Regulatory and Drug Approvals News
Regulatory Affairs and Drug Approvals News
FDA Discusses Neuromed NDA Application For Exalgo
Covidien (NYSE: COV) announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate ExalgoTM (hydromorphone HCl extended release) tablets with staff from the United States Food and Drug Administration (FDA).
Bayer Animal Health Receives Regulatory Approvals To Market Microcyn(R)-Based Vetericyn™ Animal Healthcare Products In China And Taiwan
Oculus Innovative Sciences, Inc.
Cerus Corporation Receives FDA Blood Products Advisory Committee Guidance For Proposed INTERCEPT Blood System Phase III Trial Design
Cerus Corporation (NASDAQ:CERS) announced that the FDA's Blood Products Advisory Committee (BPAC) rendered a positive opinion on the proposed hemostatic efficacy and safety endpoints for a potential U.S. Phase III clinical trial of the INTERCEPT Blood System for platelets.
Genentech Submits Supplemental Applications To FDA For Avastin Combined With Commonly Used Chemotherapies For Women With Advanced Breast Cancer
Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Avastin® (bevacizumab) for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment).
New Government Oversight Of Food Supported By Majority Of Wyoming Voters, Pew-Commissioned Poll Finds
An overwhelming majority of Wyoming voters - 88 percent - support food safety legislation that would give the Food and Drug Administration (FDA) new authority to ensure the food Americans eat does not make them sick, according to a new poll commissioned by the Pew Health Group and conducted by Hart Research and Public Opinion Strategies.
Drug Makers Hike Prices, Lobby Hard As Reform Efforts Progress
Drug makers are bracing for reform by raising their prices - by 9 percent in the last year, perhaps the fastest rate since 1992, The New York Times reports. This happened "even as drug makers promise to support Washington's health care overhaul by shaving $8 billion a year off the nation's drug costs after the legislation takes effect.
FDA Approves Additional Vaccine For 2009 H1N1 Influenza Virus
The U.S. Food and Drug Administration announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus. The vaccine is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC. As with the four previous H1N1 influenza vaccines licensed by the FDA on Sept.
Xanodyne Announces FDA Approval Of Lysteda(TM) (Tranexamic Acid) For Treatment Of Women With Heavy Menstrual Bleeding
Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, announced today that Lysteda(TM) (tranexamic acid) oral tablets has received U.S.
FDA Expands Use Of CSL Limited's Seasonal And H1N1 Vaccines To Infants And Children
The U.S. Food and Drug Administration has approved the use of the CSL Limited's seasonal and 2009 H1N1 influenza vaccines to include children ages 6 months and older.
Apogenix Receives Orphan Drug Designation For APG101 In The US And Positive Opinion On Orphan Product Designation In Europe
Apogenix GmbH, a biopharmaceutical company developing novel drugs for malignant and inflammatory diseases, announced that the European Medicines Agency adopted a positive opinion on orphan medicinal product designation for the company's lead candidate APG101 for the treatment of Glioblastoma multifome (GBM), and that it has already been granted orphan drug status in the US by the US Food and Drug
