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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
Federal efforts to protect the drug supply chain continue to bear fruit, with the FDA’s Office of Criminal Investigations announcing criminal charges for another counterfeit operation. 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
The FDA’s Psychopharmacologic Drugs Advisory Committee voted 8 to 2 to support a new claim for Takeda’s Brintellix for the treatment of cognitive dysfunction in major depressive disorder. 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
Eleven healthcare groups — including the Generic Pharmaceutical Association — are asking a Senate committee to examine alleged industry abuse of REMS safeguards as a possible cause of rising drug prices. Read More
Patent cases involving payments by brand drugmakers to delay generic competition have dropped 27 percent following a 2013 challenge to the practice, according to the Federal Trade Commission. Read More
Generic and biosimilars manufacturers are coming to the aid of Apotex in its drawn-out patent fight with Amgen, arguing that a district court order effectively punishes the Canadian drugmaker for following the law. Read More