BioPharma Today

Coming in Monday's "The Pink Sheet" DAILY -- FDA cites Sanofi, Cangene for GMP violations

FDA finds good manufacturing practice violations at Sanofi Pasteur's vaccine production facility in France.

Coming In Thursday's "The Pink Sheet" DAILY -- FDA Accepts NDA for Multiple Sclerosis Drug Cladribine, Among Other Stories

Cladribine is back in the running to be the first oral multiple sclerosis therapy to market. EMD Serono, the U.S. affiliate of Merck KGaA, announced that FDA has accepted a refiling of the NDA it rejected in Novmeber and given it a priority six-month review with an action date in the fourth quarter. Competitor Biogen Idec's candidate Gilena has an action date in September.

Coming In Monday's "The Pink Sheet" DAILY - Viiv Healthcare To Share Its IP With Generic Makers

Viiv Healthcare, the venture launched last year by GlaxoSmithKline and Pfizer to combine their HIV/AIDS portfolios, will make the intellectual property for the entire portfolio available to generic drug makers in 60 low-income countries. The initiative potentially will make generic versions of drugs like Pfizer's Selzentry (maraviroc) available to 80 percent of all people currently living with HIV.

Latest News From "The Pink Sheet" DAILY - Qnexa May Launch Despite Panel's No Vote

Bioniche Purchase Will Move Mylan Into Generic Injectables Market

Latest News From "The Pink Sheet" DAILY - Avandia May Remain On Market With New Warnings, REMS

Avandia Can Be Saved With New Warnings and REMS, Advisory Cmte. Says

Latest News From "The Pink Sheet" DAILY - BMS Ends Deal With Exelixis

Exelixis Defends Cancer Drug XL184 After Partner BMS Walks Out

Backing European Biotech: France Does Well, But Still Lacks Corporate VC

The third installment of our series on European government initiatives to support biotech focuses on France, where state money has been critical both for getting companies off the ground and attracting private investment. 

How Big Of A Pharma Opportunity Is Russia? Local Manufacturing May Help Buoy Sales

Despite the recent collapse of Russia’s economy, Nycomed reckons it can capture €900 million ($1.25 billion) in sales from the region by 2013—in part through investing in local manufacturing.