The health care reform legislation signed into law by President Obama March 23 paves the way for the launch of biosimilar drugs in the U.S., action that could save the country's health care system billions of dollars, while presenting both challenges and opportunities for the drug industry.
Sanofi-Aventis and privately held AgaMatrix agreed to co-develop and commercialize blood glucose monitoring solutions, enabling the French pharma to further round out its diabetes business.
Panel meeting on the respiratory syncytial virus product - which demonstrated non-inferiority, but not superiority, to Synagis - is set for June 2. read more
SHANGHAI - Eli Lilly and Chinese active pharmaceutical
ingredient provider Hisun recently announced the completion of a
technology transfer under which Lilly transferred technology to
Hisun to produce finished products and API of its tuberculosis drug
capreomycin.
Agency says it will be flexible in assessing if risk information in consumer-focused ads are "clear, conspicuous and neutral," but proposed rule also seeks comment on whether such information should be presented simultaneously in audio and video format. read more
FDA is considering whether the expiration of a patent is grounds for forfeiture of a first ANDA applicant's 180-day marketing exclusivity. The question arose in Teva's suit against FDA seeking exclusivity for generic versions of Merck's hypertension drugs Cozaar and Hyzaar. FDA said it recently learned that the patent at issue in the case expired in March 2009.
