FDA Approves Lucentis for Treatment of Diabetic Macular Edema; Mylan Launches Generic Version of Provigil® Print E-mail
By Staff and Wire Reports   
Friday, 10 August 2012 19:11
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 10, 2012.

Genentech, a member of the Roche Group (PINK:RHHBY), announced Lucentis (ranibizumab injection) was approved by the U.S. Food & Drug Administration for treatment of diabetic macular edema, an eye condition in people with diabetes that causes blurred vision, severe vision loss and sometimes blindness. Diabetes is now the leading cause of new cases of blindness in American adults1 and DME is estimated to affect more than 560,000 Americans with the disease.2

Lucentis is the first and only FDA-approved medicine for DME, a condition for which the standard of care has not changed significantly in more than 25 years. To date, the standard of care in the U.S. for DME has been laser surgery, which slows the rate of vision loss and helps stabilize vision, but has demonstrated only limited ability to restore lost vision.3


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Mylan Inc. (Nasdaq: MYL)
announced its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP,100 mg and 200 mg. This product is the generic version of Cephalon's Provigil® Tablets and is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work disorder.(1)

Mylan CEO Heather Bresch commented: "Mylan is pleased to bring a generic version of Provigil Tablets to the U.S. market prior to the expiration of the first-filer's 180-day marketing exclusivity period. This launch represents Mylan's continued commitment to expanding access to high quality, more affordable medicine, and we are pleased to do our part in helping to meet patients' unmet needs."

Mylan is launching this product immediately.



Also Friday:



Accelr8 Technology Corp. (NYSE MKT: AXK)
today announced that it has named Steve Reichling as Chief Financial Officer.

Home Health International Inc. (PINKSHEETS: HHII)
, a Medicare-certified home health agency and durable medical equipment (DME) supplier, announced today that the Company is currently developing a line of natural home cleaning products.

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX)
announced today that Arthur Sands, M.D., Ph.D., President and Chief Executive Officer, will present at the Wedbush PacGrow 2012 Life Sciences Management Access Conference on Tuesday, August 14th, at 10:55 AM EST in New York City.

Merus Labs International Inc. (TSX:MSL) (NASDAQ:MSLI)
today announced that Mr. Elie Farah, the President & CEO of Merus, will present at the upcoming Canaccord Genuity Growth Conference.

MultiCell Technologies, Inc. (OTC Bulletin Board: MCET)
is pleased to announce the updated preclinical research results for MCT-465 and MCT-485.  MCT-485 showed in vitro dose-effect cytotoxicity on several human hepatocellular carcinoma cell lines.  MCT-485 induced robust TNFalpha and some IL-6 expression.

PharmAthene, Inc. (NYSE Amex: PIP)
, a biodefense company developing medical countermeasures against biological and chemical threats, announced today it has received notification from the U.S. Food and Drug Administration (FDA) that its SparVax™ rPA anthrax vaccine program has been placed on clinical hold.

Remedent, Inc. (OTCBB: REMI)
, an international company specializing in research, development, and the manufacturing of oral care and cosmetic products, announced today that it will host a conference call on Monday, August 13, to update investors on the recent strategic developments.

Soligenix, Inc. (OTCBB: SNGX)
(Soligenix or the Company), a development stage biopharmaceutical company, announced today its financial results for the second quarter ending June 30, 2012.



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