|Pain Therapeutics study meets primary endpoints. Mylan launches generic breast cancer drug. FDA approves Boston Scientific stent|
|By BioMedReports.com Staff|
|Monday, 25 April 2011 18:18|
Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported top-line results of an abuse liability study with REMOXY, an investigational drug for the treatment of pain, in which REMOXY met all prospectively defined primary endpoints. Full study results were recently published in Pain Medicine, the Official Journal of the American Academy of Pain Medicine. The principal investigator on this study, Lynn R. Webster, MD, has authored over 100 scientific abstracts and is medical director of Lifetree Clinical Research.
Pain Therapeutics developed REMOXY to help address the problem of prescription drug abuse. REMOXY is an encapsulated, water insoluble, highly viscous, twice-daily oral formulation of oxycodone. It is designed to provide steady pain relief, while resisting common methods of abuse that result in 'dose-dumping', or the rapid, premature release of a large dose of oxycodone.
Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Letrozole Tablets USP, 2.5 mg, under a previously announced settlement and license agreement with Novartis. Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for Letrozole Tablets and will market the product with a period of exclusivity.
Letrozole Tablets are the generic version of Novartis' Femara Tablets, an adjuvant treatment for postmenopausal women with hormone receptor-positive early stage breast cancer. This product had U.S. sales of approximately $682 million for the 12 months ending Dec. 31, 2010, according to IMS Health.
Boston Scientific Corporation (NYSE:BSX) today announced FDA approval and launch of the ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System, the Company's third-generation drug-eluting stent technology. The ION Stent System incorporates a unique platinum chromium (PtCr) alloy designed specifically for coronary stenting and intended to improve the acute performance of coronary stent implantation in the treatment of coronary artery disease.
The ION Stent System features an innovative PtCr alloy and new stent design to offer greater strength, enhanced deliverability and exceptional visibility. The thin-strut stent is designed for improved conformability, minimal recoil, and uniform lesion coverage and drug distribution. The advanced low-profile delivery system facilitates precise delivery of the stent across challenging lesions.
Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT:SAN), announced today that the U.S. Food and Drug Administration FDA has granted licensure to expand the indication for its meningococcal conjugate vaccine, Menactra, to include a two-dose schedule for infants and children 9 months through 23 months of age. This is the first U.S. approval of a meningococcal vaccine for this age group.
XenoPort, Inc. (Nasdaq:XNPT) announced today that it had reached agreement with the FDA on a Special Protocol Assessment (SPA) for a pivotal Phase 3 clinical trial of arbaclofen placarbil (AP), previously known as XP19986, as a potential treatment of spasticity in multiple sclerosis (MS) patients. An SPA is a written agreement with the FDA on the design, including the scope and size of the patient population, the efficacy endpoints and safety assessments, the duration of treatment and the statistical analysis plan, of a pivotal Phase 3 trial to support an efficacy claim in a New Drug Application.
Auxilium Pharmaceuticals, Inc. (NASDAQ:AUXL), a specialty biopharmaceutical company, will release results for the first quarter 2011 on Monday, May 9, 2011 before the opening of the U.S. financial mark
InterMune, Inc. (NASDAQ:ITMN) today announced that it will release its first quarter 2011 financial results prior to the open of the U.S. markets on Thursday, April 28, 2011.
Pharmasset, Inc. (Nasdaq:VRUS), a clinical stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections, today reported financial results and operational highlights for the quarter ended March 31, 2011.
Volcano Corporation (NASDAQ:VOLC), a leading developer and manufacturer of precision intravascular therapy guidance tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced that it will report its operating results for the first quarter of fiscal 2011 on Wednesday, May 4.