Replimune melanoma drug wins support of FDA panel
The positive vote came despite persistent concerns from FDA scientists and positions the company to bounce back from two earlier rejections.
The U.S. Food and Drug Administration's advisory panel decided against endorsing a Capricor Therapeutics treatment for Duchenne muscular dystrophy. The decision hinged on the drug's effectiveness in treating Duchenne-related cardiomyopathy. Last year, the FDA declined to approve the therapy, requesting additional data after stating it did not meet efficacy requirements.
During the meeting, the FDA criticized Capricor for significant alterations to the study's statistical analysis plan, which compromised the robustness of the data and rendered positive outcomes difficult to interpret.
Furthermore, the U.S. Federal Trade Commission has initiated legal action against Hims & Hers. The FTC, in collaboration with Utah and California, accused Hims of misleading consumers regarding the sharing of sensitive health information with third parties. The agency also highlighted that Hims failed to clarify the process when consumers filled out medical histories and signed up for a subscription that continuously renewed and billed them for medication.
Patients were not granted an opportunity to review treatment recommendations from providers or provide consent. Additionally, the FTC alleged that the website made it challenging for users to cancel their subscriptions.
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