FDA official calls for accelerated approval use in gene therapy; Senator asks for conflict of interest probe on diet guideline panel

Taking stock of the drug industry, from the lab to the medicine chest

March 20, 2023 Check out STAT+

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By Ed Silverman Pharmalot Columnist, Senior Writer

Susan Walsh-Pool/Getty Images STAT+ | Top FDA official: Agency needs to start using accelerated approval for gene therapies FDA's Peter Marks said the oft-debated path used for some cancer drugs should be extended to gene therapies for rare diseases. By Jason Mast STAT+ | Senator calls for probe of conflict of interest on federal panel overseeing dietary guidelines One panelist was paid nearly $27,000 in recent years by Novo Nordisk, which sells two medicines used to treat obesity. By Ed Silverman STAT+ | Karuna's treatment for schizophrenia achieves study goals, bolsters FDA filing plans The company intends to file a marketing application for its drug, called KarXT, with the FDA by the middle of the year. By Adam Feuerstein Ashley L. Conti for STAT Arizona plans to dramatically increase hepatitis C testing and treatment in prisons Arizona's corrections department is promising to dramatically increase the number of incarcerated people it tests and treats for hepatitis C. By Nicholas Florko Watch: P-value, an important measurement in clinical trials, explained In clinical trials, a new drug must outperform the placebo by a statistically significant margin using a measurement called "p-value." By Alex Hogan and Damian Garde

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