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Massachusetts Attorney General Maura Healey is mulling legal action against Gilead Sciences over its sky-high prices for two hepatitis C medications, alleging that the company’s approach could violate the state’s antitrust laws. Read More
The war on high pharmaceutical prices continues, with PBM Express Scripts taking aim at what it calls an excessive price jump for Valeant Pharmaceuticals’ diabetes drug Glumetza. Read More
With 12 nations signing off on the Trans-Pacific Partnership on Wednesday, the clock has started on ratification of the treaty providing up to eight years of exclusivity for biologics. Read More
The FDA is re-examining its approval, REMS and postmarket policies for opioids in response to a growing abuse epidemic and calls to action from lawmakers. Read More
The FDA’s Psychopharmacologic Drugs Advisory Committee will convene March 29 to review Acadia Pharmaceuticals’ Nuplazid for the treatment of psychosis associated with Parkinson’s disease. Read More
CBER is asking biologics manufacturers to allow the center’s regulatory review, compliance and other relevant staff to visit facilities to help them better understand the biologics industry. Read More
Several major drugmakers are exploring development of a vaccine to prevent the Zika virus as the mosquito-borne disease spreads quickly throughout the Western Hemisphere. Read More
One week after accusing Gilead Sciences of promoting an HIV drug off-label, an AIDS nonprofit is suing the company for allegedly “manipulating the patent system” to ward off generic competition for another medication. Read More