February 5, 2012

FDA Advisory Panels: No Means No, Yes Means Maybe

MD Becker Partners' Life Science Digest: FDA Advisory Panels - No Means No, Yes Means Maybe

As the only company to receive a positive United States Food and Drug Administration [FDA] Advisory Committee [AdCom] recommendation for a product candidate to treat obesity in 2010, Orexigen Therapeutics, Inc. (OREX) appeared well positioned to receive marketing approval for Contrave® [naltrexone HCl/bupropion HCI].  However, on January 31, 2011, Orexigen and its partner Takeda Pharmaceutical [...]

For Biotechnology in 2010, it’s Déjà vu All over Again

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“It’s déjà vu all over again” – Yogi Berra With Opening Day less than a month away, it seems only fitting to reference one of the most quoted personalities of our time to describe our analysis of the biotechnology sector in 2010.  In this article, we review our favorable outlook for the industry, draw comparisons [...]

Three Recent Biotechnology Activist Wins by Carl Icahn

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Although a controversial topic, activist hedge funds and private equity firms typically use a small equity stake in an underperforming company to put public pressure on its management and board of directors with the goal of increasing stakeholder value through cost cutting, changes in corporate strategy or management, capital restructuring, asset divestiture and other tactics.  [...]