Teva Receives Marketing Authorization for ZOELY™. FDA Accepts NDA Filing For Incyte's Ruxolitinib. Print E-mail
By Mary Davila   
Wednesday, 03 August 2011 19:24
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 3, 2011.

Teva Pharmaceutical Industries Ltd (NASDAQ:TEVA)
announced its new oral contraceptive, ZOELY™, has received a Marketing Authorization in the European Union (EU) for the prevention of pregnancy. This paves the way to allow the product to be launched in Europe by the end of 2011.

Conversely to the currently available contraceptive pills, ZOELY™ is a combined oral contraceptive (COC) tablet containing a unique monophasic combination of 2 steroid hormones; 17-beta estradiol, an estrogen that is structurally identical to the major estrogen produced by the ovaries of healthy non-pregnant women, and nomegestrol acetate, a highly selective progesterone-derived progestin.


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Incyte Corporation (NASDAQ:INCY), announced the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Incyte’s lead investigational compound, ruxolitinib (INCB18424/INC424), as a potential treatment for patients with myelofibrosis (MF). MF is a potentially life-threatening blood cancer with limited treatment options and no FDA-approved medicines.

The FDA also has granted Incyte’s request for Priority Review, which is given to investigational drugs that may offer either a major advance in treatment or provide a treatment where no adequate therapy exists. The FDA has a goal to complete the Priority Review within six months. If the application is approved, Incyte anticipates that ruxolitinib could be available for U.S. patients with MF in the fourth quarter of 2011.

The NDA includes results from two Phase III trials, COMFORT-I conducted by Incyte and COMFORT-II conducted by Novartis, under the Incyte-Novartis worldwide collaboration and license agreement. Results from both studies were recently presented at the 2011 American Society of Clinical Oncology annual meeting and the 16th Congress of the European Hematology Association.


Also Wednesday:


ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, detailed the continued reimbursement progress for MuGard, highlighting the recent addition of third party payers Blue Cross Blue Shield of Hawaii, SummaCare and AvMed.

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") will announce its second quarter 2011 financial and operating results on Wednesday, August 10, 2011.

BioMed Realty Trust, Inc. (NYSE:BMR), a real estate investment trust focused on Providing Real Estate to the Life Science Industry®, today announced financial results for the second quarter ended June 30, 2011.

Dendreon Corporation (Nasdaq:DNDN) today reported results for the second quarter ended June 30, 2011.  Net revenue for the quarter ended June 30, 2011 was $49.6 million compared to $2.8 million for the quarter ended June 30, 2010.

Hadasit Bio-Holdings, Ltd. - (OTCBB: HADSY), a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, and Clal Biotechnology Industries (TASE: CBI) announced a significant clinical advancement in their portfolio company, Thrombotech ( 24% and 42% ownership, respectively).

Neuralstem, Inc. (NYSE Amex:CUR) announced it received a U.S. Department of Defense (DOD) contract to develop its human neural stem cell technology for the treatment of cancerous brain tumors.

Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. (TSX: ONC) (NASDAQ:ONCY), will present a corporate overview of the Company at the 31st Canaccord Genuity Growth Conference on Wednesday, August 10th, 2011 at 3:00 p.m. ET.

Omeros Corporation (NASDAQ:OMER), a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, bleeding and disorders of the central nervous system, today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, is scheduled to present at the following two conferences:  2011 Canaccord Genuity Growth Conference August 10, 2011 9:00 a.m. EDT Boston, MA.  Wedbush 2011 Life Sciences Management Access ConferenceAugust 17, 2011 8:35 a.m. EDT New York, NY.

Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) today reported its financial results for the second quarter 2011. Onyx reported a non-GAAP net loss of $27.2 million, or $0.43 per diluted share, for the second quarter 2011 compared to a non-GAAP net income of $2.9 million, or $0.05 per diluted share, for the same period in 2010.

Sigma Life Science, the innovative biological products and services research business of Sigma-Aldrich® (Nasdaq:SIAL), today announced a major breakthrough in the development of its proprietary CompoZr zinc finger nuclease (ZFN) technology with the release of more Knockout ZFNs covering the entire genomes of both mice and rats, while the pricing of products within the CompoZr ZFN portfolio by half.

Vermillion, Inc. (NASDAQ:VRML), a molecular diagnostics company, today announced entry into a definitive agreement with Pronto Diagnostics Ltd. as its exclusive distributor of OVA1 in Israel and the Palestinian territories. Pronto Diagnostics offers a clinical lab, regulatory expertise, a broad distribution network, and years of experience distributing oncology products into the Israeli market.



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