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 'biologics'. Sat, 03 Sep 2011 02:21:48 +0100 http://www.medworm.com/index.php?rid=5107893&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXpncqmok5No%2F Rise and shine. Another day is on the way. And it looks to be a sunny one here on the Pharmalot corporate campus, where we are brewing a delicious cup of mandatory stimulation. Our flavor today is Southern Pecan. Please join us. After all, there is much to do as meetings and deadlines beckon. You know the score, so time to dig in. Meanwhile, here are some tidbits. Have a great day and let us know if you hear of something interesting… FDA Approval Of Roche Melanoma Drug May Come Early (Reuters) Pfizer Sends Israeli Sniffing Dogs To Finland (The Jerusalem Post) Revlimid Side Effects Linked To Protein In Study (Reuters) Valeant Pharma Eyes Medicis For Another Acquisition (Pharma Times) Merck And J&J Sit On Piles Of Cash (The Star-Ledger of New Jersey) Lexicon Tumor Drug Shows Posit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5107893 Tue, 09 Aug 2011 12:06:27 +0100 5107893 http://www.medworm.com/index.php?rid=5078029&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FErKoEEBgvYc%2F A group of 40 members of the House of Representatives have written President Obama urging the Trans Pacific Partnership talks currently under way should include a requirement that countries offer 12 years of data exclusivity for new biologics. The missive is the latest move by the pharmaceutical industry to create what it calls parity with US law. “The US-led biopharmaceutical industry would be disadvantaged if the US does not ensure consistency with US law as part of the TPP, because foreign countries do not provide the same type of protection rules,” according to the July 27 letter, which PhRMA is circulating. The trade group has also distributed this document as part of its lobbying campaign. You may recall that brand-name drugmakers won a 12-year exclusivity period as part of a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5078029 Fri, 29 Jul 2011 15:16:56 +0100 5078029 http://www.medworm.com/index.php?rid=5008661&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYKkX3nU_2rg%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 our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that MTI, which provides marketing systems to drugmakers and biotechs, hired Michael Kelly as senior vp of business development. Previously, he was vp for solutions business development and marketing at Cadient Group, where he was responsible for sa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5008661 Fri, 08 Jul 2011 12:26:18 +0100 5008661 http://www.medworm.com/index.php?rid=4813675&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMOvCGSP2Uq4%2F Timing, as they say, is everything. On April 14, Octapharma announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use had recommended lifting a six-month-long, EU-wide suspension of its Octagam biologics, which are used for treating primary humoral immunodeficiency, myeloma or chronic lymphatic leukaemia. Why was there a suspension in the first place? Last September, regulators noticed an unexpectedly high number of reports of thromboembolic events in patients using the meds (see here). But last month, Octopharma announced the CHMP had decided the Swedish drugmaker had taken “appropriate corrective measures” at its manufacturing sites (read here). However, on April 15, the FDA issued a warning letter as a follow-up to inspections that to... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4813675 Tue, 10 May 2011 15:38:29 +0100 4813675 http://www.medworm.com/index.php?rid=4813676&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYU2i5W2ek7E%2F Biosimilars and interchangeable biologics are going to be a big business, of course, and so the FDA is now devising a user fee program to fund its own review efforts. Toward that end, the agency is posting a notice on the Federal Register today in order to seek comments that can be submitted to Congress by January. However, the program envisioned by the FDA may not exactly mirror PDUFA, the user fee program for prescription meds, for one simple reason - the biosimilar market is just getting started, so biosimilar user fees will have to “include different elements to ensure an equitable program that generates adequate revenue.” Meanwhile, the agency offers these principles for creating a program. One, biosimilar and interchangeable biologics represent a critical public health be... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4813676 Tue, 10 May 2011 14:44:06 +0100 4813676 http://www.medworm.com/index.php?rid=4795057&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_eT7KgKAUGw%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 our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Optimer Pharmaceuticals hired Nancy Ruiz as sr vp of R&D. Most recently, she worked at Merck Research Labs, where she was vp of project and pipeline management for infectious diseases. Before that, she was vp of anti-infectives and vaccine... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4795057 Fri, 06 May 2011 12:19:38 +0100 4795057 http://www.medworm.com/index.php?rid=4775600&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4q1xogmJvpw%2F The PhRMA trade group is urging the US Trade Representative to go beyond provisions contained in the Korea-US trade deal, known as KORUS, and include 12 years of data exclusivity for biologics in the Trans-Pacific Partnerships talks that are under way, according to Inside US Trade. The push contrasts with a White House proposal earlier this year to shrink exclusivity to seven years from 12 years, a move that would roll back a provision in health care reform. You may recall that brand-name drugmakers won a 12-year exclusivity period last year as part of an effort to create a so-called FDA approval pathway for biosimilars. Generic drugmakers, of course, wanted a shorter term. The issue is new, however, for US trade agreements. Drugmakers usually want the USTR to replicate patent provisions ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4775600 Mon, 02 May 2011 23:38:31 +0100 4775600 http://www.medworm.com/index.php?rid=4775602&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzhqisKWnv6w%2F The United States Pharmacopeia is a non–governmental organization that sets official standards for prescription and over-the-counter meds made or sold in the US. Working behind the scenes, the non-profit develops monographs that include ingredients, preparations, packaging, storage and labeling requirements, as well as specifications. The specs consist of tests, testing procedures and acceptance criteria. But advances in biotech are creating new challenges. A prime example is the Provenge vaccine for prostate cancer that is, essentially, personalized medicine, since treatment for each patient contains cells from that patient and a complicated manufacturing process. We spoke with Tina Morris, vice president of biologics and biotech at USP, about such advances and how the organization goes... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4775602 Mon, 02 May 2011 13:14:30 +0100 4775602 http://www.medworm.com/index.php?rid=4561279&cid=t_145530_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F03%2F08%2Fmaterials-available-from-fda-basics-webinar-on-fdas-role-in-ensuring-the-safety-of-the-nation%25e2%2580%2599s-blood-supply%2F Did you miss the FDA Basics webinar about FDA’s vital role in ensuring the safety of the nation’s blood supply? You can learn about FDA’s five overlapping layers of blood safety and review rules that are designed to make sure we have a safe and available blood supply, including rules related to donor screening and testing of blood for blood-borne infectious agents. Materials from the webinar are now available. We have posted a link to view and listed to 30 minute webinar and posted a link to download a copy of the presentation slides. You can also find materials from past FDA Basics webinars. (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4561279 Tue, 08 Mar 2011 20:21:21 +0100 4561279 http://www.medworm.com/index.php?rid=4549939&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzIiicEuNJck%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 our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that IBM Global Business Service hired Neil Patel as an associate partner in the Life Sciences R&D Practice. Prior to joining IBM, he was with PricewaterhouseCoopers in the Pharma Life Sciences Practice as a director and, before that, he worked... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4549939 Fri, 04 Mar 2011 13:10:43 +0100 4549939 http://www.medworm.com/index.php?rid=4532573&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-qTHowLXvTc%2F Drugmakers may be shedding thousands of primary care sales reps, but at the same time, they are increasing hospital and specialty sales teams. Over the next 12 to 24 months, 30 percent of specialty sales forces will expand, while only 5 percent expect to contract. Significantly, among hospital sales teams, 53 percent expect to grow - on average, by 14 percent - and only 5 percent see shrinkage. Consequently, the findings suggest that the “long, grim trend of sales force contraction may be coming to a close as economic conditions improve and sales forces reach statis,” according to Cutting Edge Research, which surveyed 21 drugmakers about their plans for hospitals and specialty sales staffing. Not surprisingly, the prognosis comes after a period of realignment. Over the last two... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4532573 Mon, 28 Feb 2011 15:02:47 +0100 4532573 http://www.medworm.com/index.php?rid=4522291&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEacgP4fZABY%2F And so another work week is about to draw to a close. And this means daydreaming about the weekend. Our agenda includes visiting with a favorite aunt and uncle, taking the short people to assorted sports activities and tackling our overwhelming to-do list. What about you? Will you make time to exercise? Catch a movie? You can always prepare your taxes (and perhaps your payments could narrow the deficit). Whatever you do, be safe and have a wonderful time. See you soon… Samsung And Quintiles Partner To Make Biologics (Bloomberg News) Elan And Celgene Settle Patent Lawsuit Over Abraxane (Reuters) Plague Kills Scientist In First Lab Case In 50 Years (Bloomberg News) UK Gang Jailed For Counterfeit Mecidines Plot (Securing Pharma) FDA Rejects Pfizer And Protalix Med For Gaucher’s (B... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4522291 Fri, 25 Feb 2011 13:04:10 +0100 4522291 http://www.medworm.com/index.php?rid=4495433&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbbPH3bwPNas%2F The rate at which the FDA approved new molecular entities - including NME’s filed under New Drug Applications (NDAs) and therapeutic biologics filed under Original Biologic License Applications (BLAs) - declined last year from the previous two years, according to new data released by the FDA. As the chart indicates, last year, there were 18 NMEs approved and three biologics, or 21 in total, which is down from 26 in 2009 and 24 in 2008. On the other hand, there were only 18 approvals in total in 2007 and 22 back in 2006. Since 2001, the Center for Drug Evaluation and Research has averaged 22.9 approvals a year, although there is a caveat: biologics were not included during 2001 through 2003. However, new applications are declining. Last year, the FDA received 23, a notable drop from ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4495433 Fri, 18 Feb 2011 14:35:31 +0100 4495433 http://www.medworm.com/index.php?rid=4478156&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9oaO7W1OaAM%2F Federal budgets always make interesting reading and, this year, the Obama White House does not disappoint. Tucked into the section reserved for the US Department of Health and Human Services is a section that focuses on generics and how these can save an estimated $11.1 billion over 10 years - or roughly $1 billion a year (look here). Not small change, yes? But how? There are two proposals. One would shrink exclusivity for biologics to seven years from 12 years, a move that would roll back a provision in health care reform. You may recall that brand-name drugmakers won a 12-year exclusivity period last year as part of an effort to create a so-called FDA approval pathway for biosimilars. Generic drugmakers, of course, wanted a shorter term. At issue is the balancing act between protecting R... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4478156 Mon, 14 Feb 2011 20:27:44 +0100 4478156 http://www.medworm.com/index.php?rid=4460662&cid=t_145530_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F02%2F10%2Fdid-you-know-that-fda-plays-a-vital-role-in-ensuring-the-safety-of-the-nation%25e2%2580%2599s-blood-supply%2F As part of FDA Basics, FDA is hosting a webinar where you can learn more FDA’s role in ensuring the safety of the nation’s blood supply.  The featured speaker, Richard Davey, MD, Director of the Division of Blood Applications, Office of Blood Research and Review in FDA’s Center for Biologics Evaluation and Research, will discuss how the agency safeguards the nation’s blood supply and protects the five million people who receive blood transfusions annually. Dr. Davey will provide an overview of these safeguards and will focus on the donor screening process and the testing of blood for blood-borne infectious agents.  After the presentation, there will an opportunity to ask questions. The free 30 minute webinar will be held Tuesday, February 15th, at 2 p.m. ET. There are a l... FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=4460662 Thu, 10 Feb 2011 17:23:26 +0100 4460662 http://www.medworm.com/index.php?rid=4399826&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTU6O6Hd_s60%2F Another day, another letter to the FDA commish from a group of bipartisan US senators over the biologics debate. The latest missive comes from health committee chair Tom Harkin, John McCain, Chuck Schumer and Sherrod Brown, who are “extremely concerned about possible misinterpretations” of the biosimilars statute “that could further delay the availability of generic biologic drugs.” They are referring to a provision in the healthcare reform law that says generics can enter the market after a brand-name biologic has had exclusivity for 12 years. But earlier this month, a different group of senators - Orrin Hatch, Kay Hagan, Michael Enzi and John Kerry - wrote FDA commish Margaret Hamburg to urge a different interpretation that would favor brand-name drugmakers and biotechs. At issue... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4399826 Tue, 25 Jan 2011 16:57:23 +0100 4399826 http://www.medworm.com/index.php?rid=4382949&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbWRWTVXZO5M%2F Another nasty lobbying battle has broken out over biosimilars. And the latest involves a group of generic drugmakers, insurers and pharmacy benefit managers, which are pushing back against a recent effort by brand-name drugmakers to weaken a part of healthcare reform that is supposed to create competition for expensive biologics. The provision says generics can enter the market after a brand-name biologic has had exclusivity for 12 years. But earlier this month, a bipartisan group of four US Senators - including Orrin Hatch, Kay Hagan, Michael Enzi and John Kerry - wrote FDA commish Margaret Hamburg to urge a different interpretation that would favor brand-name drugmakers and biotechs. Their letter was circulated on and beyond Capitol Hill by, among others, the BIO trade group. At issue is... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4382949 Fri, 21 Jan 2011 14:25:26 +0100 4382949 http://www.medworm.com/index.php?rid=4377792&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FshWlI8o-q9M%2F Rise and shine. Another day is on the way. And here on the Pharmalot corporate campus, where the official mascots are barking and the short people are scurrying off to the school houses, we are preparing for the usual meetings and deadlines. We imagine you are doing the same. So as always, please join us for a needed cup of stimulation and take a moment to peruse the news of the world. We hope your day is productive and please stay in touch… Vertex Hepatitis C Drug Gets Priority Review (Associated Press) Merck Confirms Bleeding Risk With New Clotbuster (Reuters) Perrigo Buys Assets Of Paddock Labs (Bloomberg News) Forest Labs Says Depression Drug Fails In Study (Associated Press) UK Plans To Overhaul The NHS (The Guardian) Parents Upset At FDA Panel Rejection Of Lilly Drug (Xconomy) ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4377792 Thu, 20 Jan 2011 13:03:28 +0100 4377792 http://www.medworm.com/index.php?rid=4372247&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fsb2Jltl930U%2F At a time when the national deficit is a growing problem, Medicare could have saved $111 million on more than a dozen Part B outpatient drugs, but its system for identifying prices for lower-cost generics is inefficient, according to a new report from the Office of Inspector General at the US Department of Health and Human Services. Here’s how it works: Drugmakers must submit average sales price (ASP) data to the Centers for Medicare & Medicaid Services within 30 days after the close of each quarter, and the data are used to calculate amounts to be paid for the following quarter. But this causes a two-quarter lag between when sales occur and payments reflect the sales, which the OIG says is “especially problematic.” That’s because the OIG found Medicare paid ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4372247 Wed, 19 Jan 2011 14:14:27 +0100 4372247 http://www.medworm.com/index.php?rid=4343334&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCgLvWskDCNk%2F Hello, everyone, and top of the morning to you. A steely, wintry sky hovers over the Pharmalot corporate campus this morning, where we are enduring the usual routine of hustling short people to this or that school house. As we cope - where is that cup of stimulation? - please join us in perusing the news of the world. Meanwhile, feel free to pass along interesting tidbits. Have a good one… AstraZeneca And Cancer Charity Strike Drug Testing Deal (Bloomberg News) FDA Warns Of Acetaminophen Risks Of Liver Toxicity (Drug Store News) Drug Shortages Persist With No End In Sight (Daily Finance) Biotechs And Generics Spar Over Biologic Exclusivity (The Wall Street Journal) FDA Says Sanofi-Aventis’ Lantus Link To Cancer Is Unclear (Reuters) US Cancer Costs Are Expected To Soar (Los Ange... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4343334 Thu, 13 Jan 2011 13:02:18 +0100 4343334 http://www.medworm.com/index.php?rid=4331240&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ffs_tQgfFVm0%2F Nothing like a trade off between generations. A new study suggests that extending data exclusivity for small molecule brand-name drugs will lead to higher drug costs in the short term, but down the road, more than 200 additional drugs would be approved as a result of the increased revenue generated, offering increased industry incentives. And this would also boost life expetancy for future generations. In other words, today’s patients pay more, but tomorrow’s patients can get a better deal. Data exclusivity, you may recall, refers to the exclusive access to clinical trial data and, right now, brand-name drugmakers are granted five years for data submitted during the FDA approval process. There’s also an extra three years for supplemental applications and six months more f... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331240 Mon, 10 Jan 2011 14:55:34 +0100 4331240 http://www.medworm.com/index.php?rid=4074446&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fz2qYZ1b8RdM%2F In an unusual move, the FDA has decided that the Menaflex knee-repair device made by ReGen Biologics should never have been approved and will move to rescind marketing clearance. The ruling comes after the agency reevaluated the scientific evidence following a September 2009 agency report that identified problems with the agency’s review of the device, which was approved in December 2008. That approval came over repeated objections of some FDA scientists and managers. Why? Outside pressure from lawmakers in New Jersey, where ReGen is based, who lobbied former FDA commish Andy von Eschenbach. The disclosure, along with an unusual letter written by nine FDA staffers to Congress to complain, prompted FDA deputy commish Josh Sharfstein to reconsider the decision, which came after ReGen i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4074446 Thu, 14 Oct 2010 19:47:23 +0100 4074446 http://www.medworm.com/index.php?rid=3806022&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fs3_divSIb8U%2F Last week, the FDA issued one of those surprise product approvals by giving a thumbs up to a generic version of Lovenox, a widely used bloodthinner sold by Sanofi-Aventis, much sooner than most people expected (see here and here). The move is something of a game-changer for the pharmaceutical industry and so we spoke briefly with Jonathan Pan, a senior associate at the Scientia Advisors consulting firm, about the implications… Pharmalot: Why is this approval such an important development? Pan: Well, it’s a $4 billion product for Sanofi-Aventis. That’s one reason it’s important. The second reason is the active ingredient is an extremely complicated molecule – a macro molecular that wraps around itself – which means it’s hard to characterize and hard to manufacture. So it r... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3806022 Fri, 30 Jul 2010 14:35:24 +0100 3806022 http://www.medworm.com/index.php?rid=3746740&cid=t_145530_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2F7-under-the-radar-healthcare-changes%2F2010.07.12 Kaiser Health News proves its value once again with an under-the-radar story covering some items you won’t see in many other news sources. An excerpt: “…several lesser-known provisions also take effect in coming months that could have a lasting impact on the nation’s health care system. These provisions include eliminating patients’ co-payments for certain preventive services such as mammograms, giving the government more power to review health insurers’ premium increases and allowing states to expand Medicaid coverage to low-income adults without children. While these changes might not have gotten at lot of attention, they could help build support for the law in the run-up to the contentious mid-term elections.” Their list: • Prevention For Less... Better Health blogs http://www.medworm.com/rss/comments.php?id=3746740 Mon, 12 Jul 2010 15:00:29 +0100 3746740 http://www.medworm.com/index.php?rid=3714447&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1qoiyO53RnY%2F Hello, everyone. How are you today? We are motoring along here on the Pharmalot corporate campus, where the heat has lifted and the birds are singing our song. Just the same, another busy day lies ahead. Your schedules, no doubt, are equally daunting. So please join us for the mandatory cup of stimulation and a bit of news of the world. Dig in and have a great day… Biogen To Hire George Scangos As CEO (Bloomberg News) Celegene To Buy Abraxis For $2.9 Billion (Associated Press) Pfizer Gets Incentives To Stay In Virginia (Richmond Times-Dispatch) Sanofi-Aventis Pays $75M For TargeGen (Bloomberg News) A Fix For The Avandia Mess (Forbes) Genzyme Expects More Cerezyme, Fabrazyme Shortages (Reuters) Sanofi-Aventis To Build New Plant In Saudi Arabia (InPharma-Technologist) Bristol-Myers Con... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3714447 Wed, 30 Jun 2010 11:47:29 +0100 3714447 http://www.medworm.com/index.php?rid=3560498&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6PUQzXUi6TE%2F Pontificators are having a field day deciphering healthcare reform and PricewaterhouseCoopers is no exception. The consulting firm has just released a report concluding that, despite expanded coverage that will increase revenue, overall drug sales will decline by 4.3 percent from what they would have been otherwise between 2010 and 2019. The bill increases Medicaid rebates, expands discounts to 340b hospitals, requires Medicare Part D discounts and adds a big fees over 10 years. Specifially, a typical big pharma should see a 4 percent drop in revenue, and a large generic drugmaker should see a 2 percent boost. Meanwhile, a medium-size drugmaker with low government sales should expect only a 1 percent decline, but a large drugmaker with lots of government sales can expect a 7 percent drop. ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3560498 Thu, 13 May 2010 11:16:46 +0100 3560498 http://www.medworm.com/index.php?rid=3511778&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FS_rvf1h3hFg%2F Top of the morning to you. Another shiny day here on the Pharmalot corporate campus, where another cup of stimulation is brewing. What will today bring? Meetings and deadlines, no doubt. To help you cope, here are a few items to jumpstart the process. We hope your day goes and do stay in touch… Icahn Wants To Fix A ‘Broken’ Genzyme (Reuters) EU Legislators Want Internet Drug Sales Regulated (PharmaTimes) Swine Flu Lifts Glaxo Profits (Reuters) Medco Gains On New Clients (Associated Press) Merck KGgA Profit Beats Estimate (Bloomberg News) Pfizer Hopes For New Biotech Drugs (The Wall Street Journal) $$ Coffee pix thx to chichcacha flickr creative commons (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3511778 Wed, 28 Apr 2010 11:49:11 +0100 3511778 http://www.medworm.com/index.php?rid=3490870&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_-OiO6NzyZM%2F Who says there is only bad news emanating from the pharmaceutical industry? With the help of tax credits, a family-owned distributor of biologics plans to create more than 1,000 jobs over the next five years in a former General Motors complex in Flint, Michigan. And by 2028, Diplomat Specialty Pharmacy hopes to employ a total of 4,000 people there. “It’s pretty bold,” Phil Hagerman, Diplomat’s president tells The Detroit Free Press, “for a company that has 400 employees today to say that we’re going to hire 1,000 in five years and 4,000 in 18 years, but the reality is, we’re in an industry where the tide is rising at 15 percent to 20 percent a year.” He adds that sales are growing 50 percent a year. “Specialty pharmacy revolves around ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3490870 Wed, 21 Apr 2010 12:02:34 +0100 3490870 http://www.medworm.com/index.php?rid=3399177&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCn7AlbthmxM%2F Hello, everyone. Nice to see you again. We were on the road part of yesterday, so resuming the usual routine is always welcome. And, of course, there is much to do. We all face meetings and deadlines, after all. To get started, we are brewing our mandatory cup of stimulation and looking forward to a day of accomplishments. We hope you achieve your own goals today. To help you along, here are a few items of interest. Stay in touch… Regeneron Shares Jump After CEO Touts Drugs (Reuters) FDA Panel Mostly Backs Controversial Knee Device (Associated Press) Sanofi-Aventis Antiplatelet Drug Gets EC Approval (MarketWatch) Novartis Gives Voltaren Emulgel Account To Starcom In China (MediaAsia) Glaxo And Pfizer Agree To Supply Pneumonia Vaccines (Associated Press) Perrigo Buys Infant Formula M... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3399177 Wed, 24 Mar 2010 11:47:28 +0100 3399177 http://www.medworm.com/index.php?rid=3395366&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4FwyWcXQYpU%2F An FDA advisory panel will hold an unusual meeting today to review a product that was already approved. At issue is whether the agency should reevaluate the Menaflex knee-repair device made by ReGen Biologics, which was approved in December 2009 over repeated objections of some FDA scientists and managers. Why? Outside pressure from lawmakers in New Jersey, where ReGen is based, who lobbied former FDA commish Andy von Eschenbach. The disclosure, along with an unusual letter written by nine FDA staffers to Congress to complain, prompted FDA deputy commish Josh Sharfstein to reconsider the decision, which came after ReGen initially complained of bias against its device by FDA staff two years ago. However, an interesting internal debate broke out among agency staff recently over whether the F... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3395366 Tue, 23 Mar 2010 13:45:04 +0100 3395366 http://www.medworm.com/index.php?rid=3322629&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbOW8qNg2sho%2F A report from the General Accountability Office found that among all Medicare Part D beneficiaries who used at least one specialty tier–eligible drug in 2007, 55 percent reached the catastrophic coverage threshold, after which Medicare pays at least 80 percent of all drug costs. In contrast, only 8 percent of all Medicare Part D beneficiaries who did not use a specialty tier–eligible drug reached this threshold in 2007. Specialty tier–eligible drugs accounted for 10 percent, or $5.6 billion, of the $54.4 billion in total prescription drug spending under Medicare Part D plans in 2007. And Medicare beneficiaries who received a low-income subsidy accounted for most of the spending on specialty tier–eligible drugs—$4.0 billion, or 70 percent of the total, according to the GAO. High-c... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3322629 Tue, 02 Mar 2010 17:21:36 +0100 3322629 http://www.medworm.com/index.php?rid=3176120&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Flr8SPbkRoWk%2F Some late-in-the-game, behind-the-scenes dealmaking appears to be under way involving generic drugmakers, the White House and Henry Waxman, who chairs the House Energy & Commerce Committee over granting biotechs 12 years of exclusivity against biogenerics, the Associated Press writes. The skirmishing comes as Congress edges closer to a final version of health care reform legislation. The drive to shrink the protection period to a rumored 10 years has prompted opposition from the pharmaceutical industry, which argues the longer period is needed to encourage investments needed to produce biotechs. “Fair data protection of at least 12 years is critically important to the future of medical progress in America,” Ken Johnson, PhRMA’s senior vp, tells the AP. Three dozen pa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3176120 Fri, 15 Jan 2010 01:44:44 +0100 3176120 http://www.medworm.com/index.php?rid=3097066&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyV6BtVwpQ2U%2F Hello, everyone. Nice to see you again. We are feeling bright and shiny today, although we are about to begin the usual process of hustling short people off to the schoolhouse. So while we grapple, here are a few items to help you endure your own routine. Hope today is a good one for you…. Roche, Ipsen Diabetes Drugs Meet Study Goals (Reuters) Glaxo To Rehire 50 Tennessee Plant Workers (TriCities.com) Merck To Acquire Avecia Biologics (press release) Coffee courtesy of Flickr Creative Commons chichcacha (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3097066 Thu, 17 Dec 2009 12:12:09 +0100 3097066 http://www.medworm.com/index.php?rid=3056882&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJB_ObJOoTjc%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? Jazz Pharmaceuticals hired Kathryn Falberg as senior vp and cfo; NovaDigm Therapeutics named R. Gordon Douglas as chairman; Pfizer named Adele Gulfo as US president of its primary care business; Amarin hired Joe Zakrzewski as executive chairman; Cardinal Health added Carrie Cox to its board of directors; Catalent Pharma Solutions hired Paul Burns as vp of global sales; Kfor... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3056882 Fri, 04 Dec 2009 13:24:18 +0100 3056882 http://www.medworm.com/index.php?rid=2954795&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FiNSA1C7Shwk%2F The media used to be filled with stories of seniors who can’t afford their pills. The latest manifestation of this war over access and affordability is now extended to biologics, the costly and profitable meds that are the subject of an intense Congressional legislative and lobbying effort. As you know, the issue is the extent to which investments and profits will be protected before lower-cost biosimilars are available. Meanwhile, there’s Rob Day. No, he doesn’t spend $32,000 a month. “I went 20 years waiting for a miracle cure to come,” the 41-year-old Michigan man with a rare blood condition tells The Port Huron Times-Herald. “Well, I got the next best thing.” That next best thing is Soliris, a biologic that allows Day to function on a day-to-da... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2954795 Tue, 03 Nov 2009 12:58:54 +0100 2954795 http://www.medworm.com/index.php?rid=2702484&cid=t_145530_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2009%2F08%2F14%2Ffda-issues-final-rules-to-help-patients-gain-access-to-investigational-drugs%2F The U.S. Food and Drug Administration (FDA) published two rules [on August 12, 2009] …that seek to clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don’t have other satisfactory treatment options. The U.S. Food and [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=2702484 Sat, 15 Aug 2009 04:34:59 +0100 2702484 http://www.medworm.com/index.php?rid=2453039&cid=t_145530_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2009%2F06%2Fmedco-cfo-sees-generic-insulin-by-2013.html This isn't meant to be a primer on the role of the Pharmacy Benefits Managers (or PBMs), but few people realize just how massive the role of the PBM really is in today's healthcare reform debate. These companies know the score when it comes to the drug costs, prescription and usage patterns and the outlook on where things are likely to be going.The Role of the PBM in the U.S. Healthcare "System"PBMs are probably one of the biggest players in the U.S. healthcare field that most people have at best, only a hazy idea of their role in managing the cost of healthcare. For people with chronic medical conditions, they may know these companies as the mail-order companies they're forced to order 90-day supplies from. Increasingly, however, many healthcare plans are placing caps on prescriptions fil... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=2453039 Wed, 03 Jun 2009 18:00:00 +0100 2453039 http://www.medworm.com/index.php?rid=2027779&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F479597413%2F The drugmaker is hosting its annual R&D briefing for Wall Street analysts and fund managers, where surprises are usually not on display. This time, however, Merck execs are saying they want to establish a new unit to make generic biotechs, which some calls biogenerics, biosimilars or follow-on biologics, although there are subtle differences between these terms. In any event, the basis for the effort is Merck’s acquistion of GlycoFi, a biotech bought two years ago for its proprietary glyco-engineering technology. The move represents what Merck execs are caling a “significant” opportunity since so patents on so many big-selling biologies are scheduled to expire through 2017. Merck’s first follow-on biologic is for anemia, with plans to in 2012, and another five ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2027779 Tue, 09 Dec 2008 15:11:13 +0100 2027779 http://www.medworm.com/index.php?rid=2006555&cid=t_145530_117_f&fid=36026&url=http%3A%2F%2Fblog.healthtalk.com%2Fzimney%2Funderstanding-biologics-how-they-differ-from-drugs-and-why-they-cost-more%2F Many of our readers either already have or will in the future encounter the possibility of being treated with a biologic medication. This is because biologics have revolutionized the treatment of such chronic illnesses as rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn’s disease, and multiple sclerosis, and are widely used in treating a variety of cancers. To name just a few, these products include Enbrel, Humira, Remicade (infliximab), Avonex (inteferon beta-1a), Betaseron (interferon beta-1b), Tysabri, Cimzia (certolizumab pegol), Herceptin (trastuzumab), Rituxan (rituximab), Neupogen (filgrastim), Neulasta (pegfilgrastim) and Leukine (sargramostim). So just what are biologics, how do they differ from more traditional drugs, and why are they so expensive?Although some b... Dr. Z's Medical Report blogs http://www.medworm.com/rss/comments.php?id=2006555 Tue, 02 Dec 2008 18:06:00 +0100 2006555 http://www.medworm.com/index.php?rid=1981289&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F458346037%2F This topic may have fallen off the radar screen amid the presidential election and the recession, but the rising cost of biologics continues to be a problem. And the Federal Trade Commission wants to shape the discussion before Congress and the FDA proceed with a framework that will permit drugmakers to create and market lower-cost versions. So, at 8:30 am EST today, the FTC will conduct a workshop organized into five panels to discuss the following issues: the price and market share effect of entry by both biosimilar and biogeneric drugs, the likely competitive effects of reference product regulatory exclusivity, biotechnology patent issues, the likely competitive effects of follow-on biologic regulatory incentives, and the patent resolution process. The FTC, you may recall, wrote a lette... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1981289 Fri, 21 Nov 2008 12:22:29 +0100 1981289 http://www.medworm.com/index.php?rid=1895595&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F427528195%2F Approximately one in four biologics approved since 1995 in the US and Europe have had at least one safety-related regulatory action issued for them 10 years after their approval, including about 11 percent receiving a Black Box warning, according to a study in the Journal of the American Medical Association. The new study is the first comprehensive examination of biologics, and among those cited were the Humira and Remicade arthritis treatments; the Rituxan and Erbitux cancer meds, and the Natrecor drug for heart failure. Most warnings, by the way, came within five years after approval (here is the study). “Between 2003 and 2006, biologicals represented 24 percent and 22 percent of all new chemical entities approved by the US and EU regulatory authorities, respectively,” the author... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1895595 Tue, 21 Oct 2008 14:37:54 +0100 1895595 http://www.medworm.com/index.php?rid=1833423&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F402967745%2F The prices of specialty meds most commonly used by Medicare Part D beneficiaries to treat such maladies as cancer, rheumatoid arthritis and multiple sclerosis have risen faster than inflation every year since 2004 and rose three times the inflation rate last year, according to a survey from AARP. “The skyrocketing cost of specialty drugs is especially tragic for those suffering from diseases like cancer and multiple sclerosis,” John Rother, AARP’s executive vp of policy and strategy, says in a statement. “These drugs can provide comfort and hope to these individuals and their families. But even the most miraculous drug is useless if a person can’t afford to take it.” The survey, which covered 144 brand-name and generic meds, will be used by AARP in its battle to speed appro... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1833423 Thu, 25 Sep 2008 17:07:22 +0100 1833423 http://www.medworm.com/index.php?rid=1833426&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F402870703%2F Ask a human resource exec or benefit managers why drug prices keep rising and you’re likely to hear them blame direct-to-consumer advertising. And why not? The ads are not only ubiquitous, but promote meds that are, generally, expensive. This year, however, a survey of 100 companies with at least 1,000 employees finds that DTC advertising is generating fewer complaints. This year, 33 percent of the managers, vp’s and directors queried blamed ads for the higher prices their employee benefit plans paid for meds. That’s down from 45.5 percent in 2007 and 36 percent in 2006. Instead, the blame is shifting to manufacturer price hikes - 13.4 percent cited this as a problem, compared with 6.9 percent last year, according to Arxcel, a pharmacy benefits consultant that sponsored t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1833426 Thu, 25 Sep 2008 15:06:56 +0100 1833426 http://www.medworm.com/index.php?rid=1809934&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F396407683%2F You’re not surprised, are you? In any event, expanding the use of low-cost generics, including versions of biologics, would be near the top of their health care agendas, according to their advisers, who were speaking at a conference for the generic industry. “We know that expanding the use of generics and eliminating barriers to that goal must be a centerpoint of any health reform effort,” Dora Hughes, a health care adviser for Obama, according to the Associated Press. And McCain adviser Douglas Holtz-Eakin echoed the sentiment: “Controlling health care costs has to be the imperative of any effective health care reform.” And both campaigns pledged their support to help create a market for generic biologics, a long-sought goal of generic makers such as Mylan L... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1809934 Thu, 18 Sep 2008 17:36:42 +0100 1809934 http://www.medworm.com/index.php?rid=1739487&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F377447735%2F Lost amid the presidential campaign, the sour economy and other sobering distractions over the past few months, the advent of follow-on biologics continues to lurk in the background as a significant issue that can be expected to regain attention sooner than later. Biologics, of course, are expensive - costing tens of thousands of dollars and up annually. But there is no approved regulatory framework allowing biotechs to develop and market follow-ons, although three bills are lingering in Washington. A Congressional Budget Office report found the cost of a Senate bill, if enacted, would reduce total expenditures on biologics by $25 billion between 2009 and 2018. Now, the Federal Trade Commission is examining the issue with an eye toward sorting out competitive issues, incentives and patents... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1739487 Fri, 29 Aug 2008 11:21:17 +0100 1739487 http://www.medworm.com/index.php?rid=1606130&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F331710557%2F In doing so, Insmed apparently becomes the first US company to demonstrate bioequivalence for a follow-on biologic. The next step is for the drugmaker to meet with the FDA in hopes of receiving a green light to proceed with a Phase III study for its INS-19 which, like Neupogen, would combat neutropenia, a common side effect of chemotherapy. Neupogen, by the way, is a $1 billion seller. A Phase I trial involving 32 patients receiving either a dose of Insmed’s INS-19 or Amgen’s Neupogen found that the way the two biologics interacted with the body was statistically indistinguishable, while the concentration of G-CSF (G-CSF stimulates the production of white blood cells) for the two products were identical, according to Insmed. Here’s the statement. Two years ago, the FDA approved O... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1606130 Thu, 10 Jul 2008 13:02:22 +0100 1606130 http://www.medworm.com/index.php?rid=1546986&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F320500932%2F The Congressional Budget Office has released its long-awaited assessment of the cost of a Senate biogenerics bill and found that the legislation, if enacted, would reduce total expenditures on biologics in the US by $25 billion between 2009 and 2018. Over that 10-year period, savings would equal roughly 0.5 percent of national spending on prescription drugs, valued at wholesale prices. Moreover, the bill would reduce budget deficits - or increase surpluses, depending on your point of view - by $6.6 billion over the same period. A few other CBO calculations: Direct spending by the federal government would decrease by $46 million over the 2009-2013 period, and by $5.9 billion over the 2009-2018 period; most of those savings would accrue to the Medicare program. Federal revenues would increa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1546986 Thu, 26 Jun 2008 12:48:53 +0100 1546986 http://www.medworm.com/index.php?rid=1396459&cid=t_145530_117_f&fid=36026&url=http%3A%2F%2Fblog.healthtalk.com%2Fzimney%2Fcimzia-approved-for-crohns-disease%2F The FDA has granted approval of Cimzia (certolizumab pegol) as the fourth biologic agent for the treatment of Crohn’s disease. Cimzia, like Remicade (infliximab) and Humira (adalimumab), is an antibody that blocks the action of TNF (tumor necrosis factor), a pro-inflammatory chemical known to play a central role in causing the pathology of a variety of inflammatory disorders including Crohn’s, ulcerative colitis, rheumatoid arthritis and psoriasis. Tysabri (natalizumab), the fourth biologic for Crohn’s, is also an antibody, but it works by blocking the action of certain types of white blood cells that are involved in the inflammatory process. Cimzia received approval for treating adults with moderate to severe Crohn’s disease who have not responded to conventional therapies. Al... Dr. Z's Medical Report blogs http://www.medworm.com/rss/comments.php?id=1396459 Thu, 24 Apr 2008 18:28:04 +0100 1396459 http://www.medworm.com/index.php?rid=1391300&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F275359444%2F In a decision that shows how difficult it is to copy biologics, the FDA has rejected Genzyme’s request to sell a version of its Pompe disease drug, called Myozyme, which the drugmaker planned to manufacture at an additional site. But the agency ruled that any Myozyme made at the second plant should be considered a different product because of small differences in its chemical structure, The Boston Globe reports. In order to sell the latest version of the drug in the US, Genzyme will have to file another application with new data showing the drug is safe and effective in large numbers of patients. Pompe disease is a rare, debilitating genetic illness that prevents people from breaking down a common sugar called glycogen, which can then build up in the body’s cells and weaken the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1391300 Tue, 22 Apr 2008 12:10:41 +0100 1391300 http://www.medworm.com/index.php?rid=1322423&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F257007687%2F As the US grapples with a pathway for biogenerics, Health Canada has beat the FDA to the punch and issued a draft guidance. The agency recently posted on its website requirements for manufacturers and says it could approve products under existing regulations until laws are amended to include the new approval pathway, FDA News reports. If finalized, a so-called subsequent-entry biologic would have to be similar to a previously approved biologic, relying in part on publicly available safety and efficacy data. Interchangeability and substitutability would not be automatic, but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes, FDA News continues. A subsequent-entry biolo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1322423 Mon, 24 Mar 2008 12:27:16 +0100 1322423 http://www.medworm.com/index.php?rid=1316796&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F254935504%2F Sharply rising expenditures for cancer drugs and other high-priced meds are prompting employers, health plans and pharmacy-benefit managers to redouble efforts to rein in spending, The Wall Street Journal writes. To curb use, payers are pushing for legislation to permit generic drugmakers to sell cheaper versions of biologics, reinforcing rules about trying cheaper therapies first, and early certification of patient prescriptions. Some seek novel solutions such as paying drugmakers based on how well a drug works, rather than how much is used. The actions come amid fresh evidence that so-called specialty pharmaceuticals are among the biggest drivers of escalating health costs. Express Scripts, the pharmacy-benefits manager, says a report due out next months shows that spending for these dru... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1316796 Thu, 20 Mar 2008 13:47:13 +0100 1316796 http://www.medworm.com/index.php?rid=1307753&cid=t_145530_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F03%2Frep-eshoo-decries-congressional.html What would you say to a Congresswoman who behaves like a hypocrite? Well, California's 14th District (an area I'm very familiar with, having lived in the district for nearly a decade during the 1990's) House Representative Anna Eshoo deserves just such a rebuke today. Ms. Eshoo, who was on the San Mateo County Board of Supervisors when I resided in Foster City, represents the district where many biotechnology firms and venture capitalists are based, encompassing much of Silicon Valley and stretches up the San Francisco Peninsula.Just what has she done? Well, she has sponsored legislation aimed at "cleaning up the House" which she claims is to restore the confidence of the American people in their government. Sounds convincing so far. One of the key elements in her proposed legislation aims... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1307753 Mon, 17 Mar 2008 15:45:00 +0100 1307753 http://www.medworm.com/index.php?rid=1305019&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F251713783%2F As promised last month, Anna Eshoo, a Democrat from California - specifically, the region where many biotechs and venture capitalists are based - has now introduced legislation that would create a so-called pathway for FDA approval while offering brand-name companies 12 years of exclusivity, plus an extra two years for a medically significant innovation. That adds up to, yes, 14 years. (This is the bill and this is the summary). Not surprisingly, the BIO trade group was ecstatic in its praise for Eshoo and Joe Barton, a Texas Republican who joined her in sponsoring the bill, which calls for studies to demonstrate safety and efficacy; requires the FDA to create a mechanism to determine whether products are interchangeable and also requires the agency to issue guidances for biosimilar approv... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1305019 Sat, 15 Mar 2008 00:50:37 +0100 1305019 http://www.medworm.com/index.php?rid=1280795&cid=t_145530_134_f&fid=35152&url=http%3A%2F%2Fsstrumello.blogspot.com%2F2008%2F03%2Ffda-needs-your-input-on-diabetes.html On Tuesday, I wrote about the opportunity for people with diabetes to attend the NIH/NIDDK's jointly-sponsored (along with JDRF) "Artificial Pancreas Workshop" in July. But I also mentioned that it was merely the first opportunity for you as patients to contribute something by representing real-life patient needs to our Government-funded agencies.Another opportunity you should be aware of is that the FDA has just issued a document with Draft Guidance for Industry for Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention, which provides recommendations to industry regarding the development of drugs and more specifically, therapeutic biologics regulated within the Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) for... Scott's Web Log blogs http://www.medworm.com/rss/comments.php?id=1280795 Wed, 05 Mar 2008 17:00:00 +0100 1280795 http://www.medworm.com/index.php?rid=1242296&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F237584533%2F Some wags say the debate over biologics may not go anywhere this year, but one congresswoman is supposedly on the verge of introducing a bill to resolve the controversy. Anna Eshoo, a Democrat from California - specifically, the region where many biotechs and venture capitalists are based - has drafted legislation that would create a so-called pathway for FDA approval while offering brand-name companies 12 years of exclusivity, according to the FDA Law blog. The draft would amend the Public Health Service Act by adding a section that would allow biologic licenses to be submitted and include info demonstrating the med is biosimilar based on analytical studies, animal studies, and a clinical study or studies (such as an immunogenicity assessment and pharmacokinetics or pharmacodynamics). Und... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1242296 Tue, 19 Feb 2008 14:16:45 +0100 1242296 http://www.medworm.com/index.php?rid=1233330&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F235193140%2F After nearly a decade of resisting, biotech companies want a law passed this year that lets generic drug companies sell cheaper copies of their medicines. Biotechs, of course, have never had the competition from generics that brand-name drugmakers face when patents expire. While the FDA lacks authority to approve generic biotechs, several bills introduced in Congress during the past year would change that, the Associated Press writes. Biotech companies say they are ready for that change - so much so that their main trade group is making the legislation a top priority in 2008. And the Bush administration recently said it supports that aim. The shift comes as election-year politics are expected to turn Washington away from biotech’s interests. Many political observers expect Democrats ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1233330 Thu, 14 Feb 2008 22:01:15 +0100 1233330 http://www.medworm.com/index.php?rid=1229432&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F234364895%2F Two-thirds of all prescriptions filled in the US are generics, the highest-ever rate, according to figures released by the Generic Pharmaceutical Association. That’s up from 63 percent. Meanwhile, Bloomberg News reminds us that more expensive brand-name meds account for about 80 percent of all dollars spent on prescriptions each year. The figures, compiled by IMS Health, show generic drugmakers are capitalizing on expiring patents and efforts by insurers to rein in health-care costs, Bloomberg notes, while adding that the companies hope to capitalize as drugs with $20 billion in annual sales lose patent protection and the presidential candidates promise to make generic drugs more widely available. Drugs facing generic competition for the first time this year include Merck’s Fos... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1229432 Wed, 13 Feb 2008 13:46:29 +0100 1229432 http://www.medworm.com/index.php?rid=1222431&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F233143829%2F The debate over generic biologics, which some call follow-on biologics, just took an interesting turn. Although the White House budget would give the FDA new funds to approve such drugs, various companies remain frustrated with the lack of a sanctioned FDA-approved pathway, which is needed before copycat versions of these expensive meds can be developed and sold in the US. So one drugmaker is turning to YouTube to press its point. Late last week, Insmed corraled one of its scientists, Mike Coleman, to offer a researcher’s view of the value of generic biologics. With his low-key, matter-of-fact delivery; youthful demeanor and standard-issue white laboratory coat, Coleman makes for an unusual lobbyist. But Insmed, which has projects under way to develop several generic biologics, is ba... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1222431 Mon, 11 Feb 2008 13:43:17 +0100 1222431 http://www.medworm.com/index.php?rid=1108786&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F203503309%2F Although increasing numbers of drugmakers talk about boosting their biological pipelines, the more-traditional small molecule approach is still leading the way in terms of numbers of drugs entering first-in-man clinical trials, according to DrugResearcher.com, which has been compiling a list of Phase I trials. Given that companies tend to announce this type of clinical trial at different stages, the site writes some molecules wound up on its list because the FDA accepted an Investigational New Drug application or perhaps through starting or completing enrollment. Unfortunately, many companies - particularly big drugmakers - often don’t announce trials at all and so DrugResearcher concedes its list can’t claim to be complete. Nonetheless, here’s what DrugResearcher conclud... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1108786 Thu, 20 Dec 2007 16:49:18 +0100 1108786 http://www.medworm.com/index.php?rid=897087&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F160606325%2F The all-cash deal for Adnexus Therapeutics, which could go another $75 million higher depending upon certain milestones, gives the big drugmaker a beachhead into biologics, a more complex science but also a lucrative field given the high prices charged for these meds. The acquisition is “an important step in accelerating the strategic transformation of our pharmaceutical business to a biopharma business model,” says Bristol-Myers ceo Jim Cornelius, in a statement. The biotech has developed a proprietary class of targeted biologics called Adnectins, which Bristol hopes will one day yield meds for various therapies. Right now, Adnexus is working on an early-stage trial for a cancer treatment called Angiocept, an anti-angiogenic drug that would stop cancerous tumors from developin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=897087 Mon, 24 Sep 2007 13:31:22 +0100 897087 http://www.medworm.com/index.php?rid=888776&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F159186869%2F We are posting our usual round-up a wee bit early this evening due to a speaking engagement, of all things. The New Jersey Intellectual Property Lawyers Association - that’s right, a group of patent lawyers - has asked us to chat about patents and how these are perceived by the media and the public. We don’t pretend to be experts, but we expect to have a good time discussing the issue and making acquaintances. And if we come across anything interesting, you can be certain we will pass it along, to you. Meanwhile, here a few items to keep you occupied until we return…. Generic Biotech Agreement Proves Elusive (Yahoo/AP) Wyeth Gets Mixed News From European Regulatory Panel (Bloomberg News) China Drafts Drug-Safety System (The International Herald Tribune) Share / E-mail (S... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=888776 Thu, 20 Sep 2007 21:22:01 +0100 888776 http://www.medworm.com/index.php?rid=883877&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F158515595%2F In a teleconference chat yesterday afternoon with a few bloggers, Jim Greenwood spent some time sharing the BIO point of view on the pressing matters of the day - follow-on biologics legislation, patent reform legislation and the FDA reform bill, which is otherwise known as PDUFA. Here are some excerpts…. FDA Reform: We think we’ve done pretty well…We’re not happy that Congress included $250 million in PDUFA fees after we spent last year negotiating with Congress…But PDUFA expires in 12 days and morale at the FDA is not good. If Congress doesn’t grant a temporary extension, it’ll be another morale killer. They (FDA staffers) really do start thinking about other offers, since government doesn’t pay.” Follow-on Biologics: This is “... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=883877 Wed, 19 Sep 2007 11:14:22 +0100 883877 http://www.medworm.com/index.php?rid=848530&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F153411914%2F Lawmakers are unlikely to add generic biologics legislation to an FDA bill that’s expected to receive congressional approval this month, two key U.S. congressmen said on Thursday, reports Reuters. Generic drugmakers have been pushing legislation that would chart a specific path for the FDA to approve cheaper copycat versions of biotech meds. The chances of adding the generic biologics measure to a broad FDA bill now moving through Congress are “extremely slim,” Rep. Henry Waxman, a California Democrat, told a Generic Pharmaceutical Association conference. Rep. Frank Pallone, a New Jersey Democrat, also said it was unlikely that House and Senate negotiators could agree on an approach for generic biologics in time to include it in the FDA bill. The FDA legislation, which i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=848530 Fri, 07 Sep 2007 11:44:42 +0100 848530 http://www.medworm.com/index.php?rid=744960&cid=t_145530_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F135408878%2F The fragile support for a Senate bill that would allow the FDA to approve generic versions of biologic drugs is deteriorating at the same time House lawmakers are trying to persuade leaders not to allow for such a provision in an FDA bill. Generic and brand name lobbyists say generic makers miight threaten to pull their support for the bill if a provision they say would give brand companies continuous monopoly rights is not changed, Congress Daily reports (subscription required). A sticking point was how long to give brand-name drugmakers exclusive rights to sell free of generic competition. The senators settled on 12 years, a number most believe can’t change without crumbling the entire deal. (more…) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=744960 Thu, 19 Jul 2007 20:56:47 +0100 744960