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The European Medicines Agency has issued guidance to help drugmakers improve their responses to scientific objections lodged by EMA review committees. Read More
Australian regulators are calling for labels on six types of nonsteroidal anti-inflammatory drugs to include strong warnings about cardiovascular and liver risks associated with excessive or prolonged use. Read More
Swiss and Chinese regulators plan to harmonize their regulations on market authorization and postmarket surveillance, with the aim of speeding access to new products in both markets. Read More
Three European industry groups are asking the European Commission to block an Italian law that encourages off-label drug use, saying it is driven entirely by economics at the expense of patient health. Read More
Five industry groups are jointly launching a new data center, the European Medicines Verification Organization, to help eliminate counterfeit drugs from the drug supply chain. Read More
The European Medicines Agency is defending its decision to redact certain clinical study reports for AbbVie’s Humira before releasing them, setting up a test case for the EU’s new trial transparency policy. Read More
Mexican regulators laid out rules for older biosimilars registered prior to Oct. 19, 2011, when the country’s biosimilarity rules were first established, mandating that companies conduct clinical trials to prove biosimilarity. Read More
NHS England has reinstated two of the three indications for Novartis’ cancer drug Afinitor to its cancer fund, which is use to reimburse cancer therapies not considered cost effective by the National Institute for Health and Care Excellence. Read More
A team of high-level FDA officials are in India meeting with officials from the Central Drugs Standard Control Organization to discuss the quality of drugs coming from the country, and the Indian regulators’ progress in stepping up oversight of drug safety and quality issues. Read More
CDER plans to increase cooperation with European counterparts and make more use of databases as sources of safety data as it hones its approach to drug safety monitoring. Read More
The FDA approved Asklepion Pharmaceuticals’ Cholbam, the first treatment for children and adults with single-enzyme bile acid disorders and peroxisomal disorders, under its pediatric rare disease priority review voucher program. Under the terms Congress set for the program, the FDA must now phase it out within 12 months unless it is reauthorized. Read More
Two new analyses showing Gilead Sciences’ Sovaldi and Harvoni hepatitis C drugs are largely cost-effective could convince payers to cover the therapies, which — at roughly $7,000 and $7,875 per week, respectively — are the costliest drugs ever marketed in the U.S. Read More