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 'amgen'. Sat, 03 Sep 2011 01:59:51 +0100 http://www.medworm.com/index.php?rid=5159826&cid=t_102447_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F08%2Ftheres-room-for-only-one-osteoporosis.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5159826 Thu, 25 Aug 2011 18:07:00 +0100 5159826 http://www.medworm.com/index.php?rid=5107898&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjT4ncXm_IJU%2F The group of drugs known as ESAs are apparently being used inappropriately in cancer patients, suggesting that the expensive treatments are being wasted and exposing patients unnecessarily to serious side effects, according to a new study in the Journal of Clinical Oncology. Specifically, the meds were administered for no more than one week in 24 percent of patients, which is an insufficient amount of time to offer a useful benefit, according to the researchers (read the abstract). Moreover, nearly eight percent of the patients received one of the drugs for more than 14 weeks, while almost 14 percent were getting the drugs when they weren’t on chemotherapy.” The meds are approved for cancer patients who are getting chemotherapy, and recommended treatment is between two and 14 w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5107898 Mon, 08 Aug 2011 12:55:04 +0100 5107898 http://www.medworm.com/index.php?rid=5062497&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeTMnwRl80K0%2F Last month, a federal court ruled that a drug or device maker remains liable under the False Claims Act even when a pharmacy or hospital was unaware that a kickback was made to a doctor to induce the sale of a product for which reimbursement was sought from Medicare and Medicaid. The decision was seen as a game changer, because dismissing whistleblower lawsuits would likely become more difficult. Until then, courts had ruled the False Claims Act could not have been violated if a pharmacy does not know that a prescription was only written because a drugmaker gave a kickback to a doctor. Whistleblowers have argued, however, that a violation occurs once reimbursement is sought from Medicaid or Medicare. But the US Court of Appeals for the First Circuit disagreed. Not surprisingly, the same co... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5062497 Mon, 25 Jul 2011 22:24:53 +0100 5062497 http://www.medworm.com/index.php?rid=4976204&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2jyWx_FI6TU%2F Now that Carl Icahn has scooped up nearly 7 percent of Forest Laboratories stock and wants to place four of his minions on the board (back story), Wall Street is eyeing the drugmaker as takeover bait. The premise is helped along by the fact that Forest has five newer products, including three that will be launched by September, and another four in the pipeline that, when taken together, could add up to an attractive package. To wit, these nine drugs have the potential to dramatically boost earnings over the next five years, according to an investor note from Credit Suisse analyst Catherine Arnold. In her view, a mere 5 percent rise in 2016 sales implies a 24 percent earnings gain. This is particularly important since the Lexapro antidepressant, which generated 53 percent of 2011 sales, los... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4976204 Tue, 28 Jun 2011 12:57:12 +0100 4976204 http://www.medworm.com/index.php?rid=4976206&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvinqO6QozGE%2F Hello, again. And how are you this morning? A beautiful day is unfolding here on the Pharmalot corporate campus - the birds are chirping, the official mascots are lounging about and the cup of stimulation is brewing. Meanwhile, we are looking forward to another day of R&D. We know you can relate. To help you along, here are some tidbits. Hope your day goes well and stay in touch… Vertex Tops Merck In Hep C Drug Launch (The Street) Glaxo R&D Chief Says Advair Is Safe From Generics (Reuters) J&J Plans To Market More Products Under The Janssen Name (Financial Times) New Prostate Cancer Drugs Are Expensive (New York Times) Amgen Sells $3 Billion In Bonds To Pay For Dividends (Bloomberg News) Diabetes Cases In Adults Worldwide Has Doubled In 30 Years (Reuters) India Suspend... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4976206 Tue, 28 Jun 2011 11:45:08 +0100 4976206 http://www.medworm.com/index.php?rid=4953365&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fzehib3Dyut8%2F For the past five years, the US Attorney in Brooklyn, New York, has been investigating Amgen for allegedly violating the False Claims Act. At issue are a host of allegations, most notably that Amgen violated HIPAA and offered kickbacks to doctors in order to boost sales of its various meds and steal market share from such rivals Johnson & Johnson. Along the way, however, the biotech believed an agreement was reached in which the government would coordinate contact with current Amgen employees, but then argued the understanding was breached when the feds began attempting to conduct interviews and subpoena documents. And so last year, Amgen filed a protective order, but late last week, a judge upheld an earlier recommendation (see this) and ruled the feds can continue pursuing Amgen emp... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4953365 Mon, 20 Jun 2011 16:28:30 +0100 4953365 http://www.medworm.com/index.php?rid=4821152&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8_ncvLrxyio%2F Having finally capitulated to long-standing calls from investors to provide a dividend (see here), Amgen ceo Kevin Sharer is now under attack over his compensation. In the run up to the annual meeting next week, one shareholder advisory firm argues there is a ‘disconnect’ between his pay and performance, and is urging stockholders to reject an Amgen proposal to ratify his package. In a 22-page report, ISS Proxy Advisory Services recommends shareholders vote no “in light of the disconnect between the ceo’s 53 percent pay increase and the company’s above-median benchmarking, in contrast to lagging and mediocre shareholder returns.” ISS goes on to argue Sharer received 200 percent of the CEO peer median figure. And so, “further analysis is warranted.&... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4821152 Thu, 12 May 2011 14:43:45 +0100 4821152 http://www.medworm.com/index.php?rid=4813667&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU-E_cUnzOJg%2F Good morning, everyone, and nice to see you again. A busy day is planned here on the Pharmalot corporate campus as we hustle to meet some deadlines and undertake our own version of R&D. No doubt, you relate. So please join us for that mandatory cup of stimulation. Meanwhile, here are some tidbits we found floating about. Hope you conquer the world and see you later… Takeda In Talks To Buy Nycomed For $12 Billion (Bloomberg News) Carl Icahn And His Big Bet On Biotech (The Boston Globe) Glaxo & Astra Hook Up With Academia For Inflammation Research (Pharma Times) Experimental AIDS Vaccine Shows Promise In Monkeys (Reuters) Shire Eyes Big Sales For New Vyvanse Uses (Reuters) Procrit And Epogen May Worsen Heart Attacks (Health Day) Docs Busted For Supplying Oxycodone Network (Th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4813667 Thu, 12 May 2011 12:15:38 +0100 4813667 http://www.medworm.com/index.php?rid=4789635&cid=t_102447_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=4724262&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeHY6DN5Y0og%2F Hard to believe, yes? But even we take a break now and then. While we have our laptop and Blackberry with us and will, periodically, check on interesting developments, regular posting will not occur this week. We apologize for any inconvenience, but we promised Mrs. Pharmalot and The Short People (that famous, non-existent ’60’s group) that we would focus on their desires. Meanwhile, we hope you enjoy any holidays that you may celebrate. Have a great time, everyone, and see you in a few days… Synthes Confirms Aquisition Talks With Johnson & Johnson (Bloomberg News) Will Amgen Declare A Dividend On Thursday? (Reuters) EU Proceeds With Plan To Cut Patent Costs By 80 Percent (Pharma Times) Merck Scientist Sees Potential HIV Vaccine As Distant Goal (Dow Jones) FDA Warns Patients Ove... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4724262 Mon, 18 Apr 2011 13:00:40 +0100 4724262 http://www.medworm.com/index.php?rid=4693508&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrnpVtSoFzBk%2F Once again, another working week will soon draw to a close. And this, of course, is our signal to begin daydreaming about weekend activities. Our modest agenda includes chauffering our short people around town, taking a nap or two and attending the latest installment in what we call the ‘Let’s See Them Before They Die’ concert series. And you? Anything special planned? Maybe a walk in the park? Curling up with a good e-book? Or you could finish your taxes, even if no one is in Washington to process your return. Whatever you do, have a great time. See you soon… Amgen CEO Got $21M Compensation In 2010 (Associated Press) Indian Company Ends Sale Of Lethal Injection Drug To The US (The Atlantic) FDA Will Be Severely Limited By Government Shutdown (CNN Money) Canadian P... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4693508 Fri, 08 Apr 2011 11:43:35 +0100 4693508 http://www.medworm.com/index.php?rid=4677108&cid=t_102447_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F04%2Famgens-prolia-website-features-stories.html You've probably been seeing DTC TV ads for several different osteoporosis drugs these days. No longer does Sally Field dominate the airwaves hawking Genentech's Boniva. AMGEN's twice-per-year injectable Prolia, for example, is now competing with once-per-month injectable Boniva.Unlike Boniva, however, Prolia does not have a celebrity spokeswoman. What it has are "Women Like You."The Prolia website prominently displays the option titled "Stories from women like you." Below is a screen shot of that option showing Karen, 71, who talks about Prolia.Unfortunately, neither Karen nor any of the other "women like you," is an actual patient. Their stories, AMGEN claims, are "examples of typical patients--not the experiences of actual patients." Maybe it's difficult to get real patient stories for a... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4677108 Mon, 04 Apr 2011 13:00:00 +0100 4677108 http://www.medworm.com/index.php?rid=4631648&cid=t_102447_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=4592695&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQzD6otG0mCU%2F One of the big gripes among biotech investors is that Amgen has refused to pay a dividend. No matter how many times the issue has been raised, execs have refused to consider the prospect. Never mind that the stock has been battered amid a raft of struggles, notably FDA warnings over health risks associated with the Aranesp and Epogen anemia meds, concerns about reduced Medicare reimbursement and uncertainty about its pipeline and acquisition strategy (see this). At one point, the combination of setbacks and miscues resulted in Kevin Sharer being named one of the worst chief executives a few years ago (see this). Now, though, attention is focused on the possibility of a dividend since Wall Street anticipates the issue will be addressed at the upcoming annual shareholder meeting. Investors, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4592695 Mon, 14 Mar 2011 13:59:30 +0100 4592695 http://www.medworm.com/index.php?rid=4540739&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fy-ozTQgTevA%2F Five former Amgen execs have ‘taken the Fifth’ in depositions that were conducted as part of a False Claims Act lawsuit scheduled to go to trial in federal court in Boston later this year. And the former Amgen sales rep and product manager who brought the lawsuit is fighting to have the depositions filed in court and made public. At issue are allegations that Amgen provided free ‘overfills’ of its Aranesp anemia medication and encouraged doctors to bill Medicare and Medicaid for the extra amounts. The lawsuit, which was filed by Kassie Westmoreland, also charges the biotech offered kickbacks to doctors in the form of fictitious consulting arrangements and weekend getaways in order to steal market share from Johnson & Johnson, which sells the rival Procrit treat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4540739 Thu, 03 Mar 2011 03:02:31 +0100 4540739 http://www.medworm.com/index.php?rid=4545251&cid=t_102447_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F03%2Fon-course-with-phil-lacks-social-media.html This is NOT an attack on Phil Mickelson! I've already done that, been there (see Phil Mickelson "Opens Up" to Arthritis Today Magazine and Is Phil Mickelson Shilling for Enbrel?). So, relax and proceed to the back nine! This is about the "non-branded" disease awareness campaign just announced by Pfizer & Amgen, the companies that bring you ENBREL. The centerpiece of the campaign is the "On Course with Phil" website, which is pretty lame by today's social media standards. Before I get to that, let me show you the homepage screen that I just captured:In case you missed it, I circled the "money shot," which is not Phil hitting the ball in the hole, but the prominent link to a "treatment option." The link, of course, leads directly to the branded ENBREL website. Surely, this biologic compo... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4545251 Wed, 02 Mar 2011 22:45:00 +0100 4545251 http://www.medworm.com/index.php?rid=4507581&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNvoAwJK_fUk%2F Oncology is a big market and getting bigger, of course, but which drugmaker ranks highest is most effective in reaching oncologists? A recent poll of 475 medical and hematological oncologists found that Novartis commands a leading 12.5 share of details, although its position slipped slightly from the previous year, while Roche jumped from 10 percent to 12 percent thanks to combining sales teams with Genentech. Meanwhile, Sanofi-Aventis slid from 8 percent to about 6.5 percent thanks to looming patent expirations for Taxotere and Eloxatin, according to ImpactRx, a market research firm. In line with the results, Genentech tied with OSI Pharmaceuticals as the drugmaker with a top tier sales force, followed by Biogen Idec, Amgen, Eli Lilly and Celgene (here is the report). For the second year ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4507581 Tue, 22 Feb 2011 14:08:29 +0100 4507581 http://www.medworm.com/index.php?rid=4501810&cid=t_102447_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F02%2Fphil-mickelson-opens-up-to-arthritis.html Top pro golfer Phil Mickelson is featured on the cover of the Mar-April 2011 issue of Arthritis Today magazine (see photo). Recall that Mickelson announced that he had psoriatic arthritis last August in a news story titled "PGA Championship 2010, Whistling Straits: Phil Mickelson Has Psoriatic Arthritis - Uses Enbrel To Help Manage Condition."In that story, Mickelson was quoted as saying "I have no aches and pains. My back feels great. I feel stronger and more flexible than I've ever been." (see "Is Phil Mickelson Shilling for Enbrel?").When he made that statement, Phil was obviously demonstrating to AMGEN/PFIZER -- the companies that market ENBREL -- what he can do to help them promote their product. AMGEN/PFIZER were suitably impressed and signed him up a few months later (or so they say... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4501810 Mon, 21 Feb 2011 16:51:00 +0100 4501810 http://www.medworm.com/index.php?rid=4489977&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTtqj3J1HvPI%2F Hello and nice to see you again. Having successfully deposited one of the short people at the local schoolhouse, we are celebrating with yet another cup of stimulation. Please join us or grab a bottle of water, if you prefer, and get ready for another day of meetings and deadlines and who-knows-what-else. Meanwhile, here are some fresh tidbits. Have a good one and stay in touch… China To Help Domestic Drugmakers Expand Overseas (Global Times) AstraZeneca Pays $150M To Settle More Seroquel Lawsuits (Bloomberg News) Amgen Haunted By Medicare Worries (Forbes) Glaxo Cuts Neuroscience Jobs In North Carolina (MedCity News) UK’s NICE Endorses Celgene Blood Cancer Med (Reuters) Allergan Wins Wider Use For Lap-Band Device (Wall Street Journal) EU Parliament Approves Tougher Counterfeit ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4489977 Thu, 17 Feb 2011 13:03:30 +0100 4489977 http://www.medworm.com/index.php?rid=4322689&cid=t_102447_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F01%2Famgen-blows-its-marketing-budget-on.html Back in August 2010, I asked "Is Phil Mickelson Shilling for Enbrel?" (see this post). My question was prompted by a couple of "news" stories, one of which proclaimed "PGA Championship 2010, Whistling Straits: Phil Mickelson Has Psoriatic Arthritis - Uses Enbrel To Help Manage Condition." The story also included this quote from Phil: "I have no aches and pains. My back feels great. I feel stronger and more flexible than I've ever been."That's quite a claim! If Phil made such a claim while being a paid spokesperson for ENBREL, he would have probably violated FDA regulations regarding unsubstantiated claims. He also would have violated FTC regulations regarding celebrity endorsements and testimonials by not disclosing "material connections" (payments or free products) between advertisers and... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4322689 Fri, 07 Jan 2011 12:30:00 +0100 4322689 http://www.medworm.com/index.php?rid=4305105&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F---sJ6wFY7c%2F This is hardly surprising. Given the ongoing talk at the FDA about placing greater emphasis on safety, no one should be shocked that the pace of drug approvals remains modest. Last year, 21 new drugs were approved, down from 25 in 2009 and 24 in 2008. However, the latest tally is actually higher than the 18 approvals issued in 2007. As The Wall Street Journal notes, the latest approvals included a few biologics that are expected to become sizeable sellers: Amgen won approval for Prolia, which is used to treat osteoporosis in postmenopausal women; Roche’s Genentech scored with Actemra for rheumatoid arthritis; Boehringer Ingelheim received approval for Pradaxa, a new type of bloodthinner and Novartis garnered FDA endorsement for its Gilenya multiple sclerosis pill. And how can anyone ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4305105 Mon, 03 Jan 2011 13:02:45 +0100 4305105 http://www.medworm.com/index.php?rid=4300551&cid=t_102447_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fremembering-gene-goldwasser-discoverer-of-epo-a-cure-for-anemia%2F2010.12.30 Gene Goldwasser died last week. He was 88, and he was my friend. I wrote previously about a series of conversations I conducted with Gene and Rabbi A.J. Wolf a few years ago. I met Gene one spring day after calling to invite him to sit in on a class I was teaching to a small group of medical students about social issues in healthcare. I’d read about him in a book called “The $800 Million Pill,” by Merrill Goozner. In the book, Goozner writes the story of Gene’s two-decade hunt to isolate the hormone erythropoietin (EPO). Part of the story relates how Gene tried to interest traditional big pharma companies in his discovery, only to be brushed aside. Instead, Gene wound up sharing his discovery with what became Amgen. The company went on to make a windfall from recomb... Better Health blogs http://www.medworm.com/rss/comments.php?id=4300551 Thu, 30 Dec 2010 16:00:00 +0100 4300551 http://www.medworm.com/index.php?rid=4245395&cid=t_102447_113_f&fid=38494&url=http%3A%2F%2Fcuretogether.com%2Fblog%2F2010%2F12%2F09%2Fand-the-winner-is%2F We’re excited to announce that CureTogether is a winner of the Amgen/Ashoka Changemakers Patient Empowerment Competition! The winners were announced here yesterday. The $10,000 prize will help us to improve CureTogether for our members, and spread it to more people who can be helped. Everyone who is reading this – do something extra nice for yourself to help us celebrate! ! (Source: The Collective Well) The Collective Well blogs http://www.medworm.com/rss/comments.php?id=4245395 Thu, 09 Dec 2010 22:12:39 +0100 4245395 http://www.medworm.com/index.php?rid=4220456&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqSI0MgV5jWg%2F More than a decade ago, Elena Ferrante worked as an oncology sales rep for Immunex and would leave her Yorkshire Terrier puppy in her car when visiting docs. One day, though, a nurse suggested Ferrante bring the dog inside in hopes of giving chemo patients a psychological lift. The gambit worked and soon Ferrante was bringing Justine with her into various offices, but only if given permission. “I brought pictures of my dog like some people bring pictures of their children with them,” she says. “My dogs are my children. And most people are interested in dogs. But it was always in a carrier. And I never brought her in if she wasn’t wanted. She would brighten the day for chemo patients. She would sit in their lap. You know, these are people who are going through chemo, whi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4220456 Wed, 01 Dec 2010 13:10:27 +0100 4220456 http://www.medworm.com/index.php?rid=4197365&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FC9Ox0nwZNCI%2F Over the past week, word has leaked out that Amgen, a beleaguered biotech, is interested in buying Actelion Pharmaceuticals in hopes of expanding into the cardiovascular market. But a couple of fund managers say they are not impressed with the possibility and one large Amgen shareholder (see photo) complains that such a move is “faulty thinking by a hard-up executive staff.” What would Amgen get? For the most part, Actelion is a one-trick pony; the drugmaker last year derived about 85 percent of its revenue from Tracleer, a med that is used to treat pulmonary arterial hypertension and generated about $1.5 billion in sales. There are also four experimental meds in the final throes of testing, including two that are also being developed to treat PAH (see pages 17 and 18 of the an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4197365 Tue, 23 Nov 2010 14:48:08 +0100 4197365 http://www.medworm.com/index.php?rid=4179381&cid=t_102447_113_f&fid=38494&url=http%3A%2F%2Fcuretogether.com%2Fblog%2F2010%2F11%2F18%2Fplease-vote-and-help-curetogether-win-10000-in-the-amgen-changemakers-contest%2F Hi everyone, Just a quick note to let you all know that CureTogether is a finalist in the Amgen/Changemakers Empowering Patients Competition!! Thank you for being part of this. Please vote today – we have a good shot at winning the $10,000 grand prize if we get enough votes in the next 13 days. It can be your good deed for the day! Please take half a minute to cast your vote. THANK YOU so much!! Wishing you all a wonderful day, Alex (Source: The Collective Well) The Collective Well blogs http://www.medworm.com/rss/comments.php?id=4179381 Thu, 18 Nov 2010 16:58:46 +0100 4179381 http://www.medworm.com/index.php?rid=4175972&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFvPTSac3G7I%2F Drugmakers may be squeamish about social media and their web sites may not be choice destinations for most consumers (see this), but the pharmaceutical industry is not shying away from using the Internet to promote meds to docs. A new analysis shows more than 150 drugs were marketed for the first time using online details and events during the first nine months of 2010, which marks a new record. Leading the pack was Merck’s Singulair asthma med, with more than 110,400 different so-called e-promotional activities that cost more than $15.5 million to generate, a 2.9 percent increase. The runner-up was Pfizer’s Pristiq, which is sold to treat depression - e-promotions rose nearly 74 percent to more than 103,700 activities that cost $13.6 million, an 86 percent rise. (In case you w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4175972 Wed, 17 Nov 2010 15:08:16 +0100 4175972 http://www.medworm.com/index.php?rid=4175977&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEy3R1iJKuAE%2F Good morning, everyone. ‘Tis a shiny day here on the Pharmalot corporate campus, where the official mascots are frolicking and short people are making their way to the local school house. Of course, the rest of us are preparing for all those meetings and deadlines. No doubt, this will be a busy day. To help you along, here are some tidbits. We hope you have a great day and achieve your goals… Novartis Plans Efficiency Steps (Reuters) China Will Be Second-Largest Pharma Market In 2015 (InPharma-Technologist) New Medicare Drug Plan For Seniors May Not Be So Great (Associated Press) CMS Committee Meets Today On Provenge (The Wall Street Journal) FDA Panel Backs Human Genome Lupus Drug (New York Times) Amgen May Bid For Actelion (Reuters) Lilly’s Alimta Patent Is Upheld (Bloo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4175977 Wed, 17 Nov 2010 12:15:21 +0100 4175977 http://www.medworm.com/index.php?rid=4098464&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIAF1KmZPK2w%2F Good morning, everyone. The end of the week is rapidly approaching and that usually means one thing - daydreaming about weekend plans. We expect to catch up on a few chores, but will spend most of our time entertaining the shortest of short people with a little bowling and ice cream, and a trip to the book store. What about you? A drive in the country to watch the leaves change? Toss a football? Pick a pumpkin? Walk your own official mascots? Whatever you do, have a good time and be safe. See you soon… EMA Revises Stance On Genzyme’s Fabrazyme (Reuters) Wyeth Must Disclose Earlier Effexor XR Patent Settlements (New Jersey Law Journal) Amgen Exec Retires And Gets $400K Consulting Deal (SEC filing) FDA Adds Heart Warning To HIV Drug Combo (Associated Press) Roche And Biogen End D... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4098464 Fri, 22 Oct 2010 12:06:06 +0100 4098464 http://www.medworm.com/index.php?rid=4018440&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhZCO9RAOfvE%2F One of the big questions about establishing a regulatory pathway for approving biologics is the extent to which the FDA will require clinical trials to prove a biosimilar is equivalent to the original brand medicine. This is what is called the great unknown. But the FDA may have sent a signal about its thinking with a decision concerning a Teva Pharmaceutical drug. The FDA issued a Complete Response Letter to Teva, which has been seeking approval to sell a version of Amgen’s Neupogen, a med used to treat infections in people with certain types of cancer. In its press release, Teva notes the FDA “does not require additional pre-marketing clinical trials to complete the review” of the application. This is the part that is interesting, since Teva had submitted its applicatio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4018440 Thu, 30 Sep 2010 18:14:13 +0100 4018440 http://www.medworm.com/index.php?rid=3972983&cid=t_102447_113_f&fid=38494&url=http%3A%2F%2Fcuretogether.com%2Fblog%2F2010%2F09%2F15%2Fcrowdsourced-patient-experience%2F This is for you. As part of our entry for the Ashoka Changemakers’/Amgen Foundation Patients| Choices| Empowerment competition, we put together this video with stories from some of our members. It’s to thank you and show you how people are being helped and how we’re moving forward. I hope you enjoy it! Please also feel free to enter a comment at the Ashoka site to show your support for CureTogether winning the competition. Thanks!! (Source: The Collective Well) The Collective Well blogs http://www.medworm.com/rss/comments.php?id=3972983 Thu, 16 Sep 2010 03:27:42 +0100 3972983 http://www.medworm.com/index.php?rid=3935855&cid=t_102447_113_f&fid=38494&url=http%3A%2F%2Fcuretogether.com%2Fblog%2F2010%2F09%2F06%2Fcuretogether-honored-with-amgenashoka-changemakers-award%2F We are so excited! CureTogether’s entry into the Ashoka Changemakers patient empowerment competition won the Early Entry Prize for best idea entered by the early deadline! From the competition website: The Amgen Foundation is supporting the Patients| Choices| Empowerment competition with Ashoka’s Changemakers to answer the question of how we can elevate patients’ voices to improve health outcomes globally. Submit your solutions, or nominate a project, in this challenge that empowers patients to make decisions with confidence and clarity, in concert with people who care and can help. Congratulations to the Early Entry Prize winner: CureTogether – Crowdsourced Patient Experience. Learn how they are working to empower patients HERE. Prizes: Enter before the competition dea... The Collective Well blogs http://www.medworm.com/rss/comments.php?id=3935855 Mon, 06 Sep 2010 08:31:12 +0100 3935855 http://www.medworm.com/index.php?rid=3827346&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FelwdGi0PLwE%2F Over the past few years, two Amgen reps have battled the biotech over arbitration proceedings they claim they were forced to enter as a consequence of employment disputes. In 2006, Elena Ferrante filed a $10 million lawsuit, charging she was fired in retaliation for not complying with an allegedly improper marketing strategy for the Enbrel rheumatoid arthritis med (background). Similarly, Marc Engleman accused Amgen of forcing reps to engage in off-label promotion and patient privacy violations. He subsequently resigned and later sued the biotech and an arbitration group for “procedurally unconscionable” practices (background here). In both cases, arbitration has dragged on with no apparent end in sight. Meanwhile, Amgen has successfully convinced arbitrators in both cases that con... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3827346 Thu, 05 Aug 2010 13:51:46 +0100 3827346 http://www.medworm.com/index.php?rid=3795053&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJqmh-OvPe3Q%2F After much anticipation, the Centers for Medicare & Medicaid Services last night issued its new rules on the bundling payment system for meds used to treat anemia. The bottom line is that after the rules goes into effect, the use of anemia drugs - notably, Amgen’s Epogen - will likely drop, which was expected. But the agency did offer one surprise: some oral meds will be exempt until 2014. Right now, Medicare pays a set fee for each dialysis treatment, but drugs such as Epogen are reimbursed separately. This sparked controversy because hospitals and clinics had more incentive to use more Epogen, which racked up $2.65 billion in sales last year. But widespread use is not only a big expense for Medicare, but also a concern ever since studies found such drugs were linked to heart ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3795053 Tue, 27 Jul 2010 14:43:05 +0100 3795053 http://www.medworm.com/index.php?rid=3784500&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FlKiFN8hyxGU%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 Spectrum Pharmaceuticals hired George Tidmarsh as senior vice president, chief scientific officer and head of R&D operations. Tidmarsh founded Horizon Pharma and Threshold Pharmaceuticals, and also held various posi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3784500 Fri, 23 Jul 2010 13:06:49 +0100 3784500 http://www.medworm.com/index.php?rid=3767316&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxlFc75cttOY%2F Hello, everyone, and welcome back. We hope your weekend was relaxing, despite the heat. Now, of course, the time has come to return to the routine as meetings and deadlines beckon. So please join us for the mandatory cup of stimulation as we scan the news of the world. Hope your day goes well and do stay in touch… AIDS Drug Cocktails Halve New Cases (Reuters) A J&J/Merck Plant Gets Flagged By The FDA (CNN Money) Sigma Pharma Receives Multiple Bids (Reuters) Teva And Sun Losing Patent Ruling On Protonix (PharmaTimes) Genetic Testing, Mix-Ups And Federal Oversight (The Washington Post) Vaginal Sex Gel Test Results To Be Released (Bloomberg News) Charles River Shareholders Says Wuxi Deal Is Inadequate (OutsourcingPharma) Amgen Gets Priority Review For Prolia (Associated Press) (Sou... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3767316 Mon, 19 Jul 2010 11:38:26 +0100 3767316 http://www.medworm.com/index.php?rid=3761629&cid=t_102447_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=3718695&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRnVigrnX3FU%2F Since the passage of the False Claims Act in 1986, the federal government has recovered about $22 billion through qui tam, or whistleblower lawsuits and a fair number of these have emanated from the pharmaceutical industry. An untold number of such lawsuits are always in the wings, as people who work with or for drugmakers attempt to expose alleged wrongdoing. There have been accusations that some whistleblowers are only in it for the money (see this), but life as a whistleblower has its challenges (see here). And so concerned that the pharmaceutical industry may not be doing enough to educate employees about whistleblowing protection, US Senator Chuck Grassley has written 16 big drugmakers to provide information about their programs. The letters went to Abbott Labs, Amgen, AstraZeneca, Br... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718695 Thu, 01 Jul 2010 14:34:30 +0100 3718695 http://www.medworm.com/index.php?rid=3676899&cid=t_102447_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=3641325&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fjh8svxjHFBA%2F Nice to see you again. Another shiny day here on the Pharmalot corporate campus. As usual, we are hustling the short people off to the schoolhouse. And yes, to cope we are downing the mandatory cup of stimulation. How will you cope today? Perhaps getting started with the news of the world. Here, in fact, are a few items. Have a great day, everyone… Genzyme Nominates Former Amgen Exec To Its Board (Reuters) Glaxo May Slash Hundreds Of Jobs In Ireland (The Irish Examiner) Merck KGgA Reapplies With FDA For MS Pill (Reuters) Australia To Review Breast Cancer Gene Patent (The Age) Otsuka Pharma To Buy 1,300 iPads For Sales Reps (Bloomberg News) Cheap Gout Drug Can Help With Angina Pain (Reuters) MS Pill Risk-Sharing Plan Is A Costly Failure To NHS (PharmaTimes) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3641325 Tue, 08 Jun 2010 11:50:44 +0100 3641325 http://www.medworm.com/index.php?rid=3632242&cid=t_102447_87_f&fid=35060&url=http%3A%2F%2Fwww.healthnewsblog.com%2Fblog%2F604101 Reuters reports that the U.S. Food and Drug Administration (FDA) has approved Prolia, a new osteoporosis drug from Amgen, Inc. The drug is designed to prvent fractures in post-menopausal women. Reuters says the drug just received European approval days ago. "Denosumab is the most potent agent ever introduced into clinical practice that blocks bone degradation," Roger Perlmutter, Amgen's research chief, said in a telephone interview. Analysts estimate the product could see annual global sales of $3.3 billion in 2014 for the world's biggest biotechnology company, according to Thomson Reuters data. "Most of us certainly expected this drug to be approved," said Cowen and Co analyst Eric Schmidt, adding it was "a surprise that it happened before" July 25. WedMD reports that Prolia is mean... HealthNewsBlog.com blogs http://www.medworm.com/rss/comments.php?id=3632242 Fri, 04 Jun 2010 23:00:00 +0100 3632242 http://www.medworm.com/index.php?rid=3621954&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbRL2qPVcAhw%2F After months of delay, Amgen finally won FDA approval for Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures. The endorsement is a big boost for the biotech, which has been counting on Prolia to reverse a series of setbacks over the past few years, notably a decline in sales of some of its largest-selling products, Aranesp and Enbrel. Some Wall Street estimates suggest peak annual sales could reach $1 billion or so, although Amgen will face some challenges along the way - convincing patients that a twice-a-year shot is better than taking a pill once a month, such as generic versions of Roche’s Boniva or Merck’s Fosamax. “The drug will be competing against generic pills and osteoporosis is not a deblitatiing diseas... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3621954 Tue, 01 Jun 2010 21:54:37 +0100 3621954 http://www.medworm.com/index.php?rid=3607816&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5EI31TVBif4%2F And so another week will soon draw to a close, although it will be a longer-than-usual weekend on this side of the pond. Have any interesting plans? So many choices, we know. Our own agenda includes walking the Pharmalot mascot, driving through the countryside, quaffing beverages with Mrs. Pharmalot and keeping the short and not-so-short people amused (wish us luck). Whatever you do, we hope you have a grand time. Meanwhile, here are a few items to help you speed through the day. Have a good one and see you soon… Amgen’s Prolia Osteoporosis Drug Wins EU Approval (PharmaTimes) Teva Stops Making The Propofol Sedative (Reuters) Daiichi Sankyo Is Confident About Resolving Ranbaxy Ban (Bloomberg News) Breast Cancer Patients Win Right To Sue Wyeth (Canadian Broadcasting) AstraZeneca&... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3607816 Fri, 28 May 2010 11:49:19 +0100 3607816 http://www.medworm.com/index.php?rid=3585833&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9py8TV-yzSg%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is something we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Qforma, which traffics in analytics and predictive modeling, hired Chris Tama as senior vp for business development. Prior to joining Qforma, he was president of Ferguson, part of the CommonHealth network of ad agencies ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3585833 Fri, 21 May 2010 12:04:13 +0100 3585833 http://www.medworm.com/index.php?rid=3526947&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGcH7rZ8YJbU%2F Another month, another list. Once again, there is speculation about which medications will generate the most revenue over the next few years. Interestingly, the latest conclusion mirrors another recent list that suggests conventional pills will easily be eclipsed. Only two small molecules make this newest ranking, which was compiled by EvaluatePharma. Not surprisingly, one of them is AstraZeneca’s Crestor cholesterol fighter, although the newest list differs slightly from this list. And so once again, there are myriad implications raised, including the strategic direction pursued by the biggest drugmakers and the costs for patients. The percentage figure refers to sales growth from 2009 to 2016… 1. Humira (arthritis) Abbott Labs/Eisai - $10.1b; 9 percent 2. Avastin (cancer) Roc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3526947 Mon, 03 May 2010 12:47:00 +0100 3526947 http://www.medworm.com/index.php?rid=3519710&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4B6g7P-pE6M%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is something we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that that Qforma, which traffics in analytics and predictive modeling, hired Judy Stein as director of client services. She most recently worked as a senior manager at GE Healthcare’s Performance Solutions unit, where s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3519710 Fri, 30 Apr 2010 11:56:30 +0100 3519710 http://www.medworm.com/index.php?rid=3494552&cid=t_102447_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=3468018&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZbwVlkKVymw%2F And the winner is…. Roche’s Avastin, which is used to treat various cancers. Everyone loves a list, of course, so Reuters compiled this ranking and the most interesting finding is there seems to be just one pill that will be among the biggest sellers in 2014. In other words, injectables will dominate. Assuming this is reasonably accurate, what might it say about big drugmakers? Will they spend more in the lab or strike still more deals with smaller prey developing the next big thing? Will pills become passe? And what will it mean for patient costs? Consensus sales forecasts for world’s top 10 drugs in 2014: 1. Avastin (cancer) Roche - $8.9b 2. Humira (arthritis) Abbott - $8.5b 3. Enbrel (arthritis) Pfizer - $8b 4. Crestor (cholestero... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3468018 Wed, 14 Apr 2010 15:58:25 +0100 3468018 http://www.medworm.com/index.php?rid=3420758&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3siamx0eDUw%2F This is a list of the top 20 drugmakers, ranked by global prescription drug sales for the 12 months ended Sept. 30, 2009, according to IMS Health, which prepared this for Reuters. The dollar sales are in billions and, next to that, is the percent change from the year-over-year period. As you can see, though, the results don’t include the mergers between Merck and Schering-Plough, and Pfizer and Wyeth, since these weren’t consummated until later in the year. 1 - Pfizer - $41.7 billion - (0.8) 2 - Novartis - $36.7 billion - 7.0 3 - Sanofi-Aventis - $35.1 billion - 3.3 4 - GlaxoSmithKline - $34.3 billion - (3.4) 5 - AstraZeneca - $33.2 billion - 7.8 6 - Roche - $31.3 billion - 8.6 7 - Johnson & Johnson - $26.9 bi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3420758 Mon, 29 Mar 2010 16:43:51 +0100 3420758 http://www.medworm.com/index.php?rid=3374375&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJHNZMyRf0k8%2F A new research collaboration involving the National Institutes of Health, the FDA and three drugmakers will be launched today in hopes of getting cancer drugs to the market faster, and test five experimental breast cancer medsReuters writes. The $26 million, five-year study will be called Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis, or I-SPY2, and use DNA to match the best drug to each patient, and more quickly toss approaches that don’t work or are too toxic. The companies - Amgen, Abbott Labs and Pfizer - agreed to share info on using genes to predict how well patients respond as part of The Biomarkers Consortium, which includes the FDA, the NIH and PhRMA, the industry trade group. “I think it is the theme for the f... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3374375 Wed, 17 Mar 2010 12:56:09 +0100 3374375 http://www.medworm.com/index.php?rid=3294809&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPxiU-CUwnfE%2F Hello, everyone, and welcome back from the weekend. We hope your time was relaxing and you had a chance to enjoy. Now, the routine, of course, returns. What lies in store this week? We can only guess, but to prepare, we are brewing the required cup of stimulation. Grab one yourself. Meanwhile, here are a few items to help you get moving. Good luck… Icahn Wants Four Genzyme Board Seats (TheStreet) USPTO Tentatively Rejects Plavix Patent (Dow Jones) Cardinal Pays $1M Fine For Missing Drugs (Columbus Business First) Novartis Wins FDA OK For Meningitis Vaccine (MarketWatch) Anthera Tries IPO With No Sales Or Products (Bloomberg News) FDA To Decide On Amgen Prolia By July (Reuters) EU Rejects J&J Drug For Skin Infections (Associated Press) Hologic Settles Patent Suit With J&J (R... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3294809 Mon, 22 Feb 2010 12:41:25 +0100 3294809 http://www.medworm.com/index.php?rid=3159974&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCT-KXAJrr3s%2F In October 2006, a former Amgen sales rep filed a complaint against the biotech for $10 million before an arbitrator, claiming she was fired in retaliation the year before for not complying with an allegedly improper marketing strategy for the Enbrel rheumatoid arthritis med. Elena Ferrante claimed Amgen sales managers encouraged reps to promote off-label and encouraged docs to prescribe Enbrel to patients who may not have needed the drug, according to Ferrante’s lawyer, Lydia Cotz (here is the complaint). When Ferrante refused to cooperate, Lydia Cotz, Ferrante’s attorney, says her client was fired, but ostensibly for other reasons, including not attending client dinners. Ferrante was a top seller who made about $400,000 a year in sales at the time she was dismissed, according to ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3159974 Mon, 11 Jan 2010 14:41:55 +0100 3159974 http://www.medworm.com/index.php?rid=3149320&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIsAn9nT5-Mg%2F The agency plans to hold an advisory committee meeting because studies have found that high dosages of Amgen’s Aranesp and Epogen and Johnson & Johnson’s Procrit boost the risk of heart attacks, strokes and blood clots in anemia patients with kidney disease. The purpose of the meeting, which hasn’t been scheduled yet, is to determine the appropriate dosages. Known as erythropoiesis-stimulating agents, or ESAs, the drugs boost hemoglobin levels in anemics, but the drugmakers have been plagued by cardiovascular risks that caused sales to decline. As it turns out, using large doses to cause hemoglobin to return normal levels may also increase the risk of heart attacks and strokes, instead of lowering the risk. “Randomized trials have endeavored to show that using ESA... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3149320 Thu, 07 Jan 2010 12:07:53 +0100 3149320 http://www.medworm.com/index.php?rid=3115285&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FP07ZTLAUfiw%2F A federal court in Boston ruled that Roche’s Mircera anemia drug does, indeed, infringe on Amgen’s patents and entered a permanent injunction preventing the big drugmaker from selling its med in the US, according to Amgen. The decision ends a five-year battle in which Roche lost legal maneuver after legal maneuver, including a jury trial (see here). The judgment was accompanied by Roche’s admission that Amgen patents for Aranesp and Epogen are valid. A limited license agreement will allow Roche, which already sells Mircera in Europe, can market its med in the US in 2014, according to an Amgen statement. There was no financial payment, by the way. The deal has its roots in a ruling last year by a federal judge, who suggested a licensing deal (see here). Over the past two y... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3115285 Wed, 23 Dec 2009 00:16:50 +0100 3115285 http://www.medworm.com/index.php?rid=2947139&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FiMYYvv5vQ5g%2F The lawsuit charges Amgen - along with a specialty group purchasing organization known as International Nephrology Network and the ASD Healthcare wholesaler - with offering kickbacks to medical providers to increase sales of its Aranesp anemia drug, Aranesp. The multi-state suit, by the way, joins a whistleblower lawsuit filed in 2006 by Amgen sales reps. The companies encouraged health care providers to bill third-party payers such as Medicaid for free Aranesp in hopes of taking business away from Johnson & Johnson’s Procrit. Amgen also conspired with INN and ASD Healthcare to provide sham consultant agreements, weekend retreats and other services to get them to purchase and prescribe Aranesp (here is the lawsuit). “Drugs should be prescribed to patients on the basis of ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2947139 Fri, 30 Oct 2009 21:31:10 +0100 2947139 http://www.medworm.com/index.php?rid=2939563&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FabXr0sBkcoo%2F The Mathilda and Terence Kennedy Institute of Rheumatology Trust filed its lawsuit in federal court in Delaware, seeking royalties and damages from Wyeth and Amgen for infringing a patent for treating arthritis. The drug makers jointly market Enbrel, a best-selling med, for treating rheumatoid arthritis. In its lawsuit, the trust alleges its 2001 patent was developed by Marc Feldmann and Ravinder Maini, both with the Imperial College London. The patent relates to treating arthritis by co-administering methotrexate and drugs that block receptors to an inflammation-causing protein called tumor necrosis factor alpha (anti-TNFa) such as Enbrel, according to the lawsuit (you can read it here). Amgen and Wyeth have refused demands for royalty payments, the complaint said. The Enbrel website says... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2939563 Wed, 28 Oct 2009 20:56:51 +0100 2939563 http://www.medworm.com/index.php?rid=2916440&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvgCad28JxBA%2F Hello, everyone. Nice to see you again. Busy week, yes? The earnings season can be overwhelming at times, but also quite interesting. Today is no exception. And so, we must get started. First, however, we must bundle one of the short people off to the school house. So please enjoy these as you start your own day. Hope it’s a good one… Schering-Plough Cholesterol Drugs Slump, Profit Falls (Reuters) Amgen Discloses More Delays For Denosumab (Bloomberg News) Bristol-Myers Sales Rise, But Profits Fall (Associated Press) Novartis Lifts Its Sales Forecast (Bloomberg News) Merck Profits Beats Forecasts (Reuters) ACIP Recommends Gardasil For Boys (NY Times) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2916440 Thu, 22 Oct 2009 11:20:48 +0100 2916440 http://www.medworm.com/index.php?rid=2912531&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqqlqnwpCc2o%2F Amgen fired a project manager for complaining that the pharmaceutical giant underreported “adverse events” involving “every product it markets,” the man claims in a lawsuit filed in Superior Court in Ventura, Ca., Courthouse News reports. Shawn O’Brien says Amgen continues to underreport “post marketing adverse event” data to the FDA and that he was ordered to “stop all work” in 2007 after he found that Amgen’s post-marketing product complaints department was underreporting adverse data for “every product it markets.” O’Brien says he was told not to discuss the issue with anyone, and four weeks later he was fired in a “reduction in force.” He seeks lost wages and punitive damages for wrongful firing, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2912531 Tue, 20 Oct 2009 21:46:57 +0100 2912531 http://www.medworm.com/index.php?rid=2762149&cid=t_102447_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F09%2Fwhat-does-phone-sex-pittsburgh-symphony.html The #pso hashtag in Twitter! Hashtags are used in the Twittersphere to allow you to follow all the Tweets about a specific topic. There are no rules for developing a hashtag; you just come up with one and announce it. Amgen announced yesterday it would use the #pso hashtag when it live-tweets about the Addressing Psoriasis(TM) Fashion Show today:"Amgen tweeting tomorrow live from Addressing Psoriasis(TM) Fashion Show. Tim Gunn is hosting the event. Hope to see you here! #pso"Get it? p, s, and o are the first three letters in the word "psoriasis."Why is Amgen tweeting about this show? Here's why:"Amgen and Wyeth announced the eight winners of the Addressing Psoriasis contest, which recognizes people with moderate to severe plaque psoriasis who have tried not to allow the condition to inhibi... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2762149 Wed, 02 Sep 2009 14:24:00 +0100 2762149 http://www.medworm.com/index.php?rid=2758128&cid=t_102447_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F09%2Fwhat-does-phone-sex-pittsburgh-symphony.html The #pso hashtag in Twitter! Hashtags are used in the Twittersphere to allow you to follow all the Tweets about a specific topic. There are no rules for developing a hashtag; you just come up with one and announce it. Amgen announced yesterday it would use the #pso hashtag when it live-tweets about the Addressing Psoriasis(TM) Fashion Show today:"Amgen tweeting tomorrow live from Addressing Psoriasis(TM) Fashion Show. Tim Gunn is hosting the event. Hope to see you here! #pso"Get it? p, s, and o are the first three letters in the word "psoriasis."Why is Amgen tweeting about this show? Here's why:"Amgen and Wyeth announced the eight winners of the Addressing Psoriasis contest, which recognizes people with moderate to severe plaque psoriasis who have tried not to allow the condition to inhibi... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2758128 Wed, 02 Sep 2009 14:24:00 +0100 2758128 http://www.medworm.com/index.php?rid=2550340&cid=t_102447_149_f&fid=35786&url=http%3A%2F%2Fkinasepro.wordpress.com%2F2009%2F06%2F28%2Famg-900%2F It’s a Ph1 Aurora A/B/C inhibitor for ’solid tumors’.  Seems likely to be a member of one of the phthalazine series’ WO/2008/124083, WO/2008/057280, WO/2007/100646, or WO/2007/087276. previously… Posted in Amgen, Aurora (Source: KinasePro) KinasePro blogs http://www.medworm.com/rss/comments.php?id=2550340 Sun, 28 Jun 2009 04:49:07 +0100 2550340 http://www.medworm.com/index.php?rid=2406145&cid=t_102447_149_f&fid=35786&url=http%3A%2F%2Fkinasepro.wordpress.com%2F2009%2F05%2F14%2Famgen-us-too%2F As a comment in another thread notes, they have a handful of these too.  The regioismer is the novelty factor: WO/2008/008539 / US2009012461 / 3CD8 / J Med Chem Posted in Amgen, c-Met (Source: KinasePro) KinasePro blogs http://www.medworm.com/rss/comments.php?id=2406145 Fri, 15 May 2009 03:23:29 +0100 2406145 http://www.medworm.com/index.php?rid=2279373&cid=t_102447_149_f&fid=35786&url=http%3A%2F%2Fkinasepro.wordpress.com%2F2009%2F03%2F18%2Famg-458%2F Here’s one where they do tell us why its off the pipeline: J Med Chem -> Chem Res Tox makes you wonder about XL-880, E-7080, & AV-951 Posted in Amgen, c-Met (Source: KinasePro) KinasePro blogs http://www.medworm.com/rss/comments.php?id=2279373 Thu, 19 Mar 2009 03:13:47 +0100 2279373 http://www.medworm.com/index.php?rid=2222559&cid=t_102447_134_f&fid=34841&url=http%3A%2F%2Fwww.diabetesmine.com%2F2009%2F02%2Fteam-type-1-new-kinds-of-heroes.html This week, Lance Armstrong is riding his first tour on American soil since he retired after winning his 7th Tour de France.  And do you know who will is riding alongside him?  More than 100 of the world’s best bicyclists, including four riders from our own Team Type 1! If you haven’t heard about them, you [...] (Source: Diabetes Mine) Diabetes Mine blogs http://www.medworm.com/rss/comments.php?id=2222559 Wed, 18 Feb 2009 13:00:20 +0100 2222559 http://www.medworm.com/index.php?rid=2047632&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F487050034%2F A former Amgen patent attorney, who claims was fired last summer for complaining of “unethical and illegal practices,” can take his case to a California state court instead of being forced to go aribitration, which Amgen requries of all employees with a dispute. The ruling means that other former and current Amgen employees may have the potential to pursue claims in public court in California, where the biotech is headquartered, instead of closed-door arbitration proceedings. “Amgen required all employees to sign an arbitration agreement as a condition of employment. This allows all employees who have a dispute to go to court and have their case heard before a jury,” says Rob Henning, the lawyer for former Amgen attorney Darrell Dotson. “A recent study showed... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2047632 Tue, 16 Dec 2008 23:04:11 +0100 2047632 http://www.medworm.com/index.php?rid=2035943&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F483040604%2F Drugmakers may be forced to change prescribing info on cancer meds already being sold in the US to advise patients that some treatments won’t work in people who carry certain genes, Bloomberg News writes. Prescribing drugs on the basis of genetic profiles can limit use of medicines to patients who will benefit most and increase their safe use, FDA staffers wrote in briefing materials for an advisory committee meeting on December 16. The change may also hinder sales of drugs that previously might have been given to more people, just on the chance they may work. The meeting is being held to discuss whether to recommend that doctors screen patients for the so-called KRAS gene mutation before prescribing Erbitux, which is marketed by Lilly and Bristol-Myers Squibb, and Amgen’s Vectib... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2035943 Fri, 12 Dec 2008 21:07:51 +0100 2035943 http://www.medworm.com/index.php?rid=1991563&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F465287822%2F You can guess some of the likely suspects, but in a lengthy investor report issued today, Deutsche Bank analyst Barbara Ryan posits that Merck and Pfizer will likely be acquirers, while Bristol-Myers Squibb and Wyeth are bait. The impetus: the approaching ‘patent cliff’ between 2010 and 2013, when many big drugmakers lost still more big sellers to cheap generics. Despite numerous cost-cutting and restructuring efforts, Ryan writes that pharma “will have to move aggressively to convert its cash and strong balance sheets into revenues and earnings to fill the void in the cliff period via M&A and mergers of equals, which will likely also serve to reduce usustainable substantial inefficiencies in the pharma/biotech model.” In her view, consolidation and more acqui... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1991563 Tue, 25 Nov 2008 18:03:41 +0100 1991563 http://www.medworm.com/index.php?rid=1975626&cid=t_102447_149_f&fid=35786&url=http%3A%2F%2Fkinasepro.wordpress.com%2F2008%2F11%2F20%2Fmotesanib-a-little-too-good%2F Looks like this one might be coming off the ph3 list… Motesanib’s got “higher early mortality rates“ Posted in Amgen, VEGF       (Source: KinasePro) KinasePro blogs http://www.medworm.com/rss/comments.php?id=1975626 Fri, 21 Nov 2008 01:28:16 +0100 1975626 http://www.medworm.com/index.php?rid=1975640&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F459465007%2F Welcome back. Another cold day here in the nation’s medicine chest. As always, though, there is much to do. So while we rummage about and get organized - and usher those short people to the schoolhouse - here are a few items to help you on your own way. Have a nice day, everyone… Theravance Wins FDA Panel OK For Antibiotic (San Francisco Business Times) Amgen Suspends Cancer Drug Trial Over Deaths (Bloomberg News) EU To Relent On Ban On Repackaged Meds (The Financial Times) Overhaul Spurs Novartis Labs (The Wall Street Journal) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1975640 Thu, 20 Nov 2008 11:21:51 +0100 1975640 http://www.medworm.com/index.php?rid=1945450&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F445453882%2F The past 18 months were not terribly kind to Kevin Sharer. There were FDA warnings over health risks associated with the Aranesp and Epogen anemia meds and reduced Medicare reimbursement. Congress is investigating marketing practices. The SEC is probing a failure to disclose that a key clinical trial ended over safety concerns. There were layoffs. And he was named one of the worst CEOs. But Kevin is unflaggingly optimistic and predicts the fallout from safety concerns and reimbursement cuts for its anemia meds should bottom out during the first half of 2009. And he tells The Wall Street Journal this should bolster Amgen’s standing as it prepares for the anticipated approval and launch of denosumab, a new drug for osteoporosis, which may receive FDA approval next year. Kevin acknowled... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1945450 Fri, 07 Nov 2008 13:05:43 +0100 1945450 http://www.medworm.com/index.php?rid=1924714&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F436851712%2F The agency sent the biotech a warning letter for using what it called a ‘false and misleading’ consumer brochure to promote its Sensipar kidney med to patients. The problem? The brochure “omits and minimizes the risks associated with the use of Sensipar and broadens the indication for Sensipar,” according to the letter. For instance, Amgen failed to note that Sensipar, which is used to treat patients undergoing dialysis for chronic kidney disease, is associated with the risk of adynamic bone disease and poses a risk to patients with hepatic impairment, the FDA letter states. And these are serious risks (here is the brochure). For its part, Amgen says it will address FDA concerns. “We immediately ceased distribution of the brochure. Amgen is committed to respon... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1924714 Thu, 30 Oct 2008 12:05:49 +0100 1924714 http://www.medworm.com/index.php?rid=1901968&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F429089619%2F Apologies for the late send-off, but we had sundry tasks to run for Mrs. Pharmalot and one of the short people. And so we would like to leave you with a couple of items we meant to run by you earlier. Hope you have a pleasant evening and see you tomorrow… Glaxo posted better-than-expected third-quarter results after the weak British pound helped outweigh the impact of increased generic competition in the US. And the financial crisis has opened the door to potential acquisition among companies that need to sell off assets. However, ceo Andrew Witty says the drugmaker will lose a total of about $5 billion in sales as demand falls for treatments like its Coreg heart med and Wellbutrin antidepressant. And ongoing controversy surrounding its Avandia diabetes pill means the outlook for sal... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1901968 Thu, 23 Oct 2008 00:29:04 +0100 1901968 http://www.medworm.com/index.php?rid=1888453&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F424021737%2F The agency has missed a good many deadlines for reviewing new drugs. And Reuters has been sporting enough to come up with the following list: - Prasugrel, a blood thinner from Lilly and Daiichi Sankyo. A decision was due September 26 and the application remains pending; - Promacta, a Glaxo drug for a clotting disorder. The deadline was September 19. and no decision has been made; - Nplate, a clotting disorder drug from Amgen. A decision was due July 23. The drug was approved August. 22; - Telavancin, an antibiotic from Theravance. No ruling was made at the deadline of July 21. The drug is now scheduled to go before an FDA advisory panel on November 19; - Entereg, a drug from Glaxo and Adolor to treat a complication of bowel surgery. The product was approved on May 20, which was 10 days af... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1888453 Fri, 17 Oct 2008 20:18:39 +0100 1888453 http://www.medworm.com/index.php?rid=1886686&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F422796997%2F A New Jersey arbitrator ruled that a former Amgen sales rep can proceed with a wrongful termination claim against the biotech, a decision that may have implications for other whistleblowers who work in the state and seek to report objectionable practices to their employers but not government agencies. Elena Ferrante, 50, marketed the Enbrel treatment for rheumatoid arthritis and psoriasis in New Jersey between 2002 and 2005, but claims she was fired in retaliation for not complying with what she calls an unethical and illegal marketing strategy after reporting the practices to her supervisors (back story). Amgen contended Ferrante was required to not only report allegedly off-label marketing directives to her company, but also to an outside agency. The ruling by the arbitrator, retired US ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1886686 Thu, 16 Oct 2008 16:12:11 +0100 1886686 http://www.medworm.com/index.php?rid=1871102&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F417432488%2F Hello, everyone. We apologize for leaving so abruptly this afternoon, but a personal matter required that we be elsewhere. And for once, it was impossible to use the laptop. Nonetheless, we are now catching up and thought it would be worth noting a few developments. Coincidentally, they all involve a legal ruling. In any event, we hope your weekend goes well. Splendid time to pick a few apples, yes? Alabama settled Medicaid drug pricing lawsuits against Bristol-Myers Squibb and four other companies, according to Jere Beasley, a lawyer representing the state. Bristol-Myers is one of more than 70 companies the state has sued for allegedly overcharging the state’s Medicaid program, and Beasley says undisclosed settlements were reached with four other companies that were not named. A tri... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1871102 Sat, 11 Oct 2008 11:59:37 +0100 1871102 http://www.medworm.com/index.php?rid=1851208&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F409871544%2F A federal judge in Boston ruled the drugmaker infringed on Amgen’s patents with its Mircera anemia med, essentially upholding a preliminary decision issued in February. The order by US District Court Judge William Young deals a big setback to Roche, which already cut costs after its plans to market Mircera flopped and further underscores its need to takeover Genentech. The ruling caps more than a year of intense legal wrangling in which Roche lost a jury trial that found Mircera infringed on Amgen patents for its Aranesp and Epogen meds. That came shortly before Roche won FDA approval to market Mircera. Young subsequently issued a preliminary injunction barring Roche from selling Mircera. At one point, though, Young declined to issue a permanent injunction, noting it may not be in th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1851208 Fri, 03 Oct 2008 03:21:48 +0100 1851208 http://www.medworm.com/index.php?rid=1834807&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F403780883%2F The FDA has just issued one of its ‘‘early communications ‘ about preliminary results from a German study that is investigating whether an anti-anemia drug can improve the neurological functioning of patients who have experienced a stroke. Three months after the start of the study, 16 percent of the patients who had received the drug, epoetin alfa, had died compared to 9 percent of those patients who did not receive the drug, according to the agency. And so the FDA is conducting what it calls an ongoing safety review (here is the back story). In the US, epoetin alfa is marketed as Procrit by Johnson & Johnson, and Epogen by Amgen, and in Germany, marketed as Eprex by J&J. The drug part of the class of erythropoiesis-stimulating agents (ESAs) approved for use in ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1834807 Fri, 26 Sep 2008 13:23:49 +0100 1834807 http://www.medworm.com/index.php?rid=1811491&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F397181786%2F The global credit crunch and the equity meltdown may have caused pain to companies in most sectors, but it has had unexpected benefits for cash-rich established drugmakers such asShire, the Ireland-based speciality pharmaceutical business, The Financial Times reports. “It has strengthened our negotiating position,” Angus Russell, Shires’ ceo, tells the FT. This has helped shift the balance of power away from biotechs in their discussions with large drugmakers that are willing to pay high prices as they compete in their search to find future drugs to replenish thin portfolios. “In the past few years, it was a sellers’ market driving up valuations for less and less mature technology,” Tibur Papp, head of advisory at PharmaVentures, tells the FT. “Now... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1811491 Fri, 19 Sep 2008 12:52:10 +0100 1811491 http://www.medworm.com/index.php?rid=1809937&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F396270911%2F The health care giant released results of a Phase III study showing ustekinumab was just as safe and effective as the top-selling med sold by Amgen and Wyeth, which has a 75 percent share of the market, but required fewer injections. Patients received either twice-weekly injections of Enbrel or 45 mg or 90 mg injections of the J&J drug at the start of the trial and four weeks later. After 12 weeks, 74 percent given the higher dose of ustekinumab and 68 percent on the lower dose saw at least a 75 percent reduction in psoriasis symptoms, such as red scaly patches. By comparison, 57 percent on Enbrel saw a similar reduction (here is the statement). The drug works by blocking interleukin-12 and interleukin-23, which are proteins linked to inflammation in psoriasis and other autoimmune dis... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1809937 Thu, 18 Sep 2008 14:20:22 +0100 1809937 http://www.medworm.com/index.php?rid=1802935&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F394258319%2F After months of hype, the results from a long-awaited trial show that denosumab reduced the risk of verterbral fractures in post-menopausal women by 68 percent compared with those given a placebo. This places Amgen’s med on a par with Novartis’ Reclast drug, which is the most effective on the market. Although some investors hoped denosumab’s effectiveness would exceed 70 percent, the results suggest Amgen has a very competitive product in a big market. The stock is up more than 5 percent in the first hour of trading after the findings were made public. The three-year study involved 7,808 women and found that 60 mg of denosumab given every six months reduced the risk of new vertebral fractures by 68 percent versus placebo - 2.3 percent on denosumab versus 7.2 percent on pl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1802935 Tue, 16 Sep 2008 14:45:45 +0100 1802935 http://www.medworm.com/index.php?rid=1798523&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F393518130%2F The important data is released tomorrow, but the biotech has other study results to share about denosumab - subcutaneous injections every six months achieved significantly greater increases in bone mineral density compared with Merck’s Fosamax at all sites measured. For the primary endpoint, denosumab resulted in significant increases in BMD at the total hip - 1.9 percent versus 1.05 percent (here is the statement). This may encourage Amgen employees and investors, but the big issue is whether denosumab significantly reduced the risk of spine fracture in a three-year trial of 7,800 post-menopausal women. Amgen released partial results this summer, but never disclosed how much the risk was reduced. That’s what everyone is waiting to hear on Tuesday at the annual meeting of the Ameri... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1798523 Mon, 15 Sep 2008 22:39:48 +0100 1798523 http://www.medworm.com/index.php?rid=1790484&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F390987933%2F Next Tuesday, the struggling biotech releases data about denosumab, an experimental osteoporosis drug, and the data could make the difference between a multi-billion-dollar med and an also-ran in a crowded field. No small moment for a company that has staggered from setback to setback with its existing meds. “Denosumab is a mega-blockbuster opportunity and will now emerge as the principal long-term value driver,” Morgan Stanley analyst Steven Harr wrote in a recent research note, Reuters reports. “We see a high probability of regulatory success given data to date.” Two months ago, Amgen reported denosumab significantly reduced the risk of spine fracture in a three-year trial of 7,800 post-menopausal women, but never disclosed exactly how much the risk was reduced. T... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1790484 Fri, 12 Sep 2008 21:02:46 +0100 1790484 http://www.medworm.com/index.php?rid=1786183&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F388673081%2F The University of Iowa filed a lawsuit this week against Amgen for allegedly using it patented biotechnology to make two best-selling drugs - Enbrel, which is marketed to treat rheumatoid arthritis and psoriasis, and Vectibix, which is used to treat patients with metastatic colorectal cancer who have failed chemotherapy. In its lawsuit, which was filed in US District Court in Iowa, the university accuses Amgen of infringing two patents that were filed in 1992 and 1995 by Mark Stinski, a microbial virology professor, who asigned them to the University of Iowa Research Foundation. Amgen is also accused of ignoring the university’s entreaties, according to the suit. Enbrel sales for 2007, 2006 and 2005 were $3.2 billion, $2.9 billion and $2.6 billion, respectively, according to Amgen&#... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1786183 Wed, 10 Sep 2008 13:26:01 +0100 1786183 http://www.medworm.com/index.php?rid=1786187&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F388586261%2F A shiny day here in the nation’s medicine chest. And as always, there is much to do preparing for our own meetings and deadlines. This can mean only one thing - time to grab our ritual cup of stimulation. So as you reach for your own, here are a few items to help your day get started. All best… Amgen In No Rush For Bone Drug Partner (Dow Jones) Takeda Is Coy About Its Future With Alizyme (Bloomberg News) Novartis Meningitis Drug May Protect Older Infants (Yahoo/Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1786187 Wed, 10 Sep 2008 11:29:52 +0100 1786187 http://www.medworm.com/index.php?rid=1769135&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F383351047%2F The agency say the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen existing warnings in the prescribing info and medication guides due to risks of developing histoplasmosis, an opportunistic fungal infection. Most of the cases in the Ohio River and Mississippi River valleys and in at least 21 of those, the infection wasn’t initially recognized. Twelve patients died. The four drugs, known as tumor necrosis factor alpha blockers, or TNF-inhibitors, which suppress the immune system, are approved to treat such conditions as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn’s disease. Humira is made by Abbott; Cimzia is made by UCB; Enbrel is sold by Amgen and Remicade is sold by Johnso... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1769135 Thu, 04 Sep 2008 15:48:11 +0100 1769135 http://www.medworm.com/index.php?rid=1739491&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F377045349%2F The biotech is responding to practices that were criticized for contributing to overuse of its flagship anemia drug at the same time safety concerns were growing, The New York Times reports. Specifically, Amgen will no longer offer rebates to oncology clinics for their use of Aranesp, although larger discounts will be offered at the time of purchase. But discounts will not be offered on two other drugs, Neulasta and Neupogen, based on a doctor’s purchase of Aranesp, the paper writes. Critics have said that by providing hundreds of millions of dollars in discounts and rebates each year to cancer clinics, Amgen provided an incentive for doctors to use more of the drug. Oncology practices typically buy the drugs they use and then are reimbursed for them by patients and insurers. If the doc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1739491 Thu, 28 Aug 2008 11:23:26 +0100 1739491 http://www.medworm.com/index.php?rid=1739495&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F376515532%2F …more accustomed to backing Republican candidates for president. As the Democratic Convention builds to its unsurprising crescendo, a few drugmakers have tried to generate some political capital behind the scenes. For instance, Merck, Amgen, Pfizer, AstraZeneca, Novartis, Mylan Labs, Abbott Labs and Lilly all signed up as official sponsors. And as FDA Legislative Watch notes, the ceo’s from Pfizer, AstraZeneca, Lilly, Amgen and Merck are showing up. (Back story on Pfizer’s Jeff Kindler). Meanwhile, the newsletter notes that Lilly teamed with the National Black Caucus of State Legislatures and the Creative Coalition, an entertainment advocacy group, to host a reception and VIP dinner in celebration of African-American leaders. Among those honored: Spike Lee and the head of... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1739495 Wed, 27 Aug 2008 21:16:54 +0100 1739495 http://www.medworm.com/index.php?rid=1726572&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F371996914%2F The FDA has finally approved the biotech’s Nplate blood clotting drug, although the agency only approved its use for patients who fail to respond to other treatments. FDA approval was due on July 24, but the endorsement never materialized. In mid-July, however, BusinessWire issued a press release saying the FDA had, indeed, approved Nplate, albeit with certain risk management requirements. The premature release embarassed Amgen, which forced the news service to issue a retraction. News of the approval, though, comes to us courtesy of Reuters. The Amgen site, oddly enough, doesn’t have any mention. Perhaps, the press release is still in a drawer in Kevin Shearer’s desk? Not to worry. The official word will be out any moment. Kevin needs to celebrate any bit of good news he... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1726572 Fri, 22 Aug 2008 16:28:20 +0100 1726572 http://www.medworm.com/index.php?rid=1714167&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F368323944%2F Company 2007 2012 Percent Change Schering-Plough 0.38 1.58 315.8% Amgen 4.50 1.46 -67.6% Bristol-Myers Squibb 1.08 0.84 -21.7% Wyeth 0.60 0.49 -18.2% Abbott Labs 1.73 0.42 -75.7% Johnson & Johnson 0.39 0.38 -2.4% GlaxoSmithKline 0.27 0.32 17.3% Eli Lilly 6.64 0.29 -95.6% Novartis 2.27 0.27 -88.2% Merck 0.51 0.26 -49.0% Pfizer 0.39 0.06 -85.7% AstraZeneca 0.58 0.04 -92.6% Roche 4.03 0.00 -100.0% Sanofi-Aventis 0.11 0.00 -100.0% Which drugmaker is projected to replace its thinning pipeline fastest? A new analysis suggests that Schering-Plough, which has suffered this year over clinical trial results for its best-selling Vytorin and Zetia cholesterol drugs. The above table, courtesy of AVOS Life Sciences, shows the replacement ratio, which the research firm d... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1714167 Mon, 18 Aug 2008 18:40:47 +0100 1714167 http://www.medworm.com/index.php?rid=1668762&cid=t_102447_136_f&fid=36051&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FCancerCommentary%2F%7E3%2F351321495%2F Amgen has recently been told by the FDA to reword the labeling of its flagship anemia drugs - Aranesp and Procrit - to further restrict their use in treating cancer patients. The move, which the F.D.A. announced on Wednesday, represents the first time the agency has invoked authority under a 2007 law that empowered it to order changes in a drug’s prescribing information. Previously, the F.D.A. could only negotiate with a drug’s manufacturer to change the label. Sales of the drugs, Aranesp and Procrit, have already plummeted in the last year because of studies suggesting that their use to treat the anemia caused by chemotherapy could actually make cancer worse or shorten lives. Procrit is manufactured by Amgen but sold under license by Johnson & Johnson. Read more from NY Times. Tag... Cancer Commentary blogs http://www.medworm.com/rss/comments.php?id=1668762 Thu, 31 Jul 2008 08:09:34 +0100 1668762 http://www.medworm.com/index.php?rid=1668700&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F350954180%2F The change is being made to Amgen’s Aranesp and Johnson & Johnson’s Procrit to address concerns about the risks to cancer patients. The labels for the drugs now must say they are not indicated for patients undergoing chemotherapy with the intention to cure the patient, Richard Pazdur, who heads the FDA’s Office of Oncologic Drugs. The move follows a recommendation made last March by an FDA advisory committee that called for new limits on use for cancer patients over worries the drugs can increase the risk of tumor growth and death (back story). This marks the first time the FDA is using authority granted last year to force a drugmaker to change labeling. Why? The agency and Amgen butted heads over two changes - Amgen wanted to include statements that weren’t su... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1668700 Wed, 30 Jul 2008 23:14:39 +0100 1668700 http://www.medworm.com/index.php?rid=1660995&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F348345167%2F Late Friday, the biotech released partial study results showing its experimental osteoporosis drug, denosumab, significantly reduced the risk of bone fracture in post-menopausal women in a large number of patients, triggering a rise of nearly 18 percent in its shares in after-hours trading. That’s because denosumab, which targets a protein involved with bone-destroying cells, is seen as a key to Amgen’s future since the growth of its flagship anemia drugs - Epogen and Aranesp - have faltered over safety concerns that have brought Black Box warnings. Even before the after-hours run-up to $63.49, Amgen shares have climbed about 28 percent over the last three months. In a research note this morning, Rodman & Renshaw analyst Michael King writes that “the worst is behind ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1660995 Mon, 28 Jul 2008 12:31:44 +0100 1660995 http://www.medworm.com/index.php?rid=1652560&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F344568560%2F Kevin Sharer can keep that celebratory press release in his desk drawer a little while longer. The FDA didn’t issue a decision on Amgen’s Nplate yesterday as the biotech had expected, casting yet another gloomy cloud over the ceo’s ability to yank his company out of an ongoing crisis. Amgen wants to market Nplate for a disorder that causes the body to attack its own platelets - the red blood cells that help blood to clot, resulting in bruising and bleeding after minor injuries. This affects about 200,000 people in the US, and Rodman & Renshaw analyst Michael King recently estimated peak annual sales of $500 million. In March, an FDA advisory panel unanimously urged approval of Nplate. “We remain optimistic that a final decision will be made soon, but Amgen cann... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1652560 Thu, 24 Jul 2008 12:55:08 +0100 1652560 http://www.medworm.com/index.php?rid=1649306&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F343830430%2F Depends who you ask. But Contract Pharma magazine decided that a biopharma company is one that makes more than 40 percent of its drug revenues by selling biologic products, including biotherapeutics, vaccines and other proteins. As the mag’s editor, Gil Roth, says: No royalty-based companies allowed! (That means you, ImClone). This can be limiting, though. Gil could only find nine companies that would qualify for his Top 10 list. So to round it off, he threw in Elan, since it co-markets Tysabri with Biogen Idec. Good editors think creatively. 1 - Amgen - $14.3 billion 2 - Genentech - $9.4 billion 3 - Novo Nordisk - $7.7 billion 4 - Merck Serono - $6.1 billion 5 - Baxter BioScience - $4.6 billion 6 - Biogen Idec - $3.1 billion 7 - Genzyme - $2.8 billion 8 - CSL - $2.3 billion 9 - Alle... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1649306 Wed, 23 Jul 2008 19:06:15 +0100 1649306 http://www.medworm.com/index.php?rid=1640369&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F341431798%2F Welcome to the working week. Good to see you again. Hope your weekend was refreshing. Ours was quiet as we stuck to our knitting by doing some chores and tending to the shortest of the short people. Now, though, the routine reasserts itself. So grab your cup of whatever and dig in… Sanofi Buys Vitamin Maker For $544M (Bloomberg News) Glaxo Pays Biota $19M To Settle Relenza Suit (Bloomberg News) Novartis Unit Recalling Prescription Eyedrops (The Associated Press) Shire Cuts Tax Bill By Moving HQ (The Financial Times) Enbrel & Alzheimer’s Causes More Criticism (Yahoo/Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1640369 Mon, 21 Jul 2008 10:50:03 +0100 1640369 http://www.medworm.com/index.php?rid=1631579&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F337475704%2F That seems to be the betting. A federal appeals court is likely to uphold a preliminary injunction barring the sale of Roche’s Mircera in the US, but the ruling will be closely watched to see if the court addresses the so-called “public interest” issue, according to The Financial Times. Last year, a federal jury in Massachusetts found that Roche infringed Amgen patents, but damages weren’t awarded because Roche had not yet launched the product in the US. Roche did threaten to launch Mircera unless an injunction barring it from doing so was issued and so Roche is now appealing the preliminary injunction that was subsequently put in place, the paper writes. The District Court is likely to wait for the Federal Circuit to decide on Roche’s appeal before addressing the i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1631579 Wed, 16 Jul 2008 22:19:01 +0100 1631579 http://www.medworm.com/index.php?rid=1622995&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F335611506%2F A busy day here on the Pharmalot corporate campus where repairs were being made to the cafeteria. Nonetheless, we managed to get some work done. We hope you did as well. Meanwhile, here a few items that cropped up more recently. Have a good night and see you tomorrow… Judge Allows Abbott Class Action To Proceed (Yahoo/Reuters) Genentech Ends Studies On Drug-Combo Safety Issue (Associated Press) Amgen Drug Prevents Bone Loss In Prostate Cancer (Yahoo/Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1622995 Tue, 15 Jul 2008 01:27:24 +0100 1622995 http://www.medworm.com/index.php?rid=1622217&cid=t_102447_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F335215370%2Fdenosumab_prevents_osteoporosis_in_trial.html Amgen Inc. (NASDAQ:AMGN) announced that its experimental drug denosumab demonstrated that it can prevent bone loss in men that are being treated with prostate cancer drugs which can cause osteoporosis.Results, based on a three-year Phase III study of over 1,400 men, found that denosumab increased bone mineral density at the lumbar spine and non-vertebral sites than a placebo. All men in the study had non-metastatic prostate cancer and were undergoing androgen deprivation therapy.Amgen also stated that during the 36 months of the trial the men who received denosumab had have the incidence of new vertebral fractures than those receiving a placebo."This pivotal study in men with prostate cancer demonstrated once again that denosumab increases BMD consistently at all sites measured. ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1622217 Mon, 14 Jul 2008 16:00:36 +0100 1622217 http://www.medworm.com/index.php?rid=1616431&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F333092282%2F The agreement resolves litigation alleging the biotech offered illegal discounts to cancer clinics. J&J’s OrthoBiotech division had filed a lawsuit charging Amgen bundled meds - Neupogen, Neulasta and Aranesp - and, by doing so, forced the clinics to buy Aranesp instead of J&J’s Procrit. Aranesp is a longer-lasting version of Amgen’s anemia drug Epogen, which is marketed for treatment of kidney disease patients. Johnson & Johnson licensed Epogen and markets it under the Procrit brand name as a treatment for cancer patients undergoing chemotherapy. Amgen’s Neulasta and Neupogen increase production of infection-fighting white blood cells and are also used in chemo. In a statement, Amgen insists its conduct was not unlawful and it admits to no wrongdoin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1616431 Fri, 11 Jul 2008 23:11:43 +0100 1616431 http://www.medworm.com/index.php?rid=1606130&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F331710557%2F In doing so, Insmed apparently becomes the first US company to demonstrate bioequivalence for a follow-on biologic. The next step is for the drugmaker to meet with the FDA in hopes of receiving a green light to proceed with a Phase III study for its INS-19 which, like Neupogen, would combat neutropenia, a common side effect of chemotherapy. Neupogen, by the way, is a $1 billion seller. A Phase I trial involving 32 patients receiving either a dose of Insmed’s INS-19 or Amgen’s Neupogen found that the way the two biologics interacted with the body was statistically indistinguishable, while the concentration of G-CSF (G-CSF stimulates the production of white blood cells) for the two products were identical, according to Insmed. Here’s the statement. Two years ago, the FDA approved O... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1606130 Thu, 10 Jul 2008 13:02:22 +0100 1606130 http://www.medworm.com/index.php?rid=1561295&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F324265427%2F Earlier this year, Amgen went out of its way to disavow a widely publicized case study that suggested Enbrel, which is only approved for treating rheumatoid arthritis and psoriasis, may be useful in combating Alzheimer’s disease. In fact, the biotech issued successive press releases due to the single-patient case study, which was published last January by a Los Angeles physician in The Journal of Neuroinflammation and that suggested “rapid cognitive improvement” occurred in an 81-year-old patient, beginning only two hours after Enbrel was administered. The case report then noted his improvement lasted during a seven-week follow-up program that included weekly injections. Not surprisingly, the case report generated significant media coverage (CNN and BBC) and Internet chatter, which i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1561295 Tue, 01 Jul 2008 19:11:06 +0100 1561295 http://www.medworm.com/index.php?rid=1551894&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F321589313%2F A research program shot down by National Cancer Institute scientific advisors earlier this week was unlike any other, according to The Cancer Letter. The NCI proposed using $5 million in pharmaceutical industry money to pay for up to three R01 (investigator-inititated) grants to study the tumor promotion potential the ESA drugs, which are sold by Amgen and Johnson & Johnson. And the money would be contributed by those same companies, and floated through the Foundation for the National Institutes of Health, which the newsletter notes is a non-profit created by Congress to raise private funds to help support biomedical research. Confronted with the proposal for a Request for Applications at its June 23 meeting, members of the NCI scientific advisory board were troubled by the ethics of ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1551894 Sat, 28 Jun 2008 00:41:34 +0100 1551894 http://www.medworm.com/index.php?rid=1531700&cid=t_102447_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D2141 Once again, had to miss the best part of this presentation, but did hear Robert Bottone of Genentech discuss the problem that some managers in biopharm and pharma have with Operational Excellence. Many of them still expect “silver bullet’ solutions. This was also a conclusion reached by those who took our recent survey. Silver bullets simply [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1531700 Fri, 20 Jun 2008 15:02:44 +0100 1531700 http://www.medworm.com/index.php?rid=1522439&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F313061209%2F An FDA advisory committee will meet on Wednesday to review a request by Amgen to market Enbrel for moderate to severe forms of psoriasis in children. The med is used to treat rheumatoid arthritis and psoriasis in adults, but is approved only for Juvenile Idiopathic Arthritis in kids. FDA medical reviewers are concerned about life-threatening complications, according to the FDA briefing documents. The reviewers noted that “plaque psoriasis is not a life-threatening disease in childhood and complications are rare and largely psychosocial.” Enbrel, however, is “associated with life-threatening toxicities such as sepsis, anaphylaxis, and significant long-term morbidities such as malignancy, congestive heart failure, and demyelinating disease.” The FDA recently reviewed ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1522439 Mon, 16 Jun 2008 14:32:13 +0100 1522439 http://www.medworm.com/index.php?rid=1516785&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F311114641%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? Amgen shifted Anna Richo senior vp, worldwide compliance; Quintiles named Chris Cabell as chief medical and scientific officer; MonoSol Rx named Vincent Viviani senior vp of manufacturing and operations; MRNA, formerly Nastech, hired J. Michael French as ceo; Microsoft promoted Michael Shiels to national pharma mgr, Microsoft advertising; Shire hired Graham ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1516785 Fri, 13 Jun 2008 12:17:14 +0100 1516785 http://www.medworm.com/index.php?rid=1497753&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F305277536%2F Each year, Fortune magazine trots out a list that means something to top execs in corporate America - its annual ranking of the best companies to work. Making the list offers bragging rights, particularly if the ranking is high. Genentech, for instance, made it to the top ten for the past three years in a row. Conspicuously absent, however, is big pharma. Except for AstraZeneca, which finished No. 83 on the latest list, drugmakers don’t show up. (Here are the lists for 2008, 2007 and 2006). During the past three rankings, the only other big drugmaker to make an appearance at all was Lilly - just once. Given the pressures to develop new meds and the ongoing layoffs, one would be hard-pressed to say this is surprising. Of course, these are big companies and many employees are likely to... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1497753 Thu, 05 Jun 2008 11:48:16 +0100 1497753 http://www.medworm.com/index.php?rid=1494559&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F304588986%2F The agency is conducting a safety review of Enbrel, Humira, Cimzia and Remicade for a possible association with lymphoma and other cancers in children and young adults who have Juvenile Idiopathic Arthritis and Crohn’s disease. So far, the FDA has received 30 reports over the past 10 years, and about half of the cancers were lymphomas and included both Hodgkin’s and non-Hodgkin’s lymphoma. The FDA notes that the drugs suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to immune system-related diseases such as JIA, and Crohn’s disease. And the agency has been aware of the possible association between the use of TNF blockers and the development of cancer - prescribing info for all four TNF blockers warns about... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1494559 Wed, 04 Jun 2008 14:40:38 +0100 1494559 http://www.medworm.com/index.php?rid=1480913&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F301660724%2F Some may consider this a surprise, given that FDA reviewers expressed several concerns in their briefing documents about the Promacta treatment for chronic ITP prior to the advisory committee meeting. Those concerns included a failure to control bleeding any better than a placebo and Glaxo’s decision to seek approval for short-term use of a drug that may be used on a chronic basis. Nonetheless, all 16 voting members of the panel decided that the clinical data supported its use short- term, defined as 6 weeks, which was the period studied. Nonetheless, some panel members did raise concners the drug may be used on a long-term basis. Chronic ITP, by the way, is an autoimmune disease that destroys blood platelets need for clotting and affects about 60,000 Americans. Given the long-term term ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1480913 Sat, 31 May 2008 04:41:11 +0100 1480913 http://www.medworm.com/index.php?rid=1464202&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F296041820%2F As a condition of employment, Amgen requires its employees to sign arbitration agreements. This has been a trend for a number of years in corporate America and the reason is that this method of resolving disputes can be less expensive for employers, since arbitration doesn’t involve the court system. One former Amgen sales rep, however, is challenging the practice. In a lawsuit, Marc Engelman accuses the biotech of forcing reps to engage in off-label promotion and patient privacy violations to market the Enbrel medication for psoriasis. But he also charges the arbitration agreement is “procedurally unconscionable” and names the American Arbitration Association as a co-defendant. How is it unconscionable? For instance, the deal doesn’t allow for dispute involving ret... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1464202 Thu, 22 May 2008 19:30:40 +0100 1464202 http://www.medworm.com/index.php?rid=1454779&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F293841932%2F Another busy day comes to an end. We hope yours was productive and even meaningful. Now, though, the time has come to gather assorted children and loose ends, so we can take stock and prepare for another day. Hope your evening is pleasant and see you in the morning… Amgen’s Denosumab Protects Bone Density: Study (Yahoo/Reuters) Novartis Stock Jumps On Promise Of Kidney Cancer Med (Yahoo/AP) Shingle Victims’ Relatives Should Get Zostavax: Study (Bloomberg News) What Pharma Is Donating To Asian Disasters (Yahoo/AP) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1454779 Mon, 19 May 2008 23:30:46 +0100 1454779 http://www.medworm.com/index.php?rid=1446424&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F291382043%2F Some folks will be pulling all-nighters reading the abstracts released by the American Society of Clinical Oncology this evening. (Please look here). But if you simply want to glean a few highlights, here are the latest news summaries moving over our transom… Lilly Drug Slows Lung Cancer (The Wall Street Journal) Rash Most Common Side Effect In Vectibix Trials (Yahoo/Reuters) Avastin Improves Brain Cancer Survival (Yahoo/Reuters) Herceptin Enhances Tykerb For Breast Cancer (Yahoo/Reuters) Amgen Says Denosumab Combats Rare Bone Tumors (Yahoo/Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1446424 Fri, 16 May 2008 03:42:00 +0100 1446424 http://www.medworm.com/index.php?rid=1440005&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F289547914%2F We our about to take a rare midday break to speak at the Healthcare Compliance Packaging Council annual meeting. But we do promise to return shortly with the usual menu of items. Meanwhile, we came across these headlines. See you soon… Pfizer To Close Indiana Plant & Shed 140 Jobs (Yahoo/AP) Moody’s Cuts Amgen Ratings (MarketWatch) Hank McKinnell Joins Angiotech Board (The Wall Street Journal) AstraZeneca’s Toprol Raises Risk Of Death: Study (Bloomberg News) Intercell To Buy Iomai For $189 Million (Yahoo/Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1440005 Tue, 13 May 2008 16:38:26 +0100 1440005 http://www.medworm.com/index.php?rid=1437089&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F288911894%2F The FDA made a series of unsuccessful attempts to stop a direct-to-consumer advertising campaign that claimed that Johnson & Johnson’s Proctit improved “fatigue” associated with chemotherapy-induced anemia, The Cancer Letter reports. The ads, which were widely credited with making ESA drugs into the biggest-selling class of oncology drugs, were allowed to proceed with relatively minor changes after the FDA Office of Chief Counsel got involved in the controversy. The details of the doomed effort by FDA staff to modify the Procrit campaign emerged in documents that were placed in the public record at the May 8 hearing of the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigation. (Look here). A sequence of internal FDA emails released by the co... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1437089 Mon, 12 May 2008 19:50:11 +0100 1437089 http://www.medworm.com/index.php?rid=1429318&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F286007702%2F The Amgen ceo confronted an often testy group of shareholders Wednesday, his first annual meeting with investors since the biotech entered a prolonged crisis. “Last year was awful. I deeply, deeply regret that,” a calm and confident Sharer told the crowd of several hundred during an hourlong presentation at the Four Seasons Hotel in Westlake Village, California, The Los Angeles Times writes. He also sought to reassure investors by maintaining Amgen was off to a good start this year and suggested many of Amgen’s woes should be viewed along with problems affecting all drugmakers. “I’m not making any excuses…but things are pretty stormy out there right now.” Some shareholders appeared unconvinced and the meeting turned contentious when investors were ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1429318 Thu, 08 May 2008 11:07:47 +0100 1429318 http://www.medworm.com/index.php?rid=1426770&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F285447649%2F What is former research scientist Gal Hever doing with those big spoons? The 35-year-old opened an ice cream parlor after being laid off by Amgen, which is in the process of shedding 2,600 jobs to cope with its crisis. His plight reflects the problems that will be picked over at Amgen’s annual meeting today. As CNBC’s Mike Huckman notes, some shareholders are unhappy and want to bounce Amgen ceo Kevin Sharer. You can watch here. (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1426770 Wed, 07 May 2008 17:40:12 +0100 1426770 http://www.medworm.com/index.php?rid=1415017&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F281711069%2F And so the time has come once again to put aside the workload and break for a little dinner. We hope your day went well and you accomplished what you set out to do. As for us, we have a little errand to run for Mrs. Pharmalot. A bit of a surprise, in fact. So don’t say anything…. Shareholders Demand Three Enzon Directors Resign (Yahoo/AP) FDA Formalizes New Black Box Warning For Enbrel (Yahoo/Reuters) Merck CEO Not Giving Up On Cordaptive (Yahoo/Reuters) Sepracor Cuts Costs And Beats Estimates (Forbes) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1415017 Thu, 01 May 2008 22:23:28 +0100 1415017 http://www.medworm.com/index.php?rid=1413599&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F281416067%2F That’s according to the latest ranking by Forbes magazine, which scrutinized performance versus pay for 175 ceo’s. Kevin came in at…drum roll…No. 169 thanks to his many accomplishments - Amgen stock dropped, on average, 4 percent each year while he earned $12.3 million, on average, annually. Click here to watch ABC News single him out. Simply put, Kevin has presided over a crisis: The stock is down about one-third in the past year, thanks to various FDA warnings over health risks associated with its Aranesp and Epogen meds, not to mention reduced Medicare reimbursement. Congress is investigating marketing practices and the SEC is probing a failure to disclose that a key clinical trial ended over safety concerns, which only became known after an industry newsletter p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1413599 Thu, 01 May 2008 12:09:47 +0100 1413599 http://www.medworm.com/index.php?rid=1404200&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F279323333%2F Drug and device makers shouldn’t be allowed to offer freebies - including meals, gifts, travel and ghost-writing helps - to docs, staffers and students in any or all 129 of the nation’s medical colleges, according to a new report from the Association of American Medical Colleges, which spents two years on the project. “Over recent decades, medical schools and teaching hospitals have become increasingly dependent on industy support of their core educational missions,” the report states. “This reliance raises concerns because such support, including gifts, can influence the objectivity and integrity of academic teaching, learning a nd practice, thereby calling into question the commitment of academia and industry together to promote the public’s interest by ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1404200 Mon, 28 Apr 2008 11:01:05 +0100 1404200 http://www.medworm.com/index.php?rid=1399366&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F277564852%2F And so the week is quickly drawing to a close. Still, today is another day - a meeting or deadline may loom somewhere. So here are a few items to help you keep up with the world at large. As for us, we will take a quick break to feed the Pharmalot mascot and grab the cherished cup of coffee, but will return momentarily. Hope your day goes well… Wyeth, Progenics Bowel Drug Wins FDA Approval (Yahoo/Reuters) Amgen Reports Flat Earnings On Lower Sales (MarketWatch) Sweden Pulls Contaminated Sanofi Heparin Batches (Bloomberg News) EMEA Committee Approves Two Merck Drugs (Dow Jones) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1399366 Fri, 25 Apr 2008 11:22:42 +0100 1399366 http://www.medworm.com/index.php?rid=1389198&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F274688926%2F The line is growing ever longer. First, the House Energy and Commerce Committee and the Senate Finance Committee opened investigations into the controversial Vytorin trial, known as Enhance. Then, the New York and Connecticut Attorneys General begin their own probes into the handling of study data and the marketing of the expensive cholesterol med. Earlier this month, New Jersey’s Anne Milgram, issued her own subpoenas to Merck and Schering-Plough, according to the Merck earnings statement that was released this morning. The subpoenas were dated April 4. The Vytorin study has attracted enormous attention because the drugmakers delayed results for nearly two years; briefly changed the primary endpoint without consulting their lead investigator; named an independent panel to review dat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1389198 Mon, 21 Apr 2008 12:53:07 +0100 1389198 http://www.medworm.com/index.php?rid=1366895&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F268380895%2F File this under ‘Say Uncle.’ A dozen drug and device makers have told Chuck Grassley, the Iowa Republican, that they have plans or are working on plans to publicly disclose grants to outside groups, and the details will be provided on each company’s Web sites, the Associated Press reports. In particular, Grassley is interested in money spent on continuing medical education. Recently, Grassley asked 15 companies whether they planned to do what Lilly does, which is disclose its grants to such programs. And the responses are in. They are wide-ranging and sometimes vague, but mostly what the senator wanted to hear - many say they will go beyond disclosing CME grants and will also disclose payments to patients advocacy groups such as the American Heart Association or the Ameri... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1366895 Fri, 11 Apr 2008 13:48:41 +0100 1366895 http://www.medworm.com/index.php?rid=1362494&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F267368692%2F Scrambling to generate needed revenue, Roche has filed an appeal of a preliminary court injunction that bars US sales of its Mircera anemia med. The move comes as US District Court Judge William Young considers whether to require Amgen to license its patents to its Aranesp and Epogen drugs in return for a licensing fee. To date, Amgen has rejected Roche’s overtures and, instead, pressed for an injunction, citing its court victory last fall in which Roche’s Mircera was found to violate Amgen’s patents. In a statement, Roche says “the judge in the federal court encouraged Roche to appeal to the Federal Circuit Court of Appeals. Roche filed its notice of appeal today and plans to vigorously pursue this appeal. Roche maintains its position that all of Amgen’s patents&... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1362494 Thu, 10 Apr 2008 01:06:25 +0100 1362494 http://www.medworm.com/index.php?rid=1358623&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F266642956%2F We are rolling up the sidewalks ealier than usual so that we will arrive on time for a speaking engagement Wednesday morning at Jefferson Medical College to discuss blogging, of all things. Unfortunately, there is no simultaneous webcast, but we will make our usual appearance at Pharmalot. Meanwhile, here are a few items to help you ease into the evening. So enjoy and see you tomorrow… FDA Cites More Heparin Deaths Since 2007 (Associated Press) FDA Delays Decision On Amgen Clotting Drug (Yahoo/Reuters) Pozen Shares Sink On FDA Warning Letter (Yahoo/AP) Drug Regime Reverses Heart Disease In Diabetics (Yahoo/Reuters) India Converts Failed Vaccine Plants To Testing Labs (In-PharmaTechnologist) Teva To Pay Depomed $10M To Settle Patent Case (Associated Press) Environmentalists Concerned ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1358623 Tue, 08 Apr 2008 23:02:12 +0100 1358623 http://www.medworm.com/index.php?rid=1352282&cid=t_102447_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=1347611&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F263545183%2F Let’s take one problem at a time. First, there are fresh concerns over potentially troubling safety data from a late-stage study of the biotech’s drug for postmenopausal osteoporosis, known as denosumab. Wall Street is worried because results show the med increased bone density in both early and late stage postmenopausal women, but patients had a higher rate of infections requiring hospitalization. Amgen says its investigators don’t believe the higher infection rate is related to the drug, noting that additional studies involving patients undergoing cancer therapy, who are typically more susceptible to infection, didn’t yield higher infection rates. Just the same, Amgen shares fell. “We caution…that if not a regulatory risk, such data included in an even... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1347611 Thu, 03 Apr 2008 20:23:09 +0100 1347611 http://www.medworm.com/index.php?rid=1347617&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F263375822%2F By and large, Amgen shareholders are not a happy bunch. The biotech’s stock is down about one-third in the past year, thanks to various FDA warnings and health risks associated with its Aranesp and Epogen anemia meds, not to mention reduced Medicare reimbursement. For awhile, ceo Kevin Sharer appeared in denial, until he began slashing jobs a few months ago. The poor performance ate away at his compensation last year by 27 percent, but Sharer still managed to get $13.2 million. Not bad for a bad year. All this has frustrated Steve Silverman,* a retired insurance executive who holds an undisclosed amount of Amgen stock in a family trust. A vocal critic of Amgen management, he wants Sharer to go. He explained his views… Pharmalot: Beyond the usual sort of research, how have you g... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1347617 Thu, 03 Apr 2008 14:59:48 +0100 1347617 http://www.medworm.com/index.php?rid=1344616&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F262141492%2F It took Kevin Sharer nearly a year to admit the biotech was having a crisis, and that’s probably because he finally realized he wouldn’t get as much money as he had in the past. His 2007 compensation was down nearly 29 percent - to $13.2 million - from $18.6 million the year before, according to the proxy filed with the Securities and Exchange Commission. Of course, that’s still a lot of money, isn’t it? Especially for a company with a laundry list of problems and embarassments - an FDA panel urged tighter restrictions for its Aranesp flagship med after studies found increased risks of cardiovascular disease, tumor growth and death. Congress is investigating the marketing and safety of several of its drugs. The SEC is probing its failure to tell Wall Street that a k... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1344616 Tue, 01 Apr 2008 18:50:25 +0100 1344616 http://www.medworm.com/index.php?rid=1340922&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F261884477%2F The House Energy and Commerce Committee wants the biotech and the health care giant to turn over documents concerning promotion of their anemia drugs, which have been linked to increased risk of death at high doses. In particular, the documents include DTC ads for Johnson & Johnson’s Procrit, and Amgen’s contracts with oncologists, because the committee is concerned that the biotech offered discounts on two of its other meds - Neupogen and Neulasta - in return for prescribing Aranesp. And so ad materials are sought for those two treatments as well. “We are concerned that such ‘bundling’ practices may have helped fuel excessive and dangerous off-label use of Aranesp,” John Dingell, the Michigan Democrat who chairs the committee, wrote a letter to Amg... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1340922 Tue, 01 Apr 2008 10:51:39 +0100 1340922 http://www.medworm.com/index.php?rid=1334571&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F259745725%2F Maybe. That’s what we hear from sources familiar with the biotech, which is enduring all manner of difficulties for more than a year. An FDA panel urged tighter restrictions for its Aranesp flagship med after studies found increased risks of cardiovascular disease, tumor growth and death. Congress is investigating the marketing and safety of Aranesp and another anemia drug. The SEC is probing its failure to tell Wall Street that a key clinical trial ended over safety concerns. Medicare reduced reimbursement. And the stock isn’t far from its 52-week low. To cope, Amgen last August announced staff cuts of 12 percent to 14 percent, which represents 2,200 to 2,600 jobs. The hope is to save between $1 billion and $1.3 billion this year. But this may not be enough, especially since a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1334571 Fri, 28 Mar 2008 17:02:29 +0100 1334571 http://www.medworm.com/index.php?rid=1329202&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F258502152%2F The federal judge overseeing the patent battle between Amgen and Roche has ordered that an expert be appointed to recommend how to compare the dosing and prices of their anemia drugs, Reuters reports. Last October, a federal court jury in Boston found that patents on Amgen’s anemia drugs were valid and that Roche’s Mircera, which has since been approved by the FDA for treating anemia in kidney disease patients, infringed three patents. But US District Court Judge William Young declined to issue a permanent injunction barring Mircera sales in the US and may instead impose a licensing deal allowing Roche to launch its drug - which is administered less often than Amgen’s Epogen and Aranesp - if certain terms are met. Roche offered to pay a 22.5 percent royalty to Amgen and a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1329202 Wed, 26 Mar 2008 19:21:47 +0100 1329202 http://www.medworm.com/index.php?rid=1314430&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F254454834%2F A federal appeals court ruled that Roche’s Mircera anemia med could be imported - so long as it wasn’t for sale, but reversed a decision from the International Trade Commission that it couldn’t rule on whether the importation infringed on patents held by Amgen, The Wall Street Journal reports. The decision is the latest twist in a searing battle between Roche and Amgen, which is trying to prevent the drugmaker from selling Mircera in the US, after winning a trial last year in which Roche was found to have violated patents on Amgen’s best-selling Aranesp anemia drug. The October decision came just one month before the FDA approved Mircera for the US market for patients with anemia caused by kidney damage. “Roche has set a course to export Amgen’s hard-ear... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1314430 Wed, 19 Mar 2008 18:59:27 +0100 1314430 http://www.medworm.com/index.php?rid=1311464&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F253804186%2F After being called the equivalent of a snake oil salesman, Roche execs accepted terms imposed by a federal judge in order to begin selling their new Mircera anemia medication. The tentative arrangement follows Roche’s defeat last October in a Boston courtroom, where the drugmaker was found to have violated patents on Amgen’s best-selling Aranesp and Epogen drugs. In November, however, Roche won FDA approval to sell Mircera and, hoping to bolster its 2008 budget with fresh revenue, worked with US District Court Judge William Young to negotiate a deal with Amgen. And so Roche has agreed to pay Amgen a royalty of 22.5 percent of US sales, compared with the 20 percent offer that Amgen rejected. Roche must also guarantee it won’t charge higher prices than Amgen. Amgen, however... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1311464 Tue, 18 Mar 2008 18:56:31 +0100 1311464 http://www.medworm.com/index.php?rid=1307878&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F253018300%2F The biologic, which is used to treat arthritis and psoriasis, which already included a warning over the risk of TB and other infections, but gets the more serious warning to suggest screening and monitoring patients for TB, including those who test negative for latent tuberculosis infection. The Black Box aslo notes that TB has been seen in patients receiving TNF-blocking agents, a group of meds that also includes Abbott’s Humira and Johnson & Johnson’s Remicade, which contain similar warnings. In its statement, Amgen says TB may be due to reactivation of latent tuberculosis infection or to new infection. Moreover, the labeling notes TB has been seen in about 0.01 percent of patients who have taken Enbrel in clinical trials, although Amgen maintains data suggests the risk... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1307878 Mon, 17 Mar 2008 14:13:13 +0100 1307878 http://www.medworm.com/index.php?rid=1307920&cid=t_102447_136_f&fid=36051&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FCancerCommentary%2F%7E3%2F252934329%2F Wow, it’s Monday again!? Yeah it is. Another manic Monday… I hope you guys had a great weekend. I hope you are recharged, rested and was able to unwind. Here are the top five I found today, at the cancer front: Fat Women ‘At Greater Cancer Risk’ Alzheimer’s or cancer: Which disease would you rather die from? Eating broccoli can help prevent bladder cancer Boy’s cancer project takes off Amgen To Use Lab21 Diagnostic Test For Cancer Gene Well, that’s all for now folks! I hope you are up and about for the daily grind this week. ;-) Tags: Alzheimers-disease, Amgen, bladder-cancer, brocolli, cancer death, cancer gene, cancer project, eating brocolli, fat women, womenShare This (Source: Cancer Commentary) Cancer Commentary blogs http://www.medworm.com/rss/comments.php?id=1307920 Mon, 17 Mar 2008 11:10:42 +0100 1307920 http://www.medworm.com/index.php?rid=1301893&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F250991696%2F A closely watched FDA panel meeting ends with not-such-great news for Amgen and Johnson & Johnson. The drugmakers can continue marketing their anemia meds for cancer patients, but the current use should be restricted over concerns the drugs can increase the risk of tumor growth and death. However, the panel decided against completely restricting use in cancer patients, which Wall Street feared might have happened. The voting: By a 13-to-1 margin, the advisory committee decided the drugmakers should market their meds for use in cancer patients undergoing chemo. But the vote was 11-to-2 for restricing use in curative patients - those with early-stage cancer whose treatments may provide a cure. And the committee voted 9-to-5 in recommending the meds shouldn’t be used in patients w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1301893 Thu, 13 Mar 2008 21:48:56 +0100 1301893 http://www.medworm.com/index.php?rid=1300632&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F250706099%2F Remember what the morning mayor used to say: Every brand new day should be unwrapped like a precious gift. So what if a meeting or deadline has you vexed? That bigger picture counts. So grab your cup of stimulation or bottle of water - even if the Associated Press found that it, too, is loaded with your favorite medicines - and get caught up with us… ImClone Systems and Bristol-Myers Squibb may test some US cancer patients for a tick-bite antibody that can cause severe allergic reactions with Erbitux, according to a study. Researchers found an antibody in some patients, particularly in southeastern states, that reacts against a sugar in Erbitux to make them allergic to the treatment. The antibody probably comes from being bitten by ticks, study senior author Thomas Platts-Mills tells... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1300632 Thu, 13 Mar 2008 11:28:06 +0100 1300632 http://www.medworm.com/index.php?rid=1297940&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F250085312%2F How’s this for imagery? For more than two decades as an oncologist, Richard Pazdur frequently delivered bad news to patients. Once, a dying man grabbed his coat and begged him to try even more chemotherapy. But the doc says he declined, because he believed further treatment wouldn’t help. The patient died less than an hour later. This sets the tone for a profile in The Wall Street Journal, which writes that Pazdur, 55, still makes life-or-death judgments - and gets a lot of criticism as a result. That’s because each decision affects millions of Americans. Pazdur heads the FDA’s Office of Oncologic Drugs, which makes him the gatekeeper for any new cancer med that goes on the US market - and an estimated 30 percent of all drugs that are in an advanced stage of develop... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1297940 Wed, 12 Mar 2008 11:55:19 +0100 1297940 http://www.medworm.com/index.php?rid=1291148&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F249040604%2F The ongoing battle between the biotech and some former sales reps - who allege they were forced to promote the psoriasis treatment off-label and violate patient privacy - now centers on a pair of older studies showing the biologic was linked to congestive heart failure. The issue, which is mentioned in a complaint filed by a former rep (look at item 17) is whether Amgen disregarded study data, altered the drug warning so that only people with advanced CHF were described as at risk, and then encouraged reps to promote Enbrel to treat congestive heart failure. The rep is suing Amgen for $10 million for wrongful termination and her complaint contains various allegations that reps were told to promote off-label and encourage docs to prescribe Enbrel to patients who may not have needed the dru... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1291148 Mon, 10 Mar 2008 19:02:02 +0100 1291148 http://www.medworm.com/index.php?rid=1291149&cid=t_102447_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F249018948%2F The agency’s staffers raised several issues ahead of a Wednesday meeting to review Nplate, which the biotech hopes to market for a disorder that causes the body to attack its own platelets - the red blood cells that help blood to clot. The condition causes bruising and bleeding after minor injuries, and affects about 200,000 people in the US, the Associated Press writes. But according to briefing documents on the FDA web site, studies showed several adverse reactions, from bone-marrow abnormalities to dangerous blood clots. The reviewers wrote that Nplate patients showed significantly higher platelet levels than those taking placebo in two, six-month studies conducted by Amgen. Patients received weekly injections of Nplate, a genetically engineered version of the protein that encoura... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1291149 Mon, 10 Mar 2008 18:18:15 +0100 1291149