An overview of product candidates in clinical trials and the more than 30 life science companies developing novel therapies for Alzheimer’s disease
FDA Advisory Panels: No Means No, Yes Means Maybe
February 6, 2011 By 4 Comments
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 [...]
Monoclonal Antibody Companies Command Premiums
July 11, 2010 By Leave a Comment
Monoclonal antibodies, which have been approved for immunological, anti-infective, ophthalmic, cancer and other categories, represent one of the most successful therapeutic drug classes. Ten monoclonal antibodies have been approved for cancer therapy alone, including three blockbuster products sold by the Roche Group (RHHBY) – Avastin® [bevacizumab], Rituxan® [rituximab], and Herceptin® [trastuzumab] that collectively represented nearly [...]
Five Key Factors Weighing on Dendreon
July 1, 2010 By Leave a Comment
Shares of Dendreon Corporation (DNDN) have declined significantly from an all-time high of $57.67 in late April 2010 when the company received U.S. Food and Drug Administration [FDA] approval for Provenge® [sipuleucel-T], the first active immunotherapy approved for the treatment of cancer in the U.S. Today, shares of Dendreon traded as low as $28.01, down [...]
Three Recent Biotechnology Activist Wins by Carl Icahn
August 30, 2009 By 1 Comment
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. [...]
Follow MD Becker Partners