TOP 100 MEDICAL SITES
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| Icahn Hopes to 'Fix' Genzyme The Burrill Report submits: By Michael FitzhughGenzyme (GENZ) investor Carl Icahn has nominated himself and three other candidates for the company's board in an effort to fix what is “broken” following production-linked shortages of some of the biopharmaceutical's top drugs. The salvo follows Genzyme's announcement that it will book a $175 million hit to first quarter earnings in anticipation of a U.S. Food and Drug Administration fine it expects to pay for manufacturing violations. Those troubles and a viral contamination in a Massachusetts plant have left the company unable to meet the market demand for Cerezyme, its Gaucher disease treatment and Fabrazyme for Fabry disease. Ichan's slate believes that “Genzyme's inability to fully manufacture and supply certain of its products leads to the conclusion that the manufacturing system at Genzyme is ‘broken’,” said the activist investor in an April 27 regulatory filing that formalized their bid. Icahn believe his nominees’ “knowledge of science, medicine, finance and business will significantly improve the science and business expertise of the board of directors of Genzyme” and that “a change in board composition at Genzyme is necessary to bring new ideas and ways of looking at problems to the existing board.” Genzyme has responded to its manufacturing mess by hiring two new experienced senior leaders for its manufacturing and quality operations, says CEO Henri Termeer. It is also urging shareholders to ignore Icahn's alternate board nominations in favor of a Genzyme-picked slate. The company says it is working on expansion projects it expects will quadruple its biologics manufacturing capacity by 2012, both to increase capacity and to create redundancy to support operational flexibility. Cambridge, Massachusetts-based Genzyme will hold its annual meeting June 16.Complete Story » seekingalpha.com |
PPD Announces Second Quarter 2010 Earnings Release, Webcast and Conference Call (Business Wire) WILMINGTON, N.C.----PPD, Inc. will release its second quarter 2010 financial results on Tuesday, July 27, 2010, after the market closes. The earnings release will be available on the PPD website at www.ppdi.com. us.rd.yahoo.com |
Three Trades on FDA, Clinical Trial Binary Events Mike Havrilla submits:Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news...Osiris Therapeutics (NASDAQ:OSIR) announced this morning that Health Canada has completed its initial evaluation and issued a priority (180-day) review for PROCHYMAL (remestemcel-L) (mesenchymal stem cells for intravenous infusion), which is seeking approval as an adult stem cell therapy for for the treatment of graft vs. host disease (GvHD).Complete Story » seekingalpha.com |
BioDelivery Sciences: Signs of Life VFC submits: Don't look now, but BioDelivery Sciences (BDSI) is showing signs of a pulse. On September 2nd, the company announced a positive meeting with the US FDA and BioDelivery's Onsolis partner, Meda. Complete Story » seekingalpha.com |
Cypress and Hedge Fund Ramius Renew Battle Over Control The Burrill Report submits: By Michael FitzhughCypress Bioscience (CYPB) will consider putting itself up for sale or unloading part of its assets in an attempt to nullify or better a pending buyout offer made by a New York hedge fund. Ramius, a Cowen Group fund that owns 10 percent of Cypress, is offering $148 million for the shares it does not own. At $4.25 per share, Cypress’ management says the bid “grossly undervalues” its current business and future prospects.Complete Story » seekingalpha.com |