Amgen, Inc. Receives Positive Opinion For Human Use For XGEVA (Denosumab) In European Union Print E-mail
By Staff and Wire Reports   
Friday, 20 May 2011 21:05
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 20, 2011.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended a positive opinion for the marketing authorization of XGEVA (denosumab) for the prevention of skeletal-related events in adults with bone metastases from solid tumors, revealed by Amgen, Inc. (NASDAQ:AMGN). The CHMP positive opinion is based on three pivotal, Phase 3 head-to-head trials that evaluated the effectiveness of XGEVA versus Zometa (zoledronic acid) at delaying SREs.

The CHMP also recommended to grant XGEVA an additional year of data and market exclusivity in the EU since the indication was considered significantly new for XGEVA, and based on the significant clinical benefit of the product in comparison with existing therapies.

If approved by the European Commission, Amgen would receive marketing authorization for XGEVA in all European Union Member States.

Also Friday:

Advanced Life Sciences Holdings, Inc. (OTCBB: ADLS.OB)
, announced today that it has cancelled its Annual Meeting of Shareholders, which was previously scheduled to take place on Tuesday, May 24, 2011.  

Auxilium Pharmaceuticals, Inc. (NASDAQ:AUXL), a specialty biopharmaceutical company, today announced that the Company received a $7.5 million regulatory milestone from Pfizer, Inc. (Pfizer) following the first sale of XIAPEX® in Germany, a major EU market.

BioSpecifics Technologies Corp. (NASDAQ:BSTC), a biopharmaceutical company developing first in class collagenase-based products, today provided an update on the launch progress of XIAPEX® (collagenase clostridium histolyticum) in Europe.

Today, the United States District Court for the District of Delaware granted a motion filed by plaintiffs Cephalon, Inc. (NASDAQ:CEPH), and Eurand, Inc., for a Temporary Restraining Order (TRO) enjoining Mylan Pharmaceuticals Inc., and Mylan Inc., from manufacturing, using, offering to sell or selling its cyclobenzaprine hydrochloride extended-release capsules, a generic version of Cephalon's branded product AMRIX®.  The TRO remains in effect pending appeal.

Gen-Probe Incorporated (NASDAQ:GPRO) announced today that the Company has filed a 510(k) application with the US Food and Drug Administration for its PANTHER™ system, a fully automated and integrated molecular testing system designed with the flexibility to handle a wide range of testing needs.

Hospira, Inc. (NYSE:HSP)
, a leading provider of clinical information and medication delivery technologies, today announced that the company has received regulatory approval from Health Canada for its software upgrade to the Symbiq™ infusion system.

Northwest Biotherapeutics (OTC Bulletin Board:NWBO) announced today that its Chief Technical Officer, Dr. Marnix Bosch, will give a presentation on "Autologous Dendritic Cells for Glioblastoma" on Saturday, on May 21, at 1:45 pm at the 14th Annual Meeting of the American Society of Cell and Gene Therapy in Seattle, WA.

PROLOR Biotech, Inc., (NYSE Amex:PBTH), a clinical stage company developing next generation biobetter therapeutic proteins, today announced that Dr. Abraham Havron, CEO of PROLOR, will give a corporate presentation at the ILSI-Biomed 2011 Conference.

Questcor Pharmaceuticals, Inc. (NASDAQ:QCOR) today announced the passage by its shareholders of the six proposals considered during the Company's annual meeting on May 19, 2011.

Southern Home Medical Equipment, Inc. (PINKSHEETS: SHOM), a holding company providing healthcare services, staffing and durable medical equipment to medical institutions, announced today that it has signed a letter of intent to merge with a network of medical clinics based in the Washington, DC area.

Therma-Med, Inc. (PINKSHEETS: THRA) ("the Company") has announced today that it has entered into a definite agreement to earn a 49% interest in Ag/Zn/Pb hosting mineral claims, situated in the Mining Division of Slocan, B.C., Canada.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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