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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
The FDA has updated its list of planned guidances for the calendar year to include one on evaluating the abuse-deterrent properties of generic solid oral opioid drugs. Read More
The South Carolina Supreme Court more than halved the $327 million in penalties imposed on Johnson & Johnson’s Janssen drug unit by a lower court for hiding the risks of its drug Risperdal, ruling that the penalties levied on the company were excessive. 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
India regulators barred two drugmakers from doing business in the country for five years for submitting false information in new drug applications. Read More