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 'bayer'. Sat, 03 Sep 2011 01:54:58 +0100 http://www.medworm.com/index.php?rid=5174864&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fb0mlnNwQLrQ%2F Over the weekend, Pfizer and Bristol-Myers Squibb released complete results of a Phase III trial for their forthcoming bloodthinner and, as expected, the findings clearly suggest the drugmakers have a treatment that will surpass rival meds. Why? Eliquis prevented more strokes with less major bleeding than warfain, the decades-old standard treatment in patients with atrial fibrillation, and also reduced the number of deaths. Consequently, the outcome underscores that one of the next, big marketing battles in the pharmaceutical industry will unfold after the drugmakers secure FDA approval, a step that is not expected until 2012. Already, Boehringer Ingelheim is marketing Pradaxa and Johnson & Johnson and Bayer expect to launch their Xarelto treatment later this year. Xarelto, by the way... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5174864 Mon, 29 Aug 2011 13:47:47 +0100 5174864 http://www.medworm.com/index.php?rid=5159840&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0qGTbAcfmZ0%2F Six months after a federal appeals court decided a pair of GlaxoSmithKline sales reps are not eligible for overtime pay, they are now asking the US Supreme Court to review their case. And the implications for the pharmaceutical industry are likely to be far-reaching, given that drugmakers have been laying off thousands of sales reps as part of a massive wave of cost cutting in recent years. The petition, however, is not surprising, because there has been a split among appeals courts over this issue. Last year, the US Court of Appeals for the Second Circuit ruled that Novartis reps are entitled to overtime (back story), and the Supreme Court earlier this year declined to review the decision (see here). That ruling came just two weeks after the US Court of Appeals for the Ninth Circuit ruled... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159840 Thu, 25 Aug 2011 12:07:40 +0100 5159840 http://www.medworm.com/index.php?rid=5159792&cid=t_111300_147_f&fid=39273&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FD72_FKYrmDU%2Fbayer-healthcare-uk-discredited-uk.html The continuing saga of Bayer Healthcare's tweets continues to be a news story in the UK drug industry.  Last year, Bayer copied two press release headlines, then released them to the public as tweets.  In coordination with the Prescription Medicines Code of Practice Authority (PMCPA), Bayer Healthcare UK has violated their Association of the British Pharmaceutical Industry Code of Conduct (ABPI Code).  This has resulted in discrediting the Pharma industry in the UK according to the governing board. According to The Register, they have discreded the industry by violating these rules: - Companies are prohibits to release information about prescription-only medicines that would encourage the public to ask their doctor for the product- Bayer Healthcare Failed to maintain high... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=5159792 Wed, 24 Aug 2011 14:20:00 +0100 5159792 http://www.medworm.com/index.php?rid=5118993&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fro-VnpB2yDg%2F If numbers tell a story, then Bayer and Johnson & Johnson may have some explaining to do. The complete results of a widely anticipated study known as Rocket were just published and show their Xarelto bloodthinner is not only just as safe as warfarin - the standard treatment - but 21 percent better at preventing stroke in patients with atrial fibrillation. But there was more, and it was sobering. An editorial in the same issue of The New England Journal of Medicine maintains the use of multiple statistical analyses to assess the medication “muddied the waters” when it comes to fully understanding efficacy and effectiveness compared with warfarin. The point raised by Gregory Zoppo of the University of Washington, and Misha Eliasziw of the University of Calgary may prompt cl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5118993 Thu, 11 Aug 2011 13:11:12 +0100 5118993 http://www.medworm.com/index.php?rid=5107899&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRkVSK5_Bu9Y%2F Good morning, everyone, and nice to see you again. We hope the weekend was invigorating. Now, of course, the time has come to resume the routine of meetings and deadlines, even if it is a slow time of year. To get started, yes, we are brewing that mandatory cup of stimulation, so feel free to join us. Meanwhile, here are some tidibts from around the world. Hope your day goes well and stay in touch… Pfizer And UCSD Collaborate On Early Drug Discovery (San Diego Union Tribune) China’s Healthcare Push May Curb Sales For Brand-Name Pharma (Bloomberg News) Nestle Eyes Pfizer Formula Milk Powder Business (Business China) EU Approves Botox For Treating Urinary Incontinence (Reuters) Takeda Pharmaceuticals Faces Rising Number Of Actos Lawsuits (Associated Press) Bayer Is Eyeing Pfizer ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5107899 Mon, 08 Aug 2011 11:50:32 +0100 5107899 http://www.medworm.com/index.php?rid=5050914&cid=t_111300_122_f&fid=36582&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSharpBrains%2F%7E3%2FO712DJOvAhQ%2F Very interesting new data reinforcing two main themes we have been analyzing for a while: 1) We better start paying serious attention (and R&D dollars) to lifestyle-based and non-invasive cognitive and emotional health interventions, which are mostly ignored in favor of invasive, drug-based options 2) Interventions will need to be personalized. The study below analyzes data at the country level, but the same logic applies to the individual level Many fear Alzheimer’s, want to be tested: survey (Reuters): - “The telephone survey of 2,678 adults aged 18 and older in the United States, France, Germany, Spain and Poland was conducted by researchers at the Harvard School of Public Health and Alzheimer Europe, with funding by Bayer AG” - “When asked to identify the most feared disea... SharpBrains blogs http://www.medworm.com/rss/comments.php?id=5050914 Thu, 21 Jul 2011 15:26:15 +0100 5050914 http://www.medworm.com/index.php?rid=5008662&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fjg8EpAu81jA%2F And so, another working week will soon draw to a close. As always, this is the signal to daydream about weekend plans. Our agenda calls for a dip in the pool, a little yardwork, hanging with assorted short people and catching up on some interesting R&D. What about you? Is a day at the beach in order? Or a drive in the country? Maybe catching up on some sleep or thinking big thoughts? Whatever you do, have a good time and be safe. Meanwhile, here are some tidbits. See you soon… Bayer Loses European Patent For Yasmin (Reuters) PETA Proposes Procter & Gamble Stop Animal Testing (Dayton Business Journal) Republicans Complain FDA Review Procedures Slow Innovation (Bloomberg News) Bydureon Diabetes Med Passed The Test In Heart Trial (Reuters) FDA Bans Imports From Dr. Reddy&#8217... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5008662 Fri, 08 Jul 2011 12:04:58 +0100 5008662 http://www.medworm.com/index.php?rid=5008665&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzOBgzIe-isc%2F To Tweet or not to Tweet? That is a question that Bayer Healthcare will be pondering for some time. The drugmaker was upbraided by the UK’s Prescription Medicines Code of Practice Authority for recently Tweeting about two medicines, which was deemed to be a cause for concern since the information went directly to the public. What were the Tweets about? In April, the @BayerUKIreland Twitter account wrote this concerning Levitra: “First & only melt-in-the-mouth erectile dysfunction treatment launched by Bayer today http://tinyurl.com/6hfxymf.” And last year, Bayer tweeted: “Sativex® launched in UK for the treatment of spasticity due to Multiple Sclerosis http://tiny.cc/kiz2y,” according to InPharm. The voluntary PMCPA industry code that allows a drugmaker to Tweet abo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5008665 Thu, 07 Jul 2011 12:55:19 +0100 5008665 http://www.medworm.com/index.php?rid=4945193&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWTPjB2gXSJE%2F The thousands of lawsuits filed against Bayer over alleged injuries and deaths relating to the Yaz and Yasmin contraceptives typically dwell on higher risks beyond those of traditional birth control pills and overly aggressively promotion that failed to disclose the possibility of blood clots, in particular. Now, though, a lawsuit charges off-label promotion for acne caused the death of a 15-year-old girl. Here’s the back story… In 2007, Brittany Prewitt began to develope the skin condition and was prescribed Yasmin, which was never approved for acne, but had allegedly been promoted, nonetheless, to dermatologists. She was not sexually active and the pill was not prescribed, in her case, for contraception, according to her lawsuit, which was filed in a North Carolina state cour... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4945193 Sat, 18 Jun 2011 17:04:58 +0100 4945193 http://www.medworm.com/index.php?rid=4883903&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FL2T8dkrEaLw%2F One month after a pair of studies found that women taking birth control pills containing a hormone called drospirenone are more likely to develop blood clots than those who take an older oral contraceptive, the FDA has decided to review the evidence. But since other studies have not reported the same risk, the agency is not taking any additional action at this time. The most widely known oral contraceptives containing this hormone are the Yaz and Yasmin pills sold by Bayer. You may recall that one study reviewed insurance data for US women aged 15 to 44 who took a contraceptive pill containing either drospirenone or levonorgestrel after January 2002, and compared 186 women who had had a blood clot with 681 who had not. Those taking newers pill had a 2.3 times greater risk for a blood clot... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4883903 Tue, 31 May 2011 22:12:39 +0100 4883903 http://www.medworm.com/index.php?rid=4883908&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F929PtH2PZsw%2F Good morning, everyone, and welcome back. We hope your weekend was relaxing and refreshing. Now, of course, the time has come to resume the routine of meetings and deadlines. And yes, we are coping by brewing the mandatory cup of stimulation - our flavor today is Mocha Nut Fudge - and we invite you to join us. Meanwhile, here are some tidbits to help you get in the groover. Hope your day goes well and see you soon… Five Lessons From The Niaspan Study (Forbes) GlaxoSmithKline Is Downgraded By Goldman Sachs (Associated Press) More Children Dying After Vaccination In India (India Times) JB Chem & Pharma To Hire 1,500 Medical Reps (The Economic Times) Sanofi Diabetes Drug Cuts Blood Sugar & Weight In Study (Reuters) No Workers, No Products: A Bleak Future For Renovo (Pharma Tim... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4883908 Tue, 31 May 2011 12:03:14 +0100 4883908 http://www.medworm.com/index.php?rid=4872471&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpHHGMxSsWCQ%2F So how is this for subtlety? A journal ad for the Yasmin contraceptive pill sold by Bayer noted that the med had a beneficial effect on acne, fluid retention, hirsutism and premenstrual symptoms. At the same time, much smaller type mentioned that acne and fluid retention may be uncommon side effects and that Yasmin is not licensed as a treatment for any of the four afflictions. And so a general practitioner in the UK filed a complaint with the Prescription Medicines Code of Practice Authority, which is responsible for administering the Association of the British Pharmaceutical Industry’s practice code. The anonymous doc believed it was “highly unethical” to put misleading info into an ad and that patents could be placed at an unnecessary risk. The upshot? A review panel found... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4872471 Fri, 27 May 2011 17:32:33 +0100 4872471 http://www.medworm.com/index.php?rid=4872480&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4QhGY2Ul8hM%2F A class action law suit alleging that Bayer HealthCare Pharmaceuticals discriminated against female employees has now been expanded to include female sales reps and all women in the Bayer HealthCare Consumer Care unit, two groups of employees who were not originally part of a discrimination complaint filed two months ago The initial lawsuit, filed by six current and former Bayer employees, charges a pattern of discrimination in pay, promotions, and the treatment of pregnant women and mothers. An amended complaint filed yesterday says sales reps were paid less but not promoted as often as men in similar jobs, while women in consumer care were sexually harassed by execs but the drugmaker ignored the problem. Such charges have emerged in many workplaces, but recently allegations of sex discr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4872480 Thu, 26 May 2011 12:40:48 +0100 4872480 http://www.medworm.com/index.php?rid=4862925&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYGVnVGNyT4k%2F Hello, everyone, and top of the morning to you. A lovely day is emerging here on the Pharmalot corporate campus, although this will be a busy one as we prepare for those meetings and deadlines. We know you relate, so please join us for a cup of stimulation - our flavor today is Rain Forest Nut. Or grab a bottle of water if you prefer. Meanwhile, here are some tidbits from around the world, such as it is. Hope your day is swell and you achieve your goals. See you later… SEC Expected To Act On Whistleblower Program (Washington Post) Deaths In Pfizer Arthritis Drug Trial Are Under A Microscope (Reuters) Vertex And Its Small, But Experienced Sales Force (Dow Jones) Watson Pays $562M For Generic Drug Developer (Reuters) Bayer and J&J’s Xarelto Prevented Repeat Strokes In Analys... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862925 Wed, 25 May 2011 12:02:24 +0100 4862925 http://www.medworm.com/index.php?rid=4853220&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_HzGxgsWQUM%2F As countless researchers and marketers gear up for the American Society of Clinical Oncology meeting in early June to review breakthroughs and close calls, one issue may warrant further inspection - the cost of these cancer meds and how patients are reacting. Why? A new analysis shows that 10 percent of patients are abandoning prescriptions for their oral cancer drugs. The reasons: higher cost-sharing for insurance coverage, a larger number of overall prescriptions for different medications, Medicare coverage and incomes, according to Avalere Health, which reviewed pharmacy transaction data between 2007 and 2009, and will present its paper at ASCO next month. The study was published in the Journal of Oncology Practice and American Journal of Managed Care (here is the abstract). To be speci... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4853220 Mon, 23 May 2011 12:54:56 +0100 4853220 http://www.medworm.com/index.php?rid=4853221&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fpok9CMr79cQ%2F Hello, everyone, and welcome to the working week. Another overcast day is unfolding here on the Pharmalot corporate campus, where we will be hosting a webinar on the injectable delivery drug market, so please join us. Meanwhile, the time has come to grab a cup of stimulation and peruse the news of the world. Hope your day goes well and stay in touch… FDA Approves Vertex Pharma Hepatitis C Drug (Reuters) Lilly Helps Create Biotech To Develop And Sell Xigris (Associated Press) How PR Tactics Skew Medical Research Presentation (The Guardian) J&J Woes Mitigated By New Drug Bets? (Bloomberg News) Lilly Chops 70 Jobs In Ireland (InPharm) Two Men Convicted Of Selling HIV Meds (NewJerseyNewsroom) Google Warned About Rogue Drug Ads (Wall Street Journal) Provenge, Medicare And Costs (CNBC... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4853221 Mon, 23 May 2011 11:59:53 +0100 4853221 http://www.medworm.com/index.php?rid=4841983&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FwGS0Lq_faZk%2F For the second time in the past year, a study has been released indicating that the little blue impotence pill can not only make one hard, but hard of hearing. To be specific, the trio of popular meds for erectile dysfunction - Viagra, Cialis and Levitra - were linked to 47 suspected cases of sensorineural hearing loss – a rapid loss of hearing in one or both ears that can become permanent, according to a study in The Laryngoscope. The UK researchers reviewed info from published literature and regulatory reports around the globe for incidents that may have been triggered by the pills. They found that hearing loss occurred within 24 hours of ingestion in nearly 67 percent of the cases, with Pfizer’s Viagra accounting for more than half of the total. The average age of those affected... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4841983 Thu, 19 May 2011 12:52:19 +0100 4841983 http://www.medworm.com/index.php?rid=4795054&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7XNwRvu223Y%2F When it comes to the animal health business, the laws of the jungle are what matters. Consider the spat between Bayer and Eli Lilly. Over the past year, Lilly’s Elanco animal health unit allegedly used a smear campaign to discredit Bayer in hopes of convincing veterinarians and distributors to end their business relationships with its rival, according to a lawsuit filed in a New York federal court. Such fingerpointing complaints are, of course, not an uncommon event among drugmakers, especially when it comes to promotional activities. But this latest lawsuit underscores the extent to which the animal health world is an increasingly important business to companies that are finding it harder and harder to develop big-selling meds to treat those two legged-creatures known as humans. At ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4795054 Fri, 06 May 2011 20:23:48 +0100 4795054 http://www.medworm.com/index.php?rid=4789635&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fh0ku9JI07Eo%2F An investigation by India’s health ministry has found that drugmakers running clinical trials in the country have not compensated survivors of most volunteers who died during their studies. Of 671 deaths that were reported last year, there is evidence that compensation was given in just three cases, The Business Standard writes. And so, the health ministry has asked 44 drugmakers to explain why they have not provided compensation, which is mandatory under the current law. Among those queried were Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson and Sanofi-Aventis. For instance, data compiled by the ministry show there were 152 deaths reported during Sanofi trials and 138 took place in Bayer trials. A Novartis spokesperson tells the paper that its clinical trial inves... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4789635 Thu, 05 May 2011 12:27:52 +0100 4789635 http://www.medworm.com/index.php?rid=4759036&cid=t_111300_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F04%2Fwho-regulates-press-releases-case-of.html Digital Pharma caught Bayer posting a Tweet - via its @BayerUKIreland Twitter account - that seems to violate new social media guidelines published by the UK's Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI).Here's the Tweet stream that Digital Pharma preserved:The tweet in question states "First and only melt-in-the-mouth erectile dysfunction (ED) treatment launches in the UK today." It includes a link to a LEVITRA BRANDED press release. I have preserved the press release as a PDF version (here) of the original Web version. I did this because Bayer might remove the original after it reads this post.The PMCPA code states: "If a company wanted to promote a medicine via twitter... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4759036 Wed, 27 Apr 2011 13:03:00 +0100 4759036 http://www.medworm.com/index.php?rid=4759042&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeYv8v5dtBmM%2F A Swiss appeals court has ruled that a series of television shows about the possible side effects attributed to the Bayer birth control pill known as Yaz and Yasmin were not inaccurate and, therefore, legal intervention was not warranged. The programs focused on side effects that included reports of nearly 200 deaths among women who used the pill. Bayer criticized the television programs as manipulative and mistakenly gave the impression that the pill is particularly dangerous. As a result, the drugmaker argued that a statutory requirement of factual accuracy has been breached. The appeals court acknowledged the programs raised tendentious questions, but did not assert the pills are dangerous and that other such pills also have side effects. And so the court found the programs raised legit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4759042 Wed, 27 Apr 2011 12:46:46 +0100 4759042 http://www.medworm.com/index.php?rid=4747886&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1NHs6gGZvRo%2F Trying to prevent one unwanted event may cause another. Women who use a newer type of birth control pill containing a hormone called drospirenone, such as Bayer’s Yaz and Yasmin, are more likely to develop blood clots than those who take an older oral contraceptive, according to a pair of studies published in BMJ. However, the overall risk of developing a clot in the lungs or legs was still low. One study reviewed insurance data for US women aged 15 to 44 who took a contraceptive pill containing either drospirenone or levonorgestrel after January 2002, and compared 186 women who had had a blood clot with 681 who had not. Those taking the newer pill had a 2.3 times greater risk for a blood clot, although the absolute risk was small - 30.8 per 100,000 among those taking drospirenone, compa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4747886 Mon, 25 Apr 2011 12:02:15 +0100 4747886 http://www.medworm.com/index.php?rid=4715022&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfKoTWEYTHfw%2F The latest monthly tally for prescription meds shows that prices rose again last month, compared with a year ago. Specifically, there were 14 price increases, up an average 6.7 percent, versus price hikes on 10 drugs in March 2010 that averaged 6.5 percent, according to Barclays Capital analyst Lawrence Marsh, who reviewed data from First DataBank on the top 130 brand-name prescription drugs. Going back in time, there were 19 price increases in March 2009, but the average price hike was 6.0 percent. In March 2008, prices rose on just eight meds at an average increase of 9 percent, while in March 2007, there were price increases on seven drugs at an average of 4.9 percent. And in March 2006, drugmakers boosted prices on seven meds at an average 5.8 percent. Last month, Marsh found price hi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4715022 Thu, 14 Apr 2011 13:43:49 +0100 4715022 http://www.medworm.com/index.php?rid=4684760&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fd_j1yofCUbQ%2F Five of the world’s biggest drugmakers failed to comply with mandatory disclosure laws for their patented medicines in India, which means they are vulnerable not only to fines, but also competition in the form of compulsory licenses that could be issued to generic drugmakers, which would then have the right to sell lower-cost versions of the patented drugs. The breach was uncovered by Shamnad Basheer, a professor of intellectual property law at the National University of Juridicial Sciences in New Delhi, India, and a contributor to the Spicy IP patent blog. He led a group of lawyers who collected information on patent disclosures made by foreign drugmakers to regulators under what is known as a Right to Information, or RTI, request. At issue is a requirement that drugmakers share in... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4684760 Thu, 07 Apr 2011 12:54:41 +0100 4684760 http://www.medworm.com/index.php?rid=4677109&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fr0Fv99YQmK0%2F Rise and shine, everyone. Another day is on the way. And it is a sunny one here on the Pharmalot corporate campus, where the short people have left for the local school house and the official Pharmalot mascots are barking at squirrels. You know what this means - it is time for a cup of stimulation. Our flavor today is Southern Pecan. Please join us as we scour the news of the world. Have a great day and do send us those interesting tidbits…. Gilead Raises Prices Of Top-Selling Meds (Dow Jones) J&J Hepatitis C Drug Price Sparks Concern In France (Bloomberg News) Bayer To Consolidate And Add Jobs In New Jersey (The Daily Record) Brand And Generic Makers Clash Over Canada/EU Trade Deal (Pharma Times) Cubist Shares Jump On Teva Patent Deal (Associated Press) Link Sought Between Lab ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4677109 Tue, 05 Apr 2011 12:09:01 +0100 4677109 http://www.medworm.com/index.php?rid=4653603&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSGckQ4pqQfc%2F The US Supreme Court ruled today that Santa Clara County cannot proceed with a lawsuit alleging its hospitals and clinics were overcharged for prescription meds by various drugmakers, which failed to offer discounts as part of what is known as the 340B program. This offers access to discounted drugs to healthcare entities certified by the US Department of Health and Human Services. The 8-to-0 decision overturned a federal appeals court ruling of a lawsuit filed in 2005 against Pfizer, AstraZeneca, Bayer, GlaxoSmithKline, Bristol-Myers Squibb, Merck and Sanofi-Aventis, among others. The county had filed suit after the HHS Office of Inspector General found the drugmakers had violated pricing ceilings between 2001 and 2005. The dispute centered on the rights of 14,500 health providers that sp... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4653603 Tue, 29 Mar 2011 15:52:55 +0100 4653603 http://www.medworm.com/index.php?rid=4631648&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLb25IzA8q8M%2F Good morning, everyone, and how are you today? Gloomy skies are hovering over the Pharmalot corporate campus again. Nonetheless, our spirits remain sunny. You know the refrain: ‘Every brand new day should be unwrapped like a precious gift.’ In other words, those meetings and deadlines may loom, but you will persevere. Meanwhile, please join us for, yes, that mandatory cup of stimulation and get ready to conquer the world. Have a good one and stay in touch… Merck Returns Blood Clot Drug to Portola (Reuters) Bayer Launches Melt-In-The-Mouth Impotence Pill In UK (Pharma Times) Abbott Settles HIV Drug Price Lawsuit With Pharmacies (Reuters) No Fracture Warnings Needed On OTC Heartburn Meds (Reuters) Canadian Access To Medicines Bill Stalls In Senate (Bridges Weekly) Amgen Say... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4631648 Thu, 24 Mar 2011 11:59:01 +0100 4631648 http://www.medworm.com/index.php?rid=4622506&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FN2UKxcXoMyU%2F What goes up….will keep going up? Ever since Novartis introduced the first pill to treat multiple sclerosis last year, prices for MS meds have jumped as much as 39 percent. Why? Other drugmakers are charging more for their older treatments in order to maintain revenue in the face of eroding unit sales, Bloomberg News writes. Novartis charges $48,000 for its new Gilenya pill, which prompted Teva Pharmaceutical to raise the price of its Copaxone injectable by 39 percent to $42,300 a year since January 2010. And the cost of MS drugs, which patients generally take for life, is now on par with many cancer meds. Consequently, patients without insurance or who do not qualify for assistance programs may be out of luck. Biogen’s Tysabri costs about $3,566 a month, or $42,788 a year, while... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4622506 Tue, 22 Mar 2011 12:28:26 +0100 4622506 http://www.medworm.com/index.php?rid=4615425&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVTA_6SZzBh8%2F Six current and former Bayer employees have filed a lawsuit against the drugmaker and its US unit over charges they suffered gender discrimination, denial of equal pay and promotions, and retaliation. And they are seeking $100 million in damages and class-action status. They are represented by the same firm that filed suit against Novartis and resulted in a $152 million over similar charges (back story). The lawsuit alleges a pattern discrimination in pay, promotions, and the treatment of pregnant women and mothers. Specifically, they charge Bayer pays women less than their male counterparts; deny promotions to better and higher paying jobs; limits employment opportunities to lower and less desirable job classifications, and exposes them to different treatment and a hostile work environmen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4615425 Mon, 21 Mar 2011 16:38:45 +0100 4615425 http://www.medworm.com/index.php?rid=4560598&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDDJwXnTTp4M%2F The Supreme Court rejected a challenge to a pay-to-delay deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop a patent lawsuit over the Cipro antibiotic (see this). The move is a blow to the Federal Trade Commission, which calls the deals anticompetitive and had been hoping the Supreme Court would review a case in the face of legislative inactivity. The issue has divided lower courts around the country for years. A wholesaler and three retailers, including CVS and Rite-Aid, asked the Supreme Court to review the settlement, arguing the deals choke off competition by stifling the arrival of lower-cost generics on their shelves. In the case they cited, Barr challenged the Cipro patent in October 1991 and struck a deal with Bayer in January 1997 tw... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4560598 Mon, 07 Mar 2011 22:44:07 +0100 4560598 http://www.medworm.com/index.php?rid=4545255&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fj7-yb8Q-oVg%2F Rise and shine, everyone, another shiny day is on the way. What lies in store? Meetings and deadlines, no doubt, and we relate. To cope, we are brewing our mandatory cup of stimulation and invite you to join us. Meanwhile, we will pause to hustle one of the short people off to the local schoolhouse. So here are a few tidbits. Also, please note that we posted some items last night, but placed them above our morning greeting in the event some people did not see them. Have a great day and stay in touch… Traditional Drug Discovery Model Is Ripe For Reform (Nature) McKesson Fights $212M Pricing Fine Levied By Arizona (Courthouse News) Lilly To Outsource Bioanalytical Work (Pharma Times) Eisai To Cut 900 Jobs Over Five Years (Bloomberg News) Panel Told No Guarantees Against Unethical Resea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4545255 Thu, 03 Mar 2011 12:00:30 +0100 4545255 http://www.medworm.com/index.php?rid=4522290&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FlhQJJzD3j_8%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 Absorption Systems hired Stacy Pritt as director of preclinical laboratory operations. Previously, she was director and general manager of the biological test center at B. Braun Medical, oversaw regulatory compliance at Covance Research Product... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4522290 Fri, 25 Feb 2011 13:06:21 +0100 4522290 http://www.medworm.com/index.php?rid=4478155&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxQAoxKq3qM0%2F Rise and shine, everyone. Another day is on the way. Here on the chilly Pharmalot corporate campus, we are, once again, hustling the short people off to the school houses. Speaking of challenging routines, meetings and deadlines are also beckoning. We assume you can relate. By the way, we would like to remind you that we are co-sponsoring a patient adherence conference and hope you can join us. Meanwhile, the time has come for another cup of stimulation. Hope your day goes well and stay in touch… Oncology Investigators Needed To Maintain Patient Recruitment (Outsourcing Pharma) EU Taken To Court Over Secrecy In India Trade Talks (Reuters) Tachi Yamada Steps Down As Gates Foundation Health Leader (Xconomy) FDA Approves Medical Devices Too Easily: Study (CBS News) Watson Pharma Earning... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4478155 Tue, 15 Feb 2011 13:16:41 +0100 4478155 http://www.medworm.com/index.php?rid=4464705&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUzPmlJi0yIs%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 AstraZeneca hired John Yee as vp and US head medical officer. Previously, he was vp and global head, evidence-based medicine and health outcomes research at Genzyme, where he spent eight years. And before that, Yee was a faculty member at Harva... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4464705 Fri, 11 Feb 2011 13:13:18 +0100 4464705 http://www.medworm.com/index.php?rid=4446036&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjcEW-wZX9A8%2F Hello, everyone, and nice to see you again. We hope the weekend was refreshing and interesting. Now, of course, the routine returns as those meetings and deadlines beckon. To cope, we are brewing our usual cup to stimulation - our flavor today is Gingerbread - and invite you to join us. Or grab a bottle of water, if you prefer. Meanwhile, here are a few tidbits to help you get started. Hope your day goes well and do stay in touch… AstraZeneca And Wellpoint To Conduct CE Studies (Dow Jones) Glaxo To Pay $250M To Resolve Avandia Lawsuits (Bloomberg News) Canada Debates HPV Vaccines For Boys (CTV) Pfizer Will Buy Danish Consumer Health Business (Associated Press) Roche Says Turkish Price Cuts Hurt Investment (Bloomberg News) Glaxo Updates Avandia Labeling (Associated Press) AstraZeneca ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4446036 Mon, 07 Feb 2011 12:54:46 +0100 4446036 http://www.medworm.com/index.php?rid=4424446&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9T5uMwVXXjQ%2F The list of product web sites that manage to get consumers to actually do something contains some very familiar names, such as Viagra, Nexium, Yaz and Lunesta. Of course, these are used to treat rather common concerns and all have, at one time or another, been widely advertised. Yet they also share something else in common - often, coupons are available, according to a recent survey that found, on average, 74 percent of consumers took some type of action after visiting a product web site. In other words, coupons appear to act as a motivator for following up in some fashion. “One thing we see when looking at satisfaction in years past is that there seems to be a high correlation beween satisfaction and a coupon,” says Meredith Ressi, president of Manhattan Research, which canvas... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4424446 Tue, 01 Feb 2011 14:04:32 +0100 4424446 http://www.medworm.com/index.php?rid=4424450&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbxEIYiZB3gI%2F Hello, everyone, and nice to see you again. Another wintry day here on the Pharmalot corporate campus where, as usual, we are doing our best to hustle the short people off to the school houses. And of course, we armed with a shovel and a cup of stimulation - our flavor today is Gingerbread - as we prepare for the next round of deadlines and meetings. We trust you are doing the same, yes? So here are some tidbits to help you get started. May your day be fruitful… Roche Returns Diabetes Drug To Ipsen Over Side Effects (Bloomberg News) Sanofi’s Multaq On Latest FDA Safety Probe List (Reuters) China Arrests 18 People For Making Fake Avastin (Shanghai Daily) Biogen Profit Falls But Tysabri Sales Were Up (Reuters) Former Pfizer Chemist Gambles On Biofuel (Biodiesel Magazine) Valeant ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4424450 Tue, 01 Feb 2011 13:08:26 +0100 4424450 http://www.medworm.com/index.php?rid=4419452&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FiDdu3SBp4VA%2F A scandal over tainted blood plasma products that made headlines periodically over the past decade has finally been settled. Although Bayer and three other companies, which were blamed for infecting hemophiliacs with HIV in nearly two dozen countries, were rather reluctant to acknowlege any resolution until an activist group in Europe disclosed the deal. The backdrop: A former Bayer division known as Cutter Biological introduced a new version of its med in 1984, but continued to sell the old one overseas, according to documents filed in federal court in Illinois. By doing so, Cutter avoided a build-up of inventory of its old Factor VIII concentrate, which provided a missing ingredient that allows a hemophiliac’s blood to clot. Why would a build-up have occurred? A new version, which was... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4419452 Mon, 31 Jan 2011 14:01:37 +0100 4419452 http://www.medworm.com/index.php?rid=4411725&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fm_6xhh7VWFQ%2F And so another week will soon draw to a close, which means the time has come to daydream, just a little, about the weekend. Anything special planned? We hope to catch up on our reading and spend time with Mrs. Pharmalot. And we also want to kvell since one of our short people is celebrating another milestone. How about you? Will you take in a movie? Find a good restaurant? Buy a new shovel, perhaps? Whatever your fancy, have a great time, and be safe. Meanwhile, here are some tidbits. See you soon… New Cypress Bioscience Owners Oust CEO (San Diego Union Tribune) Glaxo And Actelion End Development Of Insomnia Pill (Bloomberg News) Bayer And Zydus Cadila Form JV To Sell Drugs In India (Business Standard) Sanofi-Aventis Cancer Drug Has Little Effect In Study (Associated Press) Are Cipla... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4411725 Fri, 28 Jan 2011 13:14:21 +0100 4411725 http://www.medworm.com/index.php?rid=4377787&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcjCmn3mBJKE%2F Two years ago, the US Federal Trade Commission filed a highly publicized lawsuit against Cephalon over pay-to-delay deals worth an estimated $200 million with some generic drugmakers - Ranbaxy Labs, Mylan Labs and Teva Pharmaceuticals - to keep a copycat version of its Provigil sleep-disorder pill off the market until 2012 (read this). Now, though, more than three dozen other drugmakers have raced to court to try to keep details of their own deals from being disclosed as a result of this battle. In a motion filed in federal court in Philadelphia this week, no fewer than 37 drugmakers - including Abbott Laboratories, Merck, Novartis, Bristol-Myers Squibb, Sanofi-Aventis, GlaxoSmithKline, Pfizer, Bayer, AstraZeneca, Johnson & Johnson, Actavis, Waston Pharmaceuticals, Dr. Reddy’s, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4377787 Thu, 20 Jan 2011 20:48:02 +0100 4377787 http://www.medworm.com/index.php?rid=4361306&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUuhSDJneggs%2F One month after yet again raiding offices of various drugmakers (back story), the European Commission is now taking a more polite approach and telling several companies - including Bayer and Roche - to submit details of their settlements over patent disputes. The EC asked a “selected number of originator and generic companies” to submit a copy of all patent settlement agreements relevant to the 27-member EU region and which were concluded between Jan. 1, 2010 and Dec. 31, 2010, according to an EC statement. Like the US Federal Trade Commission, the EC has been probing these pay-to-delay deals in the belief that they stifle competition and, therefore, delay entry to the marketplace of lower-cost medicines (read about the FTC efforts here). This followed a report from the Europe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4361306 Tue, 18 Jan 2011 14:20:42 +0100 4361306 http://www.medworm.com/index.php?rid=4394518&cid=t_111300_107_f&fid=36672&url=http%3A%2F%2Fwww.sciencebase.com%2Fscience-blog%2Fscience-news-5.html Latest science news snippets from Sciencebase Bee team funded by Bayer – It is revealed that the lead investigator in the study that recently published results suggesting that bee colony collapse disorder (CCD) is due to the combined effect of a virus and a fungus is funded by the insecticide company (Bayer). The researcher denies that this funding is connected to the research, it pays for other work, but you can't help but wonder whether there is a conflict of interest here. Who’s your favourite scientist? – Who's your favourite scientist? For me it has to be Feynman, although Faraday would be a close second, oh and perhaps Sagan, and then there's Curie, and Kroto…oh the list goes on… Definition of a chemistry research paper – I've ... Sciencebase Science Blog blogs http://www.medworm.com/rss/comments.php?id=4394518 Mon, 17 Jan 2011 10:56:48 +0100 4394518 http://www.medworm.com/index.php?rid=4338267&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8rf99O1NZL4%2F Rise and shine, everyone. Another brand new day is on the way. And, not surprisingly, a spot of snow has descended on the Pharmalot corporate campus. But we were warned, after all. While we search for ways to dig out, here are a few items of interest. And of course, we hope your day is pleasant, even if you work from home. Enjoy and do stay in touch… Merck And Parexel To Develop Biosimilars (Reuters) Sanofi CEO Committed To Buying Genzyme (Boston Herald) Painkillers May Increase Risk Of Heart Attacks And Strokes (Bloomberg News) Lilly Alzheimer’s Med Study Has Patient With Brain Swelling (Reuters) Drugmakers Sue Czech Government Over Pricing (Pharma Times) Shingles Vaccine Lowers Risk By 55 Percent (Agence France Presse) Bayer To Enforce Property Rights After Humira Ruling (Blo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4338267 Wed, 12 Jan 2011 13:05:06 +0100 4338267 http://www.medworm.com/index.php?rid=4331236&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FED0DYDEIm1U%2F The controversy over so-called pay-to-delay settlements between brand-name and generic drugmakers has prompted attorneys general from 32 states to file an amicus, or friend-of-the-court brief urging the US Supreme Court to review the deals, which the states say thwart competition and block needed access to lower-cost medications. The move comes less than a month after three pharmacy chains and a wholesaler petitioned the court to rule on the issue, which has divided other federal courts (see this) and spurred the Federal Trade Commission into a Quixotic quest to urge Congress to pass a law to restrict these deals (back story). The case that precipitated these filings involved a deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop its patent cha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331236 Tue, 11 Jan 2011 13:26:37 +0100 4331236 http://www.medworm.com/index.php?rid=4314221&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6v6OHNUJQ_Y%2F Greetings, everyone. How are you this morning? We trust you feel invigorated as another day gets under way. As usual, we are brewing a delicious cup of stimulation and poking around for interesting items. Heard something fascinating? Send us a note. Meanwhile, we hope your workload is manageable and much gets accomplished. Catch you soon… Pfizer Faces 1,200 Chantix Lawsuits (Birmingham News) Spectrum To Make Biosimilar Of Roche’s Rituximab (Reuters) Roche Wins Wider Approval For Actemra (Bloomberg News) Evidence Links Avastin To Heart Failure In Breast Cancer Patients (HealthDay) EMA Worries Over Foreign APIs (InPharma-Technologist) J&J Files For FDA Approval Of Bloodthinner (Associated Press) Celgene Submits New Applications For Cancer Meds (Reuters) Xoma Inks $505M Diabe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4314221 Wed, 05 Jan 2011 12:48:44 +0100 4314221 http://www.medworm.com/index.php?rid=4272601&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpAmBhLecykw%2F The controversy over the so-called pay-to-delay settlements is bubbling up to the US Supreme Court. Three pharmacy chains and a wholesaler have asked the court to review the issue because they maintain the deals choke off competition by stifling the arrival of lower-cost generics on their shelves. The issue has become a cause celebre for the US Federal Trade Commission (look here), which has been lobbying Congress to enact legislation to restrict the settlements, and has also divided courts across the country, which is why the Supreme Court was asked to review the topic and settle the matter. The case cited by the retailers and wholesaler involved a deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop its patent challenge to the Cipro antibiot... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4272601 Mon, 20 Dec 2010 15:41:59 +0100 4272601 http://www.medworm.com/index.php?rid=4225659&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaUJt6QgUc6g%2F Once again, another work week is about to draw to a close. Although meetings and deadlines loom today, already we are looking ahead to spending time with the short people, a night at the movies, catching up on some reading and promenading with the official Pharmalot mascots. What about you? Anything special planned? Maybe an afternoon nap or a fancy dinner? Well, you could always pay some bills. In any event, here are a few tidbits to peruse while you consider the possibilities. Whatever you do, have a great time and stay safe. See you soon… Pharma Mergers Scrutinized In Insider Trading Probe (Reuters) Merck Pays $500 For SmartCell Diabetes Drugmaker (Bloomberg News) FDA Panel Backs AstraZeneca Thyroid Drug (MedPage Today) Licensing Deal Threatends Cheap AIDS Meds For Poor (The Indep... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4225659 Fri, 03 Dec 2010 12:36:07 +0100 4225659 http://www.medworm.com/index.php?rid=4190155&cid=t_111300_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fmeet-marcel-the-diabetic-shell%2F2010.11.21 Clara Barton Camp (CBC) is awesome — this is an indisputable fact. I talk about CBC all the time when I’m at conferences, because there is something so unique and incredibly supportive about knowing that your fellow campers are also insulin-dependent and aren’t afraid to show it. Part of what makes CBC so cool is that it makes you feel like having diabetes is…sort of cool. Almost everyone at camp has it, so if your pancreas happens to work, it makes you the odd one out instead of part of the WYOI (wear your own insulin) crowd. What’s more empowering than taking an isolating chronic illness and making it the common — and intrinsically cool — thread?  Which is why this video — a diabetes take on the Marcel the Shell with Shoes On — is... Better Health blogs http://www.medworm.com/rss/comments.php?id=4190155 Mon, 22 Nov 2010 01:00:49 +0100 4190155 http://www.medworm.com/index.php?rid=4183540&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEnQwv5e7J9A%2F Those job cuts just keep on coming. Earlier this week, Roche finally pulled the trigger on plans to eliminate 4,800 positions (see this) and close several sites. Now, Bayer is getting rid of about 4,500 jobs - including some 1,700 in Germany - over the next two years, although chairman Marijn Dekkers insists that 2,500 positions will be added in emerging markets over the same period. In explaining the move, the pharma and chemical maker says that sales and earnings are “under pressure” from generic products, rising development costs and the effects of health care reforms - which are among the factors cited earlier this week by Moody’s Investor Services in a report that reiterated a negative outlook for the pharmaceutical industry (look here). Reducing the headcount &#8220... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4183540 Fri, 19 Nov 2010 12:57:11 +0100 4183540 http://www.medworm.com/index.php?rid=4168212&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLHFTjD-DAAg%2F Good morning, everyone. Nice to see you again. We hope your weekend was refreshing and relaxing. Now, of course, the routine resumes with all those meetings and deadlines. We share the feeling, of course. To cope, we are brewing the mandatory cup of stimulation. Please join us. And as always, here are a few tidbits to help you along. Hope your day goes well and do stay in touch… J&J And Bayer’s Xarelto Beats Warfarin In Key Study (Bloomberg News) J&J’s Natrecor Doesn’t Kill Or Help Heart Patients (Forbes) Progress On Heart Disease Slows (The Milwaukee Journal-Sentinel) Genzyme Eyed Takeda As A White Knight (Bloomberg News) Pfizer Heart Drug Helps Milder Patients (Reuters) Merck Sets Growth Strategy In India (LiveMint) Brazil Lures Big Pharma (The Financial... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4168212 Mon, 15 Nov 2010 12:55:18 +0100 4168212 http://www.medworm.com/index.php?rid=4152267&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhA34mJ2aYlk%2F Two months ago, the FDA approved a new type of drug from Novartis called Gilenya to treat relapsing forms of multiple sclerosis and delay the progression of physical disabilities. MS, of course, is hard to treat and since Gilenya is a once-daily pill, the betting is that Novartis has a blockbuster on its hands (back story). But how big? A survey of 43 MS specialists by Leerink Swann finds that Gilenya may grab 13 percent of the US market within one year and 19 percent in two years. If this comes true, Gilenya’s market share by then would exceed all of the competition - Biogen’s Avonex with 18 percent market share; EMD Serono and Pfizer’s Rebif at 15 percent; Bayer’s Betaseron with 9 percent and Biogen’s Tysabri at 8 percent. Only Teva’s Copaxone would be... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4152267 Wed, 10 Nov 2010 16:46:41 +0100 4152267 http://www.medworm.com/index.php?rid=4125284&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBF0n-R7Hv1k%2F Hello, everyone. Nice to see you again. Hope your weekend was pleasant and no one was spooked by the teeming masses of goblins and ghosts that came knocking. Now, of course, the routine has resumed, which means preparing for those meetings and deadlines. So please join us for the mandatory cup of stimulation as we scan the news of the world. Hope your day goes well… Bayer’s Xarelto Bloodthinner Matches Warfarin In Trial (Bloomberg News) Nycomed Buys Major Stake In Chinese Firm (PharmaTimes) Hepatitis C Update On Merck, Vertex And Gilead (TheStreet) Roche CEO Braces For Biosimilars (The Wall Street Journal) ‘Low T’ Ads Run During The World Series (Fanhouse) Pfizer Sues To Block Generic Viagra (Bloomberg News) Hikma Pharmaceuticals Looks To Spend Its War Chest (The In... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4125284 Mon, 01 Nov 2010 12:02:25 +0100 4125284 http://www.medworm.com/index.php?rid=4122104&cid=t_111300_167_f&fid=38271&url=http%3A%2F%2Frebeccascritchfield.wordpress.com%2F2010%2F10%2F31%2Fspeaking-on-a-big-stage%2F Yes, it’s true. Public speaking is feared more than death. Now, for me, I come alive on a stage. But don’t get me wrong. I’m really nervous and want to puke up until I hear the “Please welcome…” In two weeks, my speaking partner and I, Bernie Salazar (NBC’s Biggest Loser Season 5 at-home winner) will be headed to New Orleans for some shrimp po’ boys and a major talk with families living with hemophilia. See Us @ “Living Fit” Summit November 12, 2010 New Orleans Sponsored By: Thanks to Bayer for bringing the Nurture Principles message to families attending the National Hemophilia Foundation’s Annual Meeting. Check out the postcards Bernie will be signing at the booth!   We’re also doing food demos and exer... Balanced Health and Nutrition Rebecca Scritchfield's Blog blogs http://www.medworm.com/rss/comments.php?id=4122104 Sun, 31 Oct 2010 04:39:22 +0100 4122104 http://www.medworm.com/index.php?rid=4036950&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FoXA-DZUmgEk%2F Hello, everyone. It is truly a pleasure to see you again. We apologize for the service disruption of the past two days. Unfortunately, there were those proverbial technical difficulties that were well beyond our control. Now, though, we have returned and hope to provide you with the usual flow of tidbits that will feed your habit. Meanwhile, have a nice evening… UK’s NICE To End Curbs On Alzheimer’s Drug (Reuters) The Incredible Shrinking US Biotech Sector (Bloomberg News) Bayer Bets On Sex Drug For Older Women (Agence France Presse) Pfizer Reviews Alternatives For Capsule Unit (Associated Press) Merck To Investo $30M In Netherlands Production Line (Dutch News) InterMune Sells Hepatitis C Drug Rights To Roche (Dow Jones) Novartis Jury Decides Whether Novartis Hid Bone-Dru... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4036950 Wed, 06 Oct 2010 23:51:13 +0100 4036950 http://www.medworm.com/index.php?rid=4013545&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkoB2Sk4HOgk%2F Rise and shine, everyone. Another sunny day is emerging here on the Pharmalot corporate campus where we are happily brewing our latest cup of stimulation - aromatic Southern Pecan. Please join us as we indulge, even if you prefer a healthy bottle of water instead. Meanwhile, here are a few tidbits from around your universe. Hope your day goes well and do stay in touch… Bristol-Myers Squibb Recalls Some Avalide Samples (Reuters) Failed Hepatitis Vaccine Protected Infants In Study (MedPage Today) UK’s NICE Backs Some Herceptin Use In Gastric Cancer (Reuters) Lilly Scientists Have New Home For Designing Cancer Meds (Indianapolis Star) New Bayer CEO Sees More M&A Spending (Bloomberg News) Prescription Meds Overtake Illegal Substances (Los Angeles Times) Pediatricians Want To ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4013545 Wed, 29 Sep 2010 11:47:14 +0100 4013545 http://www.medworm.com/index.php?rid=4013546&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZbkIW8inHAo%2F The US Supreme Court agreed to hear an appeal by drugmakers seeking to block thousands of public hospitals and community health clinics from suing for violations of a federal program that lets them buy medicines at a discount, according to reports (here and here). The justices agreed to review to an appeal by Pfizer, AstraZeneca, Bayer, GlaxoSmithKline, Bristol-Myers Squibb, Merck and Sanofi-Aventis, among others, which are challenging a lower court ruling permitting a suit against the drugmakers filed by the California county of Santa Clara. That suit was filed the lawsuit in 2005 for alleged overcharges at its medical facilities from 2001 to 2005. The dispute centers on the rights of 14,500 health providers that spend about $4 billion a year on outpatient drugs. A 2006 government report ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4013546 Tue, 28 Sep 2010 22:27:57 +0100 4013546 http://www.medworm.com/index.php?rid=3987235&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU68qlUuDW8M%2F Today is a big day for Boehringer Ingelheim. The FDA’s Cardiovascular and Renal Drugs Advisory Committee is reviewing its Pradaxa drug, which the German drugmaker hopes will win an endorsement for treating stroke prevention in patients with atrial fibrillation. That outcome appears highly likely, given that FDA reviewers took the unusual step of saying the med should be approved - albeit for only one of two doses sought by BI and without a superiority claim over Warfarin, the standard but difficult-to-take treatment (see the briefing documents here). But what does this mean for the competition? You may recall that several other large drugmakers are racing to get their own bloodthinners into the hands of the nation’s doctors - Bristol-Myers Squibb and Pfizer are developing apixaban,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3987235 Mon, 20 Sep 2010 13:09:12 +0100 3987235 http://www.medworm.com/index.php?rid=3981018&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFhfKaF5_N6U%2F And so another week will soon draw to a close. And not a moment too soon, yes? After all, this has been a busy stretch. What will you do this weekend? A drive in the country to pick apples? Take in a new movie? Spend time with someone special? For our part, we will reflect on the year past and the year ahead. And then take the official Pharmalot mascots for a brisk stroll. Meanwhile, the news of the world awaits. Whatever you do, we hope all goes well. See you soon… New Russian Law Eases Red Tape For Drugmakers (The Economist Intelligence) J&J Wants To Buy The Rest Of Crucell Vaccine Maker (Reuters) FDA Panel OKs Wider Use For Alkermes Drug (Reuters) Bayer Sees Huge Market For Its Bloodthinner (Bloomberg News) Childhood Vaccination Rates Remain High (The Los Angeles Times) Settl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3981018 Fri, 17 Sep 2010 11:55:07 +0100 3981018 http://www.medworm.com/index.php?rid=3973111&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsNp0T-pISJQ%2F Since working dad best describes our place in the world, we do not pretend to know what all working moms want from their employers. So we dutifully glanced at Working Mother magazine to learn that several drugmakers - 11, in fact - made the latest list of the 100 best employers in the land. Which ones? Abbott Labs, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Genentech, Johnson & Johnson, Merck, Novo Nordisk, Pfizer and Sanofi-Aventis. A notable exception is Novartis, which made the 2009 list (see here), but has since gained some notoriety for agreeing to pay a combined $402 million to settle a pair of embarassing class-action lawsuits brought by female employees who claimed the drugmaker engaged in a pattern of discrimination involving pay, promotion and pregna... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973111 Wed, 15 Sep 2010 15:33:26 +0100 3973111 http://www.medworm.com/index.php?rid=3946687&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FT2IYaC17BMc%2F In yet another blow to the US Federal Trade Commission, a federal appeals court has refused to reconsider its ruling last April that upheld the legality of so-called pay-for-delay deals that thwart the introduction of generic rivals (here is the order). However, in a dissenting opinion, Justice Rosemary Pooler writes that the issue must ultimately be decided by the US Supreme Court, given the conflicting outcomes in various cases. The initial ruling by the US Second Circuit Court of Appeals was made after reviewing a deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop its patent challenge to the Cipro antibiotic. Barr challenged the Cipro patent in October 1991 and struck a deal with Bayer in January 1997, about two weeks before the case was s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3946687 Wed, 08 Sep 2010 12:03:05 +0100 3946687 http://www.medworm.com/index.php?rid=3921076&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F94A_3qfmuDs%2F The battle to prevent blood clots is heating up this week as several drugmakers begin releasing study results for their experimental drugs. At stake, of course, is a huge market for stroke prevention that is worth billions of dollars, since the new meds are designed to supplant warfarin and aspirin, which are troublesome or simply less effective. Toward that end, Bristol-Myers Squibb and Pfizer issued results showing patients taking their apixaban blood thinner were 54 percent less likely to have a stroke or damaging clot than those taking aspirin, and did not show significant signs of bleeding. Their Averroes study, which was presented at the European Society of Cardiology conference in Stockholm, involved about 5,600 people suffering atrial fibrillation and who are unable to use warfarin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3921076 Tue, 31 Aug 2010 12:05:34 +0100 3921076 http://www.medworm.com/index.php?rid=3865454&cid=t_111300_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F08%2Fare-pharma-marketers-using-viral-social.html Subtitle: This Bayer Sexy Youtube Video is Popular, but Will It Help Levitra Sales?Is viral, peer-to-peer pharma marketing an effective tactic? Jeff Chester, who heads up the Center for Digital Democracy (CDD), thinks so. Speaking on NPR's All Things Considered show (summarized on NPR's blog), Chester commented on Bayer's funny "InBedStory" series of YouTube videos and claimed that "the drug company marketers are counting on you to forward the funny video. And," he says, "that's the idea behind all these techniques."By "all these techniques," Chester includes techniques like the infamous Novartis Share button that recently was dinged by FDA (see "Implications of FDA’s Warning Letter to Novartis Regarding Facebook Share Widget" and "Who's in Charge of Your 'Invisible' Metadata? WARNING: D... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3865454 Fri, 13 Aug 2010 13:06:00 +0100 3865454 http://www.medworm.com/index.php?rid=3827349&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxlR5KWqXo1w%2F Hello, everyone. How are you today? Hope your week is going well. We have had a rather busy time, but that is to be expected. And so you know what this means - time for two cups of stimulation. Feel free to join us as we gear up for another cycle of meetings and deadlines. Meanwhile, here are some snippets of activity that may interest you. Have a good one and please do stay in touch… Epilepsy Drugs Don’t Increase Suicide Risk (Bloomberg News) Merck Proteomics Research Matches Drugs To Activated Pathways (BioIt World) Gilead’s Ace Drug Developer Resigns (Xconomy) Bayer, J&J’s Xarelto Meets Study Goal (Reuters) Glaxo Find New Way To Fight Drug-Resistant Bacteria (Dow Jones) WHO Withdraws Pre-Qualification Of Sanofi Vaccine (Vaccine News Daily) Glaxo Signs Cancer... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3827349 Thu, 05 Aug 2010 11:47:17 +0100 3827349 http://www.medworm.com/index.php?rid=3798822&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHSVJDgpaePI%2F For two decades, a bitter controversy has taken place over a blood-clotting medicine that was blamed for infecting hemophiliacs with HIV in Asia and Latin America, while a newer, safer version was sold in the US and other Western nations. And now, after having lost a recent court battle, Taiwanese hemophiliacs have petitioned the US Supreme Court to hear their story. Their lawsuit contends Bayer and a predecessor company illegally used paid plasma donors who were at high risk for transmitting blood-borne diseases - drug users, prisoners, and promiscuous urban gay males - to make Factor VIII, which can stop uncontrolled bleeding. But even after the company began using newer and safer heat-treated process, older inventory continued to be sold in Asia. The assumption was older meds could be s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3798822 Wed, 28 Jul 2010 14:39:28 +0100 3798822 http://www.medworm.com/index.php?rid=3767034&cid=t_111300_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F07%2Fprosecuting-doctors-for-importing-iuds.html Here in Rhode Island, the big health care story recently was the use of unapproved intra-uterine devices (IUDs) by some local obstetrician-gynecologists (OB-GYNs).  The first nuanced summary of the story which just appeared in the Providence Journal, written by Felice Freyer, suggested how the consequences of possible misconduct in health care depend on the clout of those involved.The Unapproved IUDsHere are the main points. The issue that caused so much local controversy was the use of unapproved IUDs:Ten Rhode Island medical groups with 28 doctors told the Health Department that they bought IUDs, a form of birth control, from a foreign source, at prices about half what they had to pay for IUDs approved for use in the United States. Many had stopped using the unapproved devices long ... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3767034 Mon, 19 Jul 2010 16:10:00 +0100 3767034 http://www.medworm.com/index.php?rid=3761629&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fh9wBkie4zFg%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 Amgen hired Jonathan Peacock, 52, as executive vice president and chief finance officer. He was previously cfo at Novartis Pharmaceutical, which recently underwent a reorganization (see here). Before joining Novartis in ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3761629 Fri, 16 Jul 2010 12:26:26 +0100 3761629 http://www.medworm.com/index.php?rid=3758111&cid=t_111300_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FFTEHWFPnFiM%2Fbayer-launches-unbranded-birth-control.html According to Medical Marketing & Media, Bayer has started an unbranded campaign to educate women about contraception. At bayerforwomen.com, women can gain correct facts about contraception. There is also a link to Bayer's three forms of contraception: Yaz, Yasmin and Mirena.Rose Talarico, deputy director, external product communication stated,“Women today have many different birth control methods to choose from. And they often get information from a variety of sources, some of which may not be accurate, such as blogs, coworkers, TV and more. Since making a misinformed decision about birth control can lead to unnecessary risks, it's important that women have access to all the information available in a straightforward and educational format.”Read the full article here. (Source: ePh... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3758111 Thu, 15 Jul 2010 15:35:00 +0100 3758111 http://www.medworm.com/index.php?rid=3721964&cid=t_111300_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2Fw1D_7EmV3jk%2Fbayer-healthcares-latest-iphone-app.html TMC Net has an article about Bayer's latest mobile application. Those affected with Hemophilia A now have a way to track their condition with the FactorTrak(TM) app. It measures dosing history, frequency and locations of bleeds. The captured information can also be emailed to the individual or others, such as healthcare professionals. It is available on the iPhone, iTouch, iPad or other smart phones. The app captures no personal information, just tracks conditions. Find it here. (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3721964 Fri, 02 Jul 2010 15:01:00 +0100 3721964 http://www.medworm.com/index.php?rid=3683872&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEPyViqp86VU%2F And the answer is…. GlaxoSmithKline, which led its counterparts in a host of variables that formed the second-ever Access to Medicine Index. European drugmakers, in fact, bested US rivals in making medicines available to people in developing countries, although the foundation that runs the project says this lead is shrinking. The index is designed to offer investors a way to compare pharma’s social responsibility records by measuring 106 indicators that examined activities across seven criteria such as philanthropy, patents, pricing and management (see more here). The latest report - the first was issued in 2008 - covers 27 companies, including 20 brand-name drugmakers and seven generics manufacturers, which have their own list and was topped by Ranbaxy Labs, now owned by Daiic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3683872 Mon, 21 Jun 2010 12:45:18 +0100 3683872 http://www.medworm.com/index.php?rid=3676899&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZRxrE7wS55A%2F Good morning, everyone. How are you today? The weekend is just around the corner, of course, and that means looking ahead to…. what? We expect to frolic with some industry types at a soiree and, otherwise, lounge around the Pharmalot corporate campus to catch up on some reading. As for you, we hope your plans are exciting. Meanwhile, here are a few news items of the world. Have a great time and, by the way, do remember to call Dad… Sanofi-Aventis Prostate Cancer Drugs Wins FDA Approval (Reuters) UK’s NICE Approves Amgen’s Prolia (Bloomberg News) Walgreens Launches Mobile Prescription Reminders (EWeek) Malaysia Forecast To Lead Generics Growth In Asia (PharmaTimes) Pharma Urged To Develop More Orphan Drugs (Bloomberg News) Pfizer Biotech Drug Tops Placebo In Knee Pai... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3676899 Fri, 18 Jun 2010 11:48:30 +0100 3676899 http://www.medworm.com/index.php?rid=3659158&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNM47jZabUxw%2F Welcome to the working week. We hope the weekend was refreshing and restful. Now, of course, the time has come to resume the usual routine of meetings and deadlines and what-not. Are you ready? If not, grab a cup of something stimulating and scan the news of the world. What better way to get started? So dig in and have a good day, everyone. Catch you soon… Human Genome Concedes Hep C Drug Approval Is Unlikely (TheStreet) Bayer’s Nexavar Fails Phase III Lung Cancer Trial (Reuters) Glaxo Gets Complete Response Letter For MenHibrix (PharmaTimes) Debating Anti-Counterfeiting Technology In Nigeria (234Next) Dr. Reddy’s Blocked From Launching Version Of Allegra (Business Standard) Abbott Lays Off 120 Workers In California (North County Times) New KV Pharma Board Ousts CEO (St. ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3659158 Mon, 14 Jun 2010 11:41:48 +0100 3659158 http://www.medworm.com/index.php?rid=3577626&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fh_IpIo82H4Y%2F A federal appeals court last month may have upheld the legality of pay-for-delay deals that thwart the introduction of generics, but the issue isn’t dead yet. A group of consumers, union health and welfare funds, which have been certified as a class, are asking a California appeals court to review the same set of circumstances involving Bayer, Barr Pharmaceuticals and the Cipro antibiotic. At issue in both cases is a deal in which Bayer paid Barr, now owed by Teva Pharmaceuticals, to drop its 1991 patent challenge to Cipro. In 1997, Barr struck a deal with Bayer just two weeks before a lawsuit was set to go to trial, delaying the entrance of a generic version. The US Second Circuirt Court of Appeals ruled the deal was kosher (see here), although the Federal Trade Commission continues... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3577626 Wed, 19 May 2010 12:11:47 +0100 3577626 http://www.medworm.com/index.php?rid=3542873&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fdtv4OBHXOuY%2F Once again, another working week will soon draw to a close. And so the weekend agenda calls for a smattering of activities - taking the Pharmalot mascot for a constitutional, bike riding with one of the short people and watching another on the lacrosse field. And you? Whatever you plan, we hope you have a good time. And of course, do not forget mom. Have a great time… FDA To Review Lilly’s Byetta In Six Months (Reuters) Lilly To Cut 200 Sales & Marketing Jobs (Indianapolis Star) InVentiv To Be Bought For $900M By Thomas Lee (Wall Street Journal) Bayer Wins FDA Approval For New Type Of Contraceptive (Bloomberg News) Genzyme Plans $2B Buyback, May Sell Units (Associated Press) Australia Agrees To $2B In Price Cuts (PharmaTimes) photo thx to tipiro on Flickr creative commons ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3542873 Fri, 07 May 2010 11:37:14 +0100 3542873 http://www.medworm.com/index.php?rid=3538386&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FllPx_XfK0Cw%2F Hello, everyone. Nice to see you again. A busy day lies ahead and so, as you have come to expect, we are brewing the required cup of stimulation to jumpstart the process. Perhaps you wish to do the same. Meanwhile, we are scouring about for interesting items. Please let us know about anything fascinating you come across. Meanwhile, have a nice day… Cipla And Pfizer In Strategic Talks? (The Economic Times) Bayer Gets Rights To Female Sexual Dysfunction Drug (PharmaTimes) Nestle & Alcon Shareholders Reach Deal In Merger Suit (Read the Order) Wisconsin Town Sues Drugmaker Over Loan (Milwaukee Journal-Sentinel) Hepatitis C Resists Vertex Drug (Bloomberg News) FDA Sends Warning Letters To Roche & Shire (Reuters) Merck Adds Lab To NC Vaccine Facility (The News-Observer) Greek Pri... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3538386 Thu, 06 May 2010 11:49:15 +0100 3538386 http://www.medworm.com/index.php?rid=3519709&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLrxAf4BduMM%2F In a blow to the Federal Trade Commission, the US Second Circuirt Court of Appeals has upheld the legality of so-called pay-for-delay deals that thwart the introduction of generic rivals. But at the same time, the court suggested the issue needed further review (see the ruling). The ruling was made after reviewing a deal in which Bayer paid Barr Pharmaceuticals, which is now owed by Teva Pharmaceuticals, to drop its patent challenge to the Cipro antibiotic. Barr challenged the Cipro patent in October 1991 and struck a deal with Bayer in January 1997, about two weeks before the case was set to go to trial. The ruling is yet another setback for the Federal Trade Commission, which has been pushing aggressively to end pay-to-delay deals (look here). Two months ago, a federal judge dismissed an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3519709 Fri, 30 Apr 2010 12:17:52 +0100 3519709 http://www.medworm.com/index.php?rid=3515637&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1I3fCofJeb8%2F Hello, everyone, nice to see you again. The sun is shining here on the Pharmalot corporate campus as we scurry about, attempting to hustle one of the short people to the local school house. This calls for another cup of stimulation, of course. Meanwhile, more meetings and deadlines loom. So as you ready yourself for another day, here are a few items to help you along. Have a good one and stay in touch… Viagra Patent In Brazil Expires In June (Associated Press) AstraZeneca Exceeds Q1 Expectations (Reuters) Bristol-Myers Reports Big Quarterly Gain (Associated Press) Sanofi Sees Modest Effect From Healthcare Reform (Bloomberg News) Bayer Raises Financial Outlook (Bloomberg News) Australia Pays More For Generic Statins (PharmaTimes) Fate Of UK Pfizer Plant Uncertain (Leinster Leader) MDL... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3515637 Thu, 29 Apr 2010 11:54:26 +0100 3515637 http://www.medworm.com/index.php?rid=3508381&cid=t_111300_134_f&fid=34841&url=http%3A%2F%2Fwww.diabetesmine.com%2F2010%2F04%2Fmy-take-bayers-nintendo-enabled-didget-glucose-meter-available-now.html The tech blogs are all abuzz today over Bayer’s new DIDGET meter, designed just for kids, which integrates BG testing into the world of video games: “Bayer’s DIDGET is the first and only blood glucose meter that connects directly to Nintendo DS and DS Lite and helps kids manage their diabetes by rewarding them for consistent [...] (Source: Diabetes Mine) Diabetes Mine blogs http://www.medworm.com/rss/comments.php?id=3508381 Tue, 27 Apr 2010 00:30:36 +0100 3508381 http://www.medworm.com/index.php?rid=3494552&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fg_FWGGerMDQ%2F Top of the morning to you. Another shiny day here on the Pharmalot corporate campus, where we ready ourselves for still more meetings and deadlines. You, too? What a coincidence. To prepare, we have gathered a few interesting items to help you along. Meanwhile, we will brew another cup of stimulation. Have a great day, everyone. FDA Approves Novartis Organ Rejection Drug (Associated Press) Amgen Profit Rises On Sales, Price Increases (Bloomberg News) Genzyme To Pay $175M Consent Decree (Reuters) Bayer Healthcare Hires Former Novartis Exec (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3494552 Thu, 22 Apr 2010 12:08:42 +0100 3494552 http://www.medworm.com/index.php?rid=3487370&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLftZiYmSksc%2F The Mississippi Supreme Court has revived a lawsuit against Bayer, ruling the state can refile a claim the drugmaker defrauded its Medicaid program, Legal Newsline writes. Bayer Corp. USA was accused of inflating the average wholesale price of meds, causing the state to overpay and the false price reports led the state Medicaid program to spend millions of taxpayers’ dollars unnecessarily. In 2005, Mississippi Attorney General Jim Hood filed a suit against more than 86 drugmakers, including three Bayer units, accusing them of defrauding the state by inflating average wholesale prices. Bayer argued that under a 2001 settlement with Mississippi over drug pricing, the state had no grounds to sue. The 2001 settlement, in which Bayer agreed to pay the state $48,608, included a provision t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3487370 Tue, 20 Apr 2010 12:08:08 +0100 3487370 http://www.medworm.com/index.php?rid=3420758&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3siamx0eDUw%2F This is a list of the top 20 drugmakers, ranked by global prescription drug sales for the 12 months ended Sept. 30, 2009, according to IMS Health, which prepared this for Reuters. The dollar sales are in billions and, next to that, is the percent change from the year-over-year period. As you can see, though, the results don’t include the mergers between Merck and Schering-Plough, and Pfizer and Wyeth, since these weren’t consummated until later in the year. 1 - Pfizer - $41.7 billion - (0.8) 2 - Novartis - $36.7 billion - 7.0 3 - Sanofi-Aventis - $35.1 billion - 3.3 4 - GlaxoSmithKline - $34.3 billion - (3.4) 5 - AstraZeneca - $33.2 billion - 7.8 6 - Roche - $31.3 billion - 8.6 7 - Johnson & Johnson - $26.9 bi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3420758 Mon, 29 Mar 2010 16:43:51 +0100 3420758 http://www.medworm.com/index.php?rid=3416325&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAbTi8QEjMfs%2F Welcome back. We hope you had a nice weekend filled with relaxing moments and pleasant escapades. Now, though, the routine has resumed as meetings and deadlines beckon. As usual, we prepare by clutching the mandatory cup of stimulation. Grab your own or, perhaps, a bottle of water and greet the day. Here are a few items to help you on your way. Have a great day, everyone… Antisoma Halts Phase III Lung-Cancer Drug Trial (MarketWatch) Germany To Move Quickly To Enact Price Cuts (Reuters) Eisai Hit By Delay In Filing Sepsis Drug (Seeking Alpha) Roche To Cut 500 NJ Jobs (Dow Jones) Test Predicts Which Patients Benefit From MS Drugs (Bloomberg News) Merck Is A Bigger Beast To Feed (PharmaTimes) KV Pharma Sees Shipment Resuming In Fourth Quarter (St. Louis Today) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3416325 Mon, 29 Mar 2010 11:45:17 +0100 3416325 http://www.medworm.com/index.php?rid=3228008&cid=t_111300_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=3172202&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5x3gAtaxrKg%2F Earlier this week, the FDA posted warning letters on its site to four drugmakers - Lilly, Bayer, Amylin Pharmaceuticals and Cephalon - for making inaccurate or incomplete statements while promoting their drugs. Amylin, for instance, was tagged because its reps made remarks that Byetta can be used as a stand-alone therapy, which was before the drug received that approval. Bayer was chastised for suggesting its Mirena contraceptive women help would feel more romantic or intimate when, in fact, the side effects indicate the opposite may occur. A dosing card for Cephalon’s Treanda, which treats chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, minimized risk and a Lilly promotional piece for its Cymbalta antidepressant minimized risk and overstated efficacy. As The Pink She... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3172202 Thu, 14 Jan 2010 12:02:03 +0100 3172202 http://www.medworm.com/index.php?rid=3167447&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkUGyOqgkCw8%2F Hello, everyone. For those struggling with the mid-week blues, we are reminded of that uplifting comment from the Morning Mayor: ‘Every brand new day should be unwrapped like a precious gift.’ So keep that in mind as you attempt to attack those meetings and projects. You will prevail. Meanwhile, we will arm ourselves with a cup of stimulation. Here’s to a good day… Novo Starts Testing Victoza Diabetes Pill (Reuters) FDA Send Warnings To Bayer, Lilly, Cephalon & Amylin (Associated Press) Will Novartis Raise Its Bid For Alcon? (Reuters) Charles River Labs To Cut 300 Jobs (OutsourcingPharma) WHO To Review Swine Flu Response (Bloomberg News) Coffee thanks to chichcacha Flickr Common Creative (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3167447 Wed, 13 Jan 2010 13:23:06 +0100 3167447 http://www.medworm.com/index.php?rid=3045022&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fl_nzGtSnEiw%2F File this under stiff fine. The Swiss Competition Commission, which is known as WEKO, has tagged the Swiss units of Pfizer, Lilly and Bayer a total of $5.7 million for fixing the prices of their erectile dysfunction drugs - Viagra, Cialis and Levitra - through public price recommendations. These recommendations are usually made by pharmacies and medical practitioners, are illegal, Dow Jones writes. Bayer rejected the charge. Earlier this year, WEKO concluded a 2006 investigation by deciding that the publication and observance of recommended retail prices for the pills represented illegal vertical collusion between the drugmakers and distributors. At the time, this was the biggest investigation to be undertaken by WEKO, which recommended sanctions. Whether $5.7 million in collective fines c... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3045022 Tue, 01 Dec 2009 12:58:43 +0100 3045022 http://www.medworm.com/index.php?rid=3012636&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHLCJ9fj0X_c%2F Once again, the week is about to draw to a close. And not a moment too soon. Of course, we must still muddle through another deadline or meeting, but relief is in sight. What will you do this weekend? We will, of course, rake more leaves and spend time with assorted short people. With any luck, we may also read a book. Whatever you do, hope you have a nice time…. Roche’s Actemra Succeeds In Arthritis Study (Reuters) Health Canada Warns About Pet Drugs And Diabetes (Canadian Press) NICE Calls Bayer’s Nexavar Too Expensive (The Wall Street Journal) Ranbaxy Recalls Acne Drug From The US (The Business Standard) Glaxo, Merck Developing Drugs For Kala Azar (DNAIndia) Interpol Seizes 167,000 Countefeit Pills (PharmaTimes) Former McKesson Exec Convicted Of Securities Fraud (KTVU.... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3012636 Fri, 20 Nov 2009 12:52:57 +0100 3012636 http://www.medworm.com/index.php?rid=2985036&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeANG3LM0euE%2F Hello, everyone. A busy day lies ahead as the FDA holds its long-awaited meeting to discuss promotion on the Internet. More on that shortly. Meanwhile, there will also be the usual deadlines and meetings to conquer, so let’s us all grab a cup of stimulation and dig in. Hope your day goes well…. Lilly Pays Utah $24M Over Zyprexa Marketing (Salt Lake Tribune) Schering-Plough’s Digital Ad Experiment (AdAge) Ratiopharm Gets Several Bids (Bloomberg News) Bayer To Increase R&D Spending (PharmaTimes) Coffee courtesy of Flickr Creative Commons chichcacha (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2985036 Thu, 12 Nov 2009 13:17:38 +0100 2985036 http://www.medworm.com/index.php?rid=2939558&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2zGAgGj2P6s%2F The move involves bypassing on 2,000 drugs in order to produce them locally or buy cheaper versions elsewhere, AFP reports. Among them is GlaxoSmithKline, Bayer and Pfizer. “We accept the democratic decision… to legally implement this extraordinary measure,” the drugmakers announced through their local pharmaceutical industry association. “No legal right is superior to the requirements of public health, especially in such serious circumstances.” Last week, Ecuador’s socialist government decided to break 2,214 patents, issue “compulsory licenses” to local labs and pay foreign labs up to 10 percent of net sales of the drugs, AFP writes. According to a report from research firm Intercontinental Marketing Services (IMS), foreign firms control abo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2939558 Thu, 29 Oct 2009 12:55:19 +0100 2939558 http://www.medworm.com/index.php?rid=2899199&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FG-nzCnByZpU%2F Novartis sales reps fighting for overtime pay just got a powerful ally. The US Department of Labor filed an amicus brief with a federal appeals court contending that a lower court was wrong to toss their lawsuit, The Pink Sheet’s Brenda Sandburg reports. In an Oct. 13 filing, the department argued the district court “committed legal error” in concluding that sales reps are outside sales persons and, therefore, are exempt from overtime requirements of the Fair Labor Standards Act (here is the Labor Department brief). “Because the reps do not sell any drugs or obtain any orders for drugs, and can at most obtain from the physicians a non-binding commitment to prescribe [Novartis'] drugs to their patients when appropriate, the reps do not meet the regulation’s pla... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2899199 Thu, 15 Oct 2009 19:47:21 +0100 2899199 http://www.medworm.com/index.php?rid=2774847&cid=t_111300_134_f&fid=34841&url=http%3A%2F%2Fwww.diabetesmine.com%2F2009%2F09%2Fhome-a1c-testing-vs-the-lab.html So it was time again for my A1C and other blood tests last week. Over-time, in fact.  You know how I hate going in to the lab when I have to be fasting for lipid tests and can’t even have a latte on the way over in the morning. Ugh! And who ever said diabetics [...] (Source: Diabetes Mine) Diabetes Mine blogs http://www.medworm.com/rss/comments.php?id=2774847 Tue, 08 Sep 2009 13:00:35 +0100 2774847 http://www.medworm.com/index.php?rid=2639719&cid=t_111300_149_f&fid=35786&url=http%3A%2F%2Fkinasepro.wordpress.com%2F2009%2F07%2F25%2Fpi3k-bayer%2F This one hones in on the sulphonamides: (from the former site in CT) WO/2009/091550; They stuck morpholines out there previously: WO/2008/070150 Posted in Bayer, pi3k (Source: KinasePro) KinasePro blogs http://www.medworm.com/rss/comments.php?id=2639719 Sun, 26 Jul 2009 02:22:16 +0100 2639719 http://www.medworm.com/index.php?rid=2453049&cid=t_111300_134_f&fid=34841&url=http%3A%2F%2Fwww.diabetesmine.com%2F2009%2F06%2Fnewsflash-bayer-releases-new-home-a1c-kit-medtronic-acquires-new-cgm-technology.html Once again, I’ve returned from the gym to discover major diabetes announcements in my inbox. Why do these things invariably hit the wire while I’m off spinning? Anyhoo, two pieces of big diabetes device news today: * Bayer today has announced release of the new and improved A1c Now SelfCheck home testing kit, the technology it acquired [...] (Source: Diabetes Mine) Diabetes Mine blogs http://www.medworm.com/rss/comments.php?id=2453049 Tue, 02 Jun 2009 21:39:51 +0100 2453049 http://www.medworm.com/index.php?rid=2442121&cid=t_111300_122_f&fid=36582&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSharpBrains%2F%7E3%2FOjLwzbhn3DQ%2F Games for Health and SharpBrains have partnered to bring you the first Cognitive Health Track in a Games for Health Conference, June 11-12th in Boston. If you are interested, in attending the conference, you can learn more and register Here. To get a 15% off registration fees ($379), you can use discount code: sharp09, when you register Here. --- Cognitive Health Track, Powered by SharpBrains Thursday, June 11th 10.20 (50m) Bird's Eye View of Cognitive Health Innovation Speaker(s): Alvaro Fernandez, SharpBrains Scientific, technological and demographic trends have converged to create a new $265m market in the US alone: serious games, software and online applications that can help people of all ages assess and train cognitive abilities. Alvaro Fernandez will provide a Bird’s Eye View of t... SharpBrains blogs http://www.medworm.com/rss/comments.php?id=2442121 Mon, 25 May 2009 20:17:12 +0100 2442121 http://www.medworm.com/index.php?rid=2442729&cid=t_111300_149_f&fid=35786&url=http%3A%2F%2Fkinasepro.wordpress.com%2F2009%2F05%2F20%2Fbay-73-4506%2F So Bayer is in Ph2 with fluoro-sorafenib aka DAST, BAY-734506… Only this time they’re in without Onyx and I gather Onyx is none too happy about this. The distinct compound is claimed in WO/2005/009961 and the I believe the original Sorafenib app is: WO/2000/042012.  What strikes the chemist inventor about a structure like this isn’t usually about who owns it, but if it can really be considered a new invention? The claim structure in the 2000 Sorafenib application can be schematized: So for the purpose of this discussion the only meaningful definition is the ring designated as “L” and whether or not they claim the fluoride: Anyhow while this structure and their priority date may be vulnerable to obviousness, all of these applications are assigned to Bayer, and... KinasePro blogs http://www.medworm.com/rss/comments.php?id=2442729 Thu, 21 May 2009 03:01:55 +0100 2442729 http://www.medworm.com/index.php?rid=2381142&cid=t_111300_149_f&fid=35786&url=http%3A%2F%2Fkinasepro.wordpress.com%2F2009%2F04%2F29%2Frdea-119%2F Its Ardeas’s $35 million non-hydroxamate MEK inhibitor in Ph1.  The pictured structure is one of three claimed in the ‘combination w/ Nexavar’ app: WO/2009/018238. “Ardea will grant Bayer a worldwide, exclusive license to develop and commercialize Ardea’s MEK inhibitors for all indications” Posted in Bayer, MEK (Source: KinasePro) KinasePro blogs http://www.medworm.com/rss/comments.php?id=2381142 Thu, 30 Apr 2009 02:03:14 +0100 2381142 http://www.medworm.com/index.php?rid=2349462&cid=t_111300_134_f&fid=34841&url=http%3A%2F%2Fwww.diabetesmine.com%2F2009%2F04%2Fweb-based-get-healthy-contests.html I’ve been to a bunch of “Health 2.0″ events in which the question inevitably came up: does all this online stuff really have the potential to improve people’s health?  Well yes, was my response, because we don’t just use to it chat, but also to motivate each other and even create campaigns and contests for [...] (Source: Diabetes Mine) Diabetes Mine blogs http://www.medworm.com/rss/comments.php?id=2349462 Fri, 17 Apr 2009 13:00:16 +0100 2349462 http://www.medworm.com/index.php?rid=2341822&cid=t_111300_149_f&fid=35786&url=http%3A%2F%2Fkinasepro.wordpress.com%2F2009%2F04%2F07%2Fdast-bay-73-4506%2F It’s Bayer’s Ph2 follow-on to Sorafenib.  VEGF / RAF yadda yadda… Don’t have the structure, but maybe it’s one of these: from polymorph apps: WO/2008/058644 -            WO/2008/079968 WO/2008/043446 -            WO/2008/079972 & yeh, that is Fluoro-Nexavar… Posted in Bayer, c-Kit, PDGFR, RAF, VEGF (Source: KinasePro) KinasePro blogs http://www.medworm.com/rss/comments.php?id=2341822 Wed, 08 Apr 2009 01:56:35 +0100 2341822 http://www.medworm.com/index.php?rid=2232626&cid=t_111300_134_f&fid=34841&url=http%3A%2F%2Fwww.diabetesmine.com%2F2009%2F03%2Fand-now-we-are-epharma-consumers.html In our emerging world of web-based health offerings and Net-informed patients, it looks like the name-game is still heating up.  Recently I sounded off about whether we should be referred to now as patients or consumers, and don’t forget the term “ePatients” — along with eHeath Consumers, Cybercitizens, etc., etc. Now Manhattan Research, a highly respected [...] (Source: Diabetes Mine) Diabetes Mine blogs http://www.medworm.com/rss/comments.php?id=2232626 Wed, 04 Mar 2009 13:00:13 +0100 2232626 http://www.medworm.com/index.php?rid=2021733&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F478375734%2F Nice to see you again. We hope your weekend was relaxing. Now, though, Monday looms and that, of course, means the time has come to wade through your schedule and brace for deadlines and meetings. So while you grab a cup of something stimulating, here are a few headlines that should help you along. Have a good day, everyone… Bayer Faces Class-Action Lawsuit Over Trasylol (CTV.ca) Merck Relying On RNAi (Yahoo/Reuters) Orexigen Execs Quit En Masse (The Street.com) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2021733 Mon, 08 Dec 2008 11:33:16 +0100 2021733 http://www.medworm.com/index.php?rid=2017603&cid=t_111300_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F12%2Fdespite-fda-warning-letter-yaz-web-site.html YAZ birth control pill marketers seem to be thumbing their noses at the FDA, which recently sent Bayer a letter expressing concerns that two ads for the drug go too far in suggesting the drug was approved to treat acne (see "FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?"). FDA was concerned that the TV ads could be viewed as suggesting the drug also remedied PMS and broader conditions of acne.The ads in question were halted -- actually, ran their course on TV -- and removed from the YAZ Web site, but now acne is mentioned front and center on the home page in a way that implies that YAZ is approved for the treatment of the broader conditions of acne. IMHO. Tell me what you think.What immediately drew my attention was the poll that asked: "Would you consider taking birth con... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2017603 Fri, 05 Dec 2008 13:10:00 +0100 2017603 http://www.medworm.com/index.php?rid=2006400&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F471227544%2F A ban on drugs that can give kidney cancer patients many months of extra life is going to be lifted, The Guardian reports. At least two, and possibly all four, of the medicines that had previously been deemed too expensive to prescribe will be approved by the National Institute for Health and Clinical Excellence (Nice) early next year. The move is a major victory for campaigners, patients and cancer specialists, who described Nice’s refusal to approve the drugs - which cost up to $100,000 a year per patient - as unfair, inhumane and condemning patients to an unnecessarily early death, the paper writes. Oncologists believe Pfizer’s Sutent, Bayer’s Nexavar, Wyeth’s Torisel and Avastin, sold by Roche and Genentech, could benefit about half of the 7,000 people a year w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2006400 Mon, 01 Dec 2008 11:58:02 +0100 2006400 http://www.medworm.com/index.php?rid=1991560&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F465467996%2F The drugmaker reached a settlement with the US Department of Justice, which alleged Bayer paid kickbacks to diabetic suppliers, prompting them to submit false claims to Medicare. The feds claimed Bayer engaged in a ‘cash-for-patient’ scheme by paying 11 diabetic suppliers to convert their patients to Bayer products from products - such as glucose monitors and testing strips - made by competitors. According to the Justice Department Bayer allegedly paid Liberty Medical Supply, one of the largest direct-to-patient suppliers, approximately $2.5 million to convert patients to Bayer supplies. The alleged kickbacks were based on the number of patients that Liberty successfully converted to Bayer products and were disguised as payments for advertising. In addition, Bayer allegedly pai... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1991560 Wed, 26 Nov 2008 03:10:39 +0100 1991560 http://www.medworm.com/index.php?rid=1975636&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F459570317%2F Major drug makers want their voices heard as Democrats, traditionally critics of the industry, start crafting plans to expand health insurance coverage and cut the escalating costs of care. And so pharma is actively promoting the success of Medicare’s prescription drug coverage and meds to save money in the long run, Reuters writes. “We need first a seat at the table,” Fred Hassan, Schering-Plough’s ceo, tells the news service. And so pharma execs are meeting in Washington this week at a gathering of the International Federation of Pharmaceutical Manufacturers and Associations. Hassan, the group’s current president, says the location was chosen in recognition of the coming political changes. The backdrop: President-elect Barack Obama and other Democrats, who ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1975636 Thu, 20 Nov 2008 13:37:42 +0100 1975636 http://www.medworm.com/index.php?rid=1961225&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F452332184%2F And so another day draws to a close. We appreciated your patience during the early afternoon lull, when we had a very pleasant lunch with a pair of industry types (sorry, we never eat and tell). Now, the time has come to catch up on the sundry events involving our short people. Have a nice night and see you tomorrow… Wyeth Gets OK To Sell Cream For Painful Sex (Bloomberg News) Pfizer To Build Stem Cell Plant In The UK (The Financial Times) Bayer Schering To Help China Build Plants (ChinaView) Big Pharma Eyes Biotechs, But Cautiously (Dow Jones) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1961225 Fri, 14 Nov 2008 00:05:34 +0100 1961225 http://www.medworm.com/index.php?rid=1947485&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F448643380%2F A shiny day here in the nation’s medicine cabinet. We are spending a great deal of time chatting with interesting people and reading up on various things. Meanwhile, we thought to share with you some of the interesting tidbits that have floated by… AstraZeneca CEO Can’t Predict Jupiter Impact (Dow Jones) Bayer Clot Drug Misses Midstage Study Goal (Yahoo/Reuters) Pfizer’s Indiana Plant Is For Sale (The Indianapolis Star) Exelixis Lays Off 10 Percent Of Staff (San Francisco Business Times) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1947485 Mon, 10 Nov 2008 17:55:34 +0100 1947485 http://www.medworm.com/index.php?rid=1921199&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F435691396%2F ‘Tis the middle of the week and that means we are all caught up in meetings, deadlines and projects. Of course, there are always conferences. In fact, we will break shortly to speak at the Pharmaceutical Regulatory and Compliance Congress (look here) about the usual - pharma and blogging. We appear right after former FDA commish Mark McClellan, in fact. But we promise not to be gone long. Meanwhile, here are a few items to tide you over… Bayer Profit Falls On Tax Benefit (Bloomberg News) Schering-Plough’s Sugammadex Beats The Competition (Associated Press) Swiss Approve Novartis Blood Pressure Drug (Reuters) Cephalon Boosts Its Full-Year Forecast (TheSteet.com) Parexel Slides As Spending Slows (Forbes) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1921199 Wed, 29 Oct 2008 10:23:37 +0100 1921199 http://www.medworm.com/index.php?rid=1918199&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F434839486%2F The agency sent a pair of warning letters to Bayer HealthCare concerning what it calls two “unlawful,” over-the-counter aspirin products — Bayer Women’s Low Dose Aspirin + Calcium (Bayer Women’s) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage). Here is letter one and letter two. The products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application in order to be legally marketed, according to an FDA statement. In addition to being labeled for use as a pain reliever, both products are labeled for use in reducing the risks of heart disease. Bayer Women’s is also labeled for use in “fighting” osteoporosis. However, the FDA says that “neither product has b... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1918199 Tue, 28 Oct 2008 15:56:20 +0100 1918199 http://www.medworm.com/index.php?rid=1901469&cid=t_111300_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F10%2Fpfizerbayer.html Bayer shares jumped Wednesday amid market chatter that Pfizer may be interested in taking over its rival German drugs and chemicals maker.Traders in Frankfurt told Reuters that that rumors of a possible deal were behind the four percent rise in Bayer’s stock. (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1901469 Fri, 24 Oct 2008 11:28:00 +0100 1901469 http://www.medworm.com/index.php?rid=1906170&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F429532730%2F And so we start another day by scurrying about - short people to shuttle here and there, groping for that needed cup of stimulation and, of course, hunting and gathering items of interest. By the way, if you are in our area, stop by the Regulatory Affairs Professional Society meeting in Bridgewater, New Jersey, this evening where we will be speaking about all things pharma (see this link for details). Meanwhile, have a nice day… FDA Expands Use For J&J HIV Drug (Reuters) Maxygen To Explore Strategic Option, Cut Jobs (Reuters) Wyeth Employee Complained Of Discrimination (LoHud.com) Bayer Shares Rise On Pfizer Bid Rumors (Yahoo/Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1906170 Thu, 23 Oct 2008 11:09:26 +0100 1906170 http://www.medworm.com/index.php?rid=1886689&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F422612983%2F Several big drug makers are in a neck-and-neck race to introduce new drugs for treating blood clots, and the prize is a piece of a market estimated to be worth about $20 billion by 2016, The Wall Street Journal writes. Current treatments are effective and sell well but have problems - one is difficult to dose and has risks when taken with other meds and some foods, while another is an injectable, making long-term therapy difficult, the paper writes. Boehringer Ingelheim; Pfizer in a partnership with Bristol-Myers Squibb; and Bayer in a partnership with Johnson & Johnson are all in late stages of clinical trials, the Journal notes. The new drugs are taken by mouth, which makes them easier to use, their dosing is less troublesome, and they need no laboratory monitoring, according to the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1886689 Thu, 16 Oct 2008 12:31:22 +0100 1886689 http://www.medworm.com/index.php?rid=1880157&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F420811435%2F As part of its ongoing investigation into direct-to-consumer advertising, the House Energy & Commerce Committee is exploring two new lines of inquiry - why Bayer ignored FDA recommendations to refrain from marketing a version of its aspirin that is also a dietary supplement, and why the FDA hired a public relations firm that works for pharma to develop a consumer web site. The committee wants to know why Bayer promoted its Bayer Aspirin with Heart Advantage as safe and effective, when the FDA had warned against marketing such a combo. The tablet combines aspirin with a supplement Bayer claims can lower cholesterol. The FDA, however, only regulates the drug. In a letter to Bayer Healthcare prez Gary Balkema, committee chairman John Dingell and Bart Stupak, who heads the Oversight and I... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1880157 Tue, 14 Oct 2008 19:05:52 +0100 1880157 http://www.medworm.com/index.php?rid=1862754&cid=t_111300_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F10%2Ffda-and-yaz-is-fda-helping-marketers.html As reported in today's AdAge, "Bayer Healthcare Pharmaceuticals is pulling a 60-second ad for birth-control pill Yaz. The move comes after the U.S. Food and Drug Administration expressed concerns that two ads for the drug go too far in suggesting the drug could help overcome PMS and acne" (see "Bayer to Pull Yaz Ad After FDA Warning").The FDA criticized the ad, 'Balloons,' which is still in rotation and can be seen on the YAZ product website (see image above; click for enlarged view). "The warning letter said that while Yaz had been approved as a contraceptive and a treatment for PMDD (premenstrual dysphoric disorder) and in some cases for acne, the TV ads could be viewed as suggesting the drug also remedied PMS and broader conditions of acne."This broadcast DTC (direct-to-consumer) ad has... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1862754 Thu, 09 Oct 2008 12:38:00 +0100 1862754 http://www.medworm.com/index.php?rid=1865681&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F414752217%2F The two television commercials for the Yaz birth control pill overstated effectiveness, minimized risks and wrongly suggested the pill is approved for relieving premenstrual syndrome, according to an October 3 warning letter sent to the drugmaker and posted on the FDA web site (look here). The FDA notes that one TV spot, which is no longer broadcast, featured women singing “We’re not gonna take it” and kicking, punching and pushing balloons with words such as “irritability,” “moodiness” and “bloating.” These symptoms are common with PMS, but Yaz is approved for premenstrual dysphoric disorder, a more serious condition that causes anxiety, tension, persistent anger and other symptoms. A second ad features a song “Good Bye to You... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1865681 Wed, 08 Oct 2008 11:47:41 +0100 1865681 http://www.medworm.com/index.php?rid=1876041&cid=t_111300_134_f&fid=34841&url=http%3A%2F%2Fwww.diabetesmine.com%2F2008%2F10%2Fisense-and-their-glycemic-signature.html iPod, iPhone, iPump, iPort, iV-drip (?)… so no reason to look surprised when you hear about another futuristic diabetes technology company by the name of iSense. This one, a privately held company based in Oregon, has been working on developing a “minimally invasive” continuous glucose monitoring system (CGMS) for about ten years.  (I’m guessing the company [...] (Source: Diabetes Mine) Diabetes Mine blogs http://www.medworm.com/rss/comments.php?id=1876041 Mon, 06 Oct 2008 11:15:45 +0100 1876041 http://www.medworm.com/index.php?rid=1859777&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F412698859%2F Welcome back. We hope your weekend was enjoyable. We used our to catch up on sundry errands and tidy up around the Pharmalot corporate campus. Now, though, the time has come to settle back into the routine. To help you along, here are a few items to get you started. Hope your days goes well… Genetic Tests May Determine Who Gets Avastin (Yahoo) Spiriva Offers No Advantage Over Placebo (Reuters) Roche, Genentech Drugs Don’t Boost Lung Cancer Survival (Yahoo/Reuters) Dr. Reddy’s Stock Sinks On Diabetes Drug Delay (Bloomberg News) Bayer To Start Phase III Lung Drug Study (Yahoo/Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1859777 Mon, 06 Oct 2008 11:03:22 +0100 1859777 http://www.medworm.com/index.php?rid=1798531&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F393120144%2F That’s what the Bayer ceo told a German newspaper over the weekend. Werner Wenning acknowleged to Tagesspiegel that “you can’t rule out anything, especially not in the current environment.” At the same time, he maintained Bayer’s high market value should protect the drugmaker from a takeover. “Five years ago, our market value was 14 billion euros ($20 billion). Now, now it is 42 billion euros,” he told the paper, according to Reuters. “I don’t think that looks bad.” Bayer will get better than expected synergies from its purchase of Schering, Wenning insisted, and he did not rule out further takeovers to bolster the health business, pointing to a fragmented pharma market and the looming expiration of many patents, according to Reut... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1798531 Mon, 15 Sep 2008 11:19:27 +0100 1798531 http://www.medworm.com/index.php?rid=1790257&cid=t_111300_115_f&fid=34680&url=http%3A%2F%2Fcoolmristuff.blogspot.com%2F2008%2F09%2Fbayer-and-epix-to-part-ways-over.html Bayer Schering Pharma will transfer the worldwide commercial rights for the novel blood pool magnetic resonance angiography (MRA) agent, Vasovist(R) (gadofosveset trisodium) to EPIX. Thecollaboration agreementbetween the two parties will terminate effectiveMarch 1, 2009; until that time, Bayer Schering Pharma will continue to provide continued supply of Vasovist in the 19 countries where it is currently marketed."We are pleased to regain complete worldwide commercial rights for Vasovist which has a PDUFA date of December 31, 2008," said Elkan Gamzu, Ph.D., interim chief executive officer of EPIX. "Pending FDA approval, Vasovist is positioned to become the first MRA contrast agent approved in the United States and it could be launched in 2009. Our goal remains to maximize the commercial val... MRI LINKS AND OTHER COOL THINGS blogs http://www.medworm.com/rss/comments.php?id=1790257 Sun, 14 Sep 2008 01:47:00 +0100 1790257 http://www.medworm.com/index.php?rid=1750395&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F379694361%2F This may be the Labor Day weekend in the US, but in Munich, leading cardiologists and pharmaceutical mavens are gathering for the annual European Society of Cardiology meeting, which began today and runs through Wednesday. Beyond the usual stream of clinical trials, the most sensational story is likely to be the final results of the Vytorin SEAS study. Preliminary data showed an unexpected linked to cancer. The full picture will be presented Tuesday morning. Meanwhile… A prescription fish-oil pill offered moderate benefits in patients with heart failure, such as lessened risk of death and hospital admissions, unlike widely prescribed cholesterol-lowering drugs called statins. In a large trial involving almost 7,000 patients in Italy, researchers found that people taking the pill - so... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1750395 Sun, 31 Aug 2008 19:17:25 +0100 1750395 http://www.medworm.com/index.php?rid=1689198&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F358595604%2F The National Institute for Health and Clinical Excellence, or NICE, issued a preliminary decision that Pfizer’s Sutent, Wyeth’s Torisel, Bayer’s Nexavar and Avastin, sold by Roche and Genentech, are not cost effective for treating advanced or metastatic kidney cancer. And the move is causing outrage among patient groups, PharmaTimes reports. “Although these treatments are clinically effective, regrettably, the cost to the National Health Service is such that they are not a cost-effective use of resources,” says Peter Littlejohns, NICE’s clinical and public health director, adding that two of the drugmakers have developed proposals which may have the effect of reducing the cost of the drugs and “we will be happy to consider these proposals.” He explai... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1689198 Thu, 07 Aug 2008 12:18:42 +0100 1689198 http://www.medworm.com/index.php?rid=1679620&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F356263689%2F Rise and shine. ‘Tis a sunny day here in the nation’s medicine chest. And what better way to get going than to grab a cup of something stimulating and catch up on events? So we have gathered a few on your behalf. Dig in and have a great day… Wyeth Claims Retiree Lied To Get Benefits Package (LoHud.com) Daiichi Gets Regulatory OK To Buy Ranbaxy (Business Standard) Former Genentech Director Sues City Over Royalties (East Bay Business Times) Bayer Sues Sandoz Over Yaz Birth Control Pill (Bloomberg News) AstraZeneca HQ Gets Road Improvements (CommunityPub.com) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1679620 Tue, 05 Aug 2008 11:29:21 +0100 1679620 http://www.medworm.com/index.php?rid=1655675&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F345588340%2F The European Medicines Agency recommends restricting the use of antibiotics based on moxifloxacin because of the potential risk of liver damage, and also wants strengthened warnings. (EMEA statement). The EMEA’s Committee for Medicinal Products for Human Use concluded at a meeting this month that the benefits continue to outweigh its risks, but due to safety concerns, the CHMP says oral antibiotics containing moxifloxacin should only be prescribed for acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed. The CHMP opinion will now be forwarded to the European Commission to apply to all oral moxifloxacin-containing medicines authorized in the European Union. The move comes shortly after the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1655675 Fri, 25 Jul 2008 11:52:20 +0100 1655675 http://www.medworm.com/index.php?rid=1655676&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F345588341%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? Bayer hired Pfizer’s Andreas Fibig as ceo of Bayer Schering Pharma; WuXi PharmaTech hired Richard Soll as vp of medicinal chemistry; Merck named Leslie Brun, ceo of SARR Group, to its board; Innocoll named Anthony Wild to its board; Syntarga named Nitin Damle as an advisor; Isis Pharmaceuticals hired Marty Bedigian as vp and chief medical officer; Bristol-Myers Squibb... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1655676 Fri, 25 Jul 2008 11:48:22 +0100 1655676 http://www.medworm.com/index.php?rid=1655677&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F345585820%2F We are about to get a head start on the weekend in order to spruce up the Pharmalot corporate campus. We take great pride in our public image, after all. So while we keep busy, please enjoy a few of the items we have found floating about… Bayer Anticoagulant Wins Green Light From EU (Yahoo/Reuters) Genentech Forms Panel To Review Roche Bid (Bloomberg News) FDA Extends Exclusivity For J&J’s Topamax (Associated Press) Glaxo Strikes Stem Cell Deal With Harvard (The Boston Globe) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1655677 Fri, 25 Jul 2008 11:45:43 +0100 1655677 http://www.medworm.com/index.php?rid=1616433&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F333165798%2F The drugmaker, which withdrew the controversial cholesterol med seven years ago after it was linked to a severe muscle weakness that caused 31 deaths, has agreed to pay $18.5 million to settle shareholder litigation. The lawsuits charged Bayer failed to disclose serious health risks and misrepresented its “prior knowledge” of Baycol’s dangers, while understating its potential liability for claims from patients and payors. As a result, the shareholders charged the market value of Bayer securities was artificially inflated through February 2003. There was no trial or findings of fault, and Bayer denies any and all allegations of wrongdoing or liability, according to the settlement announcement, which you can read right here. A hearing is scheduled for September 26 in federa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1616433 Fri, 11 Jul 2008 23:08:08 +0100 1616433 http://www.medworm.com/index.php?rid=1575647&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F325719461%2F Good morning, everyone. This is likely to be a short day, because here in the US, the Fourth of July holiday weekend is quickly approaching. For many, this pause in the action may provide an opportunity to reflect on the national state of affairs. We will not recite a litany of problems or attempt to preach. We will only say this - whatever you do, have a good time. And drive less. A lot less… Pfizer Employee Gets Suspended Sentence For Embezzling (The Day) Abbott Drug-Coated Stents Wins FDA Approval (Yahoo/Reuters) Shire Will Pay $520M For Germany’s Jerini (Bloomberg News) Bayer Buys Maxygen Hemophilia Unit (Yahoo/AP) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1575647 Thu, 03 Jul 2008 11:32:27 +0100 1575647 http://www.medworm.com/index.php?rid=1551900&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F321276401%2F And as a result, Bayer won a court ruling that an Abbott Lab patent used in glucose-testing products isn’t enforceable. US District Court Judge William Alsup wrote in a 54-page ruling that Lawrence Pope, who has since left the drugmaker, acted with “specific intent to deceive” the US patent examiner. “Intent to deceive, not just withhold, was clearly in (Pope’s) mind…,” Alsup wrote. “If concealment of extrinsic information as close to the heart of the prosecution as was involved here is allowed to pass, then we would in effect be issuing licenses to deceive patent examiners in virtually all cases.” (please see page 36). Three years ago, Abbott sued Bayer over patent infringement, claiming test strips in two Bayer glucose-testing product... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1551900 Fri, 27 Jun 2008 12:02:30 +0100 1551900 http://www.medworm.com/index.php?rid=1551901&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F321266408%2F The director of Italy’s medicines regulatory agency has been suspended along with another top official, as the drug licenses-for-cash scandal surrounding the organization continues to unfold, PharmaTimes writes. Nello Martini, director of Aifa (the Italian Agency for Pharmaceuticals), has been suspended along with Caterina Gualano, head of medicines registration for the agency. The development follows a two-year investigation in which police found evidence that money had changed hands in return for the falsification of clinical data required for drug licences. Last month, Pasqualino Rossi, one of Aifa’s most senior reps at the European Medicines Agency, had been arrested along with another Aifa official and five pharma lobbyists. The scandal has engulfed Bayer and Glaxo, and em... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1551901 Fri, 27 Jun 2008 11:42:35 +0100 1551901 http://www.medworm.com/index.php?rid=1475415&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F300062809%2F The drugmaker was fined for fixing the price of aspirin and other over-the-counter medications in Germany, the Associated Press reported. Bayer Vital, a subsidiary, made illegal deals with more than half of Germany’s 21,000 pharmacies, according to Germany’s cartel office. Bayer offered rebates for the sale of its products at a certain price. In a statement, the Bayer unit declared that “Bayer Vital does not agree with the legal position” of the cartel office, but agreed to pay the fine in order to avoid a protracted legal fight. Since 2004, German pharmacies have been allowed to set their own prices for nonprescription medication. While pharmacies are allowed to offer reduced prices for shorter terms, long-term agreements are against the law. (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1475415 Wed, 28 May 2008 20:07:05 +0100 1475415 http://www.medworm.com/index.php?rid=1466015&cid=t_111300_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2008%2F05%2Fblogscan-guidelines-for-aprotinin.html On the GoozNews blog, anonymous blogger "PM" discussed a set of guidelines written last year on the prevention of operative bleeding. The guidelines endorsed aprotinin to reduce bleeding despite concerns raised in a 2006 New England Journal of Medicine article. Subsequently, several studies showing increased risks of mortality for patients receiving the drug, and it is now off the market. PM wondered whether these guidelines enthusiasm related to the financial ties that a majority of authors reported with Bayer, the company that made aprotinin? (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=1466015 Fri, 23 May 2008 18:52:00 +0100 1466015 http://www.medworm.com/index.php?rid=1464201&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F296516175%2F A drug licences-for-cash scandal has engulfed Italy’s medicines regulatory agency with leading officials arrested along with people linked to major drugmakers, PharmaTimes writes. The most senior figure to have been held is Pasqualino Rossi, vp of Aifa, the Italian Agency for Pharmaceuticals, and one of Italy’s most senior reps at the European Medicines Agency. Five lobbyists have also been arrested, and an eighth person is being sought. Arrest warrants were issued after an investigating judge saw a 400-word police report suggesting money had changed hands in return for falsifying clinical data required for drug licences, according to PharmaTimes. At issue are licenses awarded to around 30 meds, mostly generics. The two-year investigation used wiretaps and covert cameras. The s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1464201 Fri, 23 May 2008 12:05:19 +0100 1464201 http://www.medworm.com/index.php?rid=1443171&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F290297598%2F The controversial drug was withdrawn last year when evidence showed an increased risk of death, but appears unlikely to be available again for reducing bleeding in certain types of heart surgery, according to an eagerly awaited a study in The New England Journal of Medicine and an accompanying editorial. The study, called BART, showed patients given Trasylol had a more than 50 percent higher death rate than patients who got other, cheaper drugs. “Thus, in all likelihood, this is the end of the aprotinin story,” Wayne Ray and Michael Stein of Vanderbilt University in Tennessee wrote in their editorial. Aprotinin is the chemical name for Trasylol. Indeed, Bayer notified the FDA that it will begin removing the remaining Trasylol stock from the U.S. market, most of which is in ware... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1443171 Wed, 14 May 2008 17:06:26 +0100 1443171 http://www.medworm.com/index.php?rid=1413595&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F281626086%2F This subject has been off the collective radar screen for awhile, but a recently unearthed court document reminded us of a passionate controversy that’s played out for the past two decades ago over the use of a blood-clotting medicine that was blamed for infecting hemophiliacs with HIV in Asia and Latin America, while a newer, safer version was sold in the US and other Western nations. The backdrop: A former Bayer division known as Cutter Biological introduced a new version of its med in 1984, but continued to sell the old one overseas, according to documents filed in federal court in Illinois. By doing so, Cutter avoided a build-up of inventory of its old Factor VIII concentrate, which provided a missing ingredient that allows a hemophiliac’s blood to clot. Look here. Why woul... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1413595 Thu, 01 May 2008 19:09:03 +0100 1413595 http://www.medworm.com/index.php?rid=1409903&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F280899326%2F New Jersey may be the nation’s medicine chest, but that’s nothing compared with being the pharmacy of the world. But where is that pharmacy located? Right now, many would argue it’s the US. But the European Commission and members of the European Federation of Pharmaceutical Industries and Associations today are releasing details of plan to end Europe’s declining international role in medical research, Reuters reports. To be called the Innovative Medicines Initiative, the effort will offers grants to academic institutes and small companies to research ways of beating bottlenecks in the drug development process. Teams of commercial and not-for-profit researchers will be able to seek support on condition that their findings are publicly shared in an effort to stimulate... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1409903 Wed, 30 Apr 2008 16:43:39 +0100 1409903 http://www.medworm.com/index.php?rid=1399359&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F277754849%2F The suit was brought by Laurie Simpson, a former Bayer strategic research analyst who joined the drugmaker just after the controversial cholesterol pill was launched in 1998, and she accuses Bayer of violating the federal and state False Claims Act. The suit was initially filed last year in US District Court in Newark, New Jersey, and was just unsealed. [WHOOPS: We initially wrote the feds joined the suit, but in fact, the US Attorney has declined to do so.] The lawsuit alleges that over a three-year period, prior to its withdrawal from the market, Bayer engaged in illegal and deceptive marketing practices in selling the Baycol cholesterol pill, which was later withdrawn due to side effects, predominantly rhabdomyolysis, a severe weakening of the muscles. Numerous death and 1,600 injuries ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1399359 Fri, 25 Apr 2008 17:41:10 +0100 1399359 http://www.medworm.com/index.php?rid=1383734&cid=t_111300_133_f&fid=35096&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAutismVox%2F%7E3%2F273174081%2F What causes autism is a question to be answered by science, or so one would think rather than by, for instance, any legal decisions or court cases. Just in the past year, there have been more and more studies refuting a link between the MMR vaccine and autism and also between thimerosal and rising autism rates. More and more studies are being done that point to a complex web of genetic factors in autism. Nonetheless, legal decisions in cases involving an autistic child and claims of injury by a vaccine, as in the cases of Michelle Cedillo (whose case was brought before the “vaccine court” in June of 2007) and Hannah Poling, have continued to attract the attention of the public, and to shift attention onto the safety of vaccines, over and above the need to take care of and educate autis... Autism Vox blogs http://www.medworm.com/rss/comments.php?id=1383734 Fri, 18 Apr 2008 22:00:10 +0100 1383734 http://www.medworm.com/index.php?rid=1352282&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F264219028%2F C is for contraction. C is also for convulsion. Both describe what pharma is experiencing these days. And the number of jobs being cut makes it all too clear. The trend - whether one calls it layoffs, restructuring, downsizing or reorganization - was under way a few years ago, of course, when Merck began eliminating thousands of jobs. But since early last year, the bloodletting has been particularly severe, which is only reinforced by the latest cuts by Wyeth and Schering-Plough. The list, by the way, includes both cuts recently made and those forthcoming. Of course, C is also for collateral damage. This list doesn’t count all the layoffs in the supporting industries and vendors: advertising agencies, marketing companies, med-ed agencies, printing companies, mail houses, and venues f... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1352282 Sat, 05 Apr 2008 04:07:32 +0100 1352282 http://www.medworm.com/index.php?rid=1307879&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F253001643%2F Last November, Bayer suspended marketing of its troubled med, which is used to control bleeding during heart surgery, after a Canadian study suggested an increased risk for death. Then, we learned the FDA received 235 reports noting death in patients who received Trasylol, although a conclusive link wasn’t established. None of this, however, deterred Bayer from sponsoring a continuing med ed program in December. (Look here). The point of the CME was to dissect a meeting last September of an FDA advisory committee, which voted to allow Trasylol to remain on the market after pondering data that linked the drug to a higher risk of death, kidney failure, congestive heart failure and stroke. This followed accusations Bayer hid adverse safety data, which were denied. Not surprisingly, the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1307879 Mon, 17 Mar 2008 13:41:29 +0100 1307879 http://www.medworm.com/index.php?rid=1287937&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F247703118%2F Big drugmakers are ponying up over the AWP, or average wholesale price scandal, according to a statement by attorneys who filed the case. For those unfamiliar, the stated AWP is used to set the price paid by consumers making Medicare Part B co-payments, as well as Medicare, insurers and other third-party payors that shell out for a drug. The lawsuit charged that consumers and third-party payors paid more than they should have because the drugmakers used false AWP reporting. The issue has embroiled the entire industry. The latest settlement involves Abbott Labs, Amgen, Sanofi-Aventis, Baxter Healthcare, Bayer, Dey, Fujisawa, Pfizer’s Pharmacia unit, Watson Pharmaceuticals, Gensia Sicor Pharmaceuticals and ZLB Behring. And the drugs covered in the settlement include Aranesp, Epogen, Ne... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1287937 Sat, 08 Mar 2008 01:56:34 +0100 1287937 http://www.medworm.com/index.php?rid=1280993&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F246208275%2F There’s nothing like irony, is there? Last September, Peter Smith stood before an FDA advisory committee and attested to the safety and effectiveness of Trasylol, the controversial med that was approved in the US in 1993 to reduce transfusions and bleeding during open-heart surgery, but was later linked to kidney failure and death. Smith, the chief of thoracic and cardiovascular surgery at Duke University Medical Center, was present on behalf of Bayer, which had already weathered a scandal over safety data that wasn’t provided to the FDA and was again defending the drug’s usefulness. Here’s what Smith had to say: Trasylol “has a favorable risk-benefit profile when used in accordance with the label. It reduces blood loss, transfusion, re-exploration and it may ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1280993 Wed, 05 Mar 2008 16:23:41 +0100 1280993 http://www.medworm.com/index.php?rid=1278317&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F245474982%2F You know the old saying: Just when you think things can’t get worse…they do. The latest malady confronting the drugmaker is a ruling by a federal judge that invalidated a patent on its Yasmin contraceptive pill, which gives Barr Laboratories a chance to sell a generic before the patent was set to expire in 2020. For now, Bayer retains exclusive distribution rights in the US to the newer and different Yaz pill until March 2009, just one year from now. The news sent Bayer stock tumbling more than 5 percent, because Yasmin generated nearly $490 million in sales last year. But this is only the latest problem. On Feb. 18, Bayer ended a late-stage trial for its Nexavar cancer med after it failed to improve survival rates in lung-cancer patients. Although already approved to treat liv... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1278317 Tue, 04 Mar 2008 13:10:29 +0100 1278317 http://www.medworm.com/index.php?rid=1265295&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F242856265%2F The German conglomerate reported fourth-quarter profit fell 78 percent and also forecast the slowest sales growth in several years. Why? Blame was cast on the struggling plastics unit, but the real story is that Bayer’s drug biz isn’t doing so well. Consider the recent spate of bad news: On Feb. 18, Bayer ended a late-stage trial for its Nexavar cancer med after it failed to improve survival rates in lung-cancer patients. Although already approved to treat liver and kidney cancer, lung cancer offered the biggest market potential. Two days later, Novartis and Novo Nordisk filed a patent lawsuit, claiming Bayer’s Kogenate hemophilia drug infringes on their patents. Then last week, two new studies in the New England Journal of Medicine, one of which was funded by Bayer, fo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1265295 Thu, 28 Feb 2008 18:24:23 +0100 1265295 http://www.medworm.com/index.php?rid=1248011&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F238764352%2F Trasylol patients were 27 percent more likely to die than those getting a rival drug a decade after open-heart surgery, according to a review of 10,275 patients at Duke University Medical Center. Another study of 78,199 patients, presented to regulators last year after Bayer initially withheld the data, found a 78 percent higher death risk a week after surgery. Both were published in The New England Journal of Medicine. The controversial med was approved in the US in 1993 to reduce transfusions and bleeding during open-heart surgery, but a 2006 study linked the drug to higher rates of heart attack, stroke, kidney failure and death. Those findings prompted the FDA to hold a meeting to review Trasylol, but Bayer failed to provide data showing a higher risk of death and stroke, even though it... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1248011 Thu, 21 Feb 2008 12:24:56 +0100 1248011 http://www.medworm.com/index.php?rid=1245266&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F238358800%2F Another busy day, partly thanks to the Supremes, who some may contend have a new theme song called ‘You Can’t Hurry Justice.’ Oh, but there is so much more. Here, in fact, are a few items that have cropped up. So grab a cup of something hot or that bottle of water and dig in… Glaxo Rotavirus Vaccine Endorsed By FDA Panel (Yahoo/Reuters) Vernalis Is Cutting 120 Jobs After FDA Setback (inthenews.uk) Bayer Will ‘Vigorously’ Defend Against Novartis Patent Lawsuit (CNNMoney/Thomson) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1245266 Wed, 20 Feb 2008 20:18:45 +0100 1245266 http://www.medworm.com/index.php?rid=1239365&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F237005322%2F The lives of 22,000 people could have been saved if the FDA removed Bayer’s Trasylol two years ago, when his study revealed a growing number of deaths linked to the heart drug. That’s what Dennis Mangano, founder of the non-profit Ischemia Research and Educational Foundation, told 60 Minutes. If you missed it, take a peek right here, and read the background. You can also learn how important info on Bayer’s Trasylol web page didn’t match the product labeling in this Pharmalot exclusive. Hat tip to Pharmagossip (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1239365 Mon, 18 Feb 2008 14:51:24 +0100 1239365 http://www.medworm.com/index.php?rid=1234811&cid=t_111300_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F235538155%2F The lives of 22,000 people could have been saved if the FDA removed Bayer’s Trasylol two years ago, when his study revealed a growing number of deaths linked to the heart drug. That’s what Dennis Mangano, founder of the non-profit Ischemia Research and Educational Foundation, tells 60 Minutes in an interview to be broadcast this weekend, according to CBS News. Mangano, whose January 2006 study in The New England Journal of Medicine showed Trasylol put patients at higher risk of heart attacks, stroke and renal failure, repeats allegations that Bayer failed to tell the FDA about negative results of their own study. Despite his study, an FDA panel declared Trasylol, a drug used to reduce bleeding during bypass procedures, was safe and effective, and voted unanimously to keep the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1234811 Fri, 15 Feb 2008 12:55:37 +0100 1234811