STAT+: Alnylam thickened the plot
The results of Alnylam Pharmaceuticals’ Phase 3 cardiovascular study was already biotech’s biggest binary event in the first quarter of 2024. Now, with a delay and change in study design,…
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Hello, everyone. Damian here with a look at pharma’s struggle to make inroads in D.C., the curious story of the latest FDA drug approval, and a twist on the year’s biggest biotech event. One more thing: We’ll be taking off Monday for Presidents’ Day, but this newsletter will be back in your inbox bright and early Tuesday morning.
The need-to-know this morning
- Sarepta Therapeutics said the FDA accepted its follow-0n application seeking full approval and expanded use of Elevidys, a gene therapy for Duchenne muscular dystrophy. The agency’s decision date is June 21.
Has PhRMA lost its fangs?
Are 11th-hour changes ominous for clinical trials? And what’s next in pain medicine?
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