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A nearly two-year antitrust investigation by the Justice Department that involves more than a dozen generics makers could result in price-collusion charges before the year ends, according to a source familiar with the matter. Read More
The UK Court of Appeal affirmed an earlier ruling that invalidated Pfizer’s patent claims for Lyrica and ruled generics would not lead to infringements. Read More
Industry groups have endorsed the FDA’s commitment goals for BsUFA II, asking Congress to reauthorize the user fee program intended to improve review efficiency. Read More
The FDA’s commitment goals for GDUFA II were backed by industry at a recent meeting, bringing the user fee program closer to reauthorization. Read More
A year after the first approval of a treatment for female sexual desire disorders, the FDA has released draft guidance for drugmakers looking to develop the next female Viagra. Read More
The European Medicines Agency has begun publishing clinical study data for all new drug applications submitted after Jan. 1, 2015, regardless of approval status. Read More
The FDA’s draft guidance on companion diagnostics development needs more clarity on what products it covers and greater detail on clinical trial criteria, trade groups said in comments. Read More
Sponsors should conduct at least two randomized, double-blinded, controlled trials to establish efficacy and safety in trials for treating head lice infestations in children, the agency said in a final guidance. Read More
The International Council for Harmonisation identified the key scientific issues facing drug developers in pediatric indications in a draft updating its 16-year-old E11 guideline. Read More
With just over a month until new FDA regulations take effect mandating that all electronically submitted application data conform to a standardized format, the organization responsible for setting those standards is working to train industry to meet the requirements and is considering developing more frequent and granular updates to those standards in the future. Read More
Future cancer immunotherapy trials need new standardized endpoints and evaluation criteria, regulators and scientists said at an FDA workshop. Read More