|Actavis Confirms Generic Fortesta Patent Challenge; Life Technologies, IMEGEN Develop Horse DNA Test|
|By Staff and Wire Reports|
|Friday, 01 March 2013 20:19|
Actavis, Inc. (NYSE: ACT) confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. FDA seeking approval to market Testosterone gel 10mg/0.5g. Actavis' ANDA product is a generic version of Endo Pharmaceuticals' Fortesta®, which is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
Life Technologies Corp. (NASDAQ:LIFE) in partnership with Instituto de Medicina Genómica (IMEGEN), Spain, has developed the RapidFinder Equine ID Kit, which detects the presence of equine DNA extracted in meat samples.
The kit can be used in all Applied Biosystems Real-Time PCR Instruments. It features RapidFinder Equine ID Kit, which provides all the reagents required for 48 reactions. The detection limit is 0.01% (w/w) in fresh meat and includes a positive control consisting of 0.1% horse DNA.
The kit also features RapidFinder Quant Equine Set, which has a quantification limit of 0.05% (w/w) and includes the standard for quantification.
Life Technologies Animal Health & Food Safety vice president and general manager Nir Nimrodi said that the company recognizes the importance of public confidence in knowing that the meat on the plate is safe to eat and is exactly what it says on the label.
"The RapidFinder™ Equine ID Kit is fast and accurate and will identify the presence of horse DNA from sample to result in the same day and will provide improved traceability and control within the food supply chain," Nimrodi added.
The RapidFinder Equine ID Kit is available in Europe, Middle East & Africa and via Life Technologies distributors according to local regulatory requirements.
In addition to customized PCR assays and reagents, Life Technologies also provides testing kits for other meat products such as pork. The company also offers RapidFinder STEC Detection Workflow, which is a complete, validated screening system for E. coli O157:H7 and the six non-O157 STECs.
Allergan, Inc. (NYSE: AGN) (“Allergan”) today announced the expiration of the tender offer (the “Offer”) initiated by its wholly-owned subsidiary, Groundhog Acquisition, Inc. (“Purchaser”), on January 31, 2013 to purchase all of the outstanding shares of common stock of MAP Pharmaceuticals, Inc. (NASDAQ: MAPP) (“MAP”) for $25.00 per share, net to the seller in cash, without interest and less any applicable withholding taxes, as set forth in the Tender Offer Statement on Schedule TO filed by Purchaser and Allergan with the U.S. Securities and Exchange Commission on January 31, 2013.
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a specialty pharmaceutical company, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2012.
A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today reported fourth quarter and full year 2012 financial results and highlighted recent corporate progress.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today provided an update on the Company’s proposed merger transaction with ANI Acquisition Company d/b/a ANI Pharmaceuticals, Inc. and reported on its cash balance as of December 31, 2012 and financial results for the year ended December 31, 2012.
Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it will present at three upcoming investor conferences.
CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that Vice President of Business Development David J. Haen will present at the Cowen & Company 33rd Annual Health Care Conference on Monday, March 4, at 4:50 p.m. Eastern time (1:50 p.m. Pacific time).
EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer, announced today that it has received commitments from investors, including institutional investors Kleiner Perkins Caufield Byers China Fund II, L.P. and IDG-Accel China Growth Fund III L.P. to purchase approximately $10.7 million of securities in a registered direct offering.
Fuse Science, Inc. (OTCQB: DROP), (www.fusescience.com) a consumer products and delivery technology company that is developing new, patent-pending technologies poised to redefine how consumers receive energy, medicines, vitamins and minerals is pleased to announce that CEO Brian Tuffin and Daymond John, CEO of Shark Branding, LLC and Shark Branding Corp. are scheduled to be interviewed on Bloomberg Television's "Taking Stock with Pimm Fox" today, March 1st, 2013.
Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, today announced that Royce R. Bedward has been appointed corporate vice president, general counsel and secretary, effective immediately.
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the Company will present at the Cowen & Company 33rd Annual Health Care Conference on Wednesday, March 6, at 8:00 a.m. Eastern Standard Time.
Ingen Technologies, Inc. (PINKSHEETS: IGNT), an emerging medical device manufacturer with patented proprietary medical technology for the growing $55 Billion US home healthcare industry, is pleased to announce upcoming improvements to our distribution network.
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that Arthur Sands, M.D., Ph.D., president and chief executive officer, will present at the Cowen Healthcare Conference on Tuesday, March 5, at 10:40 AM EST in Boston.
Medidata Solutions (NASDAQ: MDSO), a leading global provider of cloud-based clinical development solutions, today announced that Bryan Spielman, executive vice president of strategy and corporate development, and Cory Douglas, chief financial officer, will present at the Raymond James 34th Annual Institutional Investors Conference on March 6, 2013, at 8:40 a.m. EST in Orlando, FL.
Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading company focused on developing and marketing stem cell products to treat serious medical conditions, announced today the introduction of a proprietary, direct sales force for Grafix®, a premium cellular repair matrix for serious wounds including diabetic foot ulcers.
Palatin Technologies, Inc. (NYSEMKT: PTN) announced bremelanotide 1.25 mg and 1.75 mg doses significantly increased sexual arousal, sexual desire and the number of sexually satisfying events, and decreased associated distress in premenopausal women with female sexual dysfunction (FSD).
VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) has received yesterday notice from the U.S. Food and Drug Administration (US-FDA) that an administrative acceptance review was conducted on the 510(k) submission for premarket notification for right heart analysis in Pulmonary Arterial Hypertension (PAH), and it was found to contain all of the necessary information needed to proceed with the substantive review.
VentriPoint Diagnostics Ltd. (TSX VENTURE:VPT) (OTCQX:VPTDF) announces today that it has appointed Ellen Briant as the Company's Chief Financial Officer and Corporate Secretary.