AMGN, GSK Get FDA Nod, CLDX Walks The Talk, OREX Awaits Light, CELG On A High

(RTTNews) - Amgen Inc.'s (AMGN) NEXAVAR has been approved by FDA for the additional indication of treating locally recurrent or metastatic, progressive, differentiated thyroid cancer.

NEXAVAR is co-developed by Bayer and Amgen's subsidiary Onyx, except in Japan where Bayer manages all development. NEXAVAR was first approved by FDA in 2005 for renal cell carcinoma.

Global net sales of NEXAVAR, including sales in Japan, were more than $1 billion in 2012.

AMGN closed Friday's trading at $113.03, up 0.69%.

Celldex Therapeutics Inc. (CLDX) said that its experimental drug Rindopepimut demonstrated promising clinical activity in advanced glioblastoma patient populations, including patients both naïve and refractory to Avastin, in an ongoing, exploratory phase II study dubbed ReACT.

CLDX closed Friday's trading 8.51% higher at $28.31.

Celgene Corp.'s (CELG) cancer drug ABRAXANE in combination with Gemcitabine as a first-line treatment for patients with metastatic pancreatic cancer has received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

The FDA approved ABRAXANE in combination with Gemcitabine as a first-line treatment of patients with metastatic pancreatic cancer as recently as September of this year.

ABRAXANE received its first FDA approval in 2005 for the treatment of breast cancer, and in 2012 for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with Carboplatin.

The drug generated sales of $427 million in 2012.

CELG touched a new high of $164 on Friday before closing at $163.33.

In a move that would supplement national stockpile, the FDA on Friday approved the first adjuvanted vaccine for the prevention of H5N1 influenza in people 18 years of age and older, manufactured by ID Biomedical Corp., a division of GlaxoSmithKline plc (GSK).

Though not intended for commercial availability, the vaccine has been included within the National Stockpile for distribution by public health officials if needed.

GSK closed Friday's trading at $53.36, up 0.26%.

Orexigen Therapeutics Inc. (OREX) will be announcing interim analysis results of a study, dubbed Light study, which is evaluating the cardiovascular outcomes of its lead obesity drug candidate - Contrave, on Monday, November 25, 2013 prior to market open.

Contrave was issued a complete response letter by FDA in January of 2011 on cardiovascular safety concerns, and Orexigen was asked to conduct a cardiovascular outcomes trial for the drug before it could be approved.

OREX closed Friday's trading at $5.68, down 1.05%.