BioPharma Today

On The Cusp Of Biosimilars: Reform Ushers In Next Generic Drug Era

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.

Latest News From "The Pink Sheet" DAILY - Big Pharma Deals

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.

Latest News From "The Pink Sheet" DAILY - Advisory Committee Scheduled For AstraZeneca's Motavizumab

Can AstraZeneca's Motavizumab Leapfrog Synagis? Advisory Committee Will Weigh In

Panel meeting on the respiratory syncytial virus product - which demonstrated non-inferiority, but not superiority, to Synagis - is set for June 2.   read more

Coming in Wednesday's "The Pink Sheet" DAILY - Abbott/AstraZeneca's Certriad and Cephalon's Nuvigil Get FDA "Complete Response" Letters

Myriad Genetics' BRCA1 and BRCA2 gene patents are ruled invalid by a New York district court.

Latest News from "The Pink Sheet" DAILY - Is BioMarin For Sale?

FDA Takes First Step Towards "Track And Trace" As Final Guidance Lengthens Identifiers For Drug Packaging

Agency had proposed an eight-digit system, but moved to 20 digits in final document after recommendation from PhRMA.   read more

Editors' Picks from the World Press

Pipeline/RD News

• Stem cell trial in Ireland will enroll Crohn's disease patients
• Scientist touts role of adipose-cell derivative in tissue repair
• Antisoma's lung cancer drug fails in Phase III study

Business Finance

• MannKind gets $1M grant from Multiple Myeloma Research Foundation
• Jubilant aims to spin off unit for polymers, fertilizers in Q4
• Emory teams up with Zirus to develop drugs for infectious diseases
• Sanofi might partner with makers of diabetes-management devices

Government Legal News

• NexMed seeks FDA clearance to conduct clinical trial of cancer therapy
• Ohio judge tosses antitrust lawsuit against Plavix makers
• Cephalon fails to gain FDA approval to market Nuvigil for jet lag

Coming In Tuesday's "The Pink Sheet" DAILY - FDA Issues Guidance on Drug Tracking

FDA starts down path to prescription drug track and trace system with final guidance on creating unique numbers for drug packages.

Lilly And China's Hisun Complete Technology Transfer For Antibiotic Capreomycin For TB

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.

Latest News From "The Pink Sheet" DAILY - FDA Releases DTC Proposed Rule

DTC Proposed Rule Leaves Room For Creativity In Meeting Standards

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

Coming in Monday's "The Pink Sheet" DAILY - FDA Is Proposing Standards for Direct-to-Consumer Ads

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.