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 'biogen'. Sat, 03 Sep 2011 02:20:27 +0100 http://www.medworm.com/index.php?rid=4968909&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVPghfLkLLqc%2F Good morning, everyone. Another working week is about to draw to a close and already, we are daydreaming about weekend plans. Our modest agenda includes catching up on some reading, tending to the official Pharmalot grounds and spending time with our short people. And you? Now that summer is here, perhaps a drive to the beach is in order. Or curling up with a good e-book. Of course, one can always take that proverbial walk in the park. Whatever you fancy, have a great time and see you soon… Patent Overhaul Bill Clears US Senate (Reuters) America’s Vanishing Science Jobs (The New York Post) EMA Delays Decision On Actos To July (Reuters) FDA Inspects New Ranbaxy Plant In India (The Economic Times) Commonly Used Drugs Raise Risk Of Death In The Elderly (Reuters) Pfizer To Keep 350... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4968909 Fri, 24 Jun 2011 11:56:33 +0100 4968909 http://www.medworm.com/index.php?rid=4813667&cid=t_116757_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=4622506&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FN2UKxcXoMyU%2F What goes up….will keep going up? Ever since Novartis introduced the first pill to treat multiple sclerosis last year, prices for MS meds have jumped as much as 39 percent. Why? Other drugmakers are charging more for their older treatments in order to maintain revenue in the face of eroding unit sales, Bloomberg News writes. Novartis charges $48,000 for its new Gilenya pill, which prompted Teva Pharmaceutical to raise the price of its Copaxone injectable by 39 percent to $42,300 a year since January 2010. And the cost of MS drugs, which patients generally take for life, is now on par with many cancer meds. Consequently, patients without insurance or who do not qualify for assistance programs may be out of luck. Biogen’s Tysabri costs about $3,566 a month, or $42,788 a year, while... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4622506 Tue, 22 Mar 2011 12:28:26 +0100 4622506 http://www.medworm.com/index.php?rid=4507581&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNvoAwJK_fUk%2F Oncology is a big market and getting bigger, of course, but which drugmaker ranks highest is most effective in reaching oncologists? A recent poll of 475 medical and hematological oncologists found that Novartis commands a leading 12.5 share of details, although its position slipped slightly from the previous year, while Roche jumped from 10 percent to 12 percent thanks to combining sales teams with Genentech. Meanwhile, Sanofi-Aventis slid from 8 percent to about 6.5 percent thanks to looming patent expirations for Taxotere and Eloxatin, according to ImpactRx, a market research firm. In line with the results, Genentech tied with OSI Pharmaceuticals as the drugmaker with a top tier sales force, followed by Biogen Idec, Amgen, Eli Lilly and Celgene (here is the report). For the second year ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4507581 Tue, 22 Feb 2011 14:08:29 +0100 4507581 http://www.medworm.com/index.php?rid=4424450&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbxEIYiZB3gI%2F Hello, everyone, and nice to see you again. Another wintry day here on the Pharmalot corporate campus where, as usual, we are doing our best to hustle the short people off to the school houses. And of course, we armed with a shovel and a cup of stimulation - our flavor today is Gingerbread - as we prepare for the next round of deadlines and meetings. We trust you are doing the same, yes? So here are some tidbits to help you get started. May your day be fruitful… Roche Returns Diabetes Drug To Ipsen Over Side Effects (Bloomberg News) Sanofi’s Multaq On Latest FDA Safety Probe List (Reuters) China Arrests 18 People For Making Fake Avastin (Shanghai Daily) Biogen Profit Falls But Tysabri Sales Were Up (Reuters) Former Pfizer Chemist Gambles On Biofuel (Biodiesel Magazine) Valeant ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4424450 Tue, 01 Feb 2011 13:08:26 +0100 4424450 http://www.medworm.com/index.php?rid=4382951&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8XrunC8mJJE%2F And so, another work week will soon draw to a close. Although once again, we are dusting off the snow on the Pharmalot corporate campus. Please excuse any delays this morning, but due to the economy, we no longer have a maintenance crew. This does give us the opportunity, though, to daydream about weekend plans - hanging out with the short people and catching up on some reading. What about you? Anything fun on the agenda? How about a good flick or spending time with someone special? Whatever you do, enjoy. Meanwhile, here are some tidbits. Catch you soon… EMA To Review Safety Of Sanofi’s Multaq (Wall Street Journal) AstraZeneca Responds To FDA About Brilinta (Bloomberg News) Biogen Boosts Prices Of MS Drug (Wall Street Journal) EU Panel Does Not Recommend Biogen MS Pill (Reuter... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4382951 Fri, 21 Jan 2011 12:55:15 +0100 4382951 http://www.medworm.com/index.php?rid=4318549&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FwwnT4B-7B8Q%2F Rise and shine, everyone. Another day is on the way. And we predict this will prove to be as busy as ever. So please join us for a cup of needed stimulation - our special flavor today is Southern Pecan - as we get ready for those meetings and deadlines. No doubt, you can relate. Meanwhile, here are some tidbits to help you along. Have a good one and do stay in touch… Merck Beats Vertex To Hepatitis C Filing (TheStreet) Merck And Ranbaxy End Development Deal (Economic Times) Biogen Names New Heads For R&D, Corporate Development (Bloomberg News) Danish Biotech Symphogen Raises A Record $131 Million (Reuters) Basilea Becomes Takeover Speculation (Bloomberg News) Pfizer And Seattle Genetics Reach Antibody Deal (Reuters) Roche Asks Employees To Act As Social Media Scouts (InPharm) Un... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4318549 Thu, 06 Jan 2011 12:45:06 +0100 4318549 http://www.medworm.com/index.php?rid=4266264&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSZ-Te091wg0%2F And so another working week draws to a close, which means the time has come to daydream, just a little, about our weekend plans - a brisk walk with the official Pharmalot mascots, spending time with our short people and taking a nap or two. What about you? Will you brave the shopping crowds? Curl up with your favorite e-book reader? Connect with a special person? Whatever you do, we hope you have a pleasant time. Meanwhile, here are some tidbits to jumpstart the day. Stay in touch…. Merck Extends Deadline For Closing Organon Dutch Facilities (Reuters) Your Pharmaceutical Cargo Theft Update (Securing Pharma) Celgene Raises Revlimid Price To $85K A Year (Dow Jones) FDA Considers Generic User Fees (Pittsburgh Post-Gazette) Sanofi-Aventis And Merck KGgA Sign Cancer Drug Deal (Bloomberg N... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4266264 Fri, 17 Dec 2010 12:44:28 +0100 4266264 http://www.medworm.com/index.php?rid=4152267&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhA34mJ2aYlk%2F Two months ago, the FDA approved a new type of drug from Novartis called Gilenya to treat relapsing forms of multiple sclerosis and delay the progression of physical disabilities. MS, of course, is hard to treat and since Gilenya is a once-daily pill, the betting is that Novartis has a blockbuster on its hands (back story). But how big? A survey of 43 MS specialists by Leerink Swann finds that Gilenya may grab 13 percent of the US market within one year and 19 percent in two years. If this comes true, Gilenya’s market share by then would exceed all of the competition - Biogen’s Avonex with 18 percent market share; EMD Serono and Pfizer’s Rebif at 15 percent; Bayer’s Betaseron with 9 percent and Biogen’s Tysabri at 8 percent. Only Teva’s Copaxone would be... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4152267 Wed, 10 Nov 2010 16:46:41 +0100 4152267 http://www.medworm.com/index.php?rid=4098464&cid=t_116757_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=3994348&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSzT24iX9osI%2F As drug approvals go, this is big news. The FDA has approved a new type of drug from Novartis called Gilenya to treat relapsing forms of multiple sclerosis and delays the progression of physical disabilities. Given that MS is difficult to treat and Gilenya is a once-daily pill, analysts predict Novartis has a big blockbuster on its hands, although Merck Serono’s Movectro, which recently won Russian approval, is widely expected to win FDA approval later this year. For now, though, Novartis is now the only company to market the convenience of an MS pill in the US, which is likely to create strong demand among docs and patients. In announcing the approval, Novartis noted its clinical trials showed Gilenya’s efficacy reduced relapses by 52 percent after a year compared with Biogen&#821... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3994348 Wed, 22 Sep 2010 13:07:06 +0100 3994348 http://www.medworm.com/index.php?rid=3865460&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7iWjrPhmH5E%2F Earlier this week, a 23-year-old Omaha man filed a lawsuit claiming that Genentech and Biogen failed to warn of the risks involving the use of their Rituxan immunosupressant -and the subsequent damage has transformed him into a “flaccid” quadriplegic who is dependent on a ventilator and requires round-the-clock care. Beyond dramatic images, what makes this case potentially significant is it may be the first product-liability lawsuit to level such charges. The story begins in 1995, when Jesse Peetz was 11 and diagnosed with thrombotic thrombocytopenia purpura, or TTP. His doctor prescribed Rituxan, which was approved to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis, but not TTP, which is an autoimmune disorder. His lawsuit claims that ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3865460 Fri, 13 Aug 2010 12:23:41 +0100 3865460 http://www.medworm.com/index.php?rid=3780568&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcWzzDOL3w6Y%2F Kelly Martin is always pissing one big investor or another. Two years ago, one of them accused the Elan ceo of mishandling the marketing of the Tysabri multiple sclerosis treatment and failing to control costs (back story). He survived a protracted spat by closing offices and striking a complicated and controversial deal with Johnson & Johnson. Now, another shareholder wants his scalp. In an open letter to the Elan board, Danish investor Ib Sonderby writes Martin has “publicly misled investors, destroyed collaborations with Elan’s corporate partners and extracted millions of dollars in compensation…Every attempt at positive, shareholder-led change has been met with resistance and entrenchment. The list of deeply flawed business decisions and shameless self-dealing gr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3780568 Thu, 22 Jul 2010 12:12:10 +0100 3780568 http://www.medworm.com/index.php?rid=3761630&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKQq7Yvuph-s%2F And so another working week will soon draw to a close. And what a week it was. How about those Avandia developments? Well, time to think of other endeavors. Perhaps a dip in the pool or a day at the beach? A night at the movies (a day at the races?) As for us, we plan to spend time with one or two short people and catch up on some rest. Whatever you do, we hope you enjoy yourself. Meanwhile, join us for a cup of stimulation and survive the day. See you soon… Toxicology Sinks Vernalis, Biogen’s Parkinson’s Drug (Reuters) UK’s NICE OKs Sanofi’s Multaq Heart Drug (Bloomberg News) Novartis Strikes Tentative Deal To Settle Zelnorm Lawsuits (Dow Jones) FDA Reviewers Question Avastin Breast Cancer Data (Reuters) Merck Ends Development Of HIV Drug (AIDSMeds) Adolor Cu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3761630 Fri, 16 Jul 2010 11:59:28 +0100 3761630 http://www.medworm.com/index.php?rid=3718698&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fh68KkPeH3gU%2F Rise and shine, everyone. Another day is on the way. This means, of course, that meetings and deadlines beckon. Never mind that a holiday weekend is just around the corner. To cope, we are brewing the mandatory cup of stimulation, and enjoying an unexpectedly cool breeze. So please join us as we peruse the news of the world. Good luck today and catch you soon… AstraZeneca Loses Bid To Overturn Antitrust Fine (Dow Jones) Biogen Names Exelisis’ George Scangos As CEO (Bloomberg News) Recession Hurts Funding For AIDS Drug Program (New York Times) FDA Issues Latest List Of Drug With Possible Risks (Reuters) Quebec To Cut Generic Drug Prices (PharmaTimes) USPTO Denies Request To Re-Examine Plavix Patent (Dow Jones) Michigan Grows CROs (Xconomy) Calistoga Raises $40M To Fund Drug Tria... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718698 Thu, 01 Jul 2010 11:56:22 +0100 3718698 http://www.medworm.com/index.php?rid=3526947&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGcH7rZ8YJbU%2F Another month, another list. Once again, there is speculation about which medications will generate the most revenue over the next few years. Interestingly, the latest conclusion mirrors another recent list that suggests conventional pills will easily be eclipsed. Only two small molecules make this newest ranking, which was compiled by EvaluatePharma. Not surprisingly, one of them is AstraZeneca’s Crestor cholesterol fighter, although the newest list differs slightly from this list. And so once again, there are myriad implications raised, including the strategic direction pursued by the biggest drugmakers and the costs for patients. The percentage figure refers to sales growth from 2009 to 2016… 1. Humira (arthritis) Abbott Labs/Eisai - $10.1b; 9 percent 2. Avastin (cancer) Roc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3526947 Mon, 03 May 2010 12:47:00 +0100 3526947 http://www.medworm.com/index.php?rid=3487371&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOyT2YYMmp-E%2F Rise and shine. Another day beckons. And this is a special one here on the Pharmalot corporate campus as one of the short people celebrates a birthday. An especially large cup of stimulation is in order…among other things. While we fuss, please enjoy these items and, of course, have a nice day… Acura Pharma Has FDA Panel Meeting (TheStreet) Biogen Profit Falls, Tysabri Sales Rise (Reuters) Boehringer-Ingelheim Considers More Takeovers (Bloomberg News) J&J Drug Sales Slump (Reuters) Novartis Profit Rises On Flu Vaccines (Bloomberg News) Roche Arthritis Drug Meets Goal, Safety Issues Linger (Reuters) Raloxifene And Tamoxifen Both Guard Against Breast Cancer (HealthDay) Array Signs $467M Deal With Novartis (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3487371 Tue, 20 Apr 2010 11:58:36 +0100 3487371 http://www.medworm.com/index.php?rid=3366428&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGIIsu18_0a8%2F Elan has quietly given Johnson & Johnson the right to acquire its 49.9 percent stake in their joint Alzheimer’s disease venture, a move that could deter potential bidders for Elan and which has riled some shareholders, Reuters reports. The agreement, which is buried in Elan’s recently filed annual report, is part of a broader deal announced last July in which J&J agreed to pay $1 billion for 18.4 percent of Elan and take a 50.1 percent stake in a new company working on Elan’s experimental Alzheimer’s drugs, Reuters continues. The terms were revised after it was disclosed Elan and J&J reached a secret agreement in which J&J could gain 50 percent in the Tysabri multiple sclerosis drug, which Elan markets in a 50-50 partnership with Biogen Idec. As ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3366428 Mon, 15 Mar 2010 12:24:04 +0100 3366428 http://www.medworm.com/index.php?rid=3350568&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWd4iws7642I%2F A pleasant morning here on the Pharmalot corporate campus. After a recent spell of snow, spring appears to have finally bloomed. And that makes it a bit easier to cope with those mid-week deadlines and meetings, yes? So grab a cup of something stimulating and dig in for another day. Here are a few interesting items to help you on your way. Cheers, everyone… Abbott Bests Biogen With Bid For Facet Biotech (Bloomberg) Bristol-Myers’ CEO 2009 Pay Was Down 22 Percent (Associated Press) Sandoz Names Don DeGolyer To Heads US Ops (Chain Drug Review) Novartis Takes Option On Transgene Cancer Vaccine (Reuters) Lilly, Amylin Diabetes Drug Await FDA OK (The Wall Street Journal) Teva Pharmaceuticals Names Phillip Frost As Chairman (Associated Press) Coffee pix thx to chichcacha flickr creat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3350568 Wed, 10 Mar 2010 12:24:03 +0100 3350568 http://www.medworm.com/index.php?rid=3153627&cid=t_116757_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_116757_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=3079580&cid=t_116757_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=3067194&cid=t_116757_129_f&fid=36038&url=http%3A%2F%2Fwww.everydayhealth.com%2Fblog%2Ftrevis-life-with-multiple-sclerosis-ms%2Ftysabri-what-do-you-want-to-know%2F Your attention to the Life with MS Blog has made us a visible part of the multiple sclerosis community and because of that, people will take our calls. I had a long and in-depth conversation the other day with the Senior VP of Drug Safety and Risk Management for Tysabri.  She was very open in proffering information and answering all of my questions so that I could relate them to the community. As I look to my pages of notes from this conversation, I know that we’ll have much to talk about in the coming weeks.  In return for the time and attention I was afforded, I wanted to give something back to the people who are trying to make our lives better: feedback from our readers. In reading through the comments on our other Tysabri blogs (and for my own purposes) it’s obvious to me that we... Life with MS blogs http://www.medworm.com/rss/comments.php?id=3067194 Mon, 07 Dec 2009 22:58:19 +0100 3067194 http://www.medworm.com/index.php?rid=3056883&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDs60YIKgPgg%2F Good morning again and nice to see you. A busy day is expected and so we are studying our to-do list as another deadline looms. Meanwhile, we are also looking ahead to the weekend. Our leaves are finally gone, which means there will be more time to cavort with the short and not-so-short people. And we look forward to catching up on some reading. What about you? While you ponder, here are a few items to jumpstart the day. Whatever you decide, have a great weekend, everyone… AstraZeneca Wins Partial FDA Approval For Seroquel XR (Associated Press) ZymoGenetics Axes Jobs, Quits Immunology Drugs (Xconomy.com) FDA Staff Suggests Liver Warning On Merck’s Cancidas (Reuters) Abbott Lays Off 80 Temp Workers (North County Times) Biogen Boosts Offer For Facet Biotech (Bloomberg News) FDA ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3056883 Fri, 04 Dec 2009 13:18:15 +0100 3056883 http://www.medworm.com/index.php?rid=2974212&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fz1e9iamahXM%2F Welcome to the working week. Hope your weekend was relaxing. Now, of course, it’s time to turn our attention to meetings, deadlines and projects, as always. So as you reach for a cup of stimulation, here are a few items to help you get oriented. Have a good day, everyone… Ranbaxy Says FDA Issues Will Take Time (The Wall Street Journal) Intercell Forecasts Fiscal-Year Loss (Reuters) Philippines Probe Bidding For H1N1 Equipment (ABS-CBNNews) Enzon To Sell Specialty Biz (MarketWatch) Biogen & Elan Change Tysabri Labeling (Reuters) Coffee courtesy of Flickr Creative Commons chichcacha (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2974212 Mon, 09 Nov 2009 13:07:49 +0100 2974212 http://www.medworm.com/index.php?rid=2944098&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FruDvp4OyN3s%2F The patients died of a deadly brain infection known as PML, and 24 cases of the disease have been diagnosed since Tysabri was reintroduced to the market in 2006, the European Medicines Agency told Bloomberg News. The FDA confirmed the number of PML cases as 24, but declined further comment. “We’re not commenting on individual cases of PML,” Jennifer Neiman, a Biogen spokeswoman, tells Bloomberg. “The incidence of PML is rare and the rate remains consistent with what was seen in clinical trials and what is described in our current label.” Just last week, the number of reported PML cases was pegged at 23, up from the 13 previously disclosed. That 10 new cases emerged in the last six weeks is “of particular concern,” UBS analysts Guillaume van Renterghem and Martin Wale... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2944098 Thu, 29 Oct 2009 22:29:38 +0100 2944098 http://www.medworm.com/index.php?rid=2927566&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXCtWyWDJzRE%2F European regulators said in a report published late last week that the number of cases of a rare brain infection linked to Biogen’s Tysabri multiple sclerosis drug are much higher than previously disclosed. And so the European Medicines Agency is reviewing the benefits and risks of the med, which is already under tight regulatory supervision in the US, The Pink Sheet reports. The EMEA counted 23 cases of the brain infection PML since Tysabri reentered the market in 2006 (here is the press release). Three more cases came to light during clinical trials, pushing the total to 26 out of more than 46,000 patients who have received the drug. The last count by the FDA was 13 cases given patients in the general population. Tysabri was originally granted a fast-track approval by the FDA in la... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2927566 Mon, 26 Oct 2009 12:21:28 +0100 2927566 http://www.medworm.com/index.php?rid=2908891&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUNUwajHMJ1E%2F Rise and shine. It’s that time again. The short people are gradually making their way to the school house and we are percolating another cup of stimulation. That can mean only one thing - the start of the day is officially upon us. So here are a few items that will hopefully help you on your way. Have a nice day, everyone… IMS Health May Be Bought By Private Equity? (Bloomberg) Biogen Profit Beats Expectations (Reuters) Drugmakers To Provide Cheap AIDS Drugs To Rwanda (AFP) Pfizer Profit Jumps on Cost Cutting (Associated Press) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2908891 Tue, 20 Oct 2009 11:56:19 +0100 2908891 http://www.medworm.com/index.php?rid=2598477&cid=t_116757_149_f&fid=35786&url=http%3A%2F%2Fkinasepro.wordpress.com%2F2009%2F07%2F14%2Fbiogen-nominated%2F … A RAF candidate & Sunesis got a milestone, In August 2004 the companies entered into a collaboration to discover and develop small molecule cancer therapeutics targeting kinases, a family of cell signaling enzymes that play a major role in the progression of cancer. The research term of this collaboration ended in June of 2008. Sunesis retains an option to participate in the co-development and co-promotion of the Raf kinase inhibitor resulting from this collaboration. Likely derived from WO/2009/006389 &  WO/2009/006404 Posted in Biogen, RAF, Sunesis (Source: KinasePro) KinasePro blogs http://www.medworm.com/rss/comments.php?id=2598477 Tue, 14 Jul 2009 05:10:04 +0100 2598477 http://www.medworm.com/index.php?rid=2056352&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F489595332%2F And so another week is about to draw to a close. To top it off, a rush of snow is about to descend on the nation’s medicine chest. So before we push the plow along the Pharmalot corporate campus, we have gathered a few items to help you close out your busy schedules. Have a nice weekend, everyone… Tysabri Patient With Brain Illness Dies (Bloomberg News) EMEA Panel Backs Lilly’s Prasugrel Blood Thinner (Indianapolis Star) Targanta Lays Off 75 Percent Of Its Staff (Boston Business Journal) Celtic Pharma Raises $100M For Drug Deals (Financial Times) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2056352 Fri, 19 Dec 2008 12:09:26 +0100 2056352 http://www.medworm.com/index.php?rid=2040401&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F485928464%2F Yet again, the multiple-sclerosis medication has caused a serious brain infection, the same malady that prompted the drug to be withdrawn in 2005 for about a year. A German MS patient contracted PML, or progressive multifocal leukoencephalopthy, and remains hospitalized, according to a filing by Biogen with the Securities and Exchange Commission. This is not good news for Biogen and its marketing partner, Elan, which have issued three previous statements this year about four other MS patients contracting PML after taking Tysabri (back story). Nonetheless, the drug has been used by about 35,500 patients as of September, and about 9,500 have taken the injection for at least 18 months, The Wall Street Journal notes. Coincidentally, the disclosure comes just a few days after Novartis reported ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2040401 Mon, 15 Dec 2008 21:17:27 +0100 2040401 http://www.medworm.com/index.php?rid=2040407&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F485504482%2F The pressure on Kelly Martin is intensifying. Amid accusations that he has mishandled the marketing of Elan’s key drug, the Tysabri multiple sclerosis treatment, and has failed to control costs (back story), Jack Schuler, a former Abbott Labs president, whose firm holds 1 percent of Elan stock, has written the board seeking Martin’s ouster. “Lack of relevant industry experience, gross incompetence related to the management of Tysabri and its partnership with Biogen, and egregious misuse of company resources have caused investors to lose confidence in Mr. Martin and his management team,” according to Schuler, a former board member of Chiron, ICOS and Amgen, who co-founded Crabtree Partners. “Given the company’s unacceptable performance, the board has a fiduciary obligati... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2040407 Mon, 15 Dec 2008 12:32:49 +0100 2040407 http://www.medworm.com/index.php?rid=1926681&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F438072630%2F Fred Baron, the wealthy Texas trial lawyer and prominent Democratic fundraiser linked to the John Edwards mistress scandal, died yesterday at 61, the Associated Press reports. Baron had been diagnosed with multiple myeloma, or bone marrow cancer. His death comes just two weeks after he obtained Biogen’s Tysabri following a public plea by his son, Andrew, who had called the drug “last chance effort for life.” Tysabri is approved for people with multiple sclerosis or Crohn’s disease, but is only in the early clinical trial stage for multiple myeloma. And the decision to provide the drug came only after several prominent people, including Hillary Clinton and Lance Armstrong, intervened on his behalf. (Read the back story and the ethics questions). That’s because... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1926681 Fri, 31 Oct 2008 13:58:00 +0100 1926681 http://www.medworm.com/index.php?rid=1926686&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F437932856%2F Decisions, decisions. What will you be this Halloween? A sales rep? A cardiologist? A brand manager? Maybe a cost-cutting consultant? How about a compliance officer? Whatever your fancy, here are a few items to peruse while you mull this over… Erbitux Gets Priority FDA Review For Broader Use (The Wall Street Journal) AstraZeneca Posts Strong Sales Gain (The Financial Times) Sanofi Raises Guidance While Profits Rise Slightly (Yahoo/Reuters) Novo Nordisk May Spend $2 Billion On Acquisitions (Bloomberg News) Biogen & Genentech Develop Blood Cancer Drug (Reuters) Mylan Profit Jumps On Blood Pressure Drug (Bloomberg News) Vanda Pharmaceuticals Halts Development (Washington Business Journal) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1926686 Fri, 31 Oct 2008 11:10:52 +0100 1926686 http://www.medworm.com/index.php?rid=1924715&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F436842035%2F Top of the morning, everyone. We are actually a bit under the weather today, but are persevering, nonetheless. Of course, we are helped by an extra large cup of steaming hot stimulation. So while we gather our strength and hustle the short people along, here are a few items to enjoy… Roche Plans $100M Expansion At Ventana (Associated Press) Glaxo To Buy Genelabs For $57 Million (Reuters) Tysabri Patient Develops Brain Infection (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1924715 Thu, 30 Oct 2008 11:50:24 +0100 1924715 http://www.medworm.com/index.php?rid=1886680&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F423167373%2F After several days of drama and debate over death, privilege and compassionate use, Fred Baron will receive the biologic medication to treat his multiple myeolma, according to a brief statement posted by on a blog written by his son, Andrew. The turnabout came after direct pleas by several high-profile personalities - including Hillary Clinton and Lance Armstrong - to Biogen, which sells Tysabri. “Thanks to the persistence and hard work of so many friends, Frederick has received Tysabri,” the statement reads. “The Mayo Clinic working with the FDA found a legal basis for this use. We have every expectation of a positive result. We cannot thank you enough for all of your thoughts and support!” Fred Baron, you may recall, is a prominent Dallas trial lawyer who helped b... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1886680 Fri, 17 Oct 2008 03:24:42 +0100 1886680 http://www.medworm.com/index.php?rid=1880342&cid=t_116757_136_f&fid=36162&url=http%3A%2F%2Fmyelomablog.com%2F2008%2F10%2F15%2Ffred-baron-mm-and-tysabri%2F Have you read about the furor over Fred Baron’s quest to get Tysabri to attempt to treat his myeloma? According to his son’s blog, they believe it could help prolong his life. Andrew Baron says that Biogen, the maker of Tysabri (a drug used to treat MS), will not allow him to have the drug.  It is, however, being tested on MM patients in a phase I trial. I still have to do some reading on this drug. The side effects are potentially serious, but, when you have only weeks left to live, I don’t suppose that matters. Andrew’s blog:  http://dembot.com/post/54498664/open-letter-to-james-c-mullen-ceo-of-biogen http://www.pharmalot.com/2008/10/biogen-tysabri-a-dying-democratic-fundraiser/ (Source: beth's myeloma blog) beth's myeloma blog blogs http://www.medworm.com/rss/comments.php?id=1880342 Thu, 16 Oct 2008 00:28:54 +0100 1880342 http://www.medworm.com/index.php?rid=1883564&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F421862289%2F Fred Baron, a prominent Dallas trial lawyer who helped bankroll John Edwards’ presidential run and also paid for the former senator’s mistress to leave Chapel Hill, North Carolina, after the affair made national headlines, is dying of multiple myeloma. But money won’t buy the wealthy, 61-year-old Democratic Party fundraiser a medication that may improve his odds of living beyond the next few days - Tysabri, which is sold by Biogen. Despite a furious publicity campaign drummed up by his son, Andrew, Biogen refuses to make the medication available. Never mind that calls to Biogen ceo Jim Mullen were placed by various politicians - Bill and Hillary Clinton, Henry Waxman, Ted Kennedy, Tom Harkin, John Kerry - or their staffs. Oh yes, Lance Armstrong also rang. Mullen is resol... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1883564 Wed, 15 Oct 2008 19:59:35 +0100 1883564 http://www.medworm.com/index.php?rid=1876479&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F419566694%2F As the big drugmaker grapples with its big slowdown, the board and top management are exploring a number of interesting ways to jumpstart business, according to sources. The moves may involve laying off still more employees - a large number of reps, for instance; plans to sell off some of the R&D units that are being eliminated and possibly purchasing a brand-name biotech, our sources tell us. How Pfizer may actually peddle units that focus on heart disease, gastrointestinal illnesses and obesity, for instance, remains to be seen, but presumably other drugmakers may be approached about a purchase or venture. The effort could include offering both intellectual property and staff, sources say. This leaves the fate of some facilities at R&D headquarters in Groton, Connecticut, up in... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1876479 Mon, 13 Oct 2008 14:35:40 +0100 1876479 http://www.medworm.com/index.php?rid=1834809&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F403751762%2F The corporate raider, who is angling to sell a 13 percent stake in Imclone Systems for more than $800 million, is piling up bets in the biotechnology industry, according to data compiled by Bloomberg News. Icahn and hedge funds he manages have accumulated stakes in at least 10 biotechs that comprise a fifth of their total publicly reported holdings, excluding shares of Icahn Enterprises LP. Icahn, 72, and the funds have about $1.3 billion invested in biotech, four times as much as two years ago, and increased those bets by $320 million in the last two months alone, according to Bloomberg. “He’s trying to identify companies that he thinks major pharmaceutical companies’ managements might be attracted to, and he’s trying to stir up that attraction,” Tim Ghrisk... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1834809 Fri, 26 Sep 2008 12:27:16 +0100 1834809 http://www.medworm.com/index.php?rid=1788915&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F390073267%2F The agency says a woman died of the rare viral infection more than a year and a half after discontinuing the drug, which is used to treat rheumatoid arthritis and non-Hodgkin’s lymphoma, and is marketed in the US by Genentech and Biogen Idec. Although cases of the infection have previously been reported in patients taking Rituxan for unapproved uses, including lupus, the FDA says the latest instance is the first reported in a patient taking the drug for arthritis. “The patient had a number of confounding factors that make it difficult to assess the potential role, if any, that Rituxan exposure may have played,” a Genentech spokeswoman tells the Associated Press, adding that the biotech disclosed the death during its July earnings call and the labeling mentions the infect... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1788915 Thu, 11 Sep 2008 22:22:38 +0100 1788915 http://www.medworm.com/index.php?rid=1689194&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F358595602%2F A federal judge dealt Biogen and Elan a blow by refusing to move a lawsuit over the death of a patient, who had been treated with their Tysabri multiple sclerosis med, from a state court in Boston, where Biogen is based, to a federal court in Iowa. And in doing so, US District Court Judge Douglas Woodcock supported the arguments against preemption as a reason for his ruling, The Wall Street Journal writes. Preemption is the notion that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining agency actions are the final word on safety and effectiveness, and the concept shields them from liability claims under state law. The US Supreme Court this November will review a case involving a Vermont woman and... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1689194 Thu, 07 Aug 2008 20:08:25 +0100 1689194 http://www.medworm.com/index.php?rid=1679702&cid=t_116757_129_f&fid=36038&url=http%3A%2F%2Fblog.healthtalk.com%2Fmultiple-sclerosis%2Flife-with-ms%2Ftwo-new-cases-of-pml-reported-in-ms-patients-taking-tysabri%2F This past week, Biogen Idec and Elan Pharmaceuticals, reported to their respective regulatory agencies that two new cases of progressive multifocal leukoencephalopathy (PML) were conclusively diagnosed in European MS patients who were undergoing Tysabri (natalizumab) mono-therapy for multiple sclerosis. The details of the reports are somewhat vague. Extensive procedures taking approximately two months for each patient have proven that two separate patients in two different countries who were using Tysabri for two separate kinds of MS for differing periods of time have contracted PML. Both patients are reported as “stable,” though company officials were vague on the patients’ prognoses. It’s not like we didn’t expect to hear this news… eventually. Everyone on Tysabri knows that... Life with MS blogs http://www.medworm.com/rss/comments.php?id=1679702 Mon, 04 Aug 2008 23:38:01 +0100 1679702 http://www.medworm.com/index.php?rid=1671773&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F352063264%2F Biogen and Elan have reported two confirmed cases of a deadly brain infection - progressive multifocal leukoencephalopathy - in patients taking their Tysabri multiple sclerosis drug, according to a filing with the Securities and Exchange Commission. Both patients were in the European Union, and were confirmed earlier this week. One remains hospitalized and the other remains clinically stable and ambulatory at home. Biogen and Elan had pulled the drug from the market for a year after two other patients developed the infections, Bloomberg News reminds us. The FDA allowed sales to resume in July 2006 after deciding benefits for slowing MS relapses outweighed the risk. (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1671773 Thu, 31 Jul 2008 23:41:03 +0100 1671773 http://www.medworm.com/index.php?rid=1649306&cid=t_116757_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=1603407&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F331625627%2F Nice to see you again. We were up quite early today foraging for interesting items and researching others. So now we will tend to the official Pharmalot mascot and grab some coffee. Meanwhile, we hope your day gets off to a good start… US, Europe & Australia Unite On Drug Inspections (Associated Press) Shareholders Approve Biogen Board (Yahoo/Reuters) Novartis Closing Two Sites In France (Thomson Financial) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1603407 Thu, 10 Jul 2008 10:49:17 +0100 1603407 http://www.medworm.com/index.php?rid=1509076&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F309585373%2F The wind and rain was ferocious last night here in the nation’s medicine chest. We spent part of our time securing the hatches and, later, hauling huge tree branches into the street. So much fun. But we have no complaints. We are, however, still getting reoriented and apologize for not posting these dispatches sooner. Hope your day is pleasant and productive… Unions Sue Law Firms Over Vioxx Settlement (Legal Newsline) Proxy Advisors Back Biogen Against Icahn (Yahoo/Reuters) Nastech Changes Name And Focus (Yahoo/AP) Bristol-Myers Stock Hits 6-Year Low On Diabetes Data (Yahoo/AP) Mylan Wins Appeal In Prilosec Patent Suit (The Wall Street Journal) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1509076 Wed, 11 Jun 2008 11:02:55 +0100 1509076 http://www.medworm.com/index.php?rid=1500289&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F306038610%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs being announced each month. Despite downsizing, there is movement. Here are some of the latest changes. Recognize anyone? Pfizer hired Charles Triano as senior vp, investor relations; Haemacure added Reinaldo Diaz to its board; InVentiv named Blane Walter as ceo; Alexza Pharma hired Anthony Clarke as vp, international development; Amazon Biotech named Michael Silver as scientific director; Biogen Idec named Hans Peter Hasler its new coo; Covidien named Chuck Bramlage pre... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1500289 Fri, 06 Jun 2008 11:26:44 +0100 1500289 http://www.medworm.com/index.php?rid=1497748&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F305491961%2F That’s what Carl Icahn is asking about Biogen Idec as he raises the volume in his increasingly messy proxy war to take control of the independent-minded biotech. And in his latest filing with the Securities and Exchange Commission, the infamous raider disagrees that Biogen’s own latest filing about its failed sales process last year is inconsistent with public statements made by Biogen execs. That failed attempt at a sale, by the way, came after Icahn pushed Biogen to put itself on the auction block, although Biogen management wasn’t really interested in the idea. Since then, Icahn refuses to take no for an answer and is trying to install his own slate of directors. The effort, though, is taking a nasty turn. For instance, he writes this in his SEC filing that “&#82... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1497748 Thu, 05 Jun 2008 18:11:20 +0100 1497748 http://www.medworm.com/index.php?rid=1407328&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F280165830%2F Investors are upset. Rituxan, which is already approved to treat non-Hodgkins lymphoma and rheumatoid arthritis, failed to prompt a response in patients when compared with placebo in a late-stage, 52-week study. Not only that, the drug failed to meet any of its six secondary goals. Genentech and Biogen Idec shares dove on the disclosure. “We are disappointed in the results of this Phase II/III study, but we understood from the outset the significant challenges in developing treatments for systemic lupus erythematosus,” Hal Barron, Genentech’s senior vp of development and chief medical officer, says in a statement. Rituxan generated sales of nearly $2.3 billion last year and the expanding its use to treat Lupus may have added another $1 billion. Meanwhile, another late-sta... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1407328 Tue, 29 Apr 2008 15:49:24 +0100 1407328 http://www.medworm.com/index.php?rid=1382621&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F272797166%2F The biotech rejected Carl’s proposed directors, setting up a proxy fight over who sits on its board, The Boston Globe reports. A Biogen Idec spokeswoman tells the paper that the current board interviewed Icahn’s three nominees, but decided they were unsuitable because they were committed to his “single-minded agenda to sell the company,” which would make it harder to attract talented employees and form partnerships. The move comes three months after Icahn announced he would seek three board seats and four months after the biotech was unable to find a buyer and ended an auction, despite interest from several large drugmakers, partly due to a huge run-up in its stock price after Icahn’s initial investment became known. (more…) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1382621 Fri, 18 Apr 2008 10:32:21 +0100 1382621 http://www.medworm.com/index.php?rid=1354217&cid=t_116757_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=1263513&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F242375810%2F More problems with the multiple sclerosis med. In a letter posted on the FDA site, Elan and Biogen Idec, which co-market the drug, warned Tysabri may harm the liver within six days of the first dose. Some patients have displayed signs that are “generally recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients,” according to the letter. Apparently, not all docs were aware of the risk, which was added to prescribing information in January when the drug was approved for Crohn’s disease. Biogen and Elan had pulled Tysabri from the market in February 2005 because two patients developed fatal brain infections. The drug was reintroduced in July 2006 after the FDA decided the benefits of slowing MS relapses o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1263513 Wed, 27 Feb 2008 23:08:46 +0100 1263513 http://www.medworm.com/index.php?rid=1242440&cid=t_116757_117_f&fid=36026&url=http%3A%2F%2Fblog.healthtalk.com%2Fzimney%2Frituxan-for-multiple-sclerosis-positive-clinical-trial-results%2F Rituxan (rituximab) is a biologic medication that is already approved by the FDA for the treatment of both non-Hodgkin’s lymphoma (NHL) and rheumatoid arthritis (RA). It is now being studied as a potential treatment for multiple sclerosis, and results of an early-stage clinical trial, recently published in the prestigious New England Journal of Medicine, show that it may have great potential in treating this chronic illness. This is not the first time that a cancer drug (Rituxan was originally approved for NHL, a type of blood cell cancer) has later been studied in MS. Novantrone (mitoxantrone) is one such cancer drug, originally approved for the treatment of certain leukemias and then later for advanced prostate cancer, which also was eventually approved by the FDA for the treatment of ... Dr. Z's Medical Report blogs http://www.medworm.com/rss/comments.php?id=1242440 Tue, 19 Feb 2008 21:08:17 +0100 1242440 http://www.medworm.com/index.php?rid=1232039&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F234942413%2F After all the rain that fell on the nation’s medicine chest, the shining sun is a welcome sight here at the Pharmalot corporate campus. We apologize for what appears to be a later start than usual, but we were shuttling short people to various schools. Now, though, the time has come for a hot cup of coffee. We hope you’ll join us and, while you do, take a peek at a few items that should help you with your day… Smaller biotechnology companies are ready to take the lead away from big pharma in developing antibiotics that can take on a new generation of deadly superbugs, writes CNNMoney.com. Targanta Therapeutics just submitted its application to the FDA. Cethromycin from Advanced Life Sciences finished late-stage studies and is on track for FDA submission. Faropenem, from R... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1232039 Thu, 14 Feb 2008 13:01:03 +0100 1232039 http://www.medworm.com/index.php?rid=1215493&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F231093310%2F Are you reading this, Carl? A letter to The New England Journal of Medicine details two dramatic, but potentially cautionary tales about Tysabri, Biogen’s troubled mulitple sclerosis med. And the news prompts one Wall Street analyst to say Biogen’s forecast for growing the number of Tysabri patients is unrealistic, perhaps dampening prospects for the biotech and Carl Icahn’s hopes of boosting the stock price. A 46-year-old woman with MS received her first dose, but then a mole that had been on her shoulder for years suddenly took on a dangerous new character; it turned out to be a melanoma that spread like wildfire and she has just a few months to live, writes Health Day News. And 45-year-old woman with MS developed melanoma in her retina after receiving several doses. S... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1215493 Thu, 07 Feb 2008 16:50:00 +0100 1215493 http://www.medworm.com/index.php?rid=1212314&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F230492766%2F Another busy day. We hardly know where to turn first. And so while we sort things out, we thought the following items may be of interest. Hope your day is going smoothly and you have a chance to take a well-deserved break… Biogen Quarterly Profits Surge (The Street.com) Three Generic Versions Of Fosamax Are Launched (Yahoo/AP) Perrigo Reports Big Sales Gains (The Grand Rapids Press) CeNeS Gets Takeover Approach (The International Herald Tribune) Alpharma To Sell API Unit (MarketWatch) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1212314 Wed, 06 Feb 2008 19:57:15 +0100 1212314 http://www.medworm.com/index.php?rid=1182989&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F224640065%2F The famed raider is seeking three seats on Biogen Idec’s board, the biotech disclosed this morning. The move raises the specter of a proxy fight and, perhaps, causing Biogen to again be up for sale. The biotech was unable to find a buyer and last month ended an auction, despite interest from several large drugmakers, partly due to a huge run-up in its stock price after Icahn’s initial investment became known. In a research note this morning, Geoff Meacham, an analyst at JP Morgan, wrote that he expects “volatility in Biogen’s shares, given what looks to be a looming proxy fight with the potential outcome of reopening the auction process that was initiated last fall,” according to Reuters. Icahn is proposing the nomination of three candidates to Biogen’s ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1182989 Mon, 28 Jan 2008 15:52:15 +0100 1182989 http://www.medworm.com/index.php?rid=1182993&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F224529356%2F Welcome to the working week. We hope you enjoyed the weekend. As always, there is much to do. No doubt, the next few days will be busy ones. And so as you prepare for meetings and projects, we hope these will help you get oriented. So grab a cup of something hot and dig in… Mylan To Appeal $69M Anti-Trust Court Ruling (MarketWatch) Genmab Stock Jumps On Speculation Of Biogen Offer (Bloomberg News) World Wrestling Sues OTC Drugmaker Over Unpaid Sponsorship (The Augusta Chronicle) Roche Gets EU Approval For Wider Avastin Use (Yahoo/Reuters) Some Flu Viruses Resistant To Tamiflu (The Guardian) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1182993 Mon, 28 Jan 2008 12:14:09 +0100 1182993 http://www.medworm.com/index.php?rid=1155901&cid=t_116757_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F217683235%2Ftysabri_gets_fda_approval_for.html Biogen Idec Inc. and Elan Corp's Tysabri received U.S. Food and Drug Administration approval to be used in patients with moderate to severe Crohn's disease when standard drug treatments are ineffective.Tysabri was previously FDA approved for the treatment of Multiple Sclerosis but was removed from market in 2005 after three patients using it developed the nervous disorder multifocal leukoencephalopathy (PML). Under restricted distribution the drug was allowed back on the market the following year and Biogen reports that 12,000 MS patients use it with no further reports of the fatal disorder.Crohn's disease patients will have to enroll in a similar distribution program to receive Tysabri. The program consists of educational information regarding the drug'... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1155901 Wed, 16 Jan 2008 14:00:41 +0100 1155901 http://www.medworm.com/index.php?rid=1152860&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F216991079%2F For the past 36 hours, the Pharmalot corporate campus has been without water due to a break in a very big pipe in the vicinity. Nonetheless, we have managed to remain squeaky clean as we sort through this messy world. Here are a few items that filtered through… Biogen’s Tysabri Approved For Crohn’s Disease (Yahoo/Reuters) Deadline Is Today For Vioxx Settlement (Bloomberg News) Genentech’s Avastin Sales Called Disappointing (Bloomberg News) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1152860 Tue, 15 Jan 2008 12:00:45 +0100 1152860 http://www.medworm.com/index.php?rid=1146757&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F215044430%2F Biogen Idec ceo Jim Mullen thinks he knows why no one bid for his company - big pharma is too conservative and his biotech looked too risky. “They never would have pursued some of the drugs we pursued or Genzyme pursued,” he tells The Boston Globe. And he seems quite happy that a sale didn’t occur. “Some say we need a business relationship with big pharma - for what? There’s nothing we need help from strategically or in terms of operations from big pharma.” The price tag was estimated at $25 billion to $30 billion, making it one of biotech’s biggest deals, but that was also seen as quite rich. Specifically, Mullen says some prospective bidders were concerned about Tysabri, Biogen’s MS drug, which was temporarily pulled from the market almost ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1146757 Fri, 11 Jan 2008 15:36:35 +0100 1146757 http://www.medworm.com/index.php?rid=1104490&cid=t_116757_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=1090648&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F199422599%2F The biotech, which was the subject of intense speculation for several months after Carl Icahn bought a stake, was unable to find a buyer, even though many big drugmakers were believed to be interested in making a bid after the For Sale sign was put up official in October. So instead, Biogen will remain independent. The news, however, sent Biogen stock plunging 26 percent in after-hours trading to about $56, after closing at $75.88. Biogen shares had a big run-up several months ago, as Wall Street speculation grew over anticipation that Biogen would be a hot item among drugmakers looking to flesh out their thinning pipelines. Pfizer, for instance, took a look last spring, but passed. Others rumors to have been interested included Glaxo, Novartis and Sanofi-Aventis. But the rumors only promp... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1090648 Wed, 12 Dec 2007 22:25:41 +0100 1090648 http://www.medworm.com/index.php?rid=1076927&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F196455853%2F New Medicare rules for a small but promising class of cancer drugs may cause thousands of lymphoma patients to lose access to the treatment, which in some cases is the only therapy available to them, The New York Times writes. As a result, the manufacturers and patient advocacy groups say the changes will sharply cut reimbursement for the meds next year, and they predict that many hospitals will stop offering the treatments. The Medicare changes come just as new data provides additional evidence that the medicines, called Bexxar and Zevalin, are effective. The drugs are given to treat non-Hodgkins lymphoma, the fifth-most-common cancer, and are usually prescribed for patients who haven’t responded to other therapies and who have few remaining treatment options. Clinical trial data sh... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1076927 Fri, 07 Dec 2007 12:27:54 +0100 1076927 http://www.medworm.com/index.php?rid=1075149&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F196212277%2F The sun is shining and there is a crisp breeze blowing past the Pharmalot corporate campus this afternoon. Wherever you are, we hope you have a chance to catch some fresh air or a bite to eat. And here are a few items to help you clear your head…. Biogen Takeover At 22 Percent Justified By Pipeline (Bloomberg News) Lilly Issues Rosy Guidance For 2008 (TheStreet.com) Nigeria Ends Settlement Talks With Pfizer (Agence-France Presse) FDA Update On AstraZeneca Heartburn Drugs Is Near (Yahoo/Reuters) Drugmaker Must Pay For Woman Who Choked To Death On Pill (Xinhua News Agency Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1075149 Thu, 06 Dec 2007 18:10:20 +0100 1075149 http://www.medworm.com/index.php?rid=1073280&cid=t_116757_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=1049953&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F190689643%2F Gerard Le Fur is being coy about whether he would pursue Biogen Idec. But while touring China with Nicolas Sarkozy, the president of France, tells Reuters that the biotech is priced a bit rich. “No comment, but the price is a little high, as you know,” says Le Fur. Carl Icahn owns about 3 percent of the biotech, which has put itself up for sale. Initiial interest was reportedly strong at first, with Pfizer eyeing the company last spring. Since then, however, the share price has climbed - rising from $52 in June to $82.51 last month, before settling back around $70. Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1049953 Mon, 26 Nov 2007 12:52:50 +0100 1049953 http://www.medworm.com/index.php?rid=1028331&cid=t_116757_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=992035&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F177247468%2F Last week, you may recall, the Pfizer vice chairman announced his Dec. 31 retirement after a 31-year career, a good portion of which was spent as a cfo with considerable credibility on Wall Street. The decision, however, came a bit sooner than some expected. Granted, Pfizer’s latest cfo, Frank D’Amelio, just arrived to replace the last one, who departed in the spring, but the timing may have been nothing more than a matter of convenience for Shedlarz. Apparently, his retirement was precipitated, in part, by other events inside the beleaguered drugmaker, according to sources. And these reflected key strategic decisions about Pfizer’s direction. One involved a debate earlier this year over whether to make a bid for for Biogen, which more recently put itself up for sale, and... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=992035 Tue, 30 Oct 2007 15:57:18 +0100 992035 http://www.medworm.com/index.php?rid=987250&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F176639757%2F That’s what some analysts who follow the biotech are saying. There’s uncertainty about Biogen’s pipeline and concern that existing products might face sales pressure because of growing competition for Avonex, a multiple sclerosis treatment, an area it now dominates. Wall Street also notes a looming decrease in Biogen’s share of the profits on drugs it co-markets with Genentech, The Wall Street Journal reports. Biogen’s shares took off after the biotech responded to an offer from Carl Icahn, who owns roughly 4% of the stock, by saying it would open the bidding to others. The stock hit a 52-week high of $84.75 on Oct. 15, but slipped as some investors have grown skeptical and the company reported weaker-than-expected earnings last week. Biogen’s market val... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=987250 Mon, 29 Oct 2007 12:18:03 +0100 987250 http://www.medworm.com/index.php?rid=982725&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F175516615%2F The first round could begin during the first 10 days of November, The Financial Times reports, citing unnamed buzz. But the paper writes that confidentiality agreements have been signed with speculation continuing to center on Pfizer and Novartis, since both companies have notably made public statements about their interest in improving their biologics offering. Although one of the people commented that with Biogen books not yet sent out, advisors are finding it very difficult to appraise the situation and to put a value on indications of interest based on public information alone. “If we don’t know the color of the cat, it is difficult to buy something you don’t know,” one wag told the paper. Another source who claimed direct access to Biogen’s management, however, said not to ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=982725 Fri, 26 Oct 2007 19:53:07 +0100 982725 http://www.medworm.com/index.php?rid=972853&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F173825742%2F For many who have trouble falling or staying asleep, sleeping pills remain popular, but aren’t terribly effective - they help you fall asleep and stay asleep a very modest amount, and cost a great deal, as The New York Times reminds us. Rozerem, for instance, gets you to sleep 7 to 16 minutes faster than a placebo, or fake pill; increases total sleep time 11 to 19 minutes, and costs $3.50 a pill, according to an analysis last year. “People seem to be getting a lot of relief from sleeping pills, but does getting 25 minutes of sleep really give you all that relief?” Wallace Mendelson, the former director of a sleep disorders unit at the University of Chicago and industry consultant, tells the paper. “A bigger aspect of this is that they change a person’s perception of their sta... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=972853 Tue, 23 Oct 2007 13:59:34 +0100 972853 http://www.medworm.com/index.php?rid=952289&cid=t_116757_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=950972&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F170096942%2F That’s what the billionaire is saying to reassure investors about his interest in the biotech. “If an offer was made, Elan would not activate its change of control provision,” for the Tysabri multiple sclerosis med, Icahn tells Bloomberg News. “I don’t think they wanted to be a poison pill. That’s very important. It opens the door a lot.” On Friday, Biogen put itself up for sale after investor Icahn made an offer and the biotech claim to have received “expressions of interest” from others. Icahn offered $23 billion last week and believes Biogen, according to Bloomberg, which notes that some analysts project Tysabri sales could exceed $2 billion in three years. Based on its market cap as of last week, Biogen is worth about $20 billion. ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=950972 Mon, 15 Oct 2007 11:01:40 +0100 950972 http://www.medworm.com/index.php?rid=947461&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F169178919%2F The biotech’s board of directors announced late today that a sale is being explored after Carl Icahn, who recently bought a stake, and other investors expressed interest in a deal. Who are those others? A Biogen spokewoman tells Bloomberg News that unnamed drugmakers have expressed interest. The move comes after the Federal Trade Commission two months ago cleared Icahn to increase his stake in the biotech, prompting a run-up in the stock as investors speculated Icahn would launch a takeover. Icahn, of course, often presses for a sale when he thinks a stock is undervalued. He bought shares in MedImmune before helping to force a $15 billion sale to AstraZeneca. “The rumor that the company has been in play for a long time has been confirmed by this,” Geoff Porges, an analyst... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=947461 Sat, 13 Oct 2007 00:41:38 +0100 947461 http://www.medworm.com/index.php?rid=922075&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F164461953%2F A slow end to a busy day, but that was only due to a slight under-the-weather feeling. Perhaps, a prescription medicine is in order. Meanwhile, a good book and a night of rest are beckoning. We wish you the same… Using both meds and therapy helps depressed teenagers get better faster than a drug or therapy alone, according to a government-funded study in the Archives of General Psychiatry (subscription may be required). The approach also yielded fewer incidents of the suicidal thoughts or behavior linked to antidepressants. Biogen Idec stock fell the most in more than seven months after analysts said the biotech’s forecast for the Tysabri multiple sclerosis med may be way too optimistic, Bloomberg News reports. Until now, speculation persisted about a takeover, given the recent... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=922075 Wed, 03 Oct 2007 01:02:50 +0100 922075 http://www.medworm.com/index.php?rid=867458&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F155684472%2F In observance of ancient traditions, we will take a break over the next two days, and return some time over the weekend. We recognize that the world will continue spinning in our absence, but assure you that we will be back soon enough to resume the daily dose of news, views and chatter that turns you on. Until then, we wish you the best. FDA Panel Votes To Keep Bayer’s Trasylol On The Market (Yahoo/AP) King Seeks Reheaing On Altace Patent Ruling (Yahoo/Reuters) Kenya’s Parliament Debates Scrapping Compulsory Licensing (IP Watch) Biogen Opens Office In India (BioPharma Reporter) Court Finds Ranbaxy Generic Would Violate Lipitor Patent (Yahoo/AP) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=867458 Wed, 12 Sep 2007 21:58:20 +0100 867458 http://www.medworm.com/index.php?rid=867459&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F155643778%2F In conclusion, it is important to restore the public’s confidence in the integrity of the FDA’s decisions by having Congress restrict the number of waivers the FDA grants.” Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=867459 Wed, 12 Sep 2007 20:04:17 +0100 867459 http://www.medworm.com/index.php?rid=847518&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F153161687%2F This was an exceptionally busy day, what with our exclusive news about Vioxx clinical trials (please see this) and still more controversy over antidepressants (please take our poll). Now, though, we must adjourn for a dinner engagement. We look forward to engaging you again tomorrow. Meanwhile, please enjoy these…. Biogen Idec Forecasts Profit Surge On Tysabri Demand (Bloomberg News) Par Pharmaceutical Reports Long-Delayed Financial Results (Yahoo/Reuters) IMS Health Exec Predicts Rosy Future For Generics (Yahoo/AP) Corporate Venture Capital Investing Grows Significantly (Pacific Business News) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=847518 Thu, 06 Sep 2007 21:44:08 +0100 847518 http://www.medworm.com/index.php?rid=839137&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F151991047%2F And so the store is again open for business. We appreciate your patience while we broke for vacation, but hope you also managed to enjoy the end of summer. Now, though, it is time to resume our place on the treadmill. While we adjust, here are a few items you may have missed over the weekend…. There are growing signs of investor discontent with GlaxoSmithKline. And so Christopher Gent, the drugmaker’s chairman, is expected to address the rumblings at his annual autumn chat with shareholders, some of whom want the consumer business spun off. Then there’s the little matter of who should succeed JP Garnier as ceo. Jp, you may recall, retires in May and Glaxo could announce his replacement by year end. Carl Icahn as Biotech Boy. Last week, he won federal approval to increase ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=839137 Tue, 04 Sep 2007 10:54:32 +0100 839137 http://www.medworm.com/index.php?rid=764508&cid=t_116757_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F138273713%2F Why are agency reviewers hesitant to approve Biogen and Elan’s expensive treatment for the gastrointestinal illness? Potentially fatal side effects and a lack of safety studies the FDA asked the drugmakers to provide, according to documents posted on the FDA web site in advance of an advisory committee meeting this Tuesday in Maryland. The FDA staffers wrote they’re concerned patients taking Tysabri, which is already approved to treat multiple sclerosis, could develop a rare and incurable nervous system disease that is usually fatal after six months, the Associated Press reports. Biogen, which codeveloped the drug with Elan, is asking the FDA to approve Tysabri to treat Crohn’s disease, which causes inflammation of the intestines and affects about 1 million people worldwi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=764508 Sat, 28 Jul 2007 14:15:04 +0100 764508 http://www.medworm.com/index.php?rid=587924&cid=t_116757_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F05%2Fphysician-empathy-vs-pre-launch.html A recent article in the Boston Globe about pharmaceutical companies "pitching empathy" to doctors focused on an exhibit at the American Academy of Neurology meeting that "claimed it could create, in a perfectly healthy person, the disorienting symptoms of multiple sclerosis.""The machine, commissioned for the meeting by Cambridge drug maker Biogen Idec Inc. and Elan Pharmaceuticals Inc., drew a line of doctors ... who were curious to experience how it might feel to have a perplexing disease known for its random, debilitating attacks on the brain and spine. With a video, headphones, and two wobbly treadmill tracks, the machine attempted to mimic the lack of coordination, blurred vision, and other signs of an attack."The marketing theory behind the simulator is that a more empathetic doctor ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=587924 Thu, 03 May 2007 12:43:00 +0100 587924