Latest News from "The Pink Sheet" DAILY - FDA Drug Safety Subject of Congressional Hearing

BMS Buys Into Promising Neuropathic Pain Market Via Allergan Deal

New compound could one day help Bristol tap into a growing area of unmet need in diabetes.   read more

 

Shake-Up in FDA's Office of Generic Drugs

Will Gary Buehler's departure energize negotiations over ANDA user fees?   read more

 

FDA Drug Safety Approach To Be Questioned At House Hearing

Principal Deputy Commissioner Joshua Sharfstein is scheduled to go before the House Energy and Commerce Health Subcommittee on March 10.   read more

 

NicOx finds new partner Bausch & Lomb for Phase II Glaucoma Candidate

Deal shows - once again - that all is not lost when Big Pharma hands back a product   read more

 

Will COX-2 + Biomarker = Success? Novartis Tests the Frontiers of Companion Diagnostics

A new genetic blood test that identifies patients at risk of liver toxicities may give Joicela (formerly Prexige) new life.   read more

 

Prospects For Pfizer/Medivation's Dimebon Dashed By Phase III Flop

The drug's inability to show an efficacy benefit highlights risks of Alzheimer's disease drug development and pressures Pfizer to pull off some pipeline wins.   read more

 

Crestor Indication Grows User Pool, But Self-Selection Hinders Statin Switch

Switching statins to OTC requires comprehensive consumer education on self-selection as well as flexibility from FDA on the types of information it considers product labeling, experts say following FDA's approval of a new Rx indication for AstraZeneca's Crestor as primary prevention of CV events in patients at risk for heart disease.   read more

 

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