While Barr's attempt to switch the emergency contraceptive Plan B to over-the-counter status is immaterial to the company, the rest of the drug industry can't afford to ignore the controversy, which could jeopardize the renewal of crucial legislation that supports fast and predictable reviews of all new drugs. Moreover, FDA may be reopening old controversies, like whether third parties can force an OTC switch against a brand company's wishes.
By Michael McCaughan
Barr Pharmaceuticals Inc. CEO Bruce Downey likes to joke about the disproportionate attention garnered by his company’s emergency contraceptive...
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Brazil is planning to update its National Clinical Research Action Plan to make the country a more competitive location to conduct R&D.
Commercial clinical trial sponsors have reported several challenges with setting up trials in the UK, which led the Health Research Authority and its partners to make “significant improvements,” to the process, a senior figure at the organization has said.
As the CVLP prepares to support its third cancer vaccine trial, the Pink Sheet examined Scancell’s experience with the initiative, which the drug company used to recruit patients for its advanced melanoma vaccine trial.
The UK government expects that its new nation-wide network will enable companies to set up clinical trials more quickly and expand access to diverse patient populations across the National Health Service.
The UK government expects that its new nation-wide network will enable companies to set up clinical trials more quickly and expand access to diverse patient populations across the National Health Service.
The FDA recommended sponsors plan ahead for potential issues if overall survival is not feasible as a primary or secondary efficacy endpoint in clinical trials and must be analyzed as a safety outcome.
Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.
