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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 trial failed, triggering layoffs.
House committee passes four health bills
The House Ways & Means Committee just passed four important federal health reimbursement bills. Among them was new legislation that would expand Medicare coverage of obesity drugs, which until now has been prohibited. The bill would only cover certain of obesity patients, however — paying for patients who were taking weight loss drugs before transitioning to Medicare.
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