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Clinical trials of drugs for treatment of chronic hepatitis B viral infections may use multiple efficacy endpoints, the FDA said in new draft guidance released Thursday. Read More
An FDA advisory panel Thursday voted against the effectiveness and benefit-risk profile of Alkermes’ NDA for buprenorphine/samidorphan to treat major depressive disorder but in favor of its safety. Read More
“A review of the claims and their intermixing dependencies presents an overall picture of a set of claims designed to preempt a conspicuously large number of different dosage regimens for a large variety of conditions using a long list of formulations, which is disconnected from a written description that is far more limited in its disclosure,” the ruling states. Read More
A federal appeals court has backed up the FDA’s decision to block prescription generics of Bayer’s MiraLax after the branded version switched to over-the-counter status. Read More
HHS invoked its emergency authority to bypass Office of Management and Budget review to quickly roll out a survey to assess prescribing trends for buprenorphine. Read More