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 'dendreon'. Sat, 03 Sep 2011 02:21:16 +0100 http://www.medworm.com/index.php?rid=5159833&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSUw2xkpf29g%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 Astellas US named Percival Barretto-Ko as senior vp of corporate strategy and government affairs. Before that, he was executive director, corporate strategy and communications at Astellas Pharma Europe. Prior to joining Astellas, he held senior... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159833 Fri, 26 Aug 2011 12:11:26 +0100 5159833 http://www.medworm.com/index.php?rid=5159838&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FknoYhABGIzg%2F As if Dendreon doesn’t have enough problems. A new survey shows that 68 percent of payers believe utilization for its controversial Provenge prostate cancer vaccine will remain flat over the next to six to nine months. And 69 percent say the true cost is anywhere from $101,000 to $120,000, when factoring in lab tests, administrative costs and lost productivity, as opposed to the $93,000 price tag. Meanwhile, 79 percent of payers report low uptake among physicians. Of that group, 60 percent also believe that many physicians are not yet prescribing Provenge. Why? They listed limited clinical value; high cost; a lack of physician confidence in the vaccine; a lack of qualifying patients and an insufficient number of cancer centers willing to administer Provenge. What’s more, the i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159838 Thu, 25 Aug 2011 12:48:41 +0100 5159838 http://www.medworm.com/index.php?rid=5107897&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQaavhu47mq4%2F Earlier this year, a Dendreon investor named Brad Loncar took the maker of the Provenge prostate cancer vaccine to task for what he believes are basic managerial shortcomings and criticized the board for failing to provide sufficient oversight and advice. The sort of complaints he expressed (read here) are familiar to investors in many stocks - repeatedly missing forecasts, failing to disclose important info and ignoring worthwhile suggestions. Irked that his missive to the Dendreon board was ignored, he went public (see this) and generated some heat, but faded from view again after the Centers for Medicare & Medicaid Services endorsed reimbursement. But last week, his criticism seemed all the more relevant when Dendreon shocked investors by disclosing that sales were slower than plan... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5107897 Mon, 08 Aug 2011 14:13:15 +0100 5107897 http://www.medworm.com/index.php?rid=5097078&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeWhDi30BCsE%2F Earlier this week, Dendreon shocked investors by scrapping its 2011 sales forecast for its controversial and innovate Provenge prostate cancer vaccine after disclosing that sales were slower than planned. The stated reason was that many doctors, particularly those in smaller settings, were slow to adopt the $93,000 vaccine since they had to wait for reimbursement. Along with unexpected layoffs, the announcement stunned investors, causing Dendreon stock to plunge 60 percent. Wall Street wags began deciphering the extent to which some doctors are truly worried about reimbursement or are simply unethusiastic about the product (back story). We spoke with Leonard Liang, a Los Angeles urologist who is sufficiently enthusiastic about Provenge that he posted his own YouTube video. He maintains he ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5097078 Fri, 05 Aug 2011 16:47:52 +0100 5097078 http://www.medworm.com/index.php?rid=4992996&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIKpuqSGxcXI%2F Good morning, everyone. And how are you today? Another beautiful morning is rising over the Pharmalot corporate campus. However, we will be rolling in the sidewalks early as we prepare for a long weekend on this side of the pond. Our modest agenda includes a dip in the pool, hanging with the short people, catching up on some research (with thanks to our sources) and one of our favorite sports - hunting for mice. What about you? Anything special planned? Maybe a ride in the country, a barbecue in the backyard or how about a day at the beach? This will be Independence Day, after all, so perhaps this is a good time to think of suggestions for trimming the national debt. The symbolism is heavy, yes? Whatever you do, have a great time and be safe. See you soon… Glaxo Kicks Off Sale Of OTC... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992996 Fri, 01 Jul 2011 11:50:16 +0100 4992996 http://www.medworm.com/index.php?rid=4976206&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvinqO6QozGE%2F Hello, again. And how are you this morning? A beautiful day is unfolding here on the Pharmalot corporate campus - the birds are chirping, the official mascots are lounging about and the cup of stimulation is brewing. Meanwhile, we are looking forward to another day of R&D. We know you can relate. To help you along, here are some tidbits. Hope your day goes well and stay in touch… Vertex Tops Merck In Hep C Drug Launch (The Street) Glaxo R&D Chief Says Advair Is Safe From Generics (Reuters) J&J Plans To Market More Products Under The Janssen Name (Financial Times) New Prostate Cancer Drugs Are Expensive (New York Times) Amgen Sells $3 Billion In Bonds To Pay For Dividends (Bloomberg News) Diabetes Cases In Adults Worldwide Has Doubled In 30 Years (Reuters) India Suspend... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4976206 Tue, 28 Jun 2011 11:45:08 +0100 4976206 http://www.medworm.com/index.php?rid=4753971&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU0H-Kz5ZdoU%2F For many people, the Provenge controversy has come and gone. The prostate cancer vaccine was approved a year ago by the FDA and, more recently, the Centers for Medicare & Medicaid Services signaled that coverage would be provided (see here). Meanwhile, Provenge sales are rising, manufacturing is increasing and Wall Street tracks shares in Dendreon, which makes the vaccine, very closely. But one aspect apparently remains unresolved, at least for some. Four years ago, the unexpected FDA delay in approving Provenge occurred amid alleged conflicts of interest involving two members of an agency advisory committee. They quietly wrote FDA officials to veto a panel recommendation in favor of approval. The episode prompted a lawsuit and patient protests, but full details were never disclosed (... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4753971 Tue, 26 Apr 2011 14:06:15 +0100 4753971 http://www.medworm.com/index.php?rid=4677114&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FC_g_bkDy5kM%2F Hello, everyone, and welcome to the working week. We hope the weekend was relaxing. Now, of course, the routine of meetings and deadlines resume. This calls, of course, for a cup or two of stimulation. So please join us as we indulge. Meanwhile, here are a few tidbits to get you started. Have a great day and keep us in mind if you hear something interesting. See you later… Dendreon Faces Investor Uprising Led By Small Shareholder (Xconomy) Vivus Diet Pill Has Heart Benefits (Bloomberg News) BASF Raises API And Excipient Prices 10 Percent (InPharma Technologist) Antidepressants Linked To Narrowed Arteries In Older Men (Bloomberg News) Glaxo Faces Talent War In Emerging Markets (Bloomberg News) Cipla Seeks Voluntary License To Make Merck AIDS Drug (MoneyControl) FDA Staff Backs Efficac... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4677114 Mon, 04 Apr 2011 11:48:39 +0100 4677114 http://www.medworm.com/index.php?rid=4658620&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FA5SmUewYtH8%2F After months of anticipation, the Centers for Medicare & Medicaid Services has decided that the Provenge prostate cancer vaccine is eligible for reimbursement. The unsurprising decision comes just four months after a CMS advisory panel voted that Dendreon’s Provenge vaccine for advanced prostate cancer shows “clinically significant” improvement in survival (look here) The panel was convened, however, after the agency last year unexpectedly initiated a so-called National Coverage Determination in response to questions raised by Medicare contractors amid concerns over off-label use. Such a review was unusual, given that Medicare generally pays automatically for FDA-approved oncology meds (read here). For that reason, the CMS review set off a firestorm of protest that the agency wa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658620 Wed, 30 Mar 2011 20:35:23 +0100 4658620 http://www.medworm.com/index.php?rid=4611003&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWXsonFvU_bM%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 Information Technologies, which provides marketing services to healthcare providers, hired Brian Tvenstrup as sr vp of business analytics. Previously, he headed analytics for First Equity Card, a commercial lender to small businesses, and w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4611003 Fri, 18 Mar 2011 12:03:11 +0100 4611003 http://www.medworm.com/index.php?rid=4495436&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUG_9mGgMAXg%2F And so, another work week will soon draw to a close. You know what that means: daydreaming about weekend plans. And this will be a long weekend here in the states. We expect to catch up with family, promenade with the official Pharmalot mascots and tend to sundry chores. What about you? Will you spend time with a special person? Take a long walk? Curl up with an e-book? Whatever you do, we hope you have a swell time. Meanwhile, here are some items to get you started. Be safe and stay in touch… FDA Rules For Biosimilars Are Coming Soon (Bloomberg News) Canada Lost More Than 3,600 Jobs Last Year (InPharma-Technologist) Inspire Pharma Restructures And Cuts 65 Jobs (Raleigh News & Observer) AstraZeneca To Invest $150M In Plant In Russia (Reuters) FDA Defends Record For Approving Dev... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4495436 Fri, 18 Feb 2011 13:07:48 +0100 4495436 http://www.medworm.com/index.php?rid=4331241&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8xGmflYIDG4%2F An unusual sideshow to the ongoing controversy over the Provenge prostate cancer vaccine has ended - for now - as a federal appeals court has rebuffed a long-running attempt by a group of investors and patients to force the FDA to turn over documents pertaining to the agency’s decision in 2007 to delay approval of the prostate cancer vaccine. The group, which calls itself Care To Live, hoped to overturn a federal court decision denying them access to FDA documents, which they believe may reveal the agency improperly handled the 2007 episode. At the time, the agency ignored the recommendation of its own advisory committee after two committee members privately wrote FDA officials not to approve the vaccine, which is made by Dendreon. Allegations subsequently emerged that the two panelists... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331241 Mon, 10 Jan 2011 13:57:00 +0100 4331241 http://www.medworm.com/index.php?rid=4318548&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOvCFdzNxo9M%2F For the second time in as many months, the Centers for Medicare & Medicaid Services is being sued by an organization that has deep suspicions about the reason the agency chose to conduct a so-called National Coverage Analysis of the controversial Provenge prostate cancer vaccine, which was approved last spring by the FDA. This time around, Judicial Watch is demanding that CMS hand over documents that the organization believes will shed light on the review process, which the organization contends may have been undertaken in an effort to begin rationing healthcare. In explaining the reason for filing its lawsuit, Judicial Watch maintains that “cost is the major factor in the unusual decision by CMS” (read the statement). The Dendreon vaccine costs $93,000 per patient, althou... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4318548 Thu, 06 Jan 2011 13:20:00 +0100 4318548 http://www.medworm.com/index.php?rid=4309850&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FY5B_olrn3eo%2F Even as the pharmaceutical industry hunkers down by cutting jobs, closing plants and eliminating research projects, there are areas where some growth occurs. And one example appears to be construction on plants and research centers across North America, at least according to research compiled by Industrial Info Resources, a research firm that tracks construction projects. In a recent report, IIR talled 85 facilities that were completed last year by drug and device makers, biotechs, diagnostics companies and government-backed research centers, including incubators. These projects represented a potential total investment value of $7.1 billion, which includes both original construction costs and possible future phases that are already planned or under consideration. This is up from the 76 th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4309850 Tue, 04 Jan 2011 15:02:59 +0100 4309850 http://www.medworm.com/index.php?rid=4305105&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F---sJ6wFY7c%2F This is hardly surprising. Given the ongoing talk at the FDA about placing greater emphasis on safety, no one should be shocked that the pace of drug approvals remains modest. Last year, 21 new drugs were approved, down from 25 in 2009 and 24 in 2008. However, the latest tally is actually higher than the 18 approvals issued in 2007. As The Wall Street Journal notes, the latest approvals included a few biologics that are expected to become sizeable sellers: Amgen won approval for Prolia, which is used to treat osteoporosis in postmenopausal women; Roche’s Genentech scored with Actemra for rheumatoid arthritis; Boehringer Ingelheim received approval for Pradaxa, a new type of bloodthinner and Novartis garnered FDA endorsement for its Gilenya multiple sclerosis pill. And how can anyone ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4305105 Mon, 03 Jan 2011 13:02:45 +0100 4305105 http://www.medworm.com/index.php?rid=4266267&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrpFWtBGMpYA%2F This may seem like a moot point in some circles, but a group of activist investors and patients have filed a lawsuit against the Centers for Medicare & Medicaid Services in hopes of forcing the agency to disclose its reasons for conducting a so-called National Coverage Analysis for the controversial Provenge prostate cancer vaccine. The move comes one month after a CMS advisory panel voted that Dendreon’s Provenge shows “clinically significant” improvement in survival as part of the NCA process, which was triggered by questions raised by Medicare contractors amid concerns over off-label use. Such a meeting is unusual, though, given that Medicare generally pays automatically for FDA-approved oncology meds. And so Care To Live, which is also locked in a legal battle with the FDA ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4266267 Thu, 16 Dec 2010 14:11:38 +0100 4266267 http://www.medworm.com/index.php?rid=4175969&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSEaiTmOqdjk%2F A closely watched meeting ended with….not much of a surprise. An advisory panel to the Centers for Medicare & Medicaid Services voted that Dendreon’s Provenge vaccine for advanced prostate cancer shows “clinically significant” improvement in survival. The meeting was held just a few months after CMS unexpectedly decided to launch a so-called National Coverage Determination in response to questions raised by Medicare contractors amid concerns over off-label use. Holding such a move is unusual, though, given that Medicare generally pays automatically for FDA-approved oncology meds (see more here). At issue is whether coverage for the $93,000 treatment, which is the first such therapeutic cancer vaccine, is deemed reasonable and necessary. The drug was approved e... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4175969 Wed, 17 Nov 2010 22:25:44 +0100 4175969 http://www.medworm.com/index.php?rid=4175977&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEy3R1iJKuAE%2F Good morning, everyone. ‘Tis a shiny day here on the Pharmalot corporate campus, where the official mascots are frolicking and short people are making their way to the local school house. Of course, the rest of us are preparing for all those meetings and deadlines. No doubt, this will be a busy day. To help you along, here are some tidbits. We hope you have a great day and achieve your goals… Novartis Plans Efficiency Steps (Reuters) China Will Be Second-Largest Pharma Market In 2015 (InPharma-Technologist) New Medicare Drug Plan For Seniors May Not Be So Great (Associated Press) CMS Committee Meets Today On Provenge (The Wall Street Journal) FDA Panel Backs Human Genome Lupus Drug (New York Times) Amgen May Bid For Actelion (Reuters) Lilly’s Alimta Patent Is Upheld (Bloo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4175977 Wed, 17 Nov 2010 12:15:21 +0100 4175977 http://www.medworm.com/index.php?rid=4167942&cid=t_131152_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2Fp-KvZOVwRUU%2F By Michael F. CannonThe new prostate-cancer vaccine Provenge (manufacturer: Dendreon) appears to extend life by an average of four months at the relatively high cost of $93,000 per patient.  This week, Medicare bureaucrats will conduct a national coverage analysis before deciding whether Medicare will cover the vaccine.  This “unusual“ step has sparked charges that government bureaucrats are rationing medical care to save money. Today’s Washington Post includes letters from two cancer survivors that neatly illustrate why the government should not be in the business of providing health insurance or purchasing medical care at all.  Cancer Survivor #1 argues that Medicare should cover Provenge: “Expensive” treatments have given me many extra years with my... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4167942 Mon, 15 Nov 2010 21:58:59 +0100 4167942 http://www.medworm.com/index.php?rid=4168209&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fo0tgfBcltr0%2F On Wednesday, the Centers for Medicare & Medicaid Services will hold a widely anticipated meeting to review the controversial Provenge vaccine for prostate cancer. At issue is whether coverage for the $93,000 treatment, which is the first such therapeutic treatment, is deemed reasonable and necessary. Such a move is unusual, though, given that Medicare generally pays automatically for FDA-approved oncology meds. But nothing about Provenge has been usual – the FDA approval was mired in charges of conflicts of interest, agency conspiracies and stock manipulation. The very fact that CMS decided to review the vaccine prompted an outcry from some investors, patients and doctors, amid concern that coverage may be nixed, although others say the real issue is separating on-label use from of... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4168209 Mon, 15 Nov 2010 14:42:59 +0100 4168209 http://www.medworm.com/index.php?rid=4155399&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8U5t5tpWzHs%2F The latest chapter in the Provenge saga emerged yesterday evening when the Agency for Healthcare and Research Quality issued an analysis of the prostate cancer vaccine, which is one of the most controversial medical and investor stories over the past three years. Not surprisingly, the report did little to quell the inflamed passions that characterize the debate over the Dendreon product. Why? The AHRQ determined there is only “moderate” evidence that Provenge helps patients. And the analysis was released just a week before a widely anticpiated meeting to be held by the Centers for Medicare and Medicaid Services, which is conducting its own analysis to determine coverage after questions were reportedly raised several months ago by regional Medicare contractors. The meeting, itse... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4155399 Thu, 11 Nov 2010 14:58:30 +0100 4155399 http://www.medworm.com/index.php?rid=4134261&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqODVu7AIJ5Q%2F Hello, everyone. How are you this morning? A spot of rain is falling on the Pharmalot corporate campus, but as usual, our spirits remain sunny. And why not? As one of favorite philosophers, 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 the news of the world. Hope your day goes well and do stay in touch… Dendreon Discusses Provenge Production And Revenues (Xconomy) Drugmakers See Some Benefits In GOP Gains (The Wall Street Journal) Parexel Profit Rises But Forecast Looks Bleaker (Outsourcing Pharma) PPD Expansion In Pennsylvania Gets State Aid (Philadelphia Inquirer) Covance Buys Sanofi Site In The UK (NE Business) Non-Profit Helps With Drug Costs (... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4134261 Thu, 04 Nov 2010 11:21:30 +0100 4134261 http://www.medworm.com/index.php?rid=4045392&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9anoFQb9cRI%2F A curious sideshow to the Provenge saga is about to play out in a federal courthouse in Cincinnati in December. That’s when a lawyer for a group of cancer patients and investors will argue the FDA should be forced to turn over documents pertaining to the agency’s controversial decision in 2007 to delay approval of the prostate cancer vaccine (see the motion). Since then, of course, Provenge was approved (see this). But the group, which calls itself Care To Live, has been itching to overturn a federal court decision denying them access to FDA documents, which they believe may reveal the agency improperly handled the 2007 episode. At the time, the agency ignored the recommendation of its own advisory committee after two committee members privately wrote FDA officials not to appro... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4045392 Fri, 08 Oct 2010 12:13:50 +0100 4045392 http://www.medworm.com/index.php?rid=4003432&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQpD3J-Qg3ds%2F There is yet another twist in the ongoing and always interesting Provenge saga. The Centers for Medicare & Medicaid Services, which last June issued a surprise decision to conduct a National Coverage Analysis, which will be used for coverage guidance by Medicare contractors, has released the questions to be answered at a Nov. 17 panel meeting and the focus is on on-label efficacy. The NCA, for those who may not recall, stunned all sorts of people because such reviews do not occur very often (see here and here). Dendreon execs subsequently downplayed the move by telling analysts NCA was sparked by concerns of off-label use, although CMS has been cryptic about its reasoning other than to point to the fact that Provenge is the first in a new class of treatments that use a patient’s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4003432 Mon, 27 Sep 2010 22:49:00 +0100 4003432 http://www.medworm.com/index.php?rid=3973117&cid=t_131152_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=3925092&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6aH2dBf1AlQ%2F Now that the Centers for Medicare & Medicaid Services has caused a ruckus by unexpectedly conducting a so-called National Coverage Analysis for the Provenge prostate cancer vaccine, the agency last night posted an announcement on its web site that a Nov. 17 meeting will be held to review on-label and off-label use of the Dendreon product. The move comes shortly after two US Senators wrote CMS asking why an NCA was being undertaken, given that only three times in the past has the agency begun an NCA to examine potential off-label use of a new med approved by the FDA (see this). Judging from their letter, the pols seem to believe there is little likelihood of off-label use of Provenge, although Dendreon execs recently told analysts they believe CMS is, in fact, concerned with such usag... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3925092 Wed, 01 Sep 2010 12:27:32 +0100 3925092 http://www.medworm.com/index.php?rid=3907782&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FdhMhoMraD94%2F The latest people to object to the recent decision by the Centers for Medicare & Medicaid Services to open a National Coverage Analysis of the Provenge prostate cancer vaccine happen to be two US Senators. John Kerry and Arlen Specter, Democrats from Massachusetts and Pennsylvania, respectively, wrote an Aug. 20 letter to the agency questioning the rationale for the review and voicing suspicion the move will lead to restricted coverage. At issue is the extent to which CMS believes coverage is reasonable and necessary. As noted previously, an NCA is uncommon for new drugs, but CMS officials have ranged from silent to vague in explaining their decision. Although marketed for $93,000, price is not supposed to factor into the analysis. Presumably, the undertaking was prompted by regional ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3907782 Thu, 26 Aug 2010 12:04:50 +0100 3907782 http://www.medworm.com/index.php?rid=3845286&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPw1WMPduq3k%2F Hello, everyone, and welcome to another working week - unless you happen to be on vacation. For those of us who remain very much grounded in the routine, however, today ushers in yet another series of meetings and deadlines. So please join us for the mandatory cup of stimulation as we scan the news of the world. We hope your weekend was refreshing and today is a good one. Stay in touch… Avastin Gives Best Lung Cancer Survival Rate: Study (Reuters) FDA Cites Dendreon For Misleading Provenge Material (Dow Jones) Gastroenterologists Prescribing Humira Off Label For Ulcerative Colitis (PharmaTimes) India’s Lambda Buys Biovail’s CRO (Outsourcing Pharma) SSRIs Are Not Effective For Autism: Study (PharmaTimes) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3845286 Mon, 09 Aug 2010 11:43:19 +0100 3845286 http://www.medworm.com/index.php?rid=3816761&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7n1Wk8OF9tg%2F In a sharply worded letter to the Centers for Medicare & Medicaid Services, the American Society of Clinical Oncology takes the federal agency to task for conducting a coverage review of the Provenge prostate cancer vaccine. You may recall that CMS unexpectedly disclosed plans for a National Coverage Analysis in late June in response to inquiries from regional Medicare programs about the novel therapy. Ever since, CMS has been bombarded with comments from patients, doctors and investors, among others. The vast majority express concern that CMS will somehow limit coverage next year, although a review of the $93,000 annual price tag per patient is not supposed to factor into the review (back story). In his letter, ASCO ceo Allen Lichter complains the reasoning given for the review is wa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3816761 Tue, 03 Aug 2010 12:26:29 +0100 3816761 http://www.medworm.com/index.php?rid=3798818&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FImNm7jCyqJg%2F After three years of hype and hope over the Provenge prostate cancer vaccine, a study published in The New England Journal of Medicine may finally offer Dendreon some long-sought validation for its controversial treatment. Ironically, the results of the IMPACT study yielded nothing new, but by showing up in the prestigious journal, the findings may bolster confidence in Provenge. The bottom-line result was, in fact, previously reported at medical conferences - overall, Provenge patients had a 22 percent decrease in the risk of death and an increase of 4.1 months median survival time. Also worth noting is that the findings were, essentially, unchanged even when analyzing patients who were treated with Taxotere, a Sanofi-Aventis chemotherapy treatment (please go here to read more and see the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3798818 Wed, 28 Jul 2010 22:37:44 +0100 3798818 http://www.medworm.com/index.php?rid=3790920&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ftt6EbIEmo_c%2F Given the intense interest in the Provenge prostate cancer vaccine, Wall Street is closely tracking the launch of the controversial Dendreon product, which was recently launched at a price tag of $93,000 a patient and is also the subject of a coverage review by the Centers for Medicare & Medicaid Services (see here and here). Getting a clear picture can be difficult, given reports of rationing (back story), a recent survey of medical and pharmacy directors that found 65 percent may restrict patient access in some form (see this) and an anonymous report that circulated among investors this month that purported to debunk Dendreon study results (see here). To gain some clarity, Leerink Swann analyst Howard Liang surveyed 17 physicians who work at 13 distinct institutions, or about a quar... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3790920 Mon, 26 Jul 2010 13:23:36 +0100 3790920 http://www.medworm.com/index.php?rid=3758110&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJ99M2vDPYsA%2F Every few weeks, something unexpected happens to keep the Provenge prostate cancer vaccine in the news in a big way. Last month, the Centers for Medicare & Medicaid Services unexpectedly decided to conduct a national coverage analysis after receiving “informal inquiries,” since the vaccine is a novel therapy, although the $93,000 price tag is not supposed to factor into the analysis. Today, another puzzling episode occurred when an anonymous memo headlined “Provenge PhIII Trials – The Alternative Explanation of Survival Results” began circulating on Internet. Basically, the analysis, such as it is, questioned the four-month survival benefit and suggests the manufacturing process used by Dendreon skewed trial results. The stock is down more than 4 percent on t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3758110 Thu, 15 Jul 2010 19:59:36 +0100 3758110 http://www.medworm.com/index.php?rid=3737295&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQ0qrV9urFMY%2F The Centers for Medicare & Medicaid Services is unexpectedly conducting a national coverage analysis of the Provenge prostate cancer vaccine (back story), but what do private insurers think? A new survey of medical and pharmacy directors from 50 national and regional insurers finds two-thirds do not have concerns the vaccine is available, but 65 percent may restrict patient access in some form. At the time the survey was conducted last month by Reimbursement Intelligence, 80 percent of the respondents hadn’t yet reviewed the Dendreon vaccine, but 74 percent expected to require some form of prior authorization - such as documented use of two courses of hormonal therapy - with only 19 percent indicating no restrictions. And 46 percent would not reimburse without prior chemotherapy... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3737295 Thu, 08 Jul 2010 12:21:35 +0100 3737295 http://www.medworm.com/index.php?rid=3733298&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyHqkGt3oVBA%2F The unending quest to ensure that the Provenge prostate cancer vaccine is approved and readily available to patients has seen a group of activists - some are investors and some are patients - take on various federal agencies, from the FDA and the National Cancer Institute to the Department of Justice and the Securities and Exchange Commission. Along the way, they have filied lawsuits and complaints (background here and here). Now, they are targeting the Centers for Medicare & Medicaid Services, which last week issued a surprise notice that an analysis would be conducted to determine whether covering the Dendreon vaccine is reasonable and necessary (back story here and here). In announcing its move, CMS indicated it was responding to “informal inquiries,” which Wall Street ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3733298 Wed, 07 Jul 2010 12:08:39 +0100 3733298 http://www.medworm.com/index.php?rid=3721958&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fp4Eet0gDYQY%2F The decision by the Centers for Medicare & Medicaid Services to review Dendreon’s Provenge prostate cancer vaccine caused investors to dump the stock in after-hours trading Wednesday night. Most analysts believe CMS will ultimately decide in favor of providing coverage, but initiated its review because Provenge is a novel treatment. Cost is not supposed to be a determinant, although the $93,000 price tag is an eye opener (back story here and here). Investors, however, are not the only ones who are upset. CMS is encouraging public comment and, not surprisingly, many patient remarks have already been filed. Whether some comments were made by stealth investors or insiders can be debated if you wish. Nonetheless, here is a smattering… “I am amazed that your agency will t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3721958 Fri, 02 Jul 2010 19:01:12 +0100 3721958 http://www.medworm.com/index.php?rid=3718697&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FlMT1GNwF2yc%2F Last night, the latest chapter in the Provenge saga was unexpectedly written - the news that the Centers for Medicare & Medicaid Services was reviewing coverage for the Provenge prostate cancer vaccine sent Dendreon shares plunging as much as 23 percent in after-hours trading. Coupled with manufacturing constraints that are causing rationing, investors were caught off guard. That’s because a National Coverage Determination usually isn’t issued for cancer treatments. In fact, an NCD is uncommon for new drugs, in general. What likely prompted this move were requests from local Medicare providers, or what RW Baird analyst Chris Raymond calls “local fiscal intermediaries.” Why? Remember that Provenge is unusual in that it works by stimulating a patient’s own ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718697 Thu, 01 Jul 2010 12:36:12 +0100 3718697 http://www.medworm.com/index.php?rid=3714442&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkbaEvFLNUu4%2F Nothing like an after-hours plunge in a stock. Dendreon shares fell as much as 23 percent this evening after the Centers for Medicare & Medicaid Services announced it is reviewing the prostate cancer vaccine to determine whether national coverage is “reasonable and necessary,” but a final decision won’t be made for an entire year. The stock later regained some of its losses to close at $26.69, but remains well below its 52-week high of $57.67 on May 3. The agency will take public comments through July 30 “on the evidence regarding the effects of this treatment on health outcomes in patients with prostate cancer,” according to a statement, adding that it is “particularly interested in clinical studies and other scientific information relevant to the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3714442 Thu, 01 Jul 2010 00:24:51 +0100 3714442 http://www.medworm.com/index.php?rid=3706996&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5v78Y_Iq3Uw%2F Patients seeking the Provenge prostate cancer vaccine may wait a year or more because Dendreon can only produce enough to meet about 2 percent of demand. The shortage is expected to last until at least mid-2011 while Dendreon works on getting three plants up and running to capacity, Bloomberg News writes. Meanwhile, hospitals are creating waiting lists as they determine who should be eligible. “Until the capacity issues can be addressed, this will not be an effective agent,” Chris Logothetis, head of prostate cancer research at MD Anderson in Houston, tells the news service. “The waiting list - even as we are telling patients we’re not starting a waiting list because we are inundated - is more than 50 patients. This is going to be a problem.” About 200,000 new prostate cance... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3706996 Mon, 28 Jun 2010 12:47:38 +0100 3706996 http://www.medworm.com/index.php?rid=3629869&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtWSO5WagTa4%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 Alnylam Pharmaceuticals hired Laurence Reid as senior vice president and chief business officer. He was previously at Ensemble Discovery, where was also chief business officer, and founded two start-up companies in stem ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3629869 Fri, 04 Jun 2010 11:22:15 +0100 3629869 http://www.medworm.com/index.php?rid=3621951&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ff7mnT2ghmmk%2F In its latest report to Congress, the US Securities and Exchange Commission’s Office of Inspector General never mentions Dendreon by name, but sources tell us the agency probe into allegations of market manipulation and a “bear raid” into an unnamed “manufacturer” do, indeed, concern the maker of the celebrated Provenge prostate cancer vaccine that was recently approved by the FDA (background). The investigation was opened last summer and the SEC’s OIG last report to Congress noted that a complaint was filed “alleging that the SEC failed to investigate instances of market manipulation and other misconduct in connection with the review, and eventual nonapproval, of a developmental drug.” The newest OIG report says the probe into the trading ap... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3621951 Wed, 02 Jun 2010 13:30:25 +0100 3621951 http://www.medworm.com/index.php?rid=3526696&cid=t_131152_83_f&fid=34856&url=http%3A%2F%2Finsidesurgery.com%2F2010%2F05%2Fprostate-cancer-vaccine-approved-fda%2F The United States Food and Drug Administration has approved the drug Provenge for use against prostate cancer. Oncologists such as Dr. Nina Bhardwaj are heralding it as a major advance. The drug is manufactured by Dendreon Corporation. (Source: Inside Surgery) Inside Surgery blogs http://www.medworm.com/rss/comments.php?id=3526696 Mon, 03 May 2010 13:34:43 +0100 3526696 http://www.medworm.com/index.php?rid=3519711&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7Najfs7cscE%2F And so another working week will soon draw to a close. As always, we look forward to spending time with the short people - a game of miniature golf, in fact, is in order. And, of course, there are those lacrosse games. What about you? A quiet ride in the country? A nice meal with a favorite person? How about a walk in the park? Whatever you fancy, we hope you have a wonderful time. Meanwhile, here are a few items to help you round out the day. Have a good one…. Glaxo Heart Drug Gets Boost From Study (Reuters) After Approval: What’s Next For Dendreon? (Seeking Alpha) Diabetes Death Watch Slipped Into Health Reform (Bloomberg News) Tripe-Based Drug Hits Gold (The New York Times) photo thx to tipiro on Flickr creative commons (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3519711 Fri, 30 Apr 2010 11:56:13 +0100 3519711 http://www.medworm.com/index.php?rid=3519652&cid=t_131152_136_f&fid=35294&url=http%3A%2F%2Fwww.psa-rising.com%2Fblog%2F2010%2F04%2Fprovenge-cost-high-availability-low%2F Dendreon is pricing Provenge high and for the first year its availability will be low, according to a report today in Xconomy, a Seattle business website. Provenge, the first immunotherapy to win FDA approval for treatment of men with prostate cancer, will cost $93,000 per patient. Only 2,000 patients will be treated with Provenge [...] (Source: psa-rising.com/blog) psa-rising.com/blog blogs http://www.medworm.com/rss/comments.php?id=3519652 Fri, 30 Apr 2010 03:27:08 +0100 3519652 http://www.medworm.com/index.php?rid=3519713&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9U4ZaJGIVmQ%2F After three years of anticipation, disappointment and controversy, the FDA has approved the Provenge prostate cancer vaccine, which threatens to revolutionize treatment. The agency endorsement comes earlier than expected, since the PDUFA date was actually May 1. Despite the rollercoaster ride this vaccine has taken, most anaylsts expected FDA approval would be granted and, in fact, the stock has been climbing in anticipation in recent months. Trading was briefly halted today, but has since resumed and Dendreon shares have jumped about 15 percent. Now that months of speculation over the fate of the vaccine has ended, the issues going forward will be whether Dendreon can deliver on its promise of essentially customizing a vaccine for each prostate cancer patient and the extent to which insur... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3519713 Thu, 29 Apr 2010 17:01:35 +0100 3519713 http://www.medworm.com/index.php?rid=3511775&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3GWzwjH8t4c%2F Everyone loves a bet and nothing, it seems, is more intensely speculative this week than the betting on Dendreon’s Provenge prostate cancer vaccine, which threatens to revolutionize the approach taken to treatment. The FDA approval date is May 1 and so investors are anxious over the news. This comes after three years of anticipation, disappointment and controversy over clinical trial results and the FDA approval process, which prompted protests (see here), lawsuits and an SEC investigation (see here), not to mention a more recent run-up in the stock over the past year. More recently, the stock has been hovering around $39 and some say that’s about where Dendreon shares should be trading. Even if approved, which most analysts expect, there is skepticism about Dendreon’s ab... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3511775 Wed, 28 Apr 2010 15:13:27 +0100 3511775 http://www.medworm.com/index.php?rid=3505137&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FubrhZ2KsmVM%2F Welcome to the working week. We hope your weekend was pleasant, despite a spot of rain that continues to linger over the Pharmalot corporate campus and our general vicinity. Nonetheless, our spirits are sunny as we ready ourselves for another day. As usual, we are armed with a cup of stimulation and a grab bag of interesting items. Dig in and have a good one… Novartis Buys Alnylam Shares (Associated Press) Dendreon Stock Will Rise On FDA Approval (TheStreet) European Medicines Agency Is Overwhelmed With Work (PharmaTimes) Merck & Nycomed To Market COPD Drug (MarketWatch) North Dakokta AG Questions Import Bill (KXNET.com) Merck Says Health Care Reform To Cost $320M (Associated Press) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3505137 Mon, 26 Apr 2010 11:50:21 +0100 3505137 http://www.medworm.com/index.php?rid=3476078&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOrdkp4nDwE8%2F This is a very big guessing game, because so much money is riding on the revenue Dendreon can realize from its vaccine - assuming FDA approval is granted on May 1. You may recall that a Provenge clinical trial showed men lived a median time of four months longer than those on a placebo, with few side effects. As Xconomy notes, Provenge would be the first in a new class of therapies that actively stimulate the immune system to fight tumors, and the site did a spot check of what analysts are betting. The average price - $61,714. Ren Benjamin - Rodman & Renshaw - $40,000 Cory Kasimov - JP Morgan - $65,000 Howard Liang - Leerink Swann - $60,000 David Miller - Biotech Stock Research - $72,000 Mark Monane - Needham - $50,000 Christopher Raymond - Robert W. Baird - $70,000 Eric Schmidt - ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3476078 Fri, 16 Apr 2010 13:01:39 +0100 3476078 http://www.medworm.com/index.php?rid=3476080&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3pw0blnXNjE%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 we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Baxter International hired Ludwig Hantson as corporate vice president and president, international. The move comes just two days after Hantson departed Novartis, where he headed the US pharmaceutical unit. A replacement ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3476080 Fri, 16 Apr 2010 11:58:44 +0100 3476080 http://www.medworm.com/index.php?rid=3468021&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fx5kKBxgumFg%2F Top of the morning to you. Another shiny day here on the Pharmalot corporate campus and our spirits are high. And why not? Once again, we would like to share a favorite saying of the Morning Mayor: ‘Every brand new day should be unwrapped like a precious gift.’ So go ahead and tug on the ribbon. Meanwhile, here are a few items to help you along. Have a great day, everyone… Buy Bullish Dendreon Options Says Analyst (Bloomberg News) Canada Made ‘Value Judgment’ In Dropping HIV Plant (InPharmaTechnologist) Harvard’s Avorn Hires Faculty To Test Comparative Effectiveness (Bloomberg News) Orexigen Revises Obesity Drug Data (Reuters) Sanofi-Aventis Shifts PR Chief To Global Responsibility Role (PR Week) Teva Strikes Deal For Mersana Cancer Drug (PharmaTimes) Me... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3468021 Wed, 14 Apr 2010 11:14:44 +0100 3468021 http://www.medworm.com/index.php?rid=3454198&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHQM_IUWAu4Q%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 we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Dendreon hired Varun Nanda as senior vice president of global commercial operations. He most recently served as the senior vice president and global head of oncology at Roche/Genentech. Nanda arrives, of course, in time ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3454198 Fri, 09 Apr 2010 12:37:44 +0100 3454198 http://www.medworm.com/index.php?rid=3327295&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzEJPPjqF0fE%2F After the ruckus over the FDA advisory meeting for the Provenge prostate cancer vaccine in 2007, there was little expectation that yet another panel would be convened, especially after favorable data was released last year. But Favus Institutional Research issued a report yesterday saying it spoke with some docs, who claimed to be invited to such a meeting, according to TheStreet.com. The news sent Dendreon stock down about 5 percent and set off a scramble to ascertain the truth. An FDA spokeswoman later said a panel isn’t planned, and a Dendreon spokeswoman said there was no indication from the agency a meeting was scheduled. Deutsche Bank analyst Mark Schoenebaum noted companies must be informed of a planned panel 55 business days before a PDUFA date. The Provenge PDUFA date is May... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3327295 Wed, 03 Mar 2010 13:18:25 +0100 3327295 http://www.medworm.com/index.php?rid=3298599&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5xxdypuLBUM%2F A rainy day here on the Pharmalot corporate campus. But our spirits remain sunny. And why not? Once again, we are reminded of one of our favorite sayings: ‘Every brand new day should be unwrapped like a precious gift.’ So untie the proverbial ribbon and forge ahead. And grab that cup of stimulation as you proceed. Have a great day, everyone… AstraZeneca Resolves UK Tax Dispute (The Wall Street Journal) Avastin Fails To Extend Lives Of Stomach Cancer Patients (Associated Press) Gilead Inhaled Antibiotic For CF Wins FDA OK (Bloomberg News) Dendreon Posts Wider Fourth-Quarter Loss (Reuters) Opening Arguments Begin In Crestor Patent Trial (Reuters) Pfizer Lays Off 72 Pearl River Workers (Times Herald-Record) Novartis Unit Pays $3.5M Fine For Medicaid Fraud (US Dept of Justice... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3298599 Tue, 23 Feb 2010 12:27:45 +0100 3298599 http://www.medworm.com/index.php?rid=3288019&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKQS2-H8vg50%2F In a bid to tout its accomplishments, the FDA is trumpeting a new study showing the agency approved more than 50 new indications for cancer and hematology meds and biologics between July 2005, when the Office of Oncology Drug Products began reviewing marketing applications, and July 2007. And during that stretch, the OCD also reviewed 60 applications for meds to treat all sorts of cancer (see statement). The OCD acted on 58 of the applications, approving 53 new cancer indications. Five were not approved, and two were withdrawn before any regulatory action was taken. The approved applications included indications for 18 new drugs that hadn’t been previously approved and 35 added indications for already approved drugs. Here is the abstract of the study in the Journal of the National Ca... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3288019 Fri, 19 Feb 2010 13:24:33 +0100 3288019 http://www.medworm.com/index.php?rid=3259246&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F67-CG6gJlqA%2F The snow is falling steadily here on the Pharmalot corporate campus, and so many other places today. We hope your shovel is at hand. Nonetheless, the world continues to spin and so here are a few interesting items to help you persevere. Elan Projects A Profit For 2010 (Reuters) Philippines Plans New Round Of Price Cuts (PharmaTimes) Dendreon Prepares Plants For Provenge Approval (Bloomberg News) Sanofi Looks To Vaccines For Growth (Reuters) Boehringer To Buy Japanese OTC Maker (Bloomberg News) snowman courtesy of ld flickr creative commons (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3259246 Wed, 10 Feb 2010 13:08:04 +0100 3259246 http://www.medworm.com/index.php?rid=3251395&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3jmG_mqpIbk%2F Much of the long-running controversy over the Provenge prostate-cancer vaccine, which could be approved by the FDA on May 1, has centered on the viability of the data or a 2007 FDA advisory panel recommendation for approval that was overturned by FDA higher-ups amid dizzying conflict of interest charges (some background here, here and here, here). The messy episode has prompted patient protests, unusual stock trades, a lawsuit accusing the FDA of illegally withholding info and countercharges from the FDA that conspiracy theorists are wasting the agency’s time. Much of the sparring, though, has centered on patients and the drug-approval process, but another subplot appears to be emerging - the U.S. Securities and Exchange Commission may be probing some of the rollercoaster trading in ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3251395 Mon, 08 Feb 2010 13:06:35 +0100 3251395 http://www.medworm.com/index.php?rid=3244047&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJpX7aiLNLRI%2F The behind-the-scenes battle continues to rage between the FDA and a determined group of patients and investors who have agitated for nearly three years for the agency to approve the Provenge prostate cancer vaccine. Known as Care To Live, they are appealing a federal court decision denying them access to FDA documents pertaining to a series of events two years ago in which the agency unexpectedly delayed approval despite the recommendation of its own advisory panel. The group alleges undisclosed conflicts of interest by two FDA advisory committee members, who wrote FDA officials to urge a go-slow approach, and Byzantine agency politics involving Richard Pazdur, the head of the oncology drugs office. The FDA has been fighting the group’s request for documents that was filed under the Fre... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3244047 Fri, 05 Feb 2010 14:33:23 +0100 3244047 http://www.medworm.com/index.php?rid=3228008&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8-FSV17UpjA%2F Which drugs will be worth watching this year? Assuming FDA approvals come through as planned - and handicapping that possibility is trickier than ever (see here) - Barron’s compiled a list with the help of a few analysts. The presumption is that, once approval occurs, these meds will likely become blockbusters, that old-fashioned term for the biggest of sellers. And so, in no particular order, here they are… Victoza - the recently approved diabetes drug from Novo Nordisk; Xarelto* - a clotbuster from Bayer and Johnson & Johnson; Prolia* - an osteoporosis treatment from Amgen; Qnexa* - the Vivus obesity pill; Provenge* - Dendreon’s controversial prostate cancer vaccine. * - not yet approved by the FDA (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3228008 Mon, 01 Feb 2010 13:21:16 +0100 3228008 http://www.medworm.com/index.php?rid=3164046&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FipITQPUrxU8%2F Morning, everyone. Nice to see you again. A busy week, yes? But that’s to be expected in January, when conferences and earnings are omnipresent. With so much to do, we hope you have time to stop for a cup of something stimulating now and then, and of course, to catch up on events. Here are a few items to help you along… Dendreon Sees Full Provenge Capacity By Mid-2011 (Reuters) EU Steps Up Antitrust Probe (Bloomberg News) FDA Rejects Wider Use Of Forest Drug (Associated Press) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3164046 Tue, 12 Jan 2010 12:47:19 +0100 3164046 http://www.medworm.com/index.php?rid=3079580&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLNFvQsbmOaY%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 we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Thomas Hofstaetter is joining VaxInnate as chief operating officer, where he will be responsible for business development, finance and HR. For the past five years, he headed corporate business development at Wyeth and, b... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3079580 Fri, 11 Dec 2009 13:01:44 +0100 3079580 http://www.medworm.com/index.php?rid=3030058&cid=t_131152_136_f&fid=35294&url=http%3A%2F%2Fwww.psa-rising.com%2Fblog%2F2009%2F11%2Fprovenge-open-label-trial%2F An open-label study of Sipuleucel-T (Provenge) is ongoing at 8 centers across the USA. This is a Phase 2 Study enrolling men with Metastatic Castrate Resistant Prostate Cancer (CRPC). The aim of this study is to measure the immune responses to treatment with sipuleucel-T (Provenge). All participants will receive the drug. “Subjects will [...] (Source: psa-rising.com/blog) psa-rising.com/blog blogs http://www.medworm.com/rss/comments.php?id=3030058 Wed, 25 Nov 2009 18:18:45 +0100 3030058 http://www.medworm.com/index.php?rid=3012633&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F33K1qeHctV0%2F A determined group of patients and investors who have agitated for more than two years for the FDA to approve the Provenge prostate cancer vaccine are pressing their case to obtain undisclosed agency documents. Known as Care To Live, they are appealing a federal court decision last year denying them access to FDA documents pertaining to a series of events two years ago in which the agency unexpectedly delayed approval despite the recommendation of its own advisory panel. The group alleges undisclosed conflicts of interest by two FDA advisory committee members, who wrote FDA officials to urge a go-slow approach, and Byzantine agency politics involving Richard Pazdur, the head of the oncology drugs office. The FDA has been fighting the group’s request for documents that was filed unde... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3012633 Fri, 20 Nov 2009 14:19:20 +0100 3012633 http://www.medworm.com/index.php?rid=2886744&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnwRgthWw_4U%2F The little vaccine maker that could has added a couple of heavyweights to its board of directors. Dendreon, which hopes to win FDA approval next month for its Provenge prostate cancer vaccine, recruited Ian Clark, a Roche exec who was recently tapped to lead the big drug maker’s Genentech unit (see photo at left), and Pedro Granadillo, who once headed manufacturing at Eli Lilly. Here’s the press release. The move prompted speculation that Roche, which has a large presence in oncology, could become a bidder for Dendreon. As Reuters notes, Dendreon stock has jumped 10-fold since last spring, when data was released showing Provenge prolonged life for patients by about four months. Meanwhile, Dendreon has been ramping up production and some investors are betting an acquisition may ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2886744 Mon, 12 Oct 2009 23:10:33 +0100 2886744 http://www.medworm.com/index.php?rid=2828429&cid=t_131152_136_f&fid=35294&url=http%3A%2F%2Fwww.psa-rising.com%2Fblog%2F2009%2F09%2Fdendreon-to-seek-provenge-approval-in-november-reuters%2F Reuters reports today that Dendreon to seek US FDA approval for Provenge prostate cancer vaccine in November. Dendreon ” expects regulators to act on the application by the middle of next year, the company said on Thursday.” Shares of Dendreon fell more than 3 percent in morning trading after the timetable, which was provided at a [...] (Source: psa-rising.com/blog) psa-rising.com/blog blogs http://www.medworm.com/rss/comments.php?id=2828429 Thu, 24 Sep 2009 14:57:22 +0100 2828429 http://www.medworm.com/index.php?rid=2376730&cid=t_131152_136_f&fid=35294&url=http%3A%2F%2Fwww.psa-rising.com%2Fblog%2F2009%2F04%2Freactions-to-provenge-data%2F “These results confirm the clinical value of Provenge to prolong survival in patients with advanced prostate cancer,” said Dr. Philip Kantoff, head of the prostate cancer program and chief of the division of solid tumor oncology at the Dana-Farber Cancer Institute and Harvard Medical School, and a principal investigator of the Provenge study, in a [...] (Source: psa-rising.com/blog) psa-rising.com/blog blogs http://www.medworm.com/rss/comments.php?id=2376730 Tue, 28 Apr 2009 20:50:30 +0100 2376730 http://www.medworm.com/index.php?rid=2368318&cid=t_131152_136_f&fid=35294&url=http%3A%2F%2Fwww.psa-rising.com%2Fblog%2F2009%2F04%2Finvestorv-interview-with-hy-levitsky%2F A four part interview with  Hy Levitsky M.D., professor of oncology and tumor immunology at Johns Hopkins Medical School and co-inventor GVAX anti-cancer vaccine, is posted on Dendreon Investor Village website. Interview conducted by rufustoehee, a dentist and Dendreon investor, published 4/22/2009. By way of introduction, Dr Levitsky’s bio is posted alphabetically downpage among those of other [...] (Source: psa-rising.com/blog) psa-rising.com/blog blogs http://www.medworm.com/rss/comments.php?id=2368318 Thu, 23 Apr 2009 03:50:15 +0100 2368318 http://www.medworm.com/index.php?rid=2347933&cid=t_131152_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F04%2Fblogscan-trial-results-via-press.html See posts by Gary Schwitzer on the Schwitzer Health News Blog, and by Merrill Goozner on the GoozNews Blog on a new low in disclosing results of randomized controlled trials. It seems that Dendreon, the maker of the Provenge vaccine intended to treat prostate cancer, put out a press release that said the vaccine prolongs survival, but was completely lacking in data. Even preliminary results of the trial have not yet been released, much less has anything subject to peer review appeared. Nonetheless, the usually reliable New York Times called the trial "decisive." PR has trumped clinical science. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2347933 Mon, 20 Apr 2009 18:23:00 +0100 2347933 http://www.medworm.com/index.php?rid=2349571&cid=t_131152_136_f&fid=35294&url=http%3A%2F%2Fwww.psa-rising.com%2Fblog%2F2009%2F04%2Fdendreon-ceo-mitchell-gold-talks-about-provenge%2F As background to the April 28 AUA medical conference presentation on Provenge (sipuleucal-T) immunology, here’s an audiocast of Dendreon CEO Mitchell Gold talking about their lead product, Provenge, at an investors’ conference, Biotechnology Industry Organization BIO CEO & Investor Conference, February 19, 2009. To hear the audio click the green button. Your computer media player (Windows [...] (Source: psa-rising.com/blog) psa-rising.com/blog blogs http://www.medworm.com/rss/comments.php?id=2349571 Sun, 19 Apr 2009 09:07:30 +0100 2349571 http://www.medworm.com/index.php?rid=2349573&cid=t_131152_136_f&fid=35294&url=http%3A%2F%2Fwww.psa-rising.com%2Fblog%2F2009%2F04%2Fdendreon-director-sells-options%2F A Dendreon Inc., director, Gerardo Canet, sold over 200,000 stock options in the company on April 14 “pursuant to a Rule 10b5-1 trading plan.” Such trading plans are set up to defend company insiders from allegations of trading on insider information. (Source: psa-rising.com/blog) psa-rising.com/blog blogs http://www.medworm.com/rss/comments.php?id=2349573 Thu, 16 Apr 2009 18:51:59 +0100 2349573 http://www.medworm.com/index.php?rid=2349574&cid=t_131152_136_f&fid=35294&url=http%3A%2F%2Fwww.psa-rising.com%2Fblog%2F2009%2F04%2F951%2F Dendreon’s prostate cancer vaccine significantly prolonged the overall survival among 500 men with advanced, metastic  prostate cancer  compared to a placebo, the company said Tuesday. Results were “robust” and “unambiguous,” a spokesman said during today’s (Tues April 14) company broadcast conference call with biotech investment analysts. “The successful outcome from the Phase 3 IMPACT study provides validation [...] (Source: psa-rising.com/blog) psa-rising.com/blog blogs http://www.medworm.com/rss/comments.php?id=2349574 Tue, 14 Apr 2009 15:15:45 +0100 2349574 http://www.medworm.com/index.php?rid=1915070&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F433545029%2F Two months after being rejected by the a federal appeals court, a group of prostate cancer patients and investors have asked the US Supreme Court to allow them to proceed with a lawsuit against the FDA over its handling of the Provenge prostate cancer vaccine. They filed their case last year, after the agency unexpectedly rejected the recommendation of its advisory committee, causing considerable controversy. The lawsuit alleged undisclosed conflicts of interest by two FDA advisory committee members, who wrote FDA officials to urge a go-slow approach, and Byzantine agency politics involving the head of the oncology drugs office. The US Court of Appeals for the Sixth Circuit in Cincinnati rejected arguments that judicial review was required because of a lack of transparency and accountabili... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1915070 Mon, 27 Oct 2008 13:00:47 +0100 1915070 http://www.medworm.com/index.php?rid=1859772&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F412904341%2F Amid the stock sell-off, a bright spot appears and, of all things, it turns out to be Dendreon, the controversial and much-maligned little company that continues to press ahead with its Provenge prostate cancer vaccine. In a statement, Dendreon says an independent data monitoring committee found Provenge reduced the risk of death by 20 percent compared to placebo in a late-stage trial of 500 patients - and its stock surged. The interim analysis also found no safety concerns and recommended the study continue. However, for Dendreon to pass muster with the FDA, Provenge will have to reduce the risk of death by 22 percent, and the final results won’t be available until mid-2009. And so the waiting game for Dendreon investors and would-be Provenge patients continues. In May 2007, the FDA... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1859772 Mon, 06 Oct 2008 15:45:32 +0100 1859772 http://www.medworm.com/index.php?rid=1742939&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F378037681%2F After months of attempting to use the courts to force the FDA to approve the Provenge prostate cancer vaccine, the US Court of Appeals for the Sixth Circuit in Cincinnati has rejected arguments that judicial review was required because of a lack of transparency and accountability in the way the FDA decided to delay approval for the Dendreon vaccine after a recommendation by an FDA panel. Here’s the decision. An ad-hoc group of patients and investors pressed their case after the agency unexpectedly rejected the recommendation of its advisory committee. The lawsuit alleged undisclosed conflicts of interest by two FDA advisory committee members, who wrote FDA officials to urge a go-slow approach, and Byzantine agency politics involving the head of the oncology drugs office. (Source: Pha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1742939 Fri, 29 Aug 2008 12:17:38 +0100 1742939 http://www.medworm.com/index.php?rid=1689195&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F358595603%2F Have you noticed that when a drugmaker announces it has received a bad news letter from the FDA - a ‘non-approvable’ or ‘unapprovable’ letter - there is little in the way of specifics? And while a drugmaker generally tries desperately to play down the disappointment, the FDA says nothing. That’s because, as a matter of law, the FDA must keep communications about unapproved drugs confidential. “Many of us at FDA would like to see greater transparency,” John Jenkins, who heads the FDA’s Office of New Drugs, tells Forbes. “But we’re restricted by the current statutory limitations.” The issue is particularly confounding when such letters are issued after an FDA advisory panel recommends a drug be approved. This happened last we... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1689195 Thu, 07 Aug 2008 16:44:57 +0100 1689195 http://www.medworm.com/index.php?rid=1679627&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F355324246%2F What are the odds the FDA will reverse its controversial decision last year to delay approval of the Provenge prostate cancer vaccine? They would appear to be low, but a diligent group of patients and investors last week continued a two-pronged attack that is, so far, yielding mixed results. In one development, their lawyer argued before the US Court of Appeals for the Sixth Circuit in Cincinnati that judicial review was required because of a lack of transparency and accountability in the way the FDA decided to delay approval for the Dendreon vaccine after a recommendation by an FDA panel. The activists charge this came amid undisclosed conflicts of interest by two FDA advisory committee members, who quietly wrote FDA offiicals urging a go-slow approach, and Byzantine agency politics invol... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1679627 Mon, 04 Aug 2008 13:25:45 +0100 1679627 http://www.medworm.com/index.php?rid=1502740&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F308121311%2F The battle to win regulatory approval of the Dendreon prostate cancer vaccine has receded from the headlines, as a lawsuit, ad campaigns and protests failed to sway the FDA to move faster or cough up documents concerning its decision last year to override an advisory commitee that voted to endorse Provenge. Now, though, a federal appeals court has granted the activists - who include prostate-cancer patients and investors - a chance to bring an oral argument over their insistence that the FDA explain its decision to delay Provenge approval amid cries of undisclosed conflicts of interest among FDA committee members and Byzantine agency politics. Although the move is procedural, the non-profit waging the lawsuit against the FDA , CareToLive, sees this as a symbolic victory that its lawsuit, w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1502740 Mon, 09 Jun 2008 16:10:21 +0100 1502740 http://www.medworm.com/index.php?rid=1478218&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F300533379%2F The agency will hold an advisory committee meeting tomorrow to review Promacta, an experimental med for short-treatment of chronic ITP, which is being developed by Glaxo and Ligand Pharmaceuticals. And as documents show, waivers were granted to two panel members holding conflicts of interest. The agency, of course, is allowed to do so, although the practice is controversial and, in response, the FDA proposed new rules that specify when exceptions can be granted. In the latest instance, the FDA issued waivers to two people on its Oncologic Drugs Advisory Committee. One is Gary Lyman, director of health services and outcomes research in oncology at Duke University, who earns less than $10,000 annually as a speaker for an unnamed rival, according to the FDA waiver form. The other is Maha Huss... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1478218 Thu, 29 May 2008 12:56:45 +0100 1478218 http://www.medworm.com/index.php?rid=1464203&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F296007432%2F Mention the name Richard Pazdur to anyone with an interest in cancer and watch their reaction. As the head of the FDA’s Office of Oncologic Drugs, Pazdur is at the heart of every important or controversial agency decision. Take the approval of Avastin for breast cancer, which some saw as a major shift in standards for assessing the effectiveness of cancer meds, or the flap over the Provenge prostate cancer vaccine. He held an interesting chat with BusinessWeek and here is an excerpt… BW: What should the pharmaceutical industry do to improve its track record of getting drugs through the clinical trial process? Pazdur: The real progress in cancer will be a better understanding of the molecular basis of the disease. Drug companies are very good at developing drugs. We’re a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1464203 Thu, 22 May 2008 18:01:54 +0100 1464203 http://www.medworm.com/index.php?rid=1454775&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F294222743%2F The bill, which will be called the Access, Compassion, Care and Ethics for Seriously Ill Patients Act, would provide terminally ill patients with access to treatments prior to FDA approval. The legislation is being co-sponsored by Sam Brownback, a Republican Senator from Kansas, and Dianne Watson, a California Democrat in the House, who plan a Wednesday morning press conference in Washington DC. The effort comes after the US Supreme Court this past January refused to review a ruling that terminally ill patients have no constitutional right to be treated with experimental drugs even if that means the patient will likely die before the medicine is approved. Last August, a federal appeals court sided with the FDA and decided the government may deny access to drugs that have not gone through ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1454775 Tue, 20 May 2008 11:43:40 +0100 1454775 http://www.medworm.com/index.php?rid=1437092&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F288704215%2F A year after approval of the Provenge prostate-cancer vaccine was delayed by the FDA, a group of prostate-cancer patients - and some investors, too - plan to stage a series of nationwide protests that will include the largest annual gathering of oncologists. The events are planned by a non-profit called Care To Live, which is battling the FDA in court in what has, so far, been an unsuccessful attempt to force the agency to reverse course. The protests are being organized for New York, Philadelphia, Cleveland, Madison, Atlanta, Seattle, Dearborn, and Tampa, as well as in Chicago, where the American Society of Clinical Oncology will hold its meeting. Other groups expected to join include the Cancer Cure Coalition, the Abigail Alliance, A Right To Live, and the Sarcoma Foundation of America. ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1437092 Mon, 12 May 2008 14:03:13 +0100 1437092 http://www.medworm.com/index.php?rid=1379581&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F272347252%2F A year after approval of the Provenge prostate-cancer vaccine was delayed by the FDA, a determined group of prostate-cancer patients - and some investors, too - plan to stage a series of nationwide protests that will include the largest annual gathering of oncologists, two organizers tell us. The events are planned by a non-profit called Care To Live, which is battling the FDA in court in what has, so far, been an unsuccessful attempt to force the agency to reverse course. The specter of a protest is likely to unnerve the American Society of Clinical Oncology, because threats were allegedly made at last year’s event against two cancer docs who were dissenters on the FDA panel that recommended approval for Provenge. After the FDA panel meeting, those two docs - Howard Scher of Sloan-K... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1379581 Thu, 17 Apr 2008 18:28:50 +0100 1379581 http://www.medworm.com/index.php?rid=1361146&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F267248945%2F At the heart of the controversy over the Provenge prostate-cancer vaccine, which an FDA panel last year recommended before the agency delayed approval, are allegations of undisclosed conflicts of interest involving two of those panel members. They quietly wrote FDA officials to urge a go-slow approach and their actions have since drawn derision and fury from prostate-cancer patients and investors in Dendreon, which is developing Provenge (back story). One of those panelists was Howard Scher, a prominent oncologist from Sloan-Kettering Memorial Cancer Center, who also sits on the scientific advisory board of ProQuest Investments, a venture capital firm that held shares in Novacea, a small company developing a rival prostate cancer med. Around the time of the FDA decision, Novacea signed a d... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1361146 Wed, 09 Apr 2008 21:19:02 +0100 1361146 http://www.medworm.com/index.php?rid=1344609&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F262661469%2F The ongoing controversy over the Provenge prostate cancer vaccine is now one year old, and some of the prostate cancer patients and investors in Dendreon, which is developing the vaccine, are commemorating the saga by taking out full-page newspapers ads. The missives, which are sponsored by Care To Live, a non-profit that has filed a lawsuit hoping to compel the FDA to approve Provenge, are aimed squarely at FDA officials, though, because they are running in The Rockville Gazette, the local newspaper in Rockville, Maryland, where FDA offices are located. In what promises to be a series, this ad is in the form of a letter written by Ted Girgus, a 60-year-old with end-stage prostate cancer who begs the FDA not treat him “like a statistic.” He both chastises the agency for demandi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1344609 Wed, 02 Apr 2008 13:24:09 +0100 1344609 http://www.medworm.com/index.php?rid=1297937&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F250113489%2F This is a rare bit of hopeful news for the many agitated prostate cancer patients and Dendreon investors, who have been angry at the FDA after the agency last spring ignored a recommendation from its own advisory panel to approve the vaccine. The FDA has approved an amended trial design of a late-stage study, which should accelerate the expected timing of final results by about one year. Not surprisingly, the news sent Dendreon shares soaring by more than 20 percent before the opening bell, Reuters notes. Interim results are still expected in the second half of 2008. However, final results are now expected in the second half of 2009 rather than 2010, according to a Dendreon statement. The FDA will still accept positive interim or final survival data from the ongoing IMPACT trial for an am... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1297937 Wed, 12 Mar 2008 13:02:17 +0100 1297937 http://www.medworm.com/index.php?rid=1297940&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F250085312%2F How’s this for imagery? For more than two decades as an oncologist, Richard Pazdur frequently delivered bad news to patients. Once, a dying man grabbed his coat and begged him to try even more chemotherapy. But the doc says he declined, because he believed further treatment wouldn’t help. The patient died less than an hour later. This sets the tone for a profile in The Wall Street Journal, which writes that Pazdur, 55, still makes life-or-death judgments - and gets a lot of criticism as a result. That’s because each decision affects millions of Americans. Pazdur heads the FDA’s Office of Oncologic Drugs, which makes him the gatekeeper for any new cancer med that goes on the US market - and an estimated 30 percent of all drugs that are in an advanced stage of develop... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1297940 Wed, 12 Mar 2008 11:55:19 +0100 1297940 http://www.medworm.com/index.php?rid=1280994&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F246196641%2F One month after a non-profit group accused the FDA of violating the Freedom of Information Act by failing to provide documents, the agency has forked over paperwork indicating FDA commish Andy von Eschenbach did hear from two panel members who last year urged him not to approve the Provenge prostate-cancer vaccine. The non-profit, Care To Live, filed a lawsuit against the FDA after the agency last spring overruled one of its advisory panels, which recommended approval of the Dendreon vaccine. At the time, no one knew that two panel members took the unusual step of writing letters to Andy in hopes that he would direct the agency to delay approval. The move was allegedly orchestrated as part of a Byzantine powerplay at the agency, according to the non-profit, which also accused the two panel... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1280994 Wed, 05 Mar 2008 16:02:03 +0100 1280994 http://www.medworm.com/index.php?rid=1260037&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F241783592%2F In the latest setback to a vociferous non-profit group that is battling the FDA over the Provenge prostate-cancer vaccine, the group’s lawyer was just sanctioned for his behavior. In an 8-page ruling, US District Court Judge Greg Frost chided Kerry Donahue, who represents Care To Live, for “unreasonable conduct” and ordered him to pay $6,000 to a newsletter that published controversial letters concerning the FDA handling of the Dendreon vaccine. You may recall that Care To Live has waged a lawsuit against the FDA for failing to approve Dendreon’s prostate-cancer vaccine, Provenge, after an agency advisory panel last spring issued a recommendation. The FDA move came after two dissenting panel members wrote the agency to go slow, prompting outcries from cancer patients an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1260037 Wed, 27 Feb 2008 00:04:11 +0100 1260037 http://www.medworm.com/index.php?rid=1232037&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F234983340%2F The battle among prostate-cancer patients and investors to have the FDA approve Dendreon’s Provenge suffered a setback yesterday when a congressional committee declined to hold a hearing into the agency’s handling of the controversial vaccine. Today, however, the drugmaker released some news that it hopes will convince regulators that their decision to delay approval should be reversed. At the American Society of Clinical Oncology meeting in San Francisco, Dendreon researchers presented data demonstrating the correlation of a measure of the cumulative potency of the vaccine with overall survival. And they claim this is “the first time that an association between higher potency of an active immune therapy and increased patient survival has been reported.” In two Phas... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1232037 Thu, 14 Feb 2008 14:33:20 +0100 1232037 http://www.medworm.com/index.php?rid=1229427&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F234546936%2F In another blow to an ad hoc group of prostate-cancer patients and stock investors, the House Energy & Commerce Committee has decided not to hold a hearing into the controversy over the FDA’s handling of Dendreon’s Provenge vaccine. In a letter sent earlier today to four congressmen who had requested a hearing on behalf of a non-profit called Care To Live, the committee declined to take up the cause. (Here is the letter). “An investigative hearing prior to an agency’s final decision runs the risk of interfering with the normal regulatory process,” wrote John Dingell, who chairs the committee, and Frank Pallone, who chairs the health subcommittee. “As you can understand, as the committee conducts oversight of the FDA or any other agency, it must be c... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1229427 Wed, 13 Feb 2008 21:19:12 +0100 1229427 http://www.medworm.com/index.php?rid=1215495&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F231054245%2F It had to happen sooner or later. Prostate-cancer patients have filed lawsuits and furiously lobbied their congressional reps to investigate FDA review of Dendreon’s Provenge vaccine. Now, several doctors, who have already been actively involved in the battle, have formed a new ad-hoc group in hopes of finding another way to generate attention to the controversy. The controversy, by the way, erupted last spring. An FDA advisory panel recommended approval, but then two FDA panel members wrote the agency urging delay and the FDA agreed. However, patient advocates filed a lawsuit against the FDA, charging the panel members held undisclosed financial conflicts of interest and alleged a Byzantine power play involving a key FDA official who sought to sway the approval. For the moment, Phys... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1215495 Thu, 07 Feb 2008 15:47:09 +0100 1215495 http://www.medworm.com/index.php?rid=1212317&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F230378457%2F As a congressional committee moves closer to deciding on whether to hold hearings into the controversy over the Dendreon’s Provenge prostate-cancer vaccine, a non-profit group and the FDA are locked in a battle over documents that may shed light on why approval was delayed. So far, though, the FDA has turned over only a few documents, and so the non-profit group, Care To Live, has filed a new complaint charging the agency with violating the Freedom of Information Act. You may recall that an FDA advisory panel last spring recommended approval. But then two FDA panel members wrote the agency urging delay and the FDA shortly thereafter agreed. However, the group’s lawsuit claims the panel members held undisclosed financial conflicts of interest - one panel member serves on the adv... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1212317 Wed, 06 Feb 2008 16:13:50 +0100 1212317 http://www.medworm.com/index.php?rid=1191568&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F226766712%2F Three more lawmakers have added their names to the list of congressman who have asked the House Energy and Commerce Committee to hold a hearing into allegations that undislosed financial conflicts of interest among FDA advisory committee members may have swayed an FDA decision to delay approval of Provenge, a prostate cancer vaccine being developed by Dendreon. Vern Buchanan, a Florida Republican, Chris Van Hollen, a Democrat from Maryland, and Pat Murphy, a Pennsylvania Democrate, each wrote letters to John Dingell, who chairs the committee, to urge him to investigate. “As a member of Congress, I believe we must provide the necessary oversight to ensure that the federal approve process of life-saving therapies such as Provenge is prompt and efficient,” Buchanan wrote. Last mon... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1191568 Thu, 31 Jan 2008 20:20:10 +0100 1191568 http://www.medworm.com/index.php?rid=1188765&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F225967071%2F As part of its ongoing effort to get the FDA to approve Dendreon’s Provenge prostate-cancer vaccine, the non-profit Care To Live group has submitted several Freedom of Information Act requests to obtain documents for use in its lawsuit. A new FDA response, however, contains something curious - FDA commish Andy von Eschenbach’s office has no trace that he received any records concerning the controversial medication, despite a ‘diligent search.’ (This is the reply). Yet, there is evidence that key letters and memos were either addressed to him directly or he was among those listed to receive copies. You may recall that an FDA advisory panel last spring recommended full agency approval. But then two FDA panel members wrote the agency - including von Eschenbach - urging... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1188765 Wed, 30 Jan 2008 15:43:40 +0100 1188765 http://www.medworm.com/index.php?rid=1152854&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F217139871%2F The day is humming along nicely, isn’t it? We are especially pleased that our water supply has returned. To celebrate, we are cheering our good fortune with a cup of coffee and foraging for more interesting items. Please enjoy… Dendreon’s Provenge Vaccine Gets European Patent (Yahoo/AP) Wyeth Sells Upstate NY Plant To Akrimax Pharma (WCAX.com) Pozen Migraine Drug Passes Safety Study (Yahoo/AP) Forest Labs Beats Earnings Estimates (TheStreet.com) XenoPort, Glaxo Restless Leg Drug Works In Trial (Yahoo/Reuters) Neurocrine Biosciences CEO Gary Lyons Resigns (The Boston Globe) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1152854 Tue, 15 Jan 2008 17:31:24 +0100 1152854 http://www.medworm.com/index.php?rid=1124944&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F209900167%2F You may recall that last month, three congressmen wrote the House Energy and Commerce Committee to ask for a hearing into allegations that undislosed financial conflicts of interest among FDA advisory committee members may have swayed an agency decision last spring to delay approval of Provenge, a prostate cancer vaccine being developed by Dendreon. The move capped several months of controversy over the role of the panel members, in particular, Howard Scher, an oncologist at Sloan-Kettering Memorial Cancer Center in New York. Scher was one of two FDA panel members who wrote the agency urging a go-slow approach. It so happens, that Scher also serves on the scientific advisory board of ProQuest Investments, a venture capital firm that invested in Novacea, which is developing a rival cancer m... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1124944 Wed, 02 Jan 2008 13:48:39 +0100 1124944 http://www.medworm.com/index.php?rid=1097779&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F201367795%2F As the weekend draws to a close, this may be a good time to catch up on events and other items of interest. And for those with a keen interest in the ongoing controversy over antidepressants and suicidal thoughts among youngsters, we are told that the Fox News show, Hannity’s America, will take a look at how the issue is being tied to several school shootings. However, the segment doesn’t yet appear on the web site’s schedule, but if our info is correct, it would air at 9 pm EST. Evan Bayh is a Democratic senator from Indiana. His wife, Susan Bayh, is something of a professional board member, earning more than $1 million annually in director fees at companies that make pharmaceuticals, operate radio stations, sell health insurance, offer online banking and distribute ing... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1097779 Sun, 16 Dec 2007 23:14:47 +0100 1097779 http://www.medworm.com/index.php?rid=1094331&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F200279907%2F Even though a federal judge largely dismissed the case recently, the non-profit group that is feverishly trying to get the FDA to approve the Provenge prostate-cancer vaccine is filing an appeal. And the lawyer for the organization, CareToLive, hopes that an emergency briefing and case schedule will soon be approved, leading to a decision within the next three to four months. “We also will be filing a new Freedom of Information Act complaint in the next week or so (with the FDA) unless we receive the documents promised us by the FDA’s Office of Oncologic Drugs,” Kerry Donahue, the group’s lawyer writes us. “The documents were promised to us last week and a call to them indicated they were behind schedule but we should get them soon. They have a few more days, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1094331 Fri, 14 Dec 2007 13:14:50 +0100 1094331 http://www.medworm.com/index.php?rid=1093203&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F199857476%2F You read it here first. Three congressmen today wrote a letter to the House Energy and Commerce Committee to hold a hearing into allegations that undislosed financial conflicts of interest among FDA advisory committee members may have swayed an FDA decision to delay approval of Provenge, a prostate cancer vaccine being developed by Dendreon. “Many ethical questions remain about the two panelists who voted no on approving this drug,” Mike Michaud (D-Maine) says in a statement. “I believe that the FDA should not be appointing scientists leading the testing of a rival drug for another firm onto an advisory committee evaluating Provenge. Congress needs to get to the bottom of this. I believe a full disclosure is necessary in order to restore confidence in the FDA.” Along with Michaud, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1093203 Thu, 13 Dec 2007 17:50:30 +0100 1093203 http://www.medworm.com/index.php?rid=1093204&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F199816650%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 being announced month after month (please look here for the latest tally for 2007). Despite the downsizing, there is movement. Here are some of the latest. Recognize anyone? MediaMind public relations is launched by former Bristol-Myers spokesman Tony Plohoros; Wolters Kluwer Health named Gregg Ciarelli vp for the Source line of sales products; Dendreon promoted Mark Frohlich to sr vp of clinical affairs and chief med officer; Roche is transferring Georg Wiebecke, who ru... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1093204 Thu, 13 Dec 2007 16:20:47 +0100 1093204 http://www.medworm.com/index.php?rid=1065938&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F194356957%2F A decade ago, the FDA introduced its Fast Track designation for drugs in development and it was intended to speed the availability of medical treatments for serious diseases. But a seven-month investigation by The Cleveland Plain Dealer shows this “government blessing” has not increased the number of drugs approved or moved them to market faster. Instead, Fast Track has given pharma, which came up with the idea for the designation and lobbied for its passage, a vehicle that promises a lot, but delivers little to anyone but investors. The news of Fast Track designation creates a boon for day traders, hedge funds and others looking to make quick money off biotech stocks. In fact, some biotech execs also have tried to turn Fast Track designation into personal gain. Top managers an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1065938 Mon, 03 Dec 2007 13:01:41 +0100 1065938 http://www.medworm.com/index.php?rid=1063011&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F193203189%2F For the past few months, a vociferous non-profit group known as Care To Live has waged a lawsuit against the FDA for failing to approve Dendreon’s prostate-cancer vaccine, Provenge, after an agency advisory panel last spring issued a recommendation. The FDA move came after two dissenting panel members wrote the agency to go slow, prompting outcries from cancer patients and Dendreon investors, who later accused one panel member of undisclosed financial conflicts of interest. You can read about the details in the lawsuit, which by the way was largely dismissed. One aspect of this melodrama has been an effort by the non-profit to learn more about the behind-the-scenes dealings that prompted the panel members to write their letters. The non-profit alleges the panel members were encourage... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1063011 Fri, 30 Nov 2007 23:13:17 +0100 1063011 http://www.medworm.com/index.php?rid=1046796&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F189344135%2F A federal judge has tossed a big chunk of a lawsuit filed by Care To Live, a non-profit group that’s fighting to get the FDA to reverse a surprise decision last spring to delay approval of a Dendreon’s Provenge prostate cancer vaccine. The agency action amounted to an about face following an advisory committee recommendation that Provenge be cleared for marketing. However, two dissenting panel members later wrote FDA officials urging a go-slow approach, setting off a firestorm over agency procedures amid accusations of undisclosed financial conflicts of interest among the dissenters. In making his ruling, US District Court Judge Gregory Frost refers to jurisdiction (see below), but primarily cites the issue of ripeness, a reference to the fact that the FDA hasn’t yet deci... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1046796 Fri, 23 Nov 2007 14:45:54 +0100 1046796 http://www.medworm.com/index.php?rid=1021390&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F183660474%2F The agency recently posted a notice in the Federal Register about its new guidance on conflict of interest issues for advisory committee members. Although comments are being accepted until Dec. 31, some aspects of the policy are apparently already in place, according to the guidance (which you can read here). A key change: the FDA will begin publicly disclosing all financial conflict-of-interest information for advisory committee members, along with copies of waivers the agency grants to allow participation on the committee. The agency has drafted a template of the form panel members are to submit, and it includes such things as stock holdings, consulting and speaking fees, research grants and patents. Until now, only a waiver was posted on the FDA site. At least one issue remains controv... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1021390 Mon, 12 Nov 2007 17:24:13 +0100 1021390 http://www.medworm.com/index.php?rid=1005357&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F180186632%2F A little company called Novacea is making big news today. A late-stage trial of its prostate-cancer medication was halted after one of arm of the study containing the drug showed a higher death rate compared with standard care. The disclosure, which you can see in the Novacea statement, sent Novacea stock tumbling so far by as much as 63 percent. The main goal of the study was to compare the benefits of a weekly dose of Asentar in combination with Taxotere, the Sanofi-Aventis cancer drug, to the current standard of care in the treatment of androgen-independent prostate cancer (AIPC). But enrollment was suspended in other trials in other indications until data is reviewed. So far, more than 900 of the 1,200 needed patients were enrolled in the study. The news, as always, reverberates in dif... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1005357 Mon, 05 Nov 2007 19:26:25 +0100 1005357 http://www.medworm.com/index.php?rid=1003706&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F180018184%2F Last week, we wrote that an ad campaign was going to be launched this week by a group that is angry and frustrated over the FDA’s refusal to reverse its decision and approve Dendreon’s controversial Provenge prostate-cancer vaccine. The group, a non-profit called CareToLive, hopes that the ads on Washington, DC-area buses will serve as reminders to FDA officials, who ignored a rally two months ago, and also alert members of Congress and the general public will be alerted to the issue. And so here is the ad for the ‘Get on the Bus’ campaign. (Click on the ad to make it larger). The gambit is the latest among a series of actions - including a lawsuit against FDA officials and YouTube videos - to generate a groundswell of sympathy and outrage in hopes of forcing the FD... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1003706 Mon, 05 Nov 2007 12:26:29 +0100 1003706 http://www.medworm.com/index.php?rid=1001137&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F178775428%2F Angry and frustrated that the FDA still refuses to approve the Dendreon prostate-cancer vaccine, an ad-hoc group of cancer patients and investors is planning to sponsor ads on Washington, DC, area buses that may appear as early as next week, according to sources familiar with the effort. The hope is to raise awareness among members of Congress and the public at large, and pester the agency, since FDA officials ignored a protest two months ago in front of the agency’s Rockville, Maryland, headquarters. The gambit is the latest among a series of actions - including a lawsuit against the FDA and YouTube videos - to generate a groundswell of sympathy and outrage in hopes of forcing the FDA to change its collective mind. (The organizers of the bus ads have declined to make a sample availa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1001137 Fri, 02 Nov 2007 15:05:16 +0100 1001137 http://www.medworm.com/index.php?rid=979401&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F174998096%2F The evidence isn’t entirely clear yet, but the latest court filing by a non-profit group, which filed a lawsuit against the FDA for not approving the Dendreon prostate-cancer vaccine, indicates an NIH doc named Alison Martin (see picture) may have helped write the letter. Which mysterious letter? And why is it mysterious? For those who haven’t followed the Provenge controversy, we will repeat some background: After an FDA advisory panel last spring recommended full agency approval, a curious thing happened - two FDA panel members wrote the agency urging a go-slow approach, and the FDA shortly thereafter decided to delay approval. The behind-the-scenes machinations caused a firestorm - the two cancer docs received threats, cancer patients have rallied outside FDA offices, and a deb... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=979401 Thu, 25 Oct 2007 19:42:09 +0100 979401 http://www.medworm.com/index.php?rid=970221&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F173472546%2F Which mysterious letter? And why is it mysterious? For those who haven’t followed the controversy over Provenge, a prostate-cancer vaccine being developed by a small company called Dendreon, an FDA advisory panel last spring recommended full agency approval. But then a curious thing happened - two FDA panel members wrote the agency urging a go-slow approach, and the FDA shortly thereafter decided to delay approval. The behind-the-scenes machinations caused a firestorm - the two cancer docs received threats; the chain of events fueled debate about the use and approval of experimental meds, and some cancer patients and Dendreon investors filed a lawsuit against the FDA. The suit claims the two panel members held undisclosed financial conflicts of interest and alleged a Byzantine power ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=970221 Mon, 22 Oct 2007 20:30:54 +0100 970221 http://www.medworm.com/index.php?rid=964753&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F172204932%2F Right now, the controversial Pazdur heads the FDA’s Office of Oncologic Drugs, but the Minyanville blog cites rumors that he’s in line to be appointed to the newly created safety chief. “Given Dr. Pazdur’s ‘Nothing Gets by Me (Unless It Is Biostatisically Pure Or Sponsored By A Firm With Many Lawyers)’ attitude at OOD, he might be exactly what proponents of this portion of the new PDUFA legislation had in mind,” Minyanville writes, referring to the new emphasis on safety in the recently enacted FDA reform bill. “The effect on this for stocks of development-stage biotechs pursuing oncology indications could be significant,” Minyanville continues. “Much would depend on who got the OOD job, but there are only a couple of people I could t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=964753 Fri, 19 Oct 2007 19:23:04 +0100 964753 http://www.medworm.com/index.php?rid=947464&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F169071232%2F And so the work week is nearing an end. Nonetheless, there is always something interesting going on. Here are a few items that may captivate you… Dendreon Obtains Up To $130M In Venture Capital Financing (Bloomberg News) FDA To Hold Nov. 27 Meeting To Review Tamiflu Safety (Bloomberg News) Sanofi-Aventis Paid $240K To Firm For Lobbying DC (Yahoo/AP) Wall Street Doesn’t Expect Surprises From Earnings Next Week (Yahoo/AP) UK’s NICE Needs Greater Authority (PharmaTimes) Teva Reports Positive Data For MS Drug (Yahoo/AP) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=947464 Fri, 12 Oct 2007 19:01:18 +0100 947464 http://www.medworm.com/index.php?rid=938932&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F167488804%2F This is one way to play connect the dots in the Provenge controversy. Before we explain, let us remind you that Provenge is the prostate-cancer vaccine that was recommended last spring by an FDA panel, but later put on hold after the agency received letters from two panel members urging a go-slow approach. The delay set off a firestorm - the two docs received threats amid allegations of conflicts of interest; and patients and investors in Dendreon, which is developing the vaccine, filed a lawsuit against the FDA, charging agency political intrigue was also involved. And so it comes to our attention that FDA commish Andy von Eschenbach - who is named in the lawsuit and held responsible by cancer patients for the Provenge delay - has a link, of sorts, to Howard Scher, a prominent oncologist ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=938932 Tue, 09 Oct 2007 15:43:24 +0100 938932 http://www.medworm.com/index.php?rid=919094&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F164175396%2F Here a conflict. There a conflict. Everywhere a conflict of interest. That’s one of the central themes in the controversy over the Provenge prostate-cancer vaccine. And the latest allegation is aimed at the Justice Department by CareToLive, a non-profit group that was formed recently to force the agency to approve the vaccine. What’s the conflict? The Justice Department simultaneously represents the FDA, the FDA commish, an FDA division head and an FDA panel member in what the group charges is a conspiracy forged by individuals who may wind up testifying against one another. The Dendreon product was recommended for approval last spring by an FDA panel, but was then delayed after two panel members wrote FDA commish Andy von Eschenbach urging a go-slow approach. CareToLive, which... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=919094 Tue, 02 Oct 2007 12:38:16 +0100 919094 http://www.medworm.com/index.php?rid=891918&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F159604183%2F The controversy prompted nearly 200 people to rally at FDA headquarters in Maryland early this week in hopes of convincing Congress to force the agency to revisit its unexpected decision last spring to delay approval of the Dendreon prostate-cancer vaccine. That followed an FDA advisory panel meeting in which a majority recommended approval, but in the interim, two panel members quietly wrote the agency to urge a go-slow approach. Since then, threats were made against those two doctors, a lawsuit was filed against the FDA, and there are allegations of conflicts of interest, which are now being probed internally by the FDA, sources tell us. At issue, though, is whether the FDA followed its own procedures properly and the larger debate over the use of experimental meds. Here’s the rece... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=891918 Fri, 21 Sep 2007 19:51:43 +0100 891918 http://www.medworm.com/index.php?rid=891920&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F159560429%2F The week may be winding down, but not the pace of news from around the world. Here are some of the latest that have trickled in. We hope these will help you feel caught up as you take that lunch or afternoon respite… Novartis’ Galvus Combo And Tasigna Get EU Approval (Bloomberg News) Barr Labs Spent $660K So Far This Year To Lobby Washington (Yahoo/AP) Chris Henney, Immunex, Icos, Dendreon Co-Founder, To Chair Start-Up (Seattle Post-Intelligencer) Chicago Pharmacies Cited For Overcharging (Yahoo/AP) Roche’s Bid For Ventana Could Start A ‘Medical Revolution’ (BusinessWeek) Bayer And Onyx Get EU Recommendation (TheStreet.com) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=891920 Fri, 21 Sep 2007 17:46:06 +0100 891920 http://www.medworm.com/index.php?rid=886438&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F158982899%2F Earlier this week, nearly 200 people protested in front of FDA headquarters in Maryland against the agency’s decision to delay approval of Dendreon’s Provenge prostate-cancer vaccine and to agitate, in general, for greater access to experimental cancer meds. The gathering follows months of controversy over the FDA’s flip-flop on Provenge and subsequent controversy over a pair of agency panel members who last spring voted against approval and later wrote the agency urging caution. Since then, the FDA has begun probling allegations of conflicts of interest among panel members, according to sources who are familiar with this episode. Meanwhile, some patients - and Dendreon investors - have filed a lawsuit against the FDA, attempting to force the agency to make Provenge avail... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=886438 Thu, 20 Sep 2007 11:53:27 +0100 886438 http://www.medworm.com/index.php?rid=883874&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F158550604%2F Not that there’s good reason to do so, but Maha Hussain may have found a way. Who is she? The University of Michigan oncology professor is best known as one of two FDA panel members who last spring voted against recommending Dendreon’s Provenge prostate-cancer vaccine. She then became notorious after she and the other panel member wrote letters to FDA staff arguing against approval. And Since then, a growing number of prostate-cancer patients (and Dendreon investors) have railed against her and the other panel member, Howard Scher of Memorial Sloan-Kettering Cancer Center, for alleged conflicts of interest. At a subsequent oncology meeting, the pair complained of threats and bodyguards were hired. Meanwhile, a lawsuit was filed against the FDA and sources familiar with this me... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=883874 Wed, 19 Sep 2007 14:06:57 +0100 883874 http://www.medworm.com/index.php?rid=876183&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F157575612%2F The growing frustration with the agency over the issue of approving experimental meds, particularly for cancer, is prompting the kind of activism last seen two decades ago among AIDS patients. Even a few companies, such as Pharmacyclics, are openly resisting FDA decisions. The Abigail Alliance patient group plans to appeal a court ruling that experimental meds shouldn’t be given to the terminally ill. And controversy continues over the FDA flip-flop on approving the Provenge prostate-cancer vaccine. So several of the more vocal patient groups are joining together tomorrow at 10 a.m. EST to protest outside FDA offices in Rockville, Md. The event is being organized by A Right To Live, which has been active in criticizing the FDA’s handling of Provenge; the Abigail Alliance for Better Acc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=876183 Mon, 17 Sep 2007 12:25:15 +0100 876183 http://www.medworm.com/index.php?rid=867459&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F155643778%2F In conclusion, it is important to restore the public’s confidence in the integrity of the FDA’s decisions by having Congress restrict the number of waivers the FDA grants.” Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=867459 Wed, 12 Sep 2007 20:04:17 +0100 867459 http://www.medworm.com/index.php?rid=862230&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F155059589%2F This isn’t surprising. Having already filed a lawsuit against the FDA for failing to approve the prostate-cancer vaccine, an anonymous group of cancer patients (and perhaps some investors) are now asking a federal court in Ohio to grant an emergency injunction that would make Dendreon’s Provenge available immediately to cancer sufferers. The move comes just before a planned Sept. 18 rally at FDA offices in Maryland. The 55-page motion, which was filed by the recently formed non-profit, CareToLive, recaps the events surrounding the controversial FDA advisory panel meeting last spring in which Provenge was recommended for approval. Although at times the filing is sarcastic and rambling, the motion is interesting reading because it lays out a conspiracy theory that an FDA official... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=862230 Tue, 11 Sep 2007 14:50:30 +0100 862230 http://www.medworm.com/index.php?rid=817601&cid=t_131152_87_f&fid=34865&url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F08%2F23%2Fneuvenge-breast-cancer-vaccine-appears-safe-effective%2F Filed under: Breast Cancer, Research, Daily newsResearchers are reporting that a new vaccine designed to treat breast cancer appears to be safe in women with advanced disease. It showed signs of slowing down tumor growth too.The Neuvenge vaccine, made by Dendreon Corporation -- maker of the Provenge prostate cancer vaccine -- targets the aggressive Her-2 positive form of breast cancer, which affects 20 to 30 percent of breast cancer patients. Using immune cells from a cancer patient's own body, Neuvenge is a tailor-made therapy.Reports about Neuvenge, published in the Journal of Clinical Oncology, indicate the vaccine did not cause any serious side effects and of the 18 women who participated in the Phase I study, there was a reduction in the size of a tumor in one patient. In three other ... The Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=817601 Thu, 23 Aug 2007 04:00:00 +0100 817601 http://www.medworm.com/index.php?rid=816793&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F147059608%2F For those who haven’t noticed, there’s a growing frustration with the agency over the issue of approving experimental meds, particularly for cancer. Several companies, such as Pharmacyclics, are openly resisting FDA decisions. The Abigail Alliance patient group plans to appeal a court ruling that experimental meds shouldn’t be given to the terminally ill. And controversy continues over the FDA flip-flop on approving the Provenge prostate-cancer vaccine. Now, some of the more vocal patient groups are joining together with plans to protest outside FDA offices on Sept. 18 in Rockville, Md. The event is being organized by A Right To Live, which has been active in criticizing the FDA’s handling of Provenge; the Abigail Alliance for Access to Developmental Drugs, and the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=816793 Wed, 22 Aug 2007 20:52:37 +0100 816793 http://www.medworm.com/index.php?rid=811319&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F146200418%2F Whether this is lunch hour or a moment to put aside the workload to stretch, here are a few items to keep you up to date… Dendreon Stock Rises On Breast-Cancer Treatment Results (Bloomberg News) Painkiller Use Skyrockets (USAToday.com) Enzon Sells Interest In Schering-Plough Drug (Yahoo/AP) Novartis Receives Additional Approval For Reclast (Yahoo/AP) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=811319 Mon, 20 Aug 2007 17:46:02 +0100 811319 http://www.medworm.com/index.php?rid=1129424&cid=t_131152_136_f&fid=35294&url=http%3A%2F%2Fpsa-rising.com%2Fblog%2Findex.php%2F2007%2F08%2F18%2Fneuvenge-breast-cancer-vaccine-phase-1-results Results from a Phase 1 study of NEUVENGE, Dendreon’s candidate vaccine for breast cancer, appeared today in Journal of Clinical Oncology. Testing of Neuvenge in clinical trials runs several years behind Provenge, which is in an ongoing Phase 3 trial. Out of 18 patients with advanced breast cancer who received Neuvenge, 1 patient showed [...] (Source: psa-rising.com/blog) psa-rising.com/blog blogs http://www.medworm.com/rss/comments.php?id=1129424 Sat, 18 Aug 2007 07:11:18 +0100 1129424 http://www.medworm.com/index.php?rid=799394&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F144197698%2F That’s the view held by David Miller, who publishes Biotech Monthly, a widely newsletter that mixes cogent analysis and clever insights. He’s followed the Provenge saga quite closely and, in fact, back in June published an essay that provided a fascinating glimpse into some of the behind-the-scene machinations at the FDA. We chatted briefly with Miller this week in light of the recent lawsuit filed by a non-profit, which was created on behalf of investors and patients who are angry the FDA back-pedaled on approving the prostate-cancer vaccine from Dendreon, even after an FDA panel recommended approval. The impetus for the about face? Two dissenting panel members - Howard Scher and Maha Hussain - wrote the agency, urging a go-slow approach, which created an uproar. Pharmalot: T... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=799394 Tue, 14 Aug 2007 23:28:50 +0100 799394 http://www.medworm.com/index.php?rid=793092&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F142764614%2F There’s nothing like the Provenge controversy to generate interesting tales. For those who don’t recall, Provenge is a prostate-cancer vaccine developed by Dendreon, and was recommended by an FDA panel last spring. But approval was unexpectedly delayed by the agency after two dissenting panel members wrote the FDA commish to think twice. That set off a firestorm - threats and charges of conflicts of interest against the two panel members; protests by cancer patients; angry Internet missives by investors and, most recently, a lawsuit against the FDA filed by a newly formed non-profit called Care To Live, which appears to have been created specifically for this battle. Now, the attorney who filed the lawsuit has posted details of how his private investigator stalked Paul Goldberg... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=793092 Fri, 10 Aug 2007 14:44:22 +0100 793092 http://www.medworm.com/index.php?rid=786997&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F141979208%2F In an earnings call last night with Wall Street analysts, Dendreon reiterated its strategy for the controversial Provenge prostate cancer vaccine, which was recommended last spring by an FDA panel, but then unexpectedly issued an approvable letter after two panel members wrote the agency urging a delay in approval. That set off a firestorm among patients and investors, as well as charges of conflicts of interest, threats against the two panel members and a lawsuit against the FDA. The key points made last night by Dendreon management include completing enrollment of a Phase III trial by the end of this year, reporting interim results in mid-2008, and an ongoing quest to find a marketing partner outside the US, according to an investor note written this morning by Needham’s Mark Monan... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=786997 Wed, 08 Aug 2007 13:13:20 +0100 786997 http://www.medworm.com/index.php?rid=786023&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F141602918%2F That’s the language attached to an agriculture appropriations bill passed by the House last week after a move by US Representative Maurice Hinchey, Democrat of New York. The funding measure heads to the Senate, where the language faces a tough fight - opponents include Ted Kennedy, the Senator from Massachusetts, The Boston Globe reports. Hinchey’s proposal goes further than a rule the FDA itself proposed earlier this year. The agency suggested barring panel members with financial ties to drug and medical device makers that exceed $50,000. Members whose grants or consulting fees totaled less than $50,000 during the previous 12 months would be allowed to serve on panels, but not vote. The FDA is still sifting public comments and has not issued a final proposal. The issue has com... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=786023 Tue, 07 Aug 2007 13:51:25 +0100 786023 http://www.medworm.com/index.php?rid=774271&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F139924800%2F More companies and cancer patients are imploring the FDA to approve experimental cancer meds, even when current approval standards aren’t met. Pharmacyclics recently refiled an application for its cancer drug, despite agency refusal to review it in February. Cell Therapeutics argues its lung-cancer drug is being delayed by the FDA’s insistence it conduct another trial. And prostate-cancer patients and shareholders have protested the FDA’s refusal in May to approve Provenge vaccine by Dendreon. Yet another example is Antigenics, which is pushing a subgroup analysis, something the FDA resists, as The Wall Street Journal (subscription required) writes this morning. The issue, however, is becoming more heated as patients - and, of course, investors - argue that meds for life-... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=774271 Thu, 02 Aug 2007 12:22:58 +0100 774271 http://www.medworm.com/index.php?rid=767711&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F138877647%2F And so the red-hot Provenge controversy just grew a little more heated. A non-profit that calls itself Care To Live this morning filed a lawsuit in federal court in Ohio against FDA commish Andy von Eschenbach; Richard Pazdur, who heads the FDA Office of Oncologic Drugs; and Howard Scher, a Sloan Kettering-Memorial oncologist and FDA advisory panel member, for their “improper conduct…and inappropriate actions,” among other alleged activities having to do with Provenge approval. The group wants the FDA to immediately approve Provenge or at least reconvene an advisory panel, without Scher, to review the medication; declare the FDA can’t interfere with Provenge marketing, sale and use, absent additional findings or tests results that indicate any further safety concern... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=767711 Mon, 30 Jul 2007 15:46:46 +0100 767711 http://www.medworm.com/index.php?rid=747349&cid=t_131152_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F135750288%2F At the center of the red-hot controversy over Provenge, the prostate-cancer vaccine that has provoked passionate debate among patients and investors, is Howard Scher, a prominent oncologist at Memorial Sloan-Kettering Cancer Center in New York. Scher sat on an FDA advisory panel that, earlier this year, unexpectedly endorsed Dendreon’s product. But Scher and one other doc weren’t fully convinced, and wrote the agency about concerns they had with Provenge trials, triggering an FDA delay. The stock, meanwhile, was gyrating. And cancer patients and their families were outraged, prompting protests, bodyguards for the docs at a recent cancer meeting and, of course, Internet missives. Some missives have focused on Scher’s alleged conflicts of interest. He was granted a waiver ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=747349 Fri, 20 Jul 2007 20:36:21 +0100 747349 http://www.medworm.com/index.php?rid=728706&cid=t_131152_150_f&fid=35781&url=http%3A%2F%2Fwww.qdinformation.com%2Fqdisblog%2F2007%2F05%2F29%2Fdendreon-will-delay-provenge-cuts-jobs%2F Dendreon hit a major snag last week when the FDA declined to approve the drug without further data. THese are somewhat misleadingly called “approvable letters. For more on approvable letters see What Do Approvable Letters Mean? from Mark over at Ee on FDA. Dendreon will delay Provenge, cuts jobs: This led to a major drop in stock price and Denreon announcing it will lay off 400 workers mainly those geared towards commercialization of Provenge. If things go well, the company said it could launch the drug as soon as 2008 but it could be as late as 2010. What is surprising in this case is the the advisory committee unanimously voted (17-0 on safety and 13-4 on efficiency) to approve the drug and it is rare that the agency would then not approve it. Looks like the FDA may be getting mo... QDIS Blog blogs http://www.medworm.com/rss/comments.php?id=728706 Tue, 29 May 2007 23:27:12 +0100 728706