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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
Janssen Pharmaceuticals plans to make its long-acting atypical schizophrenia therapy Invega Trinza commercially available by mid-June, following FDA approval Monday. 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
Compounding pharmacies continue to be plagued by sterility issues, as the FDA handed warning letters to facilities in Florida and Kentucky — bringing to nine the number of compounders cited for such deficiencies since October. 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
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