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The U.S. Supreme Court has rejected the third and final request for review of a Pennsylvania state court ruling that would allow individuals to sue generics makers for failing to update warnings on drug labels. Read More
The European Medicines Agency is taking a hard look at whether patients taking inhaled corticosteroids for chronic obstructive pulmonary disease are at higher risk for pneumonia. Read More
Two prominent lawmakers are following through on a promise to do something about recent rises in generic drug prices, with identical House and Senate bills that would force generic drugmakers to pay state Medicaid rebates when prices rise faster than inflation. 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
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
Washington State Gov. Jay Inslee has signed legislation allowing pharmacists to substitute biosimilars for brandname biologics, joining a growing list of states that have passed such laws. Read More