BioPharma Today

Coming in Friday's "The Pink Sheet" DAILY - FDA Appoints Biosimilars Czar

FDA appoints biosimilars czar in the Office of New Drugs and creates a multi-disciplinary Biosimilars Review Committee.

Interview With Roche's Joe McCracken On Partnering In Asia - Latest From PharmAsia News

Roche's Joe McCracken On Early Stage Partnering In Asia: An Interview With PharmAsia News (Part 1 Of 2)

05/20/10 9:06 GMT

Latest News From "The Pink Sheet" DAILY - FDA Task Force Offers Ways To Improve Transparency

Can FDA Do The "Right Thing" On Transparency? Ask A Lawyer

Editors' Picks From The World Press

Pipeline/RD News

• Clinical-trial sites for GSK's Avandia struggle to find participants

Coming In Thursday's "The Pink Sheet" DAILY - FDA On Transparency

FDA releases transparency proposals that include release of when NDA, PMA applications are submitted.

Business Model Innovation Needed To Reach Poor At "Bottom Of The Pyramid" - Latest From PharmAsia News

New Approaches To Innovation Needed To Reach Globe's Poor At The "Bottom Of The Pyramid" - And To Fend Off Emerging Competitors Around The World

05/19/10 13:55 GMT

Latest News From "The Pink Sheet" DAILY - What is Next For Forest's Daxas?

Daxas REMS May Be Key To Approval After "Complete Response" Letter

FDA seems more likely to approve the COPD if labeling is restricted to moderate-to-severe patients with chronic bronchitis, but Forest will probably need to show that it can limit use.   read more

India And Singapore Create Approval Fast Track - Latest From PharmAsia News

Chinese Regulators Report Steady Progress In Promoting Innovation - DIA China Conference

05/18/10 12:27 GMT

Coming in Wednesday's "The Pink Sheet" DAILY - Nycomed's Daxas Gets FDA "Complete Response" Letter

Nycomed's chronic obstructive pulmonary disorder therapy Daxas (roflumilast) gets an FDA complete response letter.

Latest News from "The Pink Sheet" DAILY - Astellas Wins OSI

Astellas Wins OSI But Victory Comes At A Price

After months of drama, Astellas ups its bid to $4 billion cash to seal its hostile-turned-friendly bid for Tarceva maker OSI.   read more