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The European Medicines Agency has released draft guidance explaining how drugmakers can use pharmacodynamic and pharmacokinetic analyses to hasten the development and review of new antibiobics.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
The FDA has banned imports of drugs made by Mumbai, India- based Polydrug Laboratories, citing good manufacturing practice violations at its Ambernath plant. Read More
Active pharmaceutical ingredient maker Pan Drugs was hit with an FDA warning letter and import alert after an inspection revealed significant data integrity and cGMP issues. Read More
In an effort to boost the integrity of the drug supply chain, the FDA has issued a final rule authorizing it to destroy drug imports valued at $2,500 or less that have been refused admission into the country. Read More
An interim report shows that, since 2013, the FDA has conducted nearly 90 meetings with more than 50 drug companies interested in producing biosimilar products — at a cost of $65.9 million. Read More
Amgen and Allergan claim their biosimilar candidate for Roche’s blockbuster Avastin is clinically equivalent in adult patients with advanced non-small cell lung cancer. Read More