Regeneron Announces FDA Approval of EYLEA; Mylan Launches First Generic of Novartis' Diovan Print E-mail
By Staff and Wire Reports   
Friday, 21 September 2012 18:43
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 21, 2012.

Regeneron Pharmaceuticals (NASDAQ: REGN)
announced that the U.S. FDA has approved EYLEA® (aflibercept) Injection for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO). The recommended dose for EYLEA is 2 milligrams (mg) every 4 weeks (monthly).

"This second U.S. approval for EYLEA provides physicians and patients with a new treatment option for the treatment of macular edema following CRVO," stated George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "Based upon the pivotal Phase 3 study results, EYLEA has been shown to significantly improve visual outcomes in a disease characterized by high VEGF levels. We thank the patients and clinical investigators who participated in our clinical studies, the FDA, and the Regeneron employees who helped make this day possible."

The approval of EYLEA for Macular Edema following CRVO was based on data from the Phase 3 COPERNICUS and GALILEO studies. In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters of Best Corrected Visual Acuity (BCVA) at 24 weeks compared to baseline as measured by ETDRS. Results for the EYLEA 2 mg monthly group were superior to those for the sham control group for the primary endpoint.

EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.


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Mylan Inc. (Nasdaq: MYL)
announced its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Valsartan and Hydrochlorothiazide Tablets USP, 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg.

This product is the generic version of Novartis' Diovan HCT^® Tablets, which are indicated for the treatment of hypertension, to lower blood pressure in patients not adequately controlled with monotherapy or as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.



Also Friday:



Abbott (NYSE: ABT)
today was again named one of the Top 20 Employers by the journal Science.Based on the views of working scientists, this prestigious annual survey identifies the most respected employers in the biotechnology and pharmaceutical industry.

eHealthInsurance (NASDAQ: EHTH)
, America's first and largest private health insurance exchange, released its top five tips to help consumers navigate the new "Summary of Benefits and Coverage" forms which will be unveiled this month in accordance with provisions of the 2010 Affordable Care Act (ACA).

Eli Lilly and Company (NYSE: LLY)
announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of Cialis® (tadalafil) tablets 5 mg for once a day use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Medical Marijuana Inc. (OTC: MJNA)
, a leading hemp industry innovator, is pleased to report on a September 18 San Francisco Chronicle Article, "Pot compound seen as tool against cancer."

Medicure Inc. (TSX VENTURE:MPH) (PINKSHEETS:MCUJ)
, a specialty pharmaceutical company, announced today that its Board of Directors have approved a consolidation of the Company's common shares ("Common Shares") on the basis of fifteen pre-consolidation Common Shares for each one post-consolidation Common Share, subject to the approval of the TSX Venture Exchange.

PROLOR Biotech, Inc. (NYSE MKT: PBTH)
today announced that data from the company's Phase II trial of hGH-CTP, its long acting human growth hormone, in growth hormone deficient adults will be presented at ESPE 2012, the 51st Annual Meeting of the European Society for Paediatric Endocrinology.

TelVue® Corporation (OTCQB: TEVE)
, the innovation leader in Television and Internet Broadcasting for cable operators, media companies and communities is pleased to announce the addition of Frank Priebe to its Professional Market Sales team as National Director, Cable & Telco Sales.

ViroPharma Incorporated (Nasdaq: VPHM)
and Halozyme Therapeutics, Inc. (Nasdaq: HALO) announced today that the U.S. Food & Drug Administration (FDA) has provided guidance enabling ViroPharma to resume clinical studies of the subcutaneous administration of Cinryze in combination with rHuPH20.

YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM)
, a drug development company advancing hematology and cancer related products, today reported operational and financial results for its 2012 fiscal year, ended June 30, 2012.



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