Latest News From "The Pink Sheet" DAILY

FDA's Handling Of Byetta Pancreatitis Risk Could Bode Well For Other Diabetes Drugs

Amylin's Byetta cleared for first-line use without a black box stigma, but sales may still not get a lift.   read more

 

Dendreon Crosses Fingers, Knocks on Wood, And Resubmits Provenge to FDA

The Seattle prostate-cancer vaccine maker has filed again for approval two and a half years after the agency's contentious rejection.   read more

 

Benlysta Back In The Spotlight With BLISS-76, But Second Phase III Still May Not Be Enough To Support Some Claims

BLISS-76 shows Benlysta 10 mg/kg is efficacious in patients with systemic lupus erythematosus; HGS/GSK expect to file in first half 2010.   read more

 

Schering-Plough Shows Off Once-Daily Hep C Drug Narlaprevir At AASLD

Next-generation ritonavir-boosted protease inhibitor is headed into Phase IIb, and if all goes well, could be a significant player in the hepatitis C market.   read more

 

Merck's NDA For A Pill That Combines Zetia And Lipitor Is Bounced By FDA

Citing a need for more data, the agency refuses to file an NDA for a pill combining ezetimibe (Zetia) and atorvastatin (Pfizer's Lipitor).   read more

 

FDA's "Complete Response" On GTx's Toremifene Moves The Goal Posts, CEO Says

Having gone through the special protocol assessment process, the sponsor was surprised by the request for a second pivotal trial and another clinical trial on effects on cancer.   read more

 

Pulmatrix Gets $30M And An NIH Grant To Develop A Broad-Spectrum Anti-Infective

Biotech's technology uses two mechanisms of action to prevent infection and keep pathogens from entering the lungs.   read more

 

Amylin And Takeda Team Up In Obesity

Obesity research space is red hot, and now one of the key players has signed a big pharma partner; under the deal Amylin will get $75 million upfront.   read more

 

Pfizer/GSK Unveiling HIV Joint Venture As ViiV Healthcare

Pfizer and GlaxoSmithKline on Nov. 3 will formally unveil their much-ballyhooed HIV joint venture, announced last April.   read more

 

FDA Will Revise Investigator Disqualification Regs In Response To GAO Report

The agency will revise its regulations to prevent clinical investigators who are disqualified from running trials for one product type to continue leading studies for other FDA-regulated categories.   read more