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Morning! Hope your blood sugar is normalizing after a feastful vacation. Right now, we probe Vinay Prasad’s “extraordinary” e mail to CBER staffers about vaccines, talk about the fallout pharmacies could face from Medicare negotiations, and extra.
The necessity-to-know this morning
- Regeneron Prescription drugs and Tessera Therapeutics have signed a partnership settlement to co-develop Tessera’s experimental gene-editing therapy for alpha-1 antitrypsin deficiency (AATD), an inherited illness that impacts the lungs and liver.
- Novocure CEO Ashley Cordovo resigned and is being changed by present president Frank Leonard.
- Belite Bio stated its oral therapy known as tinlarebant achieved the first aim of a Section 3 scientific trial by slowing the expansion of retinal lesions in comparison with a placebo in sufferers with Stargardt illness, a watch illness that results in progressive imaginative and prescient loss.
Unpacking Prasad’s CBER e mail on vaccine coverage
In an unusually blunt inner memo obtained by STAT, CBER chief Vinay Prasad shared his rationale for the company’s sweeping overhaul of U.S. vaccine regulation — one which questions pandemic-era decisions and calls for randomized scientific trial proof for almost each future product.
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