|FDA Advisory Committee Supports Approval of Gilead's Once-Daily Quad Single Tablet Regimen for HIV; Orexigen Sitting At Session Highs|
|By Staff and Wire Reports|
|Saturday, 12 May 2012 00:51|
Gilead Sciences, Inc. (Nasdaq: GILD) announced the Antiviral Drugs Advisory Committee of the U.S. FDA has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults.
The recommendations of the Advisory Committee are not binding, but will be considered by FDA as the agency completes its review of Gilead's New Drug Application (NDA) of the Quad. Gilead submitted the NDA on October 27, 2011 and FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of August 27, 2012. Applications for marketing approval of the Quad are also pending in Australia, Canada and the European Union.
Shares of Orexigen Therapeutics (NASDAQ: OREX) are surging after the FDA approved a weight loss drug from Arena Pharmaceuticals (NASDAQ: ARNA) called Lorcaserin. Orexigen has a similar drug called Contrave which has completed Phase III clinical trials and a drug called Empatic which has completed Phase II trials.
The news from Arena has sent shares of Orexigen flying higher to end the week. At last check, the small-cap biotech name had added more than 17% and was trading at $3.93. The stock has traded in a range between $1.22 and $5.14 over the last 52-weeks.
Adherex Technologies Inc. (TSX:AHX) (PINKSHEETS:ADHXF), a biopharmaceutical company focused on the development of eniluracil and 5-fluorouracil, today reported its financial results and recent developments for the first quarter ended March 31, 2012.
AmerisourceBergen Corporation (NYSE: ABC) today announced that Tim G. Guttman, 53, has been named Senior Vice President and Chief Financial Officer, effective immediately.
Aradigm Corporation (OTC BB:ARDM.OB) (the “Company”) today announced financial results for the first quarter and three months ended March 31, 2012.
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today the expansion of the lorcaserin marketing and supply agreement between Arena Pharmaceuticals, Inc.'s wholly owned subsidiary, Arena Pharmaceuticals GmbH, and Eisai Inc. Lorcaserin is an investigational drug candidate intended for weight management.
Arno Therapeutics, Inc. (OTCBB: ARNI) announced today that its investigational compound known as AR-42 has been granted orphan-drug designation by the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products for the treatment of neurofibromatosis type 2 (NF2).
BIOFUEL ENERGY CORP. (NASDAQ: BIOF), an ethanol production company, today announced its first quarter 2012 results. For the quarter ended March 31, 2012, the net loss was $11.1 million on revenues of $139.4 million, compared with a net loss of $9.0 million on revenues of $158.0 million for the quarter ended March 31, 2011.
Boston Scientific Corporation (NYSE: BSX) announces results from the ASA Plavix (ASAP) Study, which studied the WATCHMAN® Left Atrial Appendage Closure (LAAC) device.
China Biologic Products, Inc. (NASDAQ: CBPO), one of the leading plasma-based biopharmaceutical companies in the People's Republic of China, today announced that the Company's Board of Directors (the "Board") has appointed Chairman David (Xiaoying) Gao to the additional position of Chief Executive Officer, effective May 10, 2012.
Crown Dynamics Corp., (OTCBB: CDYY) today shares additional information from the clinical trials conducted on their Airware Labs AIR®Breathe product.
Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care announced today that Barry Wolfenson, the Company’s Executive Vice President for Global Marketing and Business Development will present a corporate overview and update at the Bank of America Merrill Lynch 2012 Health Care Conference taking place from Monday, May 14 - Thursday, May 17, 2012 at the Encore at the Wynn in Las Vegas, Nevada.
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) today announced its audited consolidated financial results for the quarter and full year ended March 31, 2012 under International Financial Reporting Standards (IFRS).
Dyax Corp. (NASDAQ: DYAX) today announced the launch of a free smartphone application for the iPhone – HAE Attack Tracker™.
Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today reported its financial results for first quarter, ended March 31, 2012.
GeneLink, Inc. (OTC Bulletin Board: GNLKE), a leading consumer genomics biotech company, reports financial results for the fiscal year ended December 31, 2011.
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults.
InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), announced today the appointment of Jack Harvey as Senior Director of Manufacturing and Celina Chang as Senior Scientist as the Company ramps up preparations for a human clinical trial and begins to expand its product portfolio to other nervous system conditions.
Lannett Company, Inc. (NYSE Amex: LCI), a manufacturer of generic pharmaceuticals, today announced the appointment of Paul Taveira to its board of directors, expanding the company’s board to eight members.
Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the quarter ended March 31, 2012 and provided an update on recent corporate developments.
Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and commercializing products to treat medical conditions in inflammatory, cardiovascular, orthopedic, and wound healing markets, announced today its results for the first quarter ended March 31, 2012.
PROLOR Biotech, Inc. (NYSE Amex: PBTH; TASE: PBTH), today announced the pricing of its previously announced underwritten public offering of 6.5 million shares of its common stock at a price to the public of $5.00 per share.
Seattle Genetics, Inc. (NASDAQ:SGEN) announced today that management will present at the Bank of America Merrill Lynch 2012 Health Care Conference on Tuesday, May 15, 2012 at 1:00 p.m. Pacific Time.
Synthetic Biologics, Inc. (NYSE Amex: SYN), a developer of synthetic DNA-based therapeutics and innovative disease-modifying medicines for serious illnesses, announced today that to improve its corporate governance and strengthen the Board, it has split the roles of Chairman and Chief Executive Officer, and appointed Jeffrey J. Kraws to serve as its independent, non-executive Chairman of the Board.
Taro Pharmaceutical Industries Ltd. (NYSE: TARO) announced today that the Special Committee of its Board of Directors formed to evaluate the offer from Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (together with its subsidiaries and affiliates, “Sun Pharma”) continues to evaluate Sun Pharma’s non-binding October 18, 2011 cash offer of $24.50 per share for all of the issued and outstanding shares of Taro not currently held by Sun Pharma.
VentriPoint Diagnostics Ltd. (TSX VENTURE:VPT) (OTCQX:VPTDF) has installed its latest version of the VMS™ heart analysis system at Allegheny General Hospital in Pittsburgh to support its clinical trials program and for other research purposes.
VentriPoint Diagnostics Ltd. (TSX VENTURE:VPT) (PINKSHEETS:VPTDF) is pleased to announce that it has completed the final tranche of its previously announced non-brokered private placement (the "Private Placement") of units of the Corporation (the "Units").
YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM), a drug development company advancing a diverse portfolio of hematology and cancer related products, today reported operational and financial results for its third quarter of fiscal 2012, ended March 31, 2012.