Drug Approvals Might Skip 2nd Trial, Rely More On Clinical Pharmacology
FDA looks to expand 1998 guidance with more scenarios where clinical pharmacology data may serve as confirmatory evidence for drug approval on the basis of a single adequate, well-controlled study.
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Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals leads to removal of indications for two PD-1/L-1 inhibitors, AstraZeneca’s Imfinzi and Bristol-Myers Squibb’s Opdivo, both of which had failed confirmatory trials.
Modified vaccines targeted at new SARS-CoV-2 variants must generate immune response rates not more than 10% below those of the original vaccine, agency says in one of a suite of guidances on medical product development to address variants.
COVID-19 Will Forever Change The Workplace, But Not Necessarily For The Better, Merck’s Frazier Says
Limiting interactions to two-dimensional settings will hinder collaboration, innovation and the mentoring of younger employees, Merck & Co. CEO Kenneth Frazier says. Frazier, who will retire in June, is looking forward to returning to public service but says ‘politics with a capital P is not my thing.’