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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
Sponsors of brand, generic and biosimilar drugs applying for marketing authorization through the EU’s centralized procedure must begin including facility inspection information in their applications. Read More
China is opening its market to biosimilars, issuing the country’s first-ever guideline on the technical review of the products and criteria for establishing biosimilarity. Read More
A federal judge upheld the FDA’s decision to strip Ranbaxy of its tentative ANDA approvals and first-filer rights to two drugs because of GMP problems at manufacturing facilities, but nonetheless blasted the agency, saying it never should have issued the approvals in the first place. Read More
Manufacturers of biosimilar insulin-containing products must demonstrate pharmacodynamic and pharmacokinetic similarity profiles to prove similar efficacy to their reference insulin, the European Medicines Agency says in final guidance. Read More
Brand and generic drugmakers want the FDA to take responsibility for safety labeling changes to all drugs with at least one generic equivalent and scrap its proposed rule to give generics firms the ability to update label safety information independently. Read More
The FDA still plans on finalizing the highly controversial proposed rule giving generics makers the same authority brandmakers have to update their product labels without agency approval when new safety information about a drug emerges. Read More