Responding to medical advances and new standards of care in Alzheimer’s, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing to end its 10-year-old coverage with evidence development policy that has limited Medicare reimbursement of amyloid PET scans to once in a lifetime for beneficiaries – and then only when they’re used in a CMS-approved trial.

Sanofi SA and Astrazeneca plc had a lot to celebrate July 17 when the FDA approved Beyfortus (nirsevimab) ahead of schedule, making it the first respiratory syncytial virus (RSV) prophylactic for infants in the U.S. “This is just really an historic day,” Michael Greenberg, a Sanofi vice president and medical head of the company’s North America vaccines unit, told BioWorld. The companies had been expecting the FDA decision later this quarter. The earlier approval suggests the FDA appreciated the urgency of having time for health systems and doctors to get the drug ahead of the next RSV season, Greenberg said.

Showing that much lower brand prices are possible, even in the U.S., Theracosbio Inc. announced July 13 that its diabetes drug, Brenzavvy (bexagliflozin), is coming to the U.S. market through the Mark Cuban Cost Plus Drug Co. at a monthly price that’s less than the copay most patients have to pay for other drugs in the class. A new molecular entity approved in January to improve glycemic control in adults with type 2 diabetes, Brenzavvy is an oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor that will be available through Cost Plus Drugs with a monthly price tag of $47.85, plus shipping and handling. A 30-day supply of other SGLT2 inhibitors costs hundreds of dollars, with some approaching $600 a month.