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The FDA has laid out a regulatory research agenda for the year that includes identifying better methods for assessing generics, improving drug safety and biosimilars development, and finding ways to assess advanced, new drugs as areas where the agency would like to sponsor research. Read More
The FDA is pushing ahead with efforts to spur development of hard-to-copy generics, this time sponsoring research into bioequivalence testing for long-acting periodontal drugs and developing methods for assessing generic, long-acting injectables. Read More
The FDA has postponed an advisory committee meeting that had been scheduled to consider Celltrion’s application for a biosimilar to Janssen’s Remicade — just the second advisory committee meeting to consider a biosimilar application in the U.S. Read More
Postmarket monitoring results on Hospira’s biosimilar of Janssen’s Remicade continue to show comparable patient response to the reference, the generics maker says. Read More
Mexican regulators have 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
A German regulator says European Medicines Agency plans for implementing its clinical trials database lets drugmakers withhold too much information, such as study protocols, methods and trial results, under the exemption for commercial confidentiality. Read More
Sponsors spend upwards of 23 million hours complying with clinical trial requirements, from requests for INDs to submission of NDAs, the FDA says. Read More
A federal judge has sided with the FDA in its decision to strip Ranbaxy of generic approval and first-filer rights to Nexium and Valcyte, meaning company’s efforts to control the generic market for the two drugs could be over unless it appeals. Read More
UK regulators shut down a plant in Cambridgeshire that was producing an unapproved and unlicensed product used against diseases such as HIV and cancer. 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