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…]
EMA Reviewing Pneumonia Risk With Inhaled Corticosteroids
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…]
FDA Approves Janssen’s Schizophrenia Injection Invega Trinza
Janssen Pharmaceuticals plans to make its long-acting atypical schizophrenia therapy Invega Trinza commercially available by mid-June, following FDA approval Monday. [Read more…]
Two More Compounders Warned for Poor Sterile Drug Manufacturing
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…]
India Warns Drugmakers Again to Register in Online Database
India’s drug price regulator is again warning drugmakers to immediately register in an online database or face fines and imprisonment. [Read more…]
Supreme Court Denies Last Pending Request for Review in Reglan Preemption Case
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…]
FDA Amends Bristol-Myers Squibb’s Daklinza Breakthrough Therapy
The FDA has revised Bristol-Myers Squibb’s breakthrough therapy designation for its daclatasvir/sofosbuvir combination hepatitis C therapy to cover patients with advanced cirrhosis or whose infection recurs after a liver transplant. [Read more…]
J&J Settles Risperdal Suit With Arkansas for $7.75 Million
The Arkansas attorney general agreed to a $7.75 million settlement with Johnson & Johnson over its marketing of the antipsychotic Risperdal, just over a year after the state’s top court reversed a $1.2 billion verdict. [Read more…]
FDA to Release Four Draft Guidances on Biosimilars This Year
The FDA is on track to release draft guidance on naming biosimilars this year, an FDA official said Wednesday. [Read more…]
Priority Review Voucher Program Takes Hit in Latest 21st Century Cures Draft
The House Energy & Commerce Committee released a new version of the 21st Century Cures Act that scales back the rare pediatric disease priority review voucher program. [Read more…]