Archive for September 2017

Four Democratic senators are calling for an investigation into a Native American tribe’s acquisition of four patents from Allergan, saying the deal is a “blatantly anti-competitive” scheme to avoid review of Allergan’s patents and to maintain its high prices. Source: Drug Industry Daily

Amgen has agreed to delay U.S. sales of its cheaper biosimilar to AbbVie’s Humira for the next six years under a settlement with AbbVie. Source: Drug Industry Daily

Drug wholesaler Amerisourcebergen agreed in federal court to pay $260 million and plead guilty to violating federal drug law via a criminal scheme to sell cancer drugs illegally repackaged in pre-filled syringes. Source: Drug Industry Daily

The FDA launched a new search dashboard for its adverse event reporting database, promising a more user-friendly method for industry and the general public to access the agency’s safety and surveillance data. Source: Drug Industry Daily

The FDA published a new manual of policies and procedures for reviewing staff, detailing how the agency will communicate ANDA deficiencies with applicants — meeting one of its first commitments for the next generation of GDUFA. Source: Drug Industry Daily