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The U.S. Court of Appeals for the Federal Circuit Friday denied a request by generic drugmakers for a rehearing to challenge an epilepsy drug patent’s validity. Read More
FDA draft guidance on assessing a new drug’s impact on blood pressure does not adequately explain the agency’s thinking on the use of smaller clinical trials and should incorporate a more risk-based approach, according to comments from three leading drug sponsors. Read More
The FDA is proposing to exclude three substances from its 503B Bulks List of substances for outsourcing facilities to use in compounding drugs — including one that’s the subject of an Endo lawsuit against the agency. Read More
For products that have a short shelf life and cannot be stockpiled, suppliers should have plans for products to be transported via air freight. Read More
The Senate passed an amendment Thursday to require drugmakers to list prescription drug prices in direct-to-consumer ads in an effort to promote lower prices through increased transparency. Read More
A federal appeals court affirmed last week that Novartis did not engage in antitrust violations to protect a patent on its leukemia drug Gleevec (imatinib). Read More
A coalition of health care stakeholders called on the FDA to issue final guidance on interchangeable biosimilars to help promote drug price competition, saying the agency’s failure to finalize its January 2017 draft guidance created “significant uncertainty.” Read More
Excluding certain patients “limits the ability of a trial to generate data that are relevant to the actual users of the drug,” the experts said. Read More