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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
Boehringer Ingelheim has to hand over settlement papers to the FTC after the U.S. Supreme Court rejected the company’s assertion that the documents are protected communications. Read More
Drugmakers interested in establishing bioequivalence for their products have a treasure trove of data to dig through, as the FDA has just added 35 new product-specific guidances and updated 12 more. Read More
Sharp price spikes for some orphan generics may be getting all of the attention today, but they have little real impact on overall prescription drug prices. Read More
The FDA is not in the business of regulating drug prices, CDER Director Janet Woodcock told a Senate committee Jan. 28, pushing back against criticism that the FDA should tackle rising drug prices. Read More