STAT June 28, 2024
Morning! Today, we discuss how a House committee has overwhelmingly voted in support of four health-related bills. Also, there’s still reason to believe that MDMA-assisted therapy could win FDA approval, and more.
The need-to-know this morning
- The FDA rejected Rocket Pharma’s gene therapy for severe leukocyte adhesion deficiency-I, a rare, sometimes fatal immunodeficiency syndrome. The company said the agency had manufacturing concerns.
- Apellis said CHMP, the drug-reviewing arm of the European Medicines Agency, recommended against approving Empaveli, its injectable for geographic atrophy. Apellis said it plans to appeal.
- CHMP also recommended against approving an ALS drug and once again recommended the EMA not renew authorization for Translarna, a controversial Duchenne muscular dystrophy drug.
- A tiny Swiss biotech’s long Covid...
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