FDA Accepts Teva's NDA for Quartette™; Sanofi Announces FDA Approval for Auvi-Q Print E-mail
By Staff and Wire Reports   
Monday, 13 August 2012 18:32
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 13, 2012.

Teva Women's Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), announced the U.S. FDA has accepted for filing its New Drug Application (NDA) for Quartette™ (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets).

The company is seeking approval to manufacture and market Quartette™, the first ascending-dose, extended regimen oral contraceptive for the prevention of pregnancy. The NDA was submitted to the FDA on May 31, 2012.


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Sanofi (NYSE: SNY)
announced the U.S. FDA has approved Auvi-Q (epinephrine injection, USP) for the emergency treatment of life-threatening allergic reactions in people who are at risk for or have a history of anaphylaxis. Auvi-Q is the first-and-only compact epinephrine auto-injector with audio and visual cues that guide patients and caregivers step-by-step through the injection process.



Also Monday:



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 second quarter ended June 30, 2012. All amounts are in U.S. dollars unless otherwise specified.

Applied DNA Sciences, Inc. (OTCBB: APDN)
, (Twitter: @APDN), a provider of DNA-based anti-counterfeiting technology and product authentication solutions, announced today that its SigNature® DNA product has once again helped to send criminals to prison.

BIO-key International, Inc. (OTCBB: BKYI)
, a global leader in fingerprint biometric identification solutions and advanced mobile identification technology, today reported that the company will be presenting the latest advances in fingerprint biometric authentication technology at the Allscripts Client Experience (ACE) taking place at the McCormick Center, in Chicago, IL on Wednesday, August 15th - 17th Booth # 448.

Biostem U.S., Corporation (OTCQB: HAIR) (PINKSHEETS: HAIR)
(Biostem, the Company) is a fully reporting public company in the stem cell regenerative medicine sciences sector.

Cadence Pharmaceuticals, Inc. (NASDAQ: CADX)
, a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, announced today that the company's Chief Commercial Officer, Scott Byrd, will present the company's corporate overview on Tuesday, August 14, 2012 at 1:20pm Eastern Time (10:20am  Pacific Time) during the Wedbush PACGROW Life Sciences Management Access Conference at the Le Meridien Hotel in New York City.

GeoVax Labs, Inc. (OTCQB: GOVX) (OTCBB: GOVX)
, a biotechnology company developing vaccines to prevent and fight HIV/AIDS, announced its financial results for the six months ended June 30, 2012 and provided a business update.

HPIL Holding (OTCQB: HPIL) (PINKSHEETS: HPIL)
, HPIL Holding is pleased to announce that it sold 1,000,000 shares of treasury common stock (the "Common Stock") at a price of $0.25 per share for a total purchase price of $250,000.

ProPhase Labs (NASDAQ: PRPH)
(www.ProPhaseLabs.com) today reported net sales of $1.9 million and $7.9 million for the three month and six month periods ended June 30, 2012, compared to net sales of $1.7 million and $4.9 million for the three month and six month periods ended June 30, 2011.

Quidel Corporation (NASDAQ: QDEL)
, a leading provider of diagnostic testing solutions and cellular-based virology assays, announced today that it entered into an amended and restated $140 million, five-year senior secured credit facility with a group of banks, led by Bank of America, N.A. as the sole lead arranger, and U.S. Bank National Association as the syndication agent.

Rosetta Genomics Ltd. (NASDAQ: ROSG)
, a leading developer and provider of microRNA-based molecular diagnostics, today announced that Frost & Sullivan has recognized Rosetta Genomics with the 2012 North American Next Generation Diagnostics Entrepreneurial Company of the Year Award.

University General Health System, Inc. (OTCQB: UGHS) (PINKSHEETS: UGHS)
, a diversified, integrated multi-specialty health delivery system, today announced that it will host an investor conference call at 11:15 am Eastern Time on Wednesday August 15, 2012, to discuss its operating results for the second quarter and first half of 2012, along with other topics of interest.

Z Trim Holdings, Inc. (OTC: ZTHO)
, bio-technology company and creator of environmentally-friendly agricultural functional ingredients, today announced the addition of another industry heavyweight to its growing Advisory Board.



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