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 'genzyme'. Sat, 03 Sep 2011 02:28:50 +0100 http://www.medworm.com/index.php?rid=5097091&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkBbacS-nh_o%2F What consent decree? Just one week after sending a July 26 letter to patients that limited allocations of the Fabrazyme medication would remain available this month, Genzyme is now telling patients that unspecified quality control problems have disrupted supplies. Although the disruption is supposed to be brief, Genzyme was unable to say when Fabrazyme would be shipped, according to patients. “I got a call from my nurse case manager (at Genzyme) to say there’s no drug available this month,” Tom Olshewski of Grayling, Michigan, tells us. “I was told there’ll be no medicine until further notice.” And Michael Masula of Kilbuck, Pennsylvania says that “it was due to a quality control issue and they anticipate it being short lived…but they always say ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5097091 Thu, 04 Aug 2011 16:34:58 +0100 5097091 http://www.medworm.com/index.php?rid=5078034&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpESdhESRxXI%2F And so, another working week is drawing to a close. This is, of course, our signal to daydream about weekend plans. We have not yet finalized our agenda, but we do hope to catch up on some reading and spend time with our short people. We may even tidy up the Pharmalot corporate campus. And you? Anything special in the offing? A day at the beach? A night at the movies? Maybe a dinner with someone special? Or if you have a high pain threshold, you could track the children in Washington DC as they jeopardize the economy. Whatever your pleasure, have a great time, but be safe. See you soon… Pfizer Wins Prempro Case In West Virginia (Bloomberg News) Nevada Wins Right To Continue Hormone Replacement Lawsuit (Las Vegas Sun) Sanofi Won’t Make Genzyme Milestone Payment (The Boston Globe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5078034 Fri, 29 Jul 2011 12:10:06 +0100 5078034 http://www.medworm.com/index.php?rid=4821147&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyOVyul9EBWA%2F In the latest flap over Genzyme, its ongoing manufacturing problems and subsequent product shortages, a group of Fabry patients are charging the biotech has employed a double standard when it comes to providing its Fabrazyme med to US patients and those in Europe. For the past two years, Genzyme has had difficulty supplying two drugs for rare diseases due to a series of manufacturing gaffes that led the biotech to signe a consent decree and pay a $175 million fine. Despite repeated attempts to resume full production, Genzyme has been unable to deliver and forced patients to accept rationing that amounts to lower dosages or no treatment. The ongoing delay has allegedly contributed to at least three deaths and worsening health among some patients (look here). In response, several US patients... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4821147 Fri, 13 May 2011 13:52:26 +0100 4821147 http://www.medworm.com/index.php?rid=4813667&cid=t_111518_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=4715016&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYiEPmFQ6yMo%2F And so another work week will soon draw to a close. This means, of course, the time has come to daydream about weekend plans. Our agenda includes spring cleaning, taking one of our short people to a soccer match and catching up on some sleep. What about you? Anything special planned? A walk in the park? Reaching out to an old friend? Maybe planning the rest of your life? Whatever you do, have a great time. Meanwhile, here are some tidbits. Catch you soon… EU Backs Boehringer Pradaxa Stroke Prevention Drug (Reuters) US Will Negotiate Medicare Drug Prices: Obama (Pharma Times) EU OKs Bydureon Diabetes Med From Lilly & Amylin (Reuters) Genzyme MS Drug Shows Promising Five-Year Results (Mass High Tech) Glaxo To Sell Plant And Eliminate 250 Jobs (Memphis Business Journal) Glaxo To Se... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4715016 Fri, 15 Apr 2011 11:33:47 +0100 4715016 http://www.medworm.com/index.php?rid=4704960&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIe-9hJBgDxE%2F Over the past fewl months, several patients suffering from Fabry disease – a rare, inherited disorder that causes kidney and heart problems – have tried different ways to get a needed medication called Fabrazyme. The drug, which is made by Genzyme, has been rationed due to severe manufacturing problems that led to a consent decree for the biotech, which is now part of Sanofi-Aventis. Twice, the patients have petitioned the National Institutes of Health to allow them to break a patent; they have also petitioned the FDA to insist that overseas stock of the med is first made available to US citizens, and they are suing Genzyme and Mt. Sinai Medical Center in New York, which licensed Fabrazyme to Genzyme (back story). The outcome of their efforts is unclear, although they say Fabry patient... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4704960 Mon, 11 Apr 2011 16:07:44 +0100 4704960 http://www.medworm.com/index.php?rid=4627015&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4tFBEcAGy0Q%2F Never mind a consent decree. Genzyme continues to have manufacturing problems at its Allston Landing, Massachusetts facility. The biotech today disclosed that a lot of its Fabrazyme med, which is used to treat Fabry’s disease, was rejected for failing to meet quality standards and the move will further limit supplies to patients who are already suffering from rationing. “As you know, we have been operating with very limited inventory of Fabrazyme. Because inventory is so limited, loss of this specific lot of Fabrazyme will have an impact on some patients in the coming months. For some patients, this may mean delaying scheduled infusions immediately; for some patients, it may mean missing one or more infusions altogether over the next few months. All regions will share the impac... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4627015 Wed, 23 Mar 2011 22:18:21 +0100 4627015 http://www.medworm.com/index.php?rid=4627023&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQC6EHv3GSyQ%2F Good morning, everyone. A spot of snow is falling on the Pharmalot corporate campus today. So much for spring. Nonetheless, we persevere thanks, in part, to a cup of stimulation - our flavor today is Southern Pecan. Meanwhile, we are gearing up for those meetings and deadlines, and trust you are doing the same. To help you along, here are some tidbits from around the world. Hope you have a productive day and catch you soon… Novartis Must Wait Longer For FDA Decision On COPD Drug (Reuters) Glaxo Scraps Plan To Market Prostate Cancer Med (Associated Press) Former Pfizer CEO And His Severance (Associated Press) Medicare Ordered To Pay For Off-Label Drugs (American Medical News) Bristol Pays CEO Andreotti $11M In Compensation (Associated Press) Gilead HIV Drug Meets Main Trial Goal (Reut... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4627023 Wed, 23 Mar 2011 12:05:07 +0100 4627023 http://www.medworm.com/index.php?rid=4575244&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyX0B1GekJDo%2F Earlier this week, we wrote how the European Association for the Study of the Liver had difficulty maintaining an embargo on abstracts to be reviewed at its upcoming annual conference, even though the material is freely available on the Internet (see here). Then Embargo Watch notes that the public relations firm for the EASL is Cohn & Wolfe, which also represents various drugmakers, such as Allergan, Genzyme, Sanofi-Aventis, Boehringer-Ingelheim and Merck (see this). This raises a question: how can a public relations firm equitably run the media operations for a professional society conference and simultaneously represent drugmakers who may have a great deal at stake at these conferences? You know, abstracts from one or more clients could be on display at the gathering. How can the EA... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4575244 Fri, 11 Mar 2011 16:36:35 +0100 4575244 http://www.medworm.com/index.php?rid=4570756&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqwwaHAzPqK0%2F A half dozen people who suffer from Fabry disease have filed a lawsuit against Genzyme and Mt. Sinai Medical School for the way ongoing shortages of the Fabrazyme treatment is being handled. The med is the only treatment approved by the FDA for the rare, but life-threatening genetic disease, but Genzyme is rationing due to long-running production problems. Specifically, the biotech imposed a rationing system in which patients receive only half of the approved dosage, while newly diagnosed patients are prevented from receiving Fabrazyme at all. The move came after Genzyme encountered severe manufacturing problems that began in 2009, prompting a $175 million fine, a consent decree and, more recently, a $20 billion takeover by Sanofi-Aventis. Meanwhile, as many as three Fabry patients have d... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4570756 Thu, 10 Mar 2011 20:33:10 +0100 4570756 http://www.medworm.com/index.php?rid=4560596&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBmQMqz6sngk%2F Maybe there was a perverse logic at work when Genzyme screwed up its manufacturing so badly? The serious gaffes led to a $175 million consent decree with the FDA and closed a key plant; left patients with little or no supplies; angered investors, including Carl Icahn, who waged a proxy fight; and prompted a board probe into insider stock sales (back story here, here, here and here). But the mess also drove down Genzyme stock to the point where Sanofi-Aventis found that making a bid was too tempting to ignore. And so now the big drugmaker is paying $20 billion - or $74 a share plus contingent value rights - to acquire the beleaguered biotech which, of course, does offer Sanofi entree into biologics and other therapeutic areas. Meanwhile, Genzyme ceo Henri Termeer is going to float away hol... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4560596 Tue, 08 Mar 2011 13:31:36 +0100 4560596 http://www.medworm.com/index.php?rid=4489608&cid=t_111518_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F02%2Fafter-manufacturing-problems-genzyme.html In late 2009, I posted about problems at a Genzyme plant that manufactured some fabulously expensive drugs, e.g. Cerezyme whose cost to patients approximated $160,000 a year. We thought then that for a drug costing that much, the company ought to have figured out a conservative process to provide pure and unadulterated product. In a later post I asked why a company that could afford to make its CEO very rich could not afford to adequately maintain its manufacturing facilities. In May, 2010, I posted about a legal settlement of charges related to its manufacturing problems requiring Genzyme to pay a $175 million fine and function under US government supervision.  And in August, 2010, I posted about how this series of management missteps could lead to the company's C... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4489608 Thu, 17 Feb 2011 22:16:00 +0100 4489608 http://www.medworm.com/index.php?rid=4489978&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fm5Z4_CQibSM%2F After chasing Genzyme around the table for several months, Sanofi-Aventis has finally reached a deal. Originally, the drugmaker offered $69 a share, but as you know, is paying $74 in cash, or roughly $20 billion, plus an unusual contingent value rights (CVR) that will be priced depending on various factors, such as fixing manufacturing problems and whether the Campath leukemia med is approved for multiple sclerosis. And so the CVR could require additional payouts of up to $4 per CVR later. Or maybe not. As for strategy, Sanofi ceo Chris Viehbacher has pooh-poohed stock buybacks and talked up the value of pursuing Genzyme and its biologics, an area of keen interest to big pharma. Then again, Genzyme is saddled with ongoing manufacturing difficulties that resulted in not only a consent decre... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4489978 Wed, 16 Feb 2011 16:34:00 +0100 4489978 http://www.medworm.com/index.php?rid=4482972&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTPwrSwUNAKo%2F Good morning, everyone. Nice to see you again. A sunny day is unfolding here on the Pharmalot corporate campus, where we are happily quaffing our mandatory cup of stimulation. This will be an especially busy day as we must break for a personal matter, but we will endeavor, nonethless, to hunt about for interesting items. Meanwhile, we would like to remind you that we are hosting a webinar on requirements for disclosing payments to physicians (look here). See you soon… Sanofi-Aventis To Buy Genzyme For $20 Billion (Bloomberg News) Sanofi-Aventis Will Withdraw Anzement From Five Countries (Dow Jones) Merck No Longer Has Buyer For Dutch R&D Unit (Reuters) Takeda Strikes Deal With Covance And Quintiles (Outsourcing Pharma) Generic Drugmakers To Support FDA User Fees (Wall Street Jou... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4482972 Wed, 16 Feb 2011 12:56:39 +0100 4482972 http://www.medworm.com/index.php?rid=4372246&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIzSqDJiZYhw%2F File this under ‘if at you first you don’t succeed…’ After being rejected last month by the National Institutes of Health in a bid to override the patent on a Genzyme drug that is in perpetually short supply, a pair of Fabry’s disease patients are now petitioning the FDA to insist that overseas stock of the med is first made available to US citizens. The move comes amid ongoing difficulties Genzyme has encountered in producing sufficient supplies of Fabrazyme due to severe manufacturing problems that began in 2009. These prompted a $175 million fine, a consent decree and a takeover bid from Sanofi-Aventis. Existing patients, meanwhile, are subject to inadequate rationing and newly diagnosed patients are unable to receive any meds. To rectify the situation, som... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4372246 Wed, 19 Jan 2011 15:25:39 +0100 4372246 http://www.medworm.com/index.php?rid=4349700&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5NrfDeio_0c%2F And so another working week will soon draw to a close. In this case, a long weekend is about to begin, at least on this side of the pond. Have any special plans? We expect to tidy up around the Pharmalot corporate campus, spend time with our short and not-so-short people, and take a long walk or two. What about you? Take in a movie or read a good book? Maybe get rid of some flab? Whatever you do, have a great time and come back energized. Meanwhile, here are a few tidbits to help you along. See you next week… Abbott Labs Withdraws Psoriasis Drug (Wall Street Journal) Sanofi Tells Docs About Liver Transplants In Multaq Patients (CardioBrief) Glaxo Malaria Vaccine Works For 15 Months: Study (Bloomberg News) Ambien Makes Older People Too Sleepy (Reuters) Allos Therapeutics Lays Off 13 P... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4349700 Fri, 14 Jan 2011 13:00:43 +0100 4349700 http://www.medworm.com/index.php?rid=4343334&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCgLvWskDCNk%2F Hello, everyone, and top of the morning to you. A steely, wintry sky hovers over the Pharmalot corporate campus this morning, where we are enduring the usual routine of hustling short people to this or that school house. As we cope - where is that cup of stimulation? - please join us in perusing the news of the world. Meanwhile, feel free to pass along interesting tidbits. Have a good one… AstraZeneca And Cancer Charity Strike Drug Testing Deal (Bloomberg News) FDA Warns Of Acetaminophen Risks Of Liver Toxicity (Drug Store News) Drug Shortages Persist With No End In Sight (Daily Finance) Biotechs And Generics Spar Over Biologic Exclusivity (The Wall Street Journal) FDA Says Sanofi-Aventis’ Lantus Link To Cancer Is Unclear (Reuters) US Cancer Costs Are Expected To Soar (Los Ange... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4343334 Thu, 13 Jan 2011 13:02:18 +0100 4343334 http://www.medworm.com/index.php?rid=4285353&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fj_8GX6iXEFk%2F The holiday weekend may be in the offing, but the Pharmalot corporate campus is still humming. And why not? The world has not stopped spinning, after all, and there is always something interesting going on. So while you prepare for a celebration or simply slow down the usual pace, here are a few items to help you along. Meanwhile, we pass along holiday greetings and hope everyone has a chance to catch up on some fun things and enjoy life. See you soon… Cephalon Names Kevin Buchi As CEO (statement) Lundbeck Alcoholism Pill May Be A Goldmine (Bloomberg News) Novartis To Build Vaccine Plant In North Carolina (Raleigh News & Observer) FDA Reviews Safety Of Human Growth Hormone Drugs (Reuters) Pfizer And Bristol Bloodthiners Beats Sanofi Drug In Study (Bloomberg News) Massachusetts Award... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4285353 Thu, 23 Dec 2010 12:54:53 +0100 4285353 http://www.medworm.com/index.php?rid=4272605&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FwSjIqriGttE%2F Welcome to the working week, although this will be a shortened one due to the pending holiday. Nonetheless, the usual routine is in full swing, which means we are brewing the mandatory cup of stimulation and poking about for interesting items. Let us know if you hear of anything. Meanwhile, here are a few tidbits. Hope your day goes well… Gilead To Buy Arresto Biosciences For $225M (Bloomberg News) Gunmen Raid Distribution Facility But Are Apprehended (Securing Pharma) Genzyme To Push Argument For Campath Value (Reuters) Novartis To Invest $500M In Russia And Build Plant (Bloomberg News) Sanofi-Aventis And Avila Sign Cancer Drug Deal (Reuters) Claris Promises To Resolve FDA Problems Soon (MoneyControl) Phylogica And Pfizer Sign Vaccines Deal (Sydney Morning Herald) Another Prempro Tr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4272605 Mon, 20 Dec 2010 12:58:33 +0100 4272605 http://www.medworm.com/index.php?rid=4237848&cid=t_111518_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fboards-who-ought-to-be-accountable-for.html I recently posted about the multiple conflicts of interest affecting a university health sciences leader.  While he was supposed to be running a medical school and an academic medical center, he was also responsible for the stewardship, as a board member, of three health major health care corporations, and a food and beverage corporation (whose products have bearing on nutrition and public health.)  .This one case suggested how pervasive are conflicts of interest affecting the people at the top of health care leadership in the US, and also how such conflicts may be associated with problems for all the organizations involved.  The story originally came to my attention because students were demonstrating against the lavish compensation given the health sciences leade... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4237848 Tue, 07 Dec 2010 17:44:00 +0100 4237848 http://www.medworm.com/index.php?rid=4238149&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FA1QbLY7H6xo%2F Despite an ongoing shortage of a much-needed med for Fabry’s disease, the National Institutes of Health has denied a bid by three patients to obtain a license that would allow them to produce a new treatment. The move comes as Genzyme, which makes Fabrazyme, continues to struggle with supplies after more than a year of severe manufacturing problems. The patients petitioned the US Department of Health and Human Services last summer to override the use patents held by Genzyme on its med, which is the only such treatment currently available for a rare, inherited disorder that causes kidney and heart problems (back story). Genzyme, you may recall, recently agreed to pay $175 million as part of a consent decree for its manufacturing gaffes, including viral contamination, and is now the su... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4238149 Tue, 07 Dec 2010 14:48:04 +0100 4238149 http://www.medworm.com/index.php?rid=4238151&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4wnU_lg3IY0%2F Rise and shine, everyone. Another brand new day is on the way and, once again, we are hustling the short people off to their various school houses. This calls, of course, for a cup of stimulation. So please join us, or grab a bottle of water if you prefer. Meanwhile, here are a few tidbits to get us all started. Have a great one and drop us a line if you hear anything interesting… Sanofi Unwilling To Meet Genzyme Demands (Bloomberg News) Enzon Pharma Cuts Workforce By 26 Percent (Reuters) Johnson & Johnson Faces Thousands Of Levaquin Lawsuits (Minneapolis Star-Tribune) Kindler Departure Sparked By Succession Issue? (Bloomberg News) Glaxo Buys Chinese Drugmaker For $70M (Reuters) Chris Viehbacher Is Named New PhRMA Chief (The Hill) Medicaid Drugs Are Going To Drug Dealers (Associ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4238151 Tue, 07 Dec 2010 12:56:32 +0100 4238151 http://www.medworm.com/index.php?rid=4233133&cid=t_111518_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F12%2Fduke-divinity-students-protest-pay-of.html This may be a first.  A small group of Duke University divinity students publicly protested the compensation given to some top university leaders, specifically including the Chancellor for Health Affairs.  According to the Raleigh-Durham News-Observer:Theo Luebke strolled the plaza outside Duke's Bryan Center on Thursday afternoon with a bucketful of apples and a tale of woe.'Come on! Everyone's in this together! Get your apples!' he exhorted students passing by during the lunchtime rush. 'With all the cuts we have around here and all the bonuses we have to give to the big guys, we need to raise all the money we can.'Luebke isn't really the Depression-era fruit peddler his costume suggested. Luebke and a couple of other Duke divinity students hawked apples, ostensibly to raise mo... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4233133 Mon, 06 Dec 2010 22:58:00 +0100 4233133 http://www.medworm.com/index.php?rid=4233423&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_l5xPun2CM0%2F If you thought that bundle of classified cables oozing from WikiLeaks was confined to diplomatic foibles and heads of state, but had little to offer about the pharmaceutical world, well, guess what? One cable lists overseas pharma facilities that are considered vital to US national security. How so? Losing these facilities “could critically impact the public health, economic security, and/or national and homeland security of the United States,” according to the Feb. 18, 2009, cable from the US Secretary of State to all diplomatic posts overseas (read it here). The list was part of an effort to catalog critical infrastructure and key resources as part of the National Infrastructure Protection Plan. The cable mentions plants that produce insulin and vaccines to combat small pox, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4233423 Mon, 06 Dec 2010 13:07:28 +0100 4233423 http://www.medworm.com/index.php?rid=4197366&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fw6NJeOdyDPM%2F Two years after a controversial law passed, Massachusetts has now begun disclosing payments that drug and device makers have made to doctors. A new web site (look here) lists transactions - including consulting and speaking fees, food, educational programs and any other payment with a value of at least $50, according to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (read this). The report lists $35.7 million in payments from nearly 300 companies for the six months between July 1 and Dec. 31, 2009, and The Boston Globe notes that nearly half of that money - $16.4 million - went to doctors. However, drug and device makers are not required to disclose research funding for answering legitimate scientific issues, but must report payments for marketing studies ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4197366 Tue, 23 Nov 2010 13:42:31 +0100 4197366 http://www.medworm.com/index.php?rid=4190525&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8S4VgXuJzVE%2F Welcome back, everyone. We hope your weekend was refreshing and put to good use. Now, of course, the routine returns, although this is a short week on this side of the pond. Nonetheless, meetings and deadlines loom, if only for a little while. So please join us as we brew the mandatory cup of stimulation and peruse the news of the world. Hope your day goes well and stay in touch… Bayer & Regeneron Eye Drugs Show Good Results (Bloomberg News) Genzyme Considers New Sanofi Deal Structure (TheStreet) FDA Approves 2nd Human Study Of Embryonic Stem Cells (Associated Press) Merck Wins Fosamax Trial (The New York Times) VR Labs To Build HQ In Florida (Fort Myers News-Press) Advair Poses Generic Hurdles (The Wall Street Journal) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4190525 Mon, 22 Nov 2010 13:04:07 +0100 4190525 http://www.medworm.com/index.php?rid=4183543&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9LyvHMKYP70%2F Good morning, everyone. And welcome to another busy day, although already we are daydreaming about the weekend. And why not? For our part, we envision getting exercise in the form of raking still more leaves; frolicking with the short people and catching up on sundry chores. What about you? Time for a movie or a good book? Tossing a football? Maybe stopping to appreciate a special someone? Whatever you fancy, have a great time. Meanwhile, here are some tidbits. See you soon… EMA Adopts New Guidelines On Biosimilar Antibodies (Reuters) Pfizer And Bristol-Myers Halt Study Of Bloodthinner (Bloomberg News) FDA Approves Amgen Bone Med For Some Cancers (Reuters) Merck Wins Reversal On ‘Unenforceable’ Patent Ruling (The American Lawyer) Court Says Baxter’s Heparin Was &#82... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4183543 Fri, 19 Nov 2010 12:54:35 +0100 4183543 http://www.medworm.com/index.php?rid=4179525&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXGVfJpCTsxU%2F Hello, everyone. Another shiny day is unfolding here at the Pharmalot corporate campus where, as usual, we are hustling short people off to the local school house and brewing the mandatory cup of stimulation. A truly busy day, however, lies in store. You know that feeling, yes? So please join us as we prepare for another round of meetings and deadlines. And of course, here are some tidbits to get us going. Have a good one and see you soon… Pfizer And Cipla May Ink Global Supply Deal (The Times of India) Genzyme Sells Diagnostic Unit To Sekisui Chemical (Reuters) India Tightens Clinical Trial Guidelines (Outsourcing Pharma) Israeli Biotechs Flock To Ohio For Funds And Experts (Bloomberg News) FDA Panel Backs Merck’s Gardasil To Thwart Anal Cancer (Associated Press) Montana Gover... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4179525 Thu, 18 Nov 2010 12:55:37 +0100 4179525 http://www.medworm.com/index.php?rid=4098464&cid=t_111518_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=4027355&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fxjmjpk1it7w%2F Hello, everyone. Nice to see you again. We hope the weekend was refreshing and restful. Now, of course, the time has come to resume the routine as those meetings and deadlines await. So please join us as we reach for the mandatory cups of stimulation (yes, we are two-fisted drinkers here at the Pharmalot corporate campus) and scan the news of the world. Have a good day and stay in touch… Sanofi Begins Hostile Bid For Genzyme (Associated Press) Reata Pharmaceuticals Adds Jobs After Abbott Deal (Dallas Business Journal) J&J Warns Concerta Sales Reps About Layoffs (The Wall Street Journal) Will Lilly Bid For MannKind? (The Indianapolis Star) Sihuan Pharma Sets $700M IPO (Reuters) South Africa Researches Plant That Lifts Moods (Associated Press) Antipsychotics, Illegal Marketing And... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4027355 Mon, 04 Oct 2010 11:49:48 +0100 4027355 http://www.medworm.com/index.php?rid=3965695&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrIq-yS7snsQ%2F In response to US pricing of the Norvir AIDS drug sold by Abbott Laboratories, an advocacy group plans to petition the National Institutes of Health this month to break several patents on the drug. The forthcoming move by Knowledge Ecology International comes six years after the group failed at a similar attempt to convince the agency to override patents held by the drugmaker on the grounds that a recent 400 percent price hike was unreasonable, anticompetitive and threatened the health and safety of people with AIDS (here is the 2004 petition and the NIH denial). In a recent report, however, KEI notes that for patients without some form of government assistance or insurance, Norvir continues to cost much more than in other countries, both those are that considered developed and less-devel... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965695 Tue, 14 Sep 2010 12:13:13 +0100 3965695 http://www.medworm.com/index.php?rid=3965697&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCSt3qKYXFWs%2F Top of the morning to you. We are scurrying about in hopes of depositing one of the short people at the local schoolhouse. As always, this requires fortitude and a cup of stimulation. Meanwhile, we would like to remind you that we will host a webinar today (see this) with former US Attorney Mike Loucks about brand promotion compliance. And now, let the day begin. Have a good one, everyone… Forest Labs Responds To FDA For COPD Drug (Pharma Times) Pfizer Sees A Turnaround For Its Labs (Reuters) Sanofi May Boost Genzyme Bid As Lab Unit Is Sold (Bloomberg News) Counterfeit Drug Tally Is Hard To Swallow (Wall Street Journal) Gilead Quad Pills Supresses HIV At 48 Weeks (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965697 Tue, 14 Sep 2010 11:49:31 +0100 3965697 http://www.medworm.com/index.php?rid=3965703&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDWqutsIp8sY%2F Following through on plans announced earlier this year, Lonza is eliminating 106 jobs from its plant in Conshohocken, Pennsylvania, which makes various pharmaceutical ingredients. The Swiss company, which recently signed supply deals with GlaxoSmithKline and Human Genome Sciences (see here and here), confirmed the planned job losses in a filing with the Pennsylvania Department of Labor. At the time the closure was first announced in January, Lonza also signaled plans to shutter two other plants - one in Shawinigan, Canada, and another in Workingham, UK - and eliminate a total of 175 jobs. A report at the time indicated that about 140 people work at the Conshohocken facility, although the status of those jobs is not clear. Lonza employs about 8,500 people worldwide. This is only the latest ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965703 Mon, 13 Sep 2010 12:04:56 +0100 3965703 http://www.medworm.com/index.php?rid=3943030&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3hInnF9Llts%2F Welcome back, everyone. We hope your weekend was splendid and you had a chance to recharge. The weather, after all, was magnificent. Now, of course, the time has come to return to the routine. So as you brace for those meetings and deadlines, please join us as we reach for our treasured cup of stimulation and dig in for another day. Hope yours goes well. And do stay in touch… Glaxo Will Not Bid For Genzyme (Reuters) The Problem With Gardasil (Fortune) Abbott Signs R&D Deal With Israeli Science Office (Globes) A Painful Summer For J&J CEO Bill Weldon (Fortune) Actus And Sequoia To Sell Stake In Paras (Bloomberg News) Genzyme Job Cuts To Follow Takeover (The Boston Globe) Roche Strikes Deal For Alzheimer’s And Parkinson’s Drugs (Reuters) AstraZeneca Signs Emerging... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3943030 Tue, 07 Sep 2010 11:52:27 +0100 3943030 http://www.medworm.com/index.php?rid=3925091&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCi7SP87eU1o%2F Nothing like a temperature reading to assess a situation, and Genzyme ceo Henri Termeer confronts an inevitable takeover by Sanofi-Aventis, at least according to a survey of 129 buy-side managers conducted by ISI Group biotech analyst Mark Schoenebaum. The upshot: 80.2 percent believe Sanofi will buy Genzyme and 75.7 percent believe no other bidder will emerge. But what will Sanofi have to pay? Instead of the $69 offer by the big drugmaker (look here), buysiders look for a purchase price of $74 to $77 a share. For his part, Termeer tells The Boston Globe that a sale appears increasingly possible, after all. “This is not a fixer-upper, this is beachfront property,” says Termeer, who only two days earlier rejected a deal. “It’s good to have this out in the open, to ha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3925091 Wed, 01 Sep 2010 12:27:40 +0100 3925091 http://www.medworm.com/index.php?rid=3925093&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2_AacIKJExc%2F Hello, everyone. Nice to see you again as another busy day lies in store. We have numerous housekeeping matters to mind and so we are brewing multiple cups of stimulation in order to cope. Please join us - or grab a bottle of water, if you prefer - as we dig in. Meanwhile, here is the news of the world. Have a great day and, again, please remember to send interesting tidbits our way… Sanofi Board Differs On Genzyme (The Wall Street Journal) Pfizer Buying FoldRx (Associated Press) AstraZeneca Given More Time To Settle 6,000 Seroquel Suits (Bloomberg News) Here Are 21 Drugs Facing FDA Approval Decisions (TheStreet) Merck And Adcock Expand African Distribution Deal (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3925093 Wed, 01 Sep 2010 11:51:35 +0100 3925093 http://www.medworm.com/index.php?rid=3915291&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLO4mISQLMq8%2F After weeks of leaks, Sanofi-Aventis has made public its offer to buy up Genzyme by going directly to shareholders of the beleaguered biotech. The $18.5 billion, all-cash deal comes after Sanofi ceo Christopher Viehbacher claims he has been stonewalled by Genzyme chairman and ceo Henri Termeer. The $69-a-share offer, however, is likely to go higher, given that analysts and investors have been buzzing for awhile that a richer price is probably necessary. By publicizing the offer - and couching it in terms that portray Termeer as obstructionist - Viehbacher is pursuing an approach known on Wall Street as a bear hug, in that it is designed to force the party who unwillingly receives a takeover to enter negotiations. Termeer, of course, has been under siege for the past year due to manufacturi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3915291 Sun, 29 Aug 2010 18:22:51 +0100 3915291 http://www.medworm.com/index.php?rid=3911870&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9LaUeTSAVOI%2F And so another work week will soon draw to a close. Not a moment too soon, yes? After all those meetings and deadlines, a respite is in order. We plan on spending time with two of our short people, catching up on sundry chores and maybe a nice drive somewhere with the radio turned up. What about you? Perhaps a day at the beach or a night at the movies? Whatever you do, go safely. See you soon and please do stay in touch… FDA Rejects Roche Breast Cancer Drug (Dow Jones) Genzyme To Increase Shipments Of Rationed Drugs (Boston Globe) Stallergenes Looks For US Marketing Partner (Bloomberg News) Montana Governor Has New Plan For Cheaper Drugs (Associated Press) FDA To Review Boehringer Ingelheim Blood Thinner Next Month (Reuters) Clinical Trial Patients To Get Routine Care Covered (MSNBC)... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3911870 Fri, 27 Aug 2010 11:59:09 +0100 3911870 http://www.medworm.com/index.php?rid=3896098&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPyHmKCZ3g8s%2F Hello, everyone. Nice to see you again. As promised, we have returned. We trust you had a pleasant and productive week while we were away. And we want to say thanks for the nice send-off notes so many of you posted. Much appreciated. As always, though, the time has now come to reach for that favored cup of stimulation as we gear up for another week. Here goes… Glaxo Starts Final Clinical Trials For Shingles Vaccine (Reuters) Roche Buys Imaging Company For $100 Million (SwissInfo) Pfizer Tries To Remediate Former Upjohn Site (North Haven Citizen) Archimedes Pharma Sets Up Shop (The Star-Ledger of NJ) Genzyme Shareholder Sues To Block Deal That Hasn’t Happened (Boston Globe) Taiwan Seeks To Remove Non-Tariff Barriers To China (Focus Taiwan) Jailed Psychiatrist Pleads Guilty Over ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3896098 Mon, 23 Aug 2010 11:34:15 +0100 3896098 http://www.medworm.com/index.php?rid=3865228&cid=t_111518_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F08%2Fgolden-parachute-for-making.html In late 2009, we posted about problems at a Genzyme plant that manufactured some fabulously expensive drugs, e.g. Cerezyme whose cost to patients approximated $160,000 a year. We thought then that for a drug costing that much, the company ought to have figured out a conservative process to provide pure and unadulterated product. In a later post we also why a company that could afford to make its CEO very rich could not afford to adequately maintain its manufacturing facilities.  In May, 2010, we posted about a legal settlement of charges related to its manufacturing problems requiring Genzyme to pay a $175 million fine and function under US government supervision.Recent news articles suggest that the fix of the company's inabilities to manufacture pure, unadulterated drug remained rem... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3865228 Fri, 13 Aug 2010 15:48:00 +0100 3865228 http://www.medworm.com/index.php?rid=3862193&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fmn94xwkWAbU%2F Hello, everyone, nice to see you again. There is a cool and welcome breeze wafting across the Pharmalot corporate campus this morning. And so what better way to greet such inviting weather than with a steaming cup of stimulation? Please join us. Meanwhile, here are some tidbits from around your world. We hope your day is productive and pleasant, and do stay in touch… Indian Supplier Of Gelatin Capsules To Double Output (Bloomberg News) Former Sirtris Execs Sell Resveratol Anti-Aging Supplement Online (Xconomy) Medco And CVS Are Giving A Gene Test To Millions (Bloomberg News) Antibiotic Use Rises After Part D (MedPage Today) New Superbug From India Causes Alarm In The UK (PharmaTimes) FDA Panel Backs Epilepsy Drug From Glaxo And Valeant (Reuters) Sanofi And Genzyme In A Game Of Chicke... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3862193 Thu, 12 Aug 2010 12:07:49 +0100 3862193 http://www.medworm.com/index.php?rid=3858381&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6pqiSjTCyMA%2F On one hand, one could argue that Henri Termeer, the Genzyme ceo, might deserve every penny of a $23 million golden parachute in the event that Sanofi-Aventis or some other company acquires the troubled biotech. After all, Termeer, since he joined in 1983, oversaw Genzyme’s rise into a drugmaker with a market value of more than $18 billion and innovative treatments for rare diseases. On the other hand, he is also known for imperious stewardship that, most recently, was responsible for a hugely embarassing mess: a $175 million consent decree with the FDA for a raft of manufacturing gaffes. These troubles closed a key plant; left patients with little or no supplies; angered investors, including Carl Icahn, who waged a proxy fight; and prompted a board probe into insider stock sales (ba... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3858381 Wed, 11 Aug 2010 12:33:24 +0100 3858381 http://www.medworm.com/index.php?rid=3858383&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOMw0S5fJrXc%2F Top of the morning to you. And a sunny one it is. Hope your day is getting off to a good start. As for us, we have the usual laundry list of meetings and deadlines, which calls for a cup of stimulation or three. So please join us as we brace for day ahead. And of course, drop us a line if you hear something interesting. We always enjoy a bit of insight. Meanwhile, have a great day… Gilead May Get FDA Warning Letter (San Francisco Business Journal) Genzyme Will Need An Extra Year To Fix Manufacturing Woes (Bloomberg News) Lilly To Lay Off 500 More Employees (Indianapolis Star) Merck Prostate Cancer Merits More Attention: Study (Bloomberg News) Sanofi Strikes Personalized Medicine Deal With Scripps (PharmaTimes) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3858383 Wed, 11 Aug 2010 11:09:41 +0100 3858383 http://www.medworm.com/index.php?rid=3816760&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FP6EAlh1LFi0%2F Frustrated by the ongoing shortage of Genzyme’s Fabrazyme medication for Fabry’s disease, three patients have petitioned the US Department of Health and Human Services to override the use patents held by the troubled biotech. Their hope is to find a way to produce the drug, which is the only such treatment currently available for a rare, inherited disorder that causes kidney and heart problems. The move comes after a year of turmoil at Genzyme, which recently agreed to pay $175 million as part of a consent decree for a raft of manufacturing problems, including viral contamination and even bits of trash found in some products. The gaffes prompted outrage from some large investors, a proxy fight by Carl Icahn and helped set the stage for the takeover bid by Sanofi-Aventis (backg... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3816760 Tue, 03 Aug 2010 13:10:38 +0100 3816760 http://www.medworm.com/index.php?rid=3816762&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8wCoe6kSHgk%2F Hello, everyone, and welcome to another busy day. This may be the sleepy stretch of summer, but the world is spinning as quickly as ever, yes? And so we must prepare for still more deadlines and meetings. As you do the same, here are a few tidbits to help you along. So grab a cup of something stimulating and dig in. Have a good one and stay in touch… Allergan CEO Says Company Is Not For Sale (Dow Jones) Sanofi Shareholders Want Genzyme For $19 Billion (Reuters) Alcon Shareholders Told To Vote No On Novartis Slate (PharmaTimes) FDA Guidance Aims To Cut Residual Drug In Patches (InPharma Technologist) Will Botox Be Approved For Migraines? (Reuters) Diabetes Drugs Dispensed In UK Zooms By 43% (PharmaTimes) AstraZeneca VAT Voucher Case Rings Alarm Bells (Accountancy Age) KV Pharma Gets N... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3816762 Tue, 03 Aug 2010 11:55:41 +0100 3816762 http://www.medworm.com/index.php?rid=3603871&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfK6XmYccOu0%2F Carl Icahn thinks so. He wants to remove ceo, Henri Termeer, and three others from the board of the beleaguered biotech, which is paying a $175 million consent decree for serious manufacturing problems that led to a plant closure, a halt in production of key drugs, a lack of patient confidence and an internal probe into insider trading. Oh, and let’s not forget - bits of trash were found in some meds. And so Icahn filed a ‘fight deck’ with the Securities and Exchange Commission in which he accused ceo Henri Termeer of causing “significant destruction” of shareholder value, and creating and preserving a “complacent culture.’’ He also accuses Termeer, who has been ceo since 1985 and was given compensation worth $33 million since 2007, of acting like th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3603871 Thu, 27 May 2010 12:35:46 +0100 3603871 http://www.medworm.com/index.php?rid=3599328&cid=t_111518_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F05%2Fgenzyme-settles.html In late 2009, we posted about problems at a Genzyme plant that manufactured some fabulously expensive drugs, e.g. Cerezyme whose cost to patients approximated $160,000 a year.  We thought then that for a drug costing that much, the company ought to have figured out a conservative process to provide pure and unadulterated product.  In a later post we also why a company that could afford to make its CEO very rich could not afford to adequately maintain its manufacturing facilities.Now Genzyme has reached a settlement with the US Food and Drug Administration (FDA) on the matter.  As reported by the Boston Globe,Genzyme Corp will remain under federal oversight for the next seven to eight years as it works to fix quality-control problems that have bedeviled its Allston Landi... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3599328 Tue, 25 May 2010 21:42:00 +0100 3599328 http://www.medworm.com/index.php?rid=3599740&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fl5rzkQWb88Y%2F The beleaguered biotech, which agreed to pay $175 million for its sins, disclosed the basics yesterday. These include a remediation plan that will take up to three years to complete and if milestones aren’t met, the FDA can require a fine of $15,000 a day, for each affected drug, until everything is on track. Then, there is five years of oversight and annual reports (see the consent decree here). Meanwhile, Genzyme will continue to ship Cerezyme and Fabrazyme, which are made, filled and finished in its Allston Landing, MA, plant, as well as Thyrogen, which is filled and finished there. In the US, Thyrogen distribution will be based on medical necessity until another facility is available. But Genzyme has to move fill and finish operations out of the Allston plant for those three meds... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3599740 Tue, 25 May 2010 19:58:11 +0100 3599740 http://www.medworm.com/index.php?rid=3595895&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyacNMhGx7xk%2F Hello, again. A shiny day here on the Pharmalot corporate campus, where we expect a busy day. How about you? Much to do? We look forward to shortening our to-do list. To get started, we are quaffing the usual cup of stimulation and rummaging through the news of the world. Hope your day goes well and drop us a line if you hear anything interesting…. Astellas Hires 300 Reps In China (Bloomberg News) FDA Extends Review Of Novartis MS Drug (PharmaTimes) Abbott Labs Plans To Sell $3B In Debt (BioValley) Genzyme Agrees To $175M Consent Decree (Bloomberg News) Execs Worry About FDA’s BadAd Program (Advertising Age) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3595895 Tue, 25 May 2010 11:48:01 +0100 3595895 http://www.medworm.com/index.php?rid=3556377&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FK0C6QT2IRIA%2F Sometimes, trouble begets still more trouble. Already besieged by regulators, upset patients and deep-pocketed investors, Genzyme now faces an investigation into allegations that several unnamed executives and board members “took advantage” of their knowledge of inside doings at the biotech and illegally sold some of their personal stock holdings. The Genzyme board has designated three independent directors to oversee the investigation and independent legal counsel has also been retained, although no names were offered (click here for the list of board members). This unseemly disclosure was made in a filing with the US Securities and Exchange Commission (which you can see here on page 31). The probe was prompted by nine letters from shareholders received since last August, when... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3556377 Tue, 11 May 2010 20:15:10 +0100 3556377 http://www.medworm.com/index.php?rid=3552193&cid=t_111518_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F05%2Fleaders-of-discredited-financial-rating.html This is the latest in our informal series on the cross-linkages between the thinking and leadership that lead to the global financial collapse/ great recession and that current in health care.  Last month, a US Senate sub-committee held hearings on the role of the rating agencies, actually for-profit corporations that evaluated securities, including derivatives, in the collapse.  The Fundamentally Conflicted Rating AgenciesTo briefly provide some background, these agencies were hired by the firms that created these securities to evaluate them.  Because the securities were complex, they were hard for investors to evaluate.  Investors had become used to using the rating agencies' evaluations as benchmarks for the quality and riskiness of complex securities.  Many did... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3552193 Mon, 10 May 2010 20:45:00 +0100 3552193 http://www.medworm.com/index.php?rid=3542873&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fdtv4OBHXOuY%2F Once again, another working week will soon draw to a close. And so the weekend agenda calls for a smattering of activities - taking the Pharmalot mascot for a constitutional, bike riding with one of the short people and watching another on the lacrosse field. And you? Whatever you plan, we hope you have a good time. And of course, do not forget mom. Have a great time… FDA To Review Lilly’s Byetta In Six Months (Reuters) Lilly To Cut 200 Sales & Marketing Jobs (Indianapolis Star) InVentiv To Be Bought For $900M By Thomas Lee (Wall Street Journal) Bayer Wins FDA Approval For New Type Of Contraceptive (Bloomberg News) Genzyme Plans $2B Buyback, May Sell Units (Associated Press) Australia Agrees To $2B In Price Cuts (PharmaTimes) photo thx to tipiro on Flickr creative commons ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3542873 Fri, 07 May 2010 11:37:14 +0100 3542873 http://www.medworm.com/index.php?rid=3538383&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCFEJG84zyjM%2F Declaring that Genzyme is ‘broken,’ Carl Icahn wants to remove ceo, Henri Termeer, and three others from the biotech’s board, according to a new proxy statement filed with the Securities and Exchange Commission. The move comes after months of turmoil, which began last summer when Genzyme shut its Allston Landing, Ma., plant for several weeks to remediate viral contamination. That prompted rationing of two key drugs - Cerezyme, which is used to treat Gaucher disease, and Fabrazyme for treating Fabry disease. Then, bits of trash were found in some products (background). Genzyme has scrambled to hire new execs and consultants, but the FDA is preparing a consent decree that will involve a $175 million fine. For his part, Termeer will attempt to soothe angry investors during ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3538383 Thu, 06 May 2010 13:12:17 +0100 3538383 http://www.medworm.com/index.php?rid=3511778&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FS_rvf1h3hFg%2F Top of the morning to you. Another shiny day here on the Pharmalot corporate campus, where another cup of stimulation is brewing. What will today bring? Meetings and deadlines, no doubt. To help you cope, here are a few items to jumpstart the process. We hope your day goes and do stay in touch… Icahn Wants To Fix A ‘Broken’ Genzyme (Reuters) EU Legislators Want Internet Drug Sales Regulated (PharmaTimes) Swine Flu Lifts Glaxo Profits (Reuters) Medco Gains On New Clients (Associated Press) Merck KGgA Profit Beats Estimate (Bloomberg News) Pfizer Hopes For New Biotech Drugs (The Wall Street Journal) $$ Coffee pix thx to chichcacha flickr creative commons (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3511778 Wed, 28 Apr 2010 11:49:11 +0100 3511778 http://www.medworm.com/index.php?rid=3499311&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FgAQqzpPFA-Q%2F And so another work week is about to draw to a close. What are you planning for the weekend? Mowing the lawn? Riding a bike? A walk in the park? We look forward to spending time with our short and not-so-short people and running with the official Pharmalot mascot. While you ponder your own choices, here are a few items to help you round out the day. Have a nice time, whatever you do and see you soon… Australia Tells Docs To Stop Kids’ Flu Shot (Bloomberg News) J&J Shareholders Reject Say-On-Pay Proposal (Associated Press) EU Sees Genzyme Drug Shortage Through September (Reuters) Pfizer Ends Trial Of Sutent In Liver Cancer (Associated Press) EMA Backs Nycomed COPD Drug (Reuters) EU Approves Diovan For Children (Associated Press) Roche Files For New Herceptin Use In US (Reut... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3499311 Fri, 23 Apr 2010 11:43:46 +0100 3499311 http://www.medworm.com/index.php?rid=3494552&cid=t_111518_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=3476080&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3pw0blnXNjE%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is something we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Baxter International hired Ludwig Hantson as corporate vice president and president, international. The move comes just two days after Hantson departed Novartis, where he headed the US pharmaceutical unit. A replacement ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3476080 Fri, 16 Apr 2010 11:58:44 +0100 3476080 http://www.medworm.com/index.php?rid=3476081&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUS9QAvJBpCU%2F And so another work week will soon draw to a close. What do your weekend plans call for? A walk in the park? A long, cozy nap? Tending to chores? Schlepping your own short people from place to place? Whatever you do, we hope you have a nice time. Meanwhile, there is today to wrap up. So here are a few items of note. See you soon… Genzyme Patients Feel Betrayed By Shortages (The New York Times) Pfizer Is Voted Best Employer In Czech Republic (Prague Daily Monitor) J&J Axes Execs In India (Economic Times) Cell Therapeutics Cuts 36 Employees (Xconomy) Rexahn Stumbles Over MDD Drug (Montgomery Gazette) photo thx to tipiro on Flickr creative commons (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3476081 Fri, 16 Apr 2010 11:38:17 +0100 3476081 http://www.medworm.com/index.php?rid=3472045&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrwMB_svGGyE%2F Hello, everyone. Another busy morning as we hustle various short people to the schoolhouses. And things are likely to get only more hectic with all those meetings and deadlines. So grab your cup of stimulation and dive in. Meanwhile, here are a few items to help you along. Have a good day and catch you soon…. Celgene Strikes Cancer Drug Deal With Agios (Reuters) Genzyme Board Move Could Weaken Icahn (The Wall Street Journal) Pfizer Hires Ketchum Pleon To Promote Baby Milk Biz (PR Week) Sigma Pharma CEO Quits (Bloomberg News) Roche Sales Beat Forecast (The Wall Street Journal) Sanofi Says Diabetes Drug Study Results Are Positive (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3472045 Thu, 15 Apr 2010 11:42:25 +0100 3472045 http://www.medworm.com/index.php?rid=3433165&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fuf65sY_uqao%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 Michael Durand has joined Resolute Communications as managing director of its New York office. He was the founding director of Porter Novelli’s global health care practice and also served as managing director of health... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3433165 Fri, 02 Apr 2010 12:20:05 +0100 3433165 http://www.medworm.com/index.php?rid=3399174&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfnGrxrJ2nEU%2F After months of manufacturing problems involving viral contamination and even bits of trash in some of its products, the beleaguered biotech says the FDA intends to take enforcement action that will “likely result” in a consent decree. And so a “third party” would inspect and review its operations for an extended period, and Genzyme would have to pay what is currently an unspecified fine (here is the Genzyme statement). Just the same, Genzyme expects product shipments to continue. The biotech makes and sells Cerezyme to treat Gaucher disease and Fabrazyme for treating Fabry disease, as well as Myozyme for Pompe disease. Talks will be held with the FDA about its Thyrogen treatment for thyroid cancer patients. Its troubles began last summer when its Allston Landing, M... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3399174 Wed, 24 Mar 2010 13:40:48 +0100 3399174 http://www.medworm.com/index.php?rid=3283820&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZPI95FqKeD4%2F Hello, everyone. How are you today? We hope your week is going well, despite the assorted meetings and deadlines that are lined up. Our way of coping, of course, is to grab the continual cup of stimulation. So reach for one yourself, or a bottle of water if you prefer, and get ready for another day. As always, here are a few items to help you along. Regards… Biogen Gets Rights To Hemophilia Drug (Reuters) Parkinson’s Patients Can Proceed With Addiction Suit (Ottawa Citizen) Former Searle Exec, Sheldon Gilgore, Dies At 77 (The Wall Street Journal) Genzyme Earnings Fall On Supply Interruptions (Reuters) Gilead’s Quad HIV Pill Succeeds In Mid-Stage Study (Reuters) Coffee pix thx to chichcacha flickr creative commons (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3283820 Thu, 18 Feb 2010 12:17:07 +0100 3283820 http://www.medworm.com/index.php?rid=3244050&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvsxrDoBSY9s%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 Genzyme hired Lilly’s former head of manufacturing, Scott Canute, to run manufacturing and operations. He will be in charge of pulling rabbits out of hats, given Genzyme’s embarassing problems at a plant that... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3244050 Fri, 05 Feb 2010 12:50:14 +0100 3244050 http://www.medworm.com/index.php?rid=3197886&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fckqiwvw-OmM%2F And it’s getting closer every minute. Already, we can imagine the long naps that beckon. But what about you? Any interesting plans? Whatever you do, we hope you have a nice time. While you ponder, here are a few items to help you through the end of the week. Enjoy, everyone, and see you soon… Novartis Pushes Fund For Neglected Worm Disease (Bloomberg) Glaxo’s Hussain Discusses Flex Pricing In Diverse Markets (Financial Times) J&J Withdraws European Filing For Epilepsy Drug (PharmaTimes) Glaxo & Genmab Win EU Backing For Leukemia Drug (Reuters) Mississippi Urged To Require Prescriptions For Cold Meds (Associated Press) FDA To Decide On Genzyme Pompe Drug In June (MassHighTech) photo thx to tipiro on Flickr creative commons (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3197886 Fri, 22 Jan 2010 13:03:10 +0100 3197886 http://www.medworm.com/index.php?rid=3189403&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fbc49poq9rio%2F For the past few years, the John Crowley story has been widely circulated. A former financial consultant with two children suffering from Pompe disease, he borrowed $100,000 on his home and 401(k) plan to start a biotech company, raised $27 million in venture capital and later sold his small company to Genzyme. That’s where the drama really begins, as Crowley and Genzyme tussled over the trials and whether his children could participate (more here). The saga is now a movie called ‘Extraordinary Measures,’ which stars Harrison Ford and Brendan Fraser (who plays Crowley), and opens this week. You can watch the trailer here and Crowley, who is now ceo at Amicus Therapeutics, was interviewed the other day by CNBC, which you can watch here. (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3189403 Wed, 20 Jan 2010 13:10:29 +0100 3189403 http://www.medworm.com/index.php?rid=3167446&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8TqyxkbfqrA%2F Before a crowd of some 600 people at the JP Morgan Healthcare Conference in San Francisco, Genzyme ceo Henri Termeer told investors that about 80 percent of patients who use Cerezyme, which is used to treat Gaucher’s disease, have resumed treatments after manufacturing problems at its Allston Landing, Ma., plant interrupted supplies last year. Termeer also insisted the biotech hasn’t had any contact with Carl Icahn, who holds 1.5 million Genzyme shares and has been rumored to be interested in waging a proxy fight in the wake of the production gaffes. Icahn associate’s Alex Denner attended the presentation, which drew a standing-room-only crowd for a subsequent question-and-answer session, according to The Pink Sheet. Want background? Try this, this and this. [full disclos... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3167446 Wed, 13 Jan 2010 13:25:07 +0100 3167446 http://www.medworm.com/index.php?rid=3153627&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F10sCFWCMz-w%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 Dan Schultz, a former director of the FDA’s Center for Devices and Radiological Health, has joined Greenleaf Health, a consulting firm, as senior vice president, medical devices and combo products. He’s based... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3153627 Fri, 08 Jan 2010 13:12:12 +0100 3153627 http://www.medworm.com/index.php?rid=3142835&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHYV25kXFeLE%2F Top of the morning to you. Hope your adjustment to the usual work routine went well yesterday. As always, there is much to do. First up on our agenda - shepharding one of the short people to the local schoolhouse. So while we prepare for the challenge, here are a few items to help you with your own challenges. Here’s to a good day… Schering-Plough Settles Clarinex Investor Suit For $165M (Bloomberg News) Pharmacy Goes To Trial For Distributing Steroids (FoxTV10.com) Biogen CEO To Retire In June; Is Icahn Happy? (TheStreet.com) Alcon Directors Criticize Novartis Takeover Tactic (Reuters) Genzyme Taps Hospira For Manufacturing Help (PharmaTimes) TCG Life Signs Deal With Pfizer (The Economic Times) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3142835 Tue, 05 Jan 2010 11:49:43 +0100 3142835 http://www.medworm.com/index.php?rid=3108549&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FmSgS7Op2b1A%2F Rumblings about a change at the top of the troubled biotech have been out there for months. And now, for the second time this month, those murmurings are becoming public. The latest comes from Sheridan Snyder, who founded Genzyme in 1981 and ran until he recruited Henri Termeer in the mid-1980s to take over as chief executive. Snyder wants Termeer to go. “A ceo change at Genzyme would be a good idea. Henri has had a good run of 20-plus years but what Genzyme needs now is for someone new to come in with higher energy and a different vision. This would help the company,” Snyder tells The Street. “Henri is a very bright guy but he’s also the most autocratic manager I have ever seen. He’s someone who demands absolute loyalty from everyone, but this has created a t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3108549 Mon, 21 Dec 2009 11:58:27 +0100 3108549 http://www.medworm.com/index.php?rid=3079580&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLNFvQsbmOaY%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is something we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Thomas Hofstaetter is joining VaxInnate as chief operating officer, where he will be responsible for business development, finance and HR. For the past five years, he headed corporate business development at Wyeth and, b... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3079580 Fri, 11 Dec 2009 13:01:44 +0100 3079580 http://www.medworm.com/index.php?rid=3075766&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FG8lB7BqRTC8%2F After months of serious problems, Genzyme added an independent director to its board under pressure from Relational Investors, an activist hedge fund, The Wall Street Journal reports. The biotech added Bob Bertolini, who was chief financial officer at Schering-Plough before it was acquired by Merck (see statement). Genzyme has endured nothing but trouble this year as quality control problems forced the biotech to suspend shipments of key products for such ailments as Gaucher’s and Fabry diseases, and the subsequent shortages prompted the FDA to allow rivals to jumpstart plans to produce their own meds to fill the void (see coverage here and here). The difficulties have shaken confidence in Genzyme management, leading to speculation the board would be pressured to make changes. Addi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3075766 Thu, 10 Dec 2009 11:35:30 +0100 3075766 http://www.medworm.com/index.php?rid=3035877&cid=t_111518_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F11%2Fwas-is-worst-biotech-ceo-worth.html Recently, we posted about misadventures of the leadership of biotechnology giant Genzyme.  Although the company has long priced its drug Cerezyme for the rare Gaucher's disease at a stratospheric level, it did not sufficiently reinvest money in its manufacturing facility for the drug.  Deferred maintenance at a production facility running at maximum capacity has apparently lead to two different kinds of contamination problems, forcing a shut-down of the plant, and now a shortage of the drug.  For this, Genzyme CEO Henri Termeer was just labeled the "Worst Biotech CEO of '09" by TheStreet.com.It was not always thus.  A 2008 profile of Mr Termeer in Boston Magazine chronicled the rise of Genzyme from a "startup [which] operated 15 stories above the Combat Z... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3035877 Fri, 27 Nov 2009 17:15:00 +0100 3035877 http://www.medworm.com/index.php?rid=3012624&cid=t_111518_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2009%2F11%2Fhenri-im-sure-you-are-worth-every-cent.html Jim has the story! (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3012624 Fri, 20 Nov 2009 11:08:00 +0100 3012624 http://www.medworm.com/index.php?rid=3008043&cid=t_111518_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F11%2Fgenzymes-remarkable-businessstrategy.html In June, 2009, an article in the Boston Globe described how the Boston area based biotechnology company Genzyme sold some astonishlingly expensive drugs, usinga remarkable business strategy: In countries from Colombia to Taiwan to Libya, the Cambridge firm has compiled an extraordinary track record of searching out patients like Tania, providing desperately needed treatment, and then successfully pressing their governments, even poor ones, to pay full price for the most expensive drugs in the world.The article focused on how Genzyme marketed Cerezyme for Gaucher's disease.When Genzyme Corp. first introduced a bioengineered drug for Gaucher (pronounced GO-shay) disease in the 1990s, the very idea seemed almost absurd to most people in the pharmaceutical industry. It was expensive to manufac... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3008043 Wed, 18 Nov 2009 21:42:00 +0100 3008043 http://www.medworm.com/index.php?rid=3004090&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZxJ4CeYYJHE%2F ‘Tis the middle of the week and that means deadlines and meetings are in full swing. We know the feeling. Nonetheless, the skies are clear and our spirits high. So please join us as we reach for another cup of stimulation and dig in to begin another day. Hope yours goes well… Vivus Says Impotence Pill Trial Meets Goals (Reuters) NicOx Hopes To Raise $149M In Stock Sale (Bloomberg) Genzyme To End Development Of Kidney Drug (Reuters) Former Olathe Pharma Exec Runs For Kansas Governor (KansasCity.com) FDA Says Heartburn Meds Interfere With Plavix (Associated Press) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3004090 Wed, 18 Nov 2009 12:42:52 +0100 3004090 http://www.medworm.com/index.php?rid=2999852&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFMA0kA3DKWw%2F Good morning, everyone. Nice to see you again. Another pleasant day looks to be shaping up on the Pharmalot corporate campus. But so much to do and we know you can relate. So while we shuttle to and from the schoolhouse, here are a few items to help you on your own way…. Roche Applies for Avastin Breast Cancer Use (Reuters) FDA Delays Genzyme Pompe Disease Drug Again (MassHighTech) Icahn Buys Shares in Genzyme And Forest Labs (Wall Street Journal) Novartis Teams With Malaysia For Compound Research (Bernama) Iowa Gets $4.3M From Medicaid Settlement (WCFCourier) Heartburn Pills Linked To Higher Death Rate In Artery Cleanings (Bloomberg) Talecris To Add 259 Jobs (Triangle Business Journal) Coffee courtesy of Flickr Creative Commons chichcacha (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2999852 Tue, 17 Nov 2009 12:05:01 +0100 2999852 http://www.medworm.com/index.php?rid=2993930&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBzUKzDmSJZk%2F A case of garbage in, garbage out? Not to be taken lightly, the beleaguered biotech has enough problems with contamination. But now the FDA, which has been inspecting Genzyme facilities of late, has found stainless steel fragments, non-latex rubber from vial stoppers and fiber-like material from the manufacturing process, all of which may cause serious adverse events (the FDA statement). The affected products include Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen. On the bright side, less than 1 percent of these drugs contained any junk and there were no adverse events reports. And given these meet rare medical disorders, the drugs will remain available. But Genzyme has been struggling most of the year to convince regulators, doctors and patients that it has its act together. The tr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2993930 Sat, 14 Nov 2009 19:51:51 +0100 2993930 http://www.medworm.com/index.php?rid=2992850&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBzUKzDmSJZk%2F A case of garbage in, garbage out? Not to be taken lightly, the beleaguered biotech has enough problems with contamination. But now the FDA, which has been inspecting Genzyme facilities of late, has found stainless steel fragments, non-latex rubber from vial stoppers and fiber-like material from the manufacturing process, all of which may cause serious adverse events (the FDA statement). The effected products include Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen. On the bright side, less than 1 percent of these drugs contained any junk and there were no adverse events reports. And given these meet rare medical disorders, the drugs will remain available. But Genzyme has been struggling most of the year to convince regulators, doctors and patients that it has its act together. The tr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2992850 Sat, 14 Nov 2009 00:53:40 +0100 2992850 http://www.medworm.com/index.php?rid=1895590&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F427931985%2F And so another busy day comes to a close. Since we were occupied with sundry tasks late this afternoon, we thought you may appreciate getting caught up with a few headlines that passed under our nose. Thanks for stopping by today and we hope you have a pleasant evening… FDA Panel Backs New Version Of Genzyme Drug (Yahoo/AP) FDA Extends Review Of Pfizer Osteoporosis Drug (Reuters) Sandoz Loses Bid To Sell Generic Biaxin (Bloomberg News) Glaxo Pays $170M For OTC Oral Healthcare Company (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1895590 Wed, 22 Oct 2008 02:58:25 +0100 1895590 http://www.medworm.com/index.php?rid=1888455&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F423831046%2F In studies, a new version of Genzyme’s Myozyme showed similar side effects to the existing version, which treats Pompe disease, but long-term exposure to the newer med was not adequately studied, according to FDA medical reviewers. In documents posted on the agency web site in advance of an advisory committee meeting next Tuesday, the reviewers wrote that there was also not enough data to show the new version works in children, and FDA officials should consider limiting approval for adults only (here are the Genzyme briefing documents). The FDA has already approved a version of Myozyme manufactured at a Genzyme facility that uses a 160-liter tank, but Genzyme wants to make the drug in a 2,000-liter tank. The FDA considers the version made at the larger facility to be a different prod... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1888455 Fri, 17 Oct 2008 16:03:45 +0100 1888455 http://www.medworm.com/index.php?rid=1649306&cid=t_111518_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=1531703&cid=t_111518_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D2111 On Tuesday afternoon, a panel discussed ways in which corporations might be able to stimulate the development of more therapies for serious diseases—-the world’s top killers such as malaria. The topic is one that I’m very interested, but, unfortunately, I arrived late and missed much of the discussion. Genzyme has been doing some pioneering work with [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=1531703 Fri, 20 Jun 2008 14:49:31 +0100 1531703 http://www.medworm.com/index.php?rid=1404197&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F279384627%2F Last Friday, Genzyme and Isis Pharmaceuticals disclosed that the FDA wants them to gather more data in order to win approval for a novel cholesterol drug. Specifically, the agency indicated that lowering cholesterol is an “acceptable surrogate endpoint” for using their mipomersen in patients with a rare, inherited form of high cholesterol. But an outcomes trial will be needed to win approval for other patients with high cholesterol. Such a trial can prove valuable if the outcome is achieved, but it’s also expensive and time-consuming because many more patients are needed to enroll. Interestingly, Zetia was approved six years ago on its ability to lower cholesterol, but actual outcomes data for Vytorin still isn’t available. We mention both drugs in the same breath... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1404197 Mon, 28 Apr 2008 13:20:34 +0100 1404197 http://www.medworm.com/index.php?rid=1400745&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F277929330%2F What’s the pharmaceutical angle here? Well, let’s see. Perhaps as the cost of oil continues to climb, oil companies will supplant drugmakers as the industry that upsets people most. You know, it’s called deflecting attention. And for all those overworked ceo’s - not to mention the thousands of employees who never promoted a drug off-label or hid clinical-trial data but get blamed anyway - this could be a good thing. So print this out and fill up. But before you do, take a peek at a few items to help close your week. And whatever you do this weekend - wherever you go - please enjoy. Merck/Schering-Plough Claritin-Singulair Combo Is Nixed (Press Release) Bristol-Myers, Medarex Cancer Drug Delayed By FDA (Yahoo/Reuters) FDA Wants More Data On Isis, Genzyme Drug (The S... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1400745 Sat, 26 Apr 2008 01:31:43 +0100 1400745 http://www.medworm.com/index.php?rid=1393907&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F276087547%2F Do you remember what the morning mayor used to say? Every brand new day should be unwrapped like a precious gift. And what better way to view the middle of the week, yes? So what if those deadlines and meetings are annoying. Grab a cup of stimulation in one hand and the water bottle in the other, and let’s get caught up… Genzyme Will Build A $90M R&D Center In China (The Boston Globe) Court Tells Cipla Not To Export Roche’s Tarceva (The Economic Times) Novartis Cutting Prices On Malaria Drug (Reuters) Perrigo Can Sell Generic OTC Pepcid (FDA News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1393907 Wed, 23 Apr 2008 11:09:57 +0100 1393907 http://www.medworm.com/index.php?rid=1391300&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F275359444%2F In a decision that shows how difficult it is to copy biologics, the FDA has rejected Genzyme’s request to sell a version of its Pompe disease drug, called Myozyme, which the drugmaker planned to manufacture at an additional site. But the agency ruled that any Myozyme made at the second plant should be considered a different product because of small differences in its chemical structure, The Boston Globe reports. In order to sell the latest version of the drug in the US, Genzyme will have to file another application with new data showing the drug is safe and effective in large numbers of patients. Pompe disease is a rare, debilitating genetic illness that prevents people from breaking down a common sugar called glycogen, which can then build up in the body’s cells and weaken the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1391300 Tue, 22 Apr 2008 12:10:41 +0100 1391300 http://www.medworm.com/index.php?rid=1365017&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F267954994%2F Once again, we are rolling in the sidewalks earlier than usual. This time, we are headed off to speak to the American Association of Indian Pharmaceutical Scientists about pharma and, yes, blogging. Rupee for us, you say? Thank you, but, no, there is no payment. But we do expect to enjoy some some chicken tandoori. So until tomorrow, we hope your world remains calm and interesting. See you in the morning… Genzyme CEO Gets $12.6 Million In Pay (Associated Press) Genentech Profit Beats Wall Street Expectations (TheStreet.com) Will Takeda Sharerholders Like The Millenium Deal? (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1365017 Thu, 10 Apr 2008 21:09:18 +0100 1365017 http://www.medworm.com/index.php?rid=1354217&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F265595218%2F In addition to raising venture capital and launching stock offerings, Massachusetts biotechs are increasingly turning to another source of funding to support early drug research: nonprofit foundations dedicated to fighting serious diseases, The Boston Globe writes. For instance, the Cystic Fibrosis Foundation, has awarded more than $300 million to for-profit companies over the past decade to help develop cutting-edge therapies, including $192 million in the Boston area. Epix Pharmaceuticals is receiving up to $37 million, in addition to about $12 million it has already received, to help discover new cystic fibrosis drugs. The money is contingent on Epix’s meeting certain goals. Other foundations are following suit. For example: The Juvenile Diabetes Research Foundation said it has gi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1354217 Mon, 07 Apr 2008 11:12:59 +0100 1354217 http://www.medworm.com/index.php?rid=1344613&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F262325928%2F Please forgive the silence of the past few hours. We encountered all manner of technical difficulties, the least of which is a somewhat mangled lap top. These things happen when you spend all your time with one of these machines. Now, though, the time has come to turn our attention to our short people and their assorted adventures. See you tomorrow… Yet another disappointment for Pfizer. This time, the drugmaker halted a Phase III study of a drug for advanced melanoma after data showed it was no better than chemotherapy. The news sent its stock down about 2 percent in after-hours trading. At a recent meeting with analysts, Pfizer made a point of saying oncology is a big priority. PDL BioPharma will pay four top execs close to $1 million in retention bonuses through 2009 as a restruct... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1344613 Wed, 02 Apr 2008 01:31:53 +0100 1344613 http://www.medworm.com/index.php?rid=1307881&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F252948952%2F Is $300,000 a lot to pay for one drug for a year? If so, the correct dose is rather important, yes? That’s the issue concerning Cerezyme, which is used to treat a rare inherited enzyme deficiency called Gaucher disease, The New York Times writes, which notes that some experts say, for most patients, as little as one-fourth the standard top dose would work, saving the health care system more than $200,000 a year per Gaucher patient. “It is economic malpractice to give a much higher dose of an expensive drug than is required,” Ernest Beutler, an authority on Gaucher disease at the Scripps Research Institute, tells the Times. Some other Gaucher specialists argue otherwise, saying that skimping on the med could endanger patients, but all sides agree on one thing. “Nobody would eve... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1307881 Mon, 17 Mar 2008 11:17:57 +0100 1307881 http://www.medworm.com/index.php?rid=1233328&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F235254770%2F Another busy day draws to a close. At least for now. Who knows what may turn up later? Maybe another high-ranking exec will suddenly resign? Nonetheless, we will break to entertain one of the short people and check back later. We will also compile the results of our two latest unscientific polls - one concerning Fred Hassan, and the other about Andy Bonfield at Bristol-Myers Squibb. Meanwhile, these should help you keep busy….. Carl Icahn dumped his Genzyme shares, according to Xconomy.com. Regulatory filings posted today show that during the fourth quarter of 2007 the activist investor dumped all 1.5 million shares he bought in Genzyme during the third quarter. You may recall that Genzyme ceo Henry Termeer in December told Carl to go away, but the site speculates the real reason Car... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1233328 Fri, 15 Feb 2008 04:33:23 +0100 1233328 http://www.medworm.com/index.php?rid=1194992&cid=t_111518_147_f&fid=35750&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FHealthCareVox%2F%7E3%2F227360768%2Fgenzyme_highlights_gaucherrela.html In 2006, I wrote a blog post focusing on why I thought Genzyme should start a blog where it would discuss its charitable efforts related to Cerezyme, its expensive Gaucher treatment.  While I don’t think my post had much to do with their decision, Genzyme quietly launched a blog last year on this very topic.  Titled, “Face to Face,” the blog highlights the efforts of longtime Genzyme employee Tomye Tierney.  She serves as the company’s Vice President and General Manager of Emerging Markets.Currently, the blog features three entries about  Tierney’s global travels and her efforts to help Gaucher patients.  Her latest entry focuses on a trip she took to Vietnam in April 2007.  While there, she visited three patients who have been re... HealthCareVox blogs http://www.medworm.com/rss/comments.php?id=1194992 Fri, 01 Feb 2008 17:23:12 +0100 1194992 http://www.medworm.com/index.php?rid=1173449&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F221956748%2F Another busy day will be followed by a quite evening - we hope. For those of you just catching up or trying to unwind, here are a few items to help you along. See you in the morning… Wyeth Paid Wexler & Walker $160K To Lobby Washington (Associated Press) Gilead Sciences Tops Estimates (TheStreet.com) Abbott Labs Posts $1.2B Quarterly Profit (Yahoo/AP) Genzyme Senior VP Exercises Options (Yahoo/AP) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1173449 Thu, 24 Jan 2008 00:31:05 +0100 1173449 http://www.medworm.com/index.php?rid=1106342&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F202868283%2F Grey skies and chilly temperatures can mean only one thing - a cup of coffee. And so we shall venture out in search of something of hot and delicious. We hope you have a chance to do the same. And here are a few of the latest missives to help you digest…. Enzon Tries To Remake Itself (NJ.com) Idera Licenses Drug Technology To Merck KGaA (Yahoo/AP) DEA Eases Restrictions On Some Meds (Bloomberg News) Genzyme Osteoarthritis Drug Gets EU OK (Yahoo/AP) Glaxo Completes $1.65 Billion Acquisition Of Reliant (MarketWatch) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1106342 Wed, 19 Dec 2007 18:11:18 +0100 1106342 http://www.medworm.com/index.php?rid=1104490&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F202743699%2F Just as big drugmakers are spanning the universe in search of the next hot biotech, some biotechs are doing a version of the same thing. Today, for instance, Biogen Idec will formally announce that its first tenant has been signed up for a new incubator near its Cambridge headquarters, The Boston Globe writes. Genzyme is also considering creating a virtual incubator - funding, but no housing. And Vertex Pharmaceuticals is trying yet another tactic - a deal with Harvard University in which researchers can publish results freely and retain rights to any technology developed. “We felt we needed to pursue another mechanism” to support early-stage companies, Rainer Fuchs, executive director of the Biogen Idec Innovation Incubator, tells the Globe. The first tenant, by the way, is Es... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1104490 Wed, 19 Dec 2007 14:22:48 +0100 1104490 http://www.medworm.com/index.php?rid=1073280&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F196038200%2F That’s what Henry Termeer, the biotech’s ceo, has to say, despite recent interest shown by Carl Icahn. Simply put - there are no plans to put for a For Sale sign outside, he tells The Wall Street Journal. After recently pushing two other biotechs into seeking buyers, Icahn last month reported he had taken a small stake in Genzyme, sparking predictions that the biotech would soon be in play. But Termeer says selling to a big pharma doesn’t make sense. “To integrate us to into a very large entity is not that attractive,” he tells the paper. “It is not that good a logical fit. It is much stronger as it is right now - as a stand-alone rather than as part of a company 10 times our size.” Why? Genzyme already has a global sales force, and its focus on dr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1073280 Thu, 06 Dec 2007 11:38:43 +0100 1073280 http://www.medworm.com/index.php?rid=1028331&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F185219531%2F He overhauls ImClone Systems. Pushes MedImmune into the arms of AstraZeneca. And forces Biogen into play. Now, Carl The Raider may be going after Genzyme. Icahn Capital Management reported it owned 1.5 million shares of Genzyme stock as of Sept. 30, or less than 1 percent of the biotech, in a filing with the Securities and Exchange Commission, The Boston Globe reports. It’s too early to know exactly what Icahn has in mind for Genzyme, one of the world’s biggest biotech companies with a market value of close to $19 billion and more than 9,000 employees, the Globe notes. The company, led by industry veteran Henri Termeer, is known for producing powerful treatments for rare disorders, such as Gaucher’s disease and Pompe disease. Icahn hasn’t publicly stated whether he ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1028331 Thu, 15 Nov 2007 13:22:11 +0100 1028331 http://www.medworm.com/index.php?rid=1024397&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F184290390%2F The sun is peeking through the nation’s medicine chest. Perhaps, this calls for a walk in the park or a stroll down the street. Or a cup of your favorite pick-me-up. Whatever your choice, here are some of the latest happenings to peruse while you indulge… Biotech Growing Quickly In Massachusetts (The Boston Globe) Novartis’ Galvus May Not Get To The US: Analyst (CNNMoney.com) FDA Asks Genzyme For More Synvisc-One Data (Yahoo/Reuters) Consort Medical Closes Exubera Plant (Milton Keynes Citizen) BioCryst Can Proceed With Flu Vaccine Trial (The Financial Times) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1024397 Tue, 13 Nov 2007 20:16:43 +0100 1024397 http://www.medworm.com/index.php?rid=995114&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F177812246%2F As you gaze out the window at the ghouls and goblins running by, please do remember to stay focused a wee bit longer. Here are a few items to help you… Amylin Says Once-Weekly Byetta Meets Study Goal (Yahoo/Reuters) MedImmune To Make $1.5M Payment To Seattle Genetics (bizjournals.com) Alpharma Is Loading Up (The Motley Fool) Genzyme CEO Exercises Options (Yahoo/Reuters) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=995114 Wed, 31 Oct 2007 17:22:38 +0100 995114 http://www.medworm.com/index.php?rid=971521&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F173770484%2F Another day beckons. And so we begin by capturing some interesting items. Grab a cup of coffee or tea and enjoy. Those meetings and projects await you… Doctor Groups Revise Guidelines On Amgen, J&J Anemia Meds (Yahoo/Reuters) Pfizer Has No Regrets About Trovan Tests (AllAfrica.com) EU Backs Bayer, Genzyme Leukemia Drug (Yahoo/Reuters) Court Ruling On Gleevec Case In India Expected Today (The Hindu Business) Chugai Reports Third Quarter Profit Gains (Bloomberg News) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=971521 Tue, 23 Oct 2007 10:43:02 +0100 971521 http://www.medworm.com/index.php?rid=970220&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F173545947%2F A busy day, this was. Computer problems. Earnings. Novel legislation. And mysterious letters. We hope you had as much fun as we did (except for the computer problem, that is). Now, the time has come to regroup and prepare for tomorrow. Of course, we will return shortly with more for you to digest. There is always something interesting rumbling around out there, after all. But meanwhile, please enjoy these… New Warnings Won’t Sink Erectile Dysfunction Drugs (The Motley Fool) Glaxo Has Sold 2 Million Alli Starter Kits Since June (International Herald Tribune) Bioenvision Shareholders Approve Genzyme Offer (Yahoo/AP) Sepracor Stock Falls On Analyst Downgrade (Associated Press) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=970220 Mon, 22 Oct 2007 23:48:33 +0100 970220 http://www.medworm.com/index.php?rid=970225&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F173398138%2F You may notice that we were absent for a while. There was a technology glitch that required a quick trip for a new part. We apologize for the disruption, but as you can see, service is now restored… Nigeria Extends Pfizer Lawsuit To Target Neimeth (Yahoo/Reuters) Genzyme’s Renvela Wins FDA Approval For Kidney Dialysis (Bloomberg News) Theravance Antibiotic Approval Delayed By FDA (press release) More Pfizer People Tranfer To Connecticut Than Expected (The Day) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=970225 Mon, 22 Oct 2007 16:41:00 +0100 970225 http://www.medworm.com/index.php?rid=958992&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F171208078%2F Finally, the sun has broken through the clouds that were hovering over the nation’s medicine chest. On the East Coast, this calls for a quick walk outdoors or, perhaps, a chance to gaze out the window. Here are a few items to help you decompress… Pfizer Growth Strategy May Include Biogen, Analyst Says (Bloomberg News) FDA Panel Recommends Wider Use Of Kidney Drugs (Yahoo/AP) VaxGen Restructures Lease On Key Building To Cut Costs (bizjournals.com) FDA Backs Limits On Amgen, J&J Anemia Drugs (Bloomberg News) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=958992 Wed, 17 Oct 2007 17:03:22 +0100 958992 http://www.medworm.com/index.php?rid=952289&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F170227979%2F Why not? Another meeting is always on the horizon. There are deadlines looming. Numbers to make. What better way to recharge and prepare than to catch up with the world. Here you go… Who Won’t Bid For Biogen? (Yahoo/AP) Glaxo Wins FDA Approval For Lung Cancer Capsules (Yahoo/Reuters) Sepracor Hires Novartis And Glaxo Execs (press release) Pozen Submits Response To FDA About Migraine Drug (Yahoo/AP) Barr And Par Settle Dispute With Valeant Pharma (Yahoo/AP) Genzyme’s Campath Is Effective In Treating MS: Study (Yahoo/AP) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=952289 Mon, 15 Oct 2007 17:05:59 +0100 952289 http://www.medworm.com/index.php?rid=928091&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F165392400%2F As the day winds down, take a moment to catch up on items you may have missed while sitting through that big meeting or maneuvering those career obstacles… Health Canada Removes Novartis’ Prexige From The Market (CanadianPress.com) Medco Health CFO To Retire In March (Yahoo/Reuters) Bioenvision Says 47 Percent Of Shareholders Back Genzyme Deal (Bloomberg News) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=928091 Thu, 04 Oct 2007 21:07:20 +0100 928091 http://www.medworm.com/index.php?rid=922078&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F164289721%2F The biotech was slapped by the agency after inspectors visited a manufacturing facility last June in France, where Genzyme makes Thymoglobulin, which is used to treat acute rejection in organ transplant recipients, according to a Sept. 19 warning letter from the FDA. Genzyme employees on “several occasions” continued to use components that failed to meet limits on pathogenic microorganisms, according to the FDA letter. The final med all specs, “however, based on FDA’s experience, there is a high probability that the observed (manufacturing) deviations, if not corrected, would substantially increase the risk” that future batches would fail to meet production standards, the FDA wrote. The agency told Genzyme to correct those problems and others documented during... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=922078 Tue, 02 Oct 2007 17:20:29 +0100 922078 http://www.medworm.com/index.php?rid=918141&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F163760614%2F As midday nears, here are a few of the latest items that may be of interest… US Supreme Court Rejects Pfizer Appeal On Norvasc Patent (Yahoo/AP) GE And Lilly Sign Diagnostic Research Pact (Yahoo/Reuters) Next Acquisition Target? Shire, Lundbeck And Sepracor? (The Financial Times) Bioenvision Shareholder Still Oppose Genzyme Offer (TheStreet.com) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=918141 Mon, 01 Oct 2007 15:41:22 +0100 918141 http://www.medworm.com/index.php?rid=908786&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F162063100%2F Wal-Mart Expands Generic Drug Program (MarketWatch.com) Genzyme Says $345M Offer For Bioenvision Is Final (Bloomberg News) Pfizer Names Two New Board Members (MarketWatch.com) FTC OK’s Mylan’s Purchase of Merck KgGA’s Generic Unit (Yahoo/Reuters) AstraZeneca Pays $71M For US Dental Products Company (Yahoo/AP) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=908786 Thu, 27 Sep 2007 16:53:47 +0100 908786 http://www.medworm.com/index.php?rid=875457&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F157377372%2F Six years ago, the biotech embarked on a secret mission, dubbed ‘Project Eleanor,’ to buyback shares of its biosurgery division, which was, essentially, the former Biomatrix, a company Genzyme purchased in 2000. To pay for the deal, Genzyme created separate tracking shares, but six months later, soured on the unit and sought to reabsorb it. However, Genzyme Biosurgery shareholders filed suit, claiming Genzyme attempted the buyback at an unfairly low price, according to The Boston Globe. Last month, days before the case was to go to trial in New York, Genzyme agreed to pay $64 million to settle the case and the paper obtained court records and company documents that were unsealed after a federal judge lifted a secrecy order. The documents provide an interesting - and disturbing ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=875457 Mon, 17 Sep 2007 01:09:22 +0100 875457 http://www.medworm.com/index.php?rid=872129&cid=t_111518_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2007%2F09%2Fgenzyme-settles-one.html The Boston Globe just reported about some questionable tactics the biotechnology firm Genzyme used in the course of a merger and subsequent stock buy-back. Here is the background,Like many large biotech firms, Genzyme has built its success as much by acquiring businesses and clever financing as by developing new drugs. The biosurgery division was a typical Genzyme creation.The company set up Genzyme Biosurgery in December 2000 when it bought Biomatrix Inc., a New Jersey company. The attraction was Synvisc, a promising material that could be injected into arthritic knees to ease pain. Genzyme used tracking shares in the new division to pay for most of the transaction, worth about $860 million....At the outset, the appeal for shareholders of Genzyme Biosurgery was that Synvisc and the divisi... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=872129 Fri, 14 Sep 2007 15:19:00 +0100 872129 http://www.medworm.com/index.php?rid=790721&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F142358541%2F Genzyme faces an unwanted paradox - a biotech that has strong demand for a new product. The problem, however, is Genzyme can’t deliver the goods. Rising use of Myozyme, its treatment for Pompe disease, a rare and sometimes fatal enzyme disorder, is creating unexpected problems that is making some investors skittish, The Wall Street Journal reports (subscription required). The biotech can’t meet demand, because the FDA is refusing to approve a Boston factory where most of the med is to be produced. And this means Genzyme can’t sell Myozyme from the factory to US patients. FDA approval, initially expected later this year, likely won’t come until the first half of next year at the earliest, the company says. And so Genzyme says some new patients will have to delay the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=790721 Thu, 09 Aug 2007 13:17:08 +0100 790721 http://www.medworm.com/index.php?rid=763190&cid=t_111518_150_f&fid=35779&url=http%3A%2F%2Fwww.pharmamanufacturing.com%2Fonpharma%2F%3Fp%3D1294 Reuters reported this week that a patient who became ill following two experimental gene therapy injections for arthritis has died. U.S. health regulators are investigating the cause, officials said yesterday. The gene therapy trial by Targeted Genetics Corp. was placed on hold before the death, after the patient suffered a serious, unidentified health problem. The hold [...] (Source: On Pharma) On Pharma blogs http://www.medworm.com/rss/comments.php?id=763190 Fri, 27 Jul 2007 19:18:32 +0100 763190 http://www.medworm.com/index.php?rid=751831&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F136563965%2F This morning, we wrote that Genzyme, which two months ago launched a controversial $350 million bid for Bioenvision, last week filed court papers indicating it wants to subpoena documents belonging to a Bioenvision shareholder. This shareholder, Adam Shay, created an outspoken web site urging other shareholders to reject the deal. Genzyme also wants to depose Shay, who manages a tax service in Wilmington, NC. A Genzyme spokeswoman, Maria Cantor, insisted that issuing a third-party subpoena is a “routine” part of litigation and wouldn’t discuss “strategy or tactics.” When pressed, however, about Shay’s free-speech rights, she denies Genzyme is trying to shut down Shay’s web site. “It’s part of the issue, but it doesn’t involve stopping the blog. We’re not targeting the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=751831 Mon, 23 Jul 2007 17:30:36 +0100 751831 http://www.medworm.com/index.php?rid=750323&cid=t_111518_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F136464417%2F The drugmaker, which two months ago launched a controversial $350 million bid for Bioenvision, last week filed court papers indicating it wants to subpoena documents belonging to a Bioenvision shareholder who created an outspoken web site that urges other shareholders to reject the deal. Genzyme also wants to depose web site creator Adam Shay, who manages a tax service in Wilmington, North Carolina. In court papers, Genzyme says “the testimony and documents sought are relevant to the claims in (a suit brought by Bioenvision shareholders) and may lead to admissible evidence.” Shay isn’t a party to the lawsuit, though. And there’s no further indication why Genzyme is so interested in Shay. A Genzyme spokeswoman, Maria Cantor, tells Pharmalot that issuing a third-party... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=750323 Mon, 23 Jul 2007 11:50:18 +0100 750323