Valeant, GSK Prepare for Approval of Anti-Epileptic Drug Despite Latest Delay

By Stephen Simpson:I have to give credit where credit is due - ISTA Pharmaceuticals (ISTA) management stuck to its guns, remained patient, and ultimately got a much better deal for shareholders. With a solid deal in hand from Bausch & Lomb, ISTA management has given shareholders a pretty happy ending. A Little Bit Of History Repeated

Zacks.com submits: Orexigen Therapeutics Inc. (OREX) was dealt a severe blow by the U.S. Food and Drug Administration (FDA) when the regulatory body declined to approve its obesity drug, Contrave in the present form and issued a complete response letter (CRL).

EP Vantage submits:The phrase "medical breakthrough" is often overused and misplaced, but in Gilenia’s (fingolimod) case this is truly appropriate as it is on the verge of becoming the first oral drug to treat MS patients, up to 40% of whom are estimated to delay or refuse initial treatment with currently available injectable agents.

The Burrill Report submits: AstraZeneca (AZN) said it will eliminate an additional 8,000 jobs or about 12 percent of its workforce as it seeks to cut costs in the face of declining revenue and lowered its forecast for 2010. The announcement came as the company reported earnings that fell short of expectation. The company said the next five years will be difficult as key products come off-patent.

By Brian L. Wilson:The diversified drug developer Theravance (THRX) and its investors are patiently awaiting the results of an FDA advisory committee meeting scheduled for March 7, 2013, which is generally expected to yield some positive feedback on the NDA that the company submitted for the COPD/Asthma drug Breo in 2012.

Michael Becker submits: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].

Pharmalot submits: One of the big questions about establishing a regulatory pathway for approving biologics is the extent to which the FDA will require clinical trials to prove a biosimilar is equivalent to the original brand medicine. This is what is called the great unknown.

The Burrill Report submits: