Why did the Meals and Drug Administration immediately oust one among its high gene remedy regulators? Is the company rising too political? And may non-public corporations fund tutorial analysis?
We chat about all that and extra on this on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast. We focus on the tragic information {that a} second teenage boy with Duchenne muscular dystrophy died after taking Sarepta Therapeutics’ gene remedy, elevating renewed questions concerning the FDA’s requirements for approving medicine.
We have a look at the continued turmoil throughout the FDA, together with the pressured dismissal of high gene remedy regulator Nicole Verdun, in addition to the announcement of a controversial drug-review voucher program that appears to be steering the company into politics.
We additionally discuss a personal fairness agency’s choice to fund a analysis lab at Harvard College, filling a void created by authorities spending cuts. And we have a look at the approval of a groundbreaking HIV prevention drugs from Gilead Sciences, in addition to a recap of the large BIO conference this week and a preview of the upcoming American Diabetes Affiliation assembly this weekend.
Make sure to join “The Readout LOUD” on Apple Podcasts, Spotify, or wherever you get your podcasts.
