Latest News From "The Pink Sheet" DAILY - Brilinta's Poor U.S. Results Dog Advisory Committee Discussion

UK Government Moves to Combat Low Uptake of Innovative Cancer Drugs

A report highlighting the low use of innovative cancer drugs in the U.K. has prompted the government to target more funding at this area. It may involve a shake-up of NICE, which the pharmaceutical industry has welcomed.   read more

 

Strong Quarter For Cephalon, But Questions Linger on Provigil/Nuvigil

Despite setbacks in its plans to expand indications for its next-generation wakefulness drug, Nuvigil, Cephalon executives are confident of the drug's future.   read more

 

Brilinta Panel Leaves FDA With The Task Of Crafting Labeling That Describes Poor U.S Efficacy Results

FDA's Cardiovascular and Renal Drugs Advisory Committee votes 7-1 in favor of ticagrelor's approval for acute coronary syndromes despite rejecting AstraZeneca's aspirin-dosing theory as the sole cause of lack of benefit in the U.S. population.   read more

 

Astellas Pays, And Pays Big, To Extend VelocImmune License With Regeneron

The Japanese pharma is paying $165 million upfront for continued access to the fully human monoclonal antibody discovery platform through 2018.   read more

 

Merck KGaA And Novartis Back In Horse Race For First Oral MS Drug To Market

FDA granted the reworked cladribine NDA submitted in June by U.S. affiliate EMD Serono a six-month priority review, with approval possible in the fourth quarter, while action is anticipated on Gilenia in September.   read more

 

Aetna Will Retain Formulary, Rebate Contracting Duties In CVS Caremark Contract

Aetna will retain responsibility for formulary contracting and drug rebate arrangements under its new 12-year pharmacy benefit management contract with CVS Caremark.   read more

 

REMS Templates Get Nod From FDA, With Nudge From Pharmacists

At workshop, agency acknowledges efficiency and implementation burdens that the myriad risk management program programs create, but developing a standardized approach will not easy task either.   read more

 

Advocates For Switching Birth Control Pill Face Social, Risk Obstacles

In addition to meeting with FDA on the types of studies, such as actual use and label comprehension studies, needed for a switch, the Oral Contraceptives Over-the-Counter Working Group would need a drug firm as a partner to sponsor a potential switch application.   read more

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