Senators Draft Legislation for Follow-On Biologics Approval
June 28th 2007Washington, DC (June 22)-Senators Orrin Hatch (R-UT), Edward Kennedy (D-MA), Michael Enzi (R-WY), and Hillary Clinton (D-NY) agreed on legislation that would authorize the US Food and Drug Administration (Rockville, MD) to approve follow-on versions of biologic therapies.
FDA, EMEA, EC Extend Regulatory Collaboration Efforts
June 21st 2007Rockville, MD (June 18)-The US Food and Drug Administration, the European Commission, and the European Medicines Agency have agreed to extend cooperative activities to the areas of pediatrics and medicinal products for rare diseases (i.e., orphan drugs).
Court Upholds Sanofi-Aventis's Plavix Patent
June 21st 2007New York (June 19)-The US District Court for the Southern District of New York affirmed the validity and enforceability of Sanofi-Aventis's patent on clopidogrel bisulfate, the active ingredient in the company's coronary artery disease treatment "Plavix."
FDA to Take Action Against Companies Marketing Unapproved Guaifenesin Products
May 31st 2007Rockville, MD (May 25)-The US Food and Drug Administration issued a statement announcing its intention to take action against companies that market unapproved timed-release drug products that contain the expectorant guaifenesin.
Sun Pharmaceutical Agrees to Acquire Taro Pharmaceutical
May 24th 2007Mumbai, India (May 21)-Sun Pharmaceutical Industries and its subsidiaries signed definitive agreements to acquire Taro Pharmaceutical Industries, a generics manufacturer with subsidiaries and manufacturing operations in the United States, Canada, and Israel.
BIO Calls for 14-Year Data-Exclusivity Period for Biologics
May 10th 2007Washington, DC (May 3)-The Biotechnology Industry Organization published a position paper stating that any legislation establishing a regulatory pathway for follow-on biologics should grant pioneering products 14 years of data exclusivity.
Cardinal Plans to Use RFID in California
May 10th 2007Dublin, OH (May 3)-In preparation for California?s new pedigree legislation, Cardinal Health plans to integrate radio frequency identification (RFID) technology into the operations at its pharmaceutical distribution center in Sacramento by fall 2007.
Amylin Expands Manufacturing Facility in Ohio
May 10th 2007Hamilton, OH (May 2)-Amylin Ohio LLC, a subsidiary of Amylin Pharmaceuticals, is expanding construction at its manufacturing facility in West Chester, Ohio. The expansion increases the company?s total investment to approximately $400 million.