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The FDA is on track to release draft guidance on naming biosimilars this year, an FDA official said Wednesday.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…]
The Ebola outbreak highlights shortcomings in disease surveillance and response – and where we can do better
By Grant Hill-Cawthorne, Lecturer in Communicable Disease Epidemiology at University of Sydney
At this time last year, Ebola Virus Disease (EVD) was rapidly spreading through West Africa, and the outbreak is rightly a major item on this year’s assembly agenda. Attention will be paid to the decisions made in response to the outbreak and what this tells us about how best to respond to the next one, including for advance preparation and early warning. [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…]
European Medicines Agency Advises Gene Therapy Developers on Regulatory Requirements
The European Medicines Agency (EMA) has issued draft guidance describing the types of evidence developers of gene therapies need to support marketing authorization — saying very small firms, which comprise the majority of this segment, may not be familiar with the regulatory process. [Read more…]