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Morning! Hope your blood sugar is normalizing after a feastful holiday. Today, we probe Vinay Prasad’s “extraordinary” email to CBER staffers about vaccines, discuss the fallout pharmacies may face from Medicare negotiations, and more.
The need-to-know this morning
- Regeneron Pharmaceuticals and Tessera Therapeutics have signed a partnership agreement to co-develop Tessera’s experimental gene-editing treatment for alpha-1 antitrypsin deficiency (AATD), an inherited disease that affects the lungs and liver.
- Novocure CEO Ashley Cordovo resigned and is being replaced by current president Frank Leonard.
- Belite Bio said its oral treatment called tinlarebant achieved the primary goal of a Phase 3 clinical trial by slowing the growth of retinal lesions compared to a placebo in patients with Stargardt disease, an eye disease that leads to progressive vision loss.
Unpacking Prasad’s CBER email on vaccine policy
In an unusually blunt internal memo obtained by STAT, CBER chief Vinay Prasad shared his rationale for the agency’s sweeping overhaul of U.S. vaccine regulation — one that questions pandemic-era choices and demands randomized clinical trial evidence for nearly every future product.
Continue to STAT+ to read the full story…
STAT Pharma: The science and business of new drug development
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