behind the results seen in this study would mandate the only ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3052386 Thu, 03 Dec 2009 15:51:43 +0100 3052386 http://www.medworm.com/index.php?rid=3045023&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0jJwPStVWMc%2F The drugmakers finally found a way to resolve litigation that began a decade ago over Abbott Labs’ TriCor cholesterol drug, which generated more than $1 billion in US sales last year. Teva sought to sell a generic version, but as part of their settlement, agreed to postpone such a move untill March 2011. Terms, however, weren’t disclosed in this SEC filing made by Abbott. An Abbott spokeswoman tells The Wall Street Journal that Teva isn’t being paid to delay selling a generic, and calls the deal a “pure licensing agreement.” Laboratoires Fournier SA of France, which discovered the drug, also agreed to the settlement. For the record, drugmakers have often struck deals with generic rivals in which they agreed to make a payment or offered them something else to ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3045023 Tue, 01 Dec 2009 12:50:29 +0100 3045023 http://www.medworm.com/index.php?rid=3026906&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FshtFKZn8T4I%2F Prescriptions for both of Merck’s cholesterol pills - Vytorin and Zetia - fell last week, while scrips for Abbott Labs’ Niaspan rose following the results of the widely reported Arbiter clinical trial, according to SDI, a market research firm, Dow Jones reports. The Arbiter trial found that Niaspan helped reverse narrowing of the arteries in heart patients, while Zetia patients didn’t experience any significant changes (see here). Along with simvastatin, Zetia is a component in Vytorin. This was the second study in two years to question Vytorin’s efficacy. Since the controversy over the earlier Enhance trial, Vytorin and Zetia scrips have been in a perpetual slump. “There’s a lot of switching taking place,” Tim McGee, associate director of client s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3026906 Tue, 24 Nov 2009 22:27:59 +0100 3026906 http://www.medworm.com/index.php?rid=3019234&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtqORbrPPWwI%2F Hello, everyone. And welcome to a shorter working week, at least here in the states. Although, we suspect the next couple of days will be jam-packed, as everyone tries to squeeze a lot of work into not a lot of time. In any event, time to grab a cup of stimulation and dig in. Hope your day goes well… Merck-Sorono Opening R&D Hub In China (The Wall Street Journal) Abbott’s Meridia Linked To Cardiovascular Events (PharmaTimes) Pfizer Must Pay $6.3M In Damages Over Prempro (Bloomberg) FDA OKs Abilify For Child Autism Irritability (Reuters) Coffee courtesy of Flickr Creative Commons chichcacha (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3019234 Mon, 23 Nov 2009 13:05:38 +0100 3019234 http://www.medworm.com/index.php?rid=2996029&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKSZ-CmIQqbU%2F Abbott Labs’ Niaspan appeared safer and more effective that Merck’s Zetia as a secondary cholesterol treatment, according to a study released Sunday night. Funded by Abbott and called Arbiter-6, the study measured thickness of the carotid artery leading to the brain in 208 patients, who were given simvastatin along with either Niaspan or Zetia over 14 months. The study only looked at patients who had already lowered their LDL cholesterol to the recommended level by taking a statin. The upshot: Niaspan patients had reductions in artery wall thickness, while those on Zetia had no change. Docs view artery thickness as a way of predicting heart attack and stroke risks (here is the abstract). There were nine heart attacks among Zetia patients but just two in the Niaspan group. Rese... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2996029 Mon, 16 Nov 2009 13:08:57 +0100 2996029 http://www.medworm.com/index.php?rid=2989409&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfwMa_oLZ8dU%2F And so another work week is drawing to a close. And not a moment too soon, yes? What will you do this weekend? Our favorite sport is raking leaves - the exercise is worth the effort. Of course, there are errands to run and keeping up with the short and not-so-short people is a favorite pre-occupation. Meanwhile, though, today beckons. So time to get moving. Have a nice weekend, everyone… Pfizer May Have To Repay Missouri Tax Breaks (St.LouisToday) Cephalon And Barr Settle Fentora Patent Dispute (Reuters) Abbott Grabs Experimental Pain Drug (Chicago Tribune) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2989409 Fri, 13 Nov 2009 13:04:41 +0100 2989409 http://www.medworm.com/index.php?rid=2977568&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBKf6UvLaxzA%2F The big drugmaker may encounter its third negative study result within two years for Vytorin and Zetia which, along with Zocor, is a component in the expensive cholesterol pill. The latest trial is scheduled to be presented this coming Monday at the American Heart Association meeting, and pits Merck’s drugs against Abbott Labs’ Niaspan, Bloomberg News notes. The results are likely to show that Niaspan unclogged arteries better than Vytorin, according to Leerink Swann analyst Seamus Fernandez and Wells Fargo Advisors analyst Larry Biegelsen, Bloomberg writes. If so, Vytorin and Zetia revenue may be reduced by $800 million yearly, or 20 percent, Fernandez forecasts. Since January, sales have declined $480 million, or 14 percent, to about $3 billion. A win by Niaspan may discourage ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2977568 Tue, 10 Nov 2009 13:42:12 +0100 2977568 http://www.medworm.com/index.php?rid=2970418&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FH3evCBwKRAw%2F As they say: another day, another probe into a drugmaker. The latest - the US Department of Justice is investigating Abbott’s sales and marketing activities of the pill, which is used to treat bipolar disorder, seizures and migraines, according to its quarterly filing with the US Securities and Exchange Commission for Depakote. The government wants to know whether the drugmaker violated civil and/or criminal laws, including the Federal False Claims Act, the Food and Drug Cosmetic Act, and the Anti-Kickback Statute in connection with Medicare and/or Medicaid reimbursement to third parties. An Abbott spokeswoman tells Dow Jones that the drugmaker is cooperating, but declined further comment. And a spokesman for the US Attorney in the Western District of Virginia, which is handling the prob... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2970418 Fri, 06 Nov 2009 19:58:32 +0100 2970418 http://www.medworm.com/index.php?rid=2890943&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FwN_iuHno4A8%2F Nice to see you again. We hope your week is going well. As usual, we are busy scrounging around for interesting items. If you know of something worthy or curious, don’t be shy, get in touch. Meanwhile, here are a few things to help you get started. Have a nice day, everyone… Mylan Settles Vfend Dispute With Pfizer (Associated Press) PureTech Ventures’ Take On Biotechs (TheStreet.com) Digitas Loses Small Piece Of Viagra Business (MediaBistro) Galapagos Expands Deal With Merck (Reuters) Abbott Laboratories Third-Quarter Results (press release) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2890943 Wed, 14 Oct 2009 12:00:32 +0100 2890943 http://www.medworm.com/index.php?rid=2886740&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsJGLCefFxFY%2F During this year’s third quarter, eight of the biggest drug makers undertook hefty price increases - the average among this group was 8.7 percent, easily outdistancing the core Consumer Price Index of 1.4 percent, according to a recent research report by Credit Suisse analyst Catherine Arnold. Who led the pack? Schering-Plough (soon to be bought by Merck) with a 12.8 percent hike, while Abbott imposed a 4.4 increase (Abbott’s price hikes have, in fact, been declining over the past year, the report notes). What about the others? Merck upped the ante by 9.9 percent; Wyeth (soon to be part of Pfizer) drove prices higher by 9.3 percent; Lilly was at 9.1 percent; Bristol-Myers Squibb prices rose 8.9 percent; Johnson & Johnson increased prices by 7.8 percent, and Pfizer prices r... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2886740 Tue, 13 Oct 2009 13:10:41 +0100 2886740 http://www.medworm.com/index.php?rid=2513161&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fpharmalot%2F%7E3%2FvNl-T0TpJzI%2F As the holidays settle in, the week has slowed considerably. Nonetheless, we thought it would be still be fun and useful to pass along a few interesting items. The world has not exactly stopped spinning, after all. So here you go…. FDA Wants More Seroquel Depression Data (Associated Press) Takeda Diabetes Drug Faces Delay (Bloomberg News) Abbott Downplayed Risk In Humira Ad (Reuters) Dr. Reddy’s Settles Patent Dispute Over Clarinex (Associated Press) Merck Groundwater Pollution Probed (The Modesto Bee) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2513161 Wed, 24 Dec 2008 12:41:19 +0100 2513161 http://www.medworm.com/index.php?rid=2011549&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F473739851%2F That’s the charge by a watchdog group known as The Prescription Project, which today petitioned the FDA and asked the agency to enforce its rules by requiring Abbott Labs, Medtronic and Stryker to withdraw YouTube.com video ads for medical devices used in heart, hip and neck surgeries (see full petition and videos here). The group claims that four Abbott videos on YouTube promote its XIENCE V drug-coated stent for use in coronary angioplasty surgery, but fail to mention federally-mandated warnings. Similarly, the Medtronic videos tout the use of its Prestige Cervical Disk for surgery for degenerative disk disease and the Stryker video promotes its Cormet hip resurfacing technology without required warnings. “The videos raise serious questions about whether drug and device compa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2011549 Wed, 03 Dec 2008 16:21:53 +0100 2011549 http://www.medworm.com/index.php?rid=1996754&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F466741372%2F So we got an early start on the Thanksgiving break and disappeared with one of our short people. But we have returned momentarily to pass along a few interesting items and, of course, to wish you all a relaxing day off, at least those of you in the US. Have a nice time, everyone, whatever you do, and see you soon… Ailing FDA Needs Restructuring (The Washington Post) Merck Outlook Lowered By Citigroup Analyst (Associated Press) FDA Finds Melamine In US Infant Formula (Associated Press) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1996754 Wed, 26 Nov 2008 23:36:23 +0100 1996754 http://www.medworm.com/index.php?rid=1975633&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F460065199%2F The deal comes 10 days after a trial had begun in federal court in Delaware into allegations the drugmaker tried to keep generic versions of its TriCor cholesterol med from becoming available by making minor changes in formulation. Lawsuits were filed by a group of generic drugmakers, retailers and wholesalers, including Teva Pharmaceuticals, Walgreen and Rite-Aid (Here is the Walgreen suit). Essentially, Abbott was accused of “product switching,” which involves retiring an existing drug and replacing it with a modified version that is marketed as “new and improved.” However, this prevents pharmacists from substituting a generic for the branded drug when filling prescriptions. The practice is not illegal, but the lawsuit alleges that Abbott acted improperly by using this and o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1975633 Thu, 20 Nov 2008 21:40:17 +0100 1975633 http://www.medworm.com/index.php?rid=1915065&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F434035028%2F A new government-funded study suggests that patients with HIV may have less risk of dying if they begin HAART, or highly active antiretroviral therapy, sooner than current guidelines currently recommend. The existing treatment guidelines call for meds to be considered when CD4+ T-cell counts fall below 350 cells per cubic millimeter. HIV, you may recall, ravages CD4+ T-cells, which fight off infection, but as virus levels increase, a decrease in CD4+ T-cells occurs. The HAART regimen, which combines at least three HIV meds, is used to reduce virus levels. However, the ideal time to start treatment therapy has been unclear because of insufficient clinical trial data. And so researchers worked with the International Epidemiology Databases to Evaluate AIDS (IeDEA), which is a global network... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1915065 Tue, 28 Oct 2008 04:05:26 +0100 1915065 http://www.medworm.com/index.php?rid=1907880&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F431089121%2F Kansas Attorney General Steve Six sued 13 drugmakers today, alleging they unlawfully inflated drug costs paid by taxpayers through the state’s Medicaid program. The suit claims the drugmakers deliberately misreported pricing info in order to hike reimbursement. “We believe Kansas has lost millions of dollars as a result of these drug companies’ fraudulent pricing schemes,” Six says in a statement. “We allege that the drug manufacturers deliberately inflated the reported average wholesale prices and other wholesale prices for their drugs in order to increase market share for their products. This is a disturbing abuse of the Medicaid reimbursement system.” “Because of the drug companies’ inaccurate pricing, the Kansas’s Medicaid program ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1907880 Fri, 24 Oct 2008 23:10:31 +0100 1907880 http://www.medworm.com/index.php?rid=1871109&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F416662941%2F United Nations Secretary-General Ban Ki-moon says that several major drugmakers promised to invest more on researching treatments for the AIDS virus and diagnostic procedures for poorer regions. The drugmakers also agreed to invest more in prevention, including vaccines and pre- and post-exposure prophylaxis, Ban said in a statement issued after he met with top execs at pharma and diagnostic firms working on AIDS. “We noted that despite the gains, the epidemic continues to outstrip our best efforts. Only one-third of those who need antiretroviral treatment in low-and middle-income countries are getting it,” he said. “Each day, for every two people who are placed on antiretroviral treatment, five more are infected. Collectively, we still have more work to do.” Ban a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1871109 Fri, 10 Oct 2008 10:05:32 +0100 1871109 http://www.medworm.com/index.php?rid=1809937&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F396270911%2F The health care giant released results of a Phase III study showing ustekinumab was just as safe and effective as the top-selling med sold by Amgen and Wyeth, which has a 75 percent share of the market, but required fewer injections. Patients received either twice-weekly injections of Enbrel or 45 mg or 90 mg injections of the J&J drug at the start of the trial and four weeks later. After 12 weeks, 74 percent given the higher dose of ustekinumab and 68 percent on the lower dose saw at least a 75 percent reduction in psoriasis symptoms, such as red scaly patches. By comparison, 57 percent on Enbrel saw a similar reduction (here is the statement). The drug works by blocking interleukin-12 and interleukin-23, which are proteins linked to inflammation in psoriasis and other autoimmune dis... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1809937 Thu, 18 Sep 2008 14:20:22 +0100 1809937 http://www.medworm.com/index.php?rid=1802931&cid=t_132556_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F394626772%2F The AIDS Healthcare Foundation is stepping up an ad campaign against the drugmaker over the price of Kaletra, claiming Abbott charges Mexico five times more than other middle-income countries. The example cited - $5,400 a year in Mexico compared with $1,000 per year in Brazil for the second-line AIDS treatment. The ads are running in newspapers in Illinois, where Abbott is headquartered. “Abbott is once again living up to its terrible record on AIDS by abusing NAFTA’s patent protections to charge five times as much for Kaletra in Mexico as it does in other middle-income countries, a heartless business calculation that effectively makes this drug all but out of reach for nearly all those living with HIV/AIDS in Mexico,” Michael Weinstein, AIDS Healthcare Foundation’s preside... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1802931 Tue, 16 Sep 2008 22:55:48 +0100 1802931