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A UK-funded report is calling for drugmakers and regulators to set a goal of creating 15 new antibiotics every 10 years, at least four of which would be breakthrough products, to fight the rise in antibiotic resistant bacteria. Read More
Drugmakers are asking the European Commission to clarify new requirements for factory acceptance and site acceptance testing, including when it is okay to perform only the factory tests. Read More
Endo International has agreed to buy Par Pharmaceutical from private equity firm TPG for $8 billion in a deal the companies say will put them in the top five firms in the U.S. generics market. Read More
The FDA is considering expanding access to naloxone to cut down on deaths from opioid overdoses and wants industry and others to weigh in on the clinical, legal and regulatory barriers to doing so. Read More
The FDA has dubbed AbbVie’s autoimmune disease treatment Humira an orphan drug for the investigational treatment of moderate-to-severe hidradenitis suppurativa — paving the way for the drug’s ninth indication and seven years added exclusivity. Read More
The agency is inviting web developers to tap into data on adverse drug events, recalls and labeling and assess their impact for drug research Read More