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With a growing number of biologics set to lose patent protection in coming years, a leading industry group is calling for regulatory reforms to encourage the development and approval of biosimilars. Read More
President Barack Obama late Wednesday was expected to sign a measure to fund the federal government at fiscal year 2015 levels through Dec. 11, thereby averting a government shutdown. Read More
The European Medicines Agency has released draft guidance explaining how drugmakers can use pharmacodynamic and pharmacokinetic analyses to hasten the development and review of new antibiobics.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
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
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