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A report from AARP contends that prices for prescription drugs widely used by retirees consistently outpaced inflation between 2006 and 2013, the most recent year for which complete data was available. Read More
The European Medicines Agency has begun a public consultation on revised module V of the good pharmacovigilance practices on risk management systems, which clarifies what risk management plans should focus on over a product’s lifecycle. Read More
Refuting testimony provided by CDER Director Janet Woodcock during a Senate HELP Committee hearing, Sen. Tom Cotton (R-Ark.) sent a letter to new FDA Commissioner Robert Califf seeking information on the agency’s ANDA backlog. Read More
Jordanian drugmaker Hikma Pharmaceuticals will sell off two drugs and relinquish marketing rights to a third to avoid tangling with the Federal Trade Commission on its planned purchase of a Boehringer Ingelheim subsidiary. Read More
The FDA sent PTC Therapeutics a refusal to file letter for Translarna, its candidate for the treatment of nonsense mutation Duchenne muscular dystrophy. Read More