by Jeffrey Clark on February 23, 2012
 The FDA continues to fret over weight loss treatments. A new weight loss treatment has not been approved in more than a decade. In the past two years alone, the FDA as rejected pills from all of the three small drugmakers focused on obesity: Arena Pharmaceuticals, Orexigen Therapeutics and Vivus. And, all three continue to press the FDA on their decisions by resubmitting their products.
Vivus is up next….again. The CA-based company has an advisory panel decision next week and an April time frame for a final FDA decision. This following its initial rejection in October 2010 over two safety concerns.
So how will it play out? Doctors believe new weight-loss therapies are desperately needed. Investors know that even a modestly effective drug could have blockbuster potential. But none of the three medicines before the FDA represents a breakthrough in research. For certain, the next two months will go a long way toward deciding the fate of these specialty pharmaceutical companies and whether the industry as a hole should consider weight loss a viable category moving forward.
MSNBC
by Jeffrey Clark on February 22, 2012
While venture markets, drug approval and the overall economy are lagging, investor markets seem to be bullish on biotechnology in early 2012. Proof? The S&P biotech index is up 13% so far this year.
While at the BIO CEO Investor conference this week, CEO of Alkermes, Richard Pops, shares his opinion of what’s behind the surge.
February 21, 2012
Some of our team at Beaker had a chance to watch Chris Viehbacher, CEO of Sanofi, speak this week. He is wildly impressive but was also the 2nd place finisher in the race to lead GlaxoSmithkline following the retirement of JP Garnier. Viehbacher obviously lost to Andrew Witty but the two are remarkably similar in [...]
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February 20, 2012
Gilead Sciences set the industry on fire just months ago and sparked a frenzy over potential hepatitis C therapies with its $11 billion purchase of Pharmasset. Most saw the acquisition price as staggering if not irrational for a Phase II product from a company with less than 125 employees. Now some bad news leaves Gilead [...]
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February 17, 2012
In the past, the CEO’s of Amgen, Gilead, Genentech, Chiron, Immunex and others would attend the BIO International convention every year. When the convention became overwhelming, they started attending this more exclusive CEO event. Now they send Business Development executives on their behalf to source deals. So where do CEO’s hang out? Most are now [...]
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February 13, 2012
The 2.3% medical device levy is more of a tax issue than a health reform issue, and repealing it “is the first down payment on much-needed tax reform,” according to AdvaMed President and CEO Stephen Ubl. In doing what its member companies expect, Advamed is pulling out all the stops to give legislators a reason [...]
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February 11, 2012
Severin Schwan, Roche CEO, discusses Roche’s offer for Illumina. CNBC’s Faber does a great job digging into the motivations of Roche in pursuing Illumina. He even quotes Craig Venter who himself questions the rationalization of the deal, in such a changing market for sequencing. As we’ve learned from Roche’s acquisitions of Ventana Medical Systems and [...]
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February 10, 2012
Based just outside Boston, Abiomed is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. The company’s products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart. The [...]
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February 9, 2012
FierceBiotech has released its 25 Most Influential People in Biopharma list. These lists crop up once every few months from different sources. Many of the names are consistently present; others offer a surprise. For us, its difficult to leave off the biomedical, medical device and diagnostics leaders who should be considered. If you’re going to [...]
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February 8, 2012
New Jersey Governor Chris Christie has lost his Chief of Staff to the pharmaceutical industry. What else do expect in Big Pharma country? Richard Bagger joined Celgene at the end of January in a newly created position with the pharmaceutical company. Bagger serves as senior vice president, corporate affairs and strategic market access, with responsibility [...]
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