Bluebird Bio submitted an application for its sickle cell therapy lovo-cel to the Food and Drug Administration for approval. The move follows both Vertex and CRISPR Therapeutics, who have also recently submitted applications to the FDA for their own sickle cell therapies. (STAT News)
The FDA put another Foghorn Therapeutics study on partial hold after a patient had a serious heart-related safety event, the biotech announced Monday. A sarcoma patient who received the second highest dose of its drug candidate had a grade 3 QTc prolongation event with signs and symptoms of grade 4 with Torsades de Pointes, a type of arrhythmia in which the heart beats very rapidly and can be life-threatening. (Endpoints News)
Florida’s plan to get cheaper prescription drugs from Canada has been snarled in a legal back-and-forth. Four years after Florida lawmakers passed a plan to import cheaper prescription drugs from Canada, the plan remains in limbo in disputes between the state and federal government. (Sun Sentinel)
The impact of gender-affirming care bans in Republican states has made it more difficult for physicians to safely provide care for transgender youth, even in non-Republican states. Healthcare providers who provide transgender care have noted that they face barrages of harassment, death threats and misinformation as a result of the push to ban gender-affirming care. (POLITICO)
Johnson & Johnson’s consumer health unit, Kenvue, is being valued at $40 billion before it goes public later this year. Kenvue, which includes brands like Band-Aid, Neutrogena and Tylenol, aims to raise $3.5 billion in the offering. (CNBC)
