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Oh, hi. Today, we discuss delays in the launch of TrumpRx. Also, Sanofi is deprioritizing its mRNA flu vaccine.
The need-to-know this morning
Regeneron Pharmaceuticals expects an FDA approval decision in the first half of this year for its gene therapy to treat a rare, genetic cause of hearing loss. An application for the therapy, called DB-OTO, was filed in December, the company said. The FDA awarded DB-OTO a Commissioner’s National Priority Voucher last October. Regeneron also reported fourth-quarter and 2025 earnings.
European regulators have started a review of Amgen’s drug Tavneos following “emerging information that raises questions regarding the data integrity” of the main study that supported approval, the European Medicines Agency said. Tavneos is used to treat patients with two, severe inflammatory conditions affecting blood vessels.
Moderna Chief Medical Officer Jaqueline Miller is stepping down, the company said. No reason was given for her departure. Moderna also named David Berman as its new chief development officer. Berman was most recently the R&D chief at Immunocore, a maker of cell-based immunotherapies.
TrumpRx launch is delayed, though details are murky
From STAT’s John Wilkerson: The Trump administration was expected to launch its TrumpRx website today, but those plans have been delayed, according to individuals familiar with the effort. Health secretary Robert F. Kennedy Jr. said yesterday during a cabinet meeting to expect the launch sometime “in the next 10 days,” while one report emerged suggesting technical problems were to blame for delays.Continue to STAT+ to read the full story…