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.
Continue reading "On The Cusp Of Biosimilars: Reform Ushers In Next Generic Drug Era " »
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.
Continue reading "Latest News From "The Pink Sheet" DAILY - Big Pharma Deals" »
Panel meeting on the respiratory syncytial virus product - which demonstrated non-inferiority, but not superiority, to Synagis - is set for June 2.
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Continue reading "Latest News From "The Pink Sheet" DAILY - Advisory Committee Scheduled For AstraZeneca's Motavizumab" »
Agency had proposed an eight-digit system, but moved to 20 digits in final document after recommendation from PhRMA.
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Continue reading "Latest News from "The Pink Sheet" DAILY - Is BioMarin For Sale? " »
FDA starts down path to prescription drug track and trace system with final guidance on creating unique numbers for drug packages.
Continue reading "Coming In Tuesday's "The Pink Sheet" DAILY - FDA Issues Guidance on Drug Tracking" »
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.
Continue reading "Lilly And China's Hisun Complete Technology Transfer For Antibiotic Capreomycin For TB " »
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.
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Continue reading "Latest News From "The Pink Sheet" DAILY - FDA Releases DTC Proposed Rule" »
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.
Continue reading "Coming in Monday's "The Pink Sheet" DAILY - FDA Is Proposing Standards for Direct-to-Consumer Ads" »