Biotechnology news

Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse®.

Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) announced that it has completed enrollment in the second of two pivotal Phase 3 clinical trials evaluating the safety and efficacy of fidaxomicin (OPT-80) for the treatment of Clostridium difficile infection, or CDI. "Completing enrollment in the second Phase 3 trial is a major milestone in the development of fidaxomicin.

Tobira Therapeutics, a clinical stage biotechnology company committed to research and product discovery for the treatment of life-threatening and life-altering infectious diseases, announced pharmacokinetic data and results from two double-blind, placebo-controlled studies of TBR-652 in eighty-four healthy volunteers.

While the debate over prescription drug advertising persists, a new study released online in the American Journal of Public Health offers guidelines for improving drug ads in order to minimize potential harm and maximize benefits.

Drug companies and nonprofit organizations are joining forces to develop new drugs and vaccines to target so-called "neglected" diseases that claim millions of lives in the developing world each year. Those hard-to-treat diseases include malaria, tuberculosis, dengue fever, and other conditions.

Engineers at the University of Leeds have developed a simple technology which can be used in existing chemical reactors to ensure "right first time" drug crystal formation. Ensuring drug crystals are formed correctly is crucial to their efficacy and the efficiency of pharmaceutical manufacturers' operations.

GlaxoSmithKline (GSK) announced the results from the clinical trial assessing Pandemrix™, GSK's adjuvanted H1N1 pandemic influenza vaccine, administered at the same time as the annual seasonal influenza vaccine, Fluarix ®.

Viron Therapeutics Inc., a biopharmaceutical company pioneering the development of viral protein therapeutics, announced that the Company's research collaborator, Dr. Jean-Claude Tardif, Director of the Research Center at the Montreal Heart Institute, will present data from a Phase IIa clinical trial evaluating VT-111 at the American Heart Association (AHA) Scientific Sessions 2009 conference.

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced the final analyses of data from clinical trials of the U.S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine in adults and children.

Mylan Inc. (NASDAQ: MYL) announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) Capsules, 15 mg and 30 mg. This product is shipping immediately and will be sold under the Mylan Pharmaceuticals brand.