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The European Medicines Agency has released draft guidance explaining how drugmakers can use pharmacodynamic and pharmacokinetic analyses to hasten the development and review of new antibiobics. Read More
Roche’s ocrelizumab proved effective in treating primary progressive multiple sclerosis in a Phase 3 study, making it the first investigational drug to show positive results for both PPMS and relapsing remitting MS. Read More
The Patent Trial and Appeal Board has invalidated a patent for Novartis’ multiple sclerosis drug Gilenya, in one of the first successful uses of the inter partes review process by generics drugmakers. Read More
The U.S. House of Representatives late Monday approved a bill that would compensate patients for participating in clinical studies of rare diseases, sending it to President Barack Obama’s desk to be signed. Read More
Democrats on the House Oversight and Government Reform Committee are demanding answers on Valeant Pharmaceuticals’ massive price increases on two heart disease drugs. Read More
Legislation to avoid a federal government shutdown cleared an important procedural hurdle in the Senate on Monday, as lawmakers voted 77 to 19 to end debate on a stopgap funding bill to extend current spending levels until Dec. 11. Read More
The European Commission has approved Sanofi and Regeneron’s bad cholesterol treatment Praluent, two months after it was cleared by the FDA for the U.S. market. Read More
Novo Nordisk expects to launch its once daily insulin Tresiba in the first quarter of 2016, following FDA approval of that and another diabetes treatment on Friday. Read More
The FDA is seeking feedback on a draft addendum to the International Conference on Harmonisation’s good clinical practice guideline aimed at streamlining approaches to trial design, conduct, oversight, recording and reporting. Read More
The U.S. Patent and Trademark Office has denied Celgene’s request to sanction a hedge fund owner for seeking to profit by challenging the validity of drug patents, saying there was nothing inherently wrong with the action. Read More
The FDA has issued final guidance for generics makers on making formal requests for information, including on topics that are still under agency consideration. Read More