Top of the morning to you, and a fine one it is. Skies are gray but rain is not expected on the Pharmalot campus today, making it possible for the official mascots to eat breakfast on the deck and take long, luxurious naps. As for us, we are firing up the trusty kettle to make another cuppa stimulation. Our choice today is English breakfast, another old standby from the pantry. Please feel free to join us. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …
A U.S. Food and Drug Administration advisory panel voted 9-to-3 against effectiveness data for a Capricor Therapeutics treatment for Duchenne muscular dystrophy, STAT tells us. The key question centered on whether the drug had shown it could treat Duchenne-related cardiomyopathy. Last year, the agency declined to approve the therapy and sought additional data after saying the treatment did not meet efficacy requirements. During the meeting, the FDA spent a good deal of time calling out Capricor, saying it made major changes to the study’s statistical analysis plan that degraded the robustness of the data and made even seemingly positive outcomes hard to interpret.
The U.S. Federal Trade Commission sued Hims & Hers, continuing a pattern of action against the business practices and use of consumer health data by digital health companies, STAT notes. The agency, along with Utah and California, alleged that Hims misled consumers about sharing sensitive health information with third parties, and that the company is not clear when consumers fill out medical histories and are signing up for a subscription that continually renews and bills them for medicine. Patients also are not given an opportunity to review a provider’s recommended treatment or provide consent. The FTC also alleges the site makes it difficult for users to cancel their subscriptions.
