The U.S. FDA is insisting that another study is needed to bolster the sNDA for Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. in treating adults with post-traumatic stress disorder (PTSD). The agency’s Psychopharmacologic Drugs Advisory Committee and the company, one of Japan’s biggest pharmas, will discuss this during July 18’s adcom hearing regarding the efficacy of Rexulti in combination with sertraline.

Synchrony Medical Ltd. received the greenlight from the U.S. FDA for its Libairty airway clearance system which is expected to transform the lives of people with chronic lung diseases. The company is now looking to raise $5 million in series A funding to support the launch of the product in the U.S. later this year.

The U.S. Centers for Medicare & Medicaid Services (CMS) has pulled off the gloves when it comes to spending on skin substitutes in the draft Medicare physician fee schedule for 2026, proposing a payment methodology that would slash spending by 90%. However, the doc fee draft also proposes to simplify the process by which telehealth coverage is provided for a physician service, a move that may significantly expand the types of services that can be handled without an in-office visit.

To the surprise of no one in the device industry, the Medicare national coverage analysis for renal denervation (RDN) includes both radiofrequency and ultrasound technologies, but the agency has listed a range of specialists to be part of the patient’s care team, including but not limited to an endocrinologist.

Under a new licensing deal announced July 8, JCR Pharmaceuticals Co. Ltd. granted Alexion Pharmaceuticals Inc. rights to its adeno-associated virus (AAV) capsids for use in up to five of Alexion’s genomic medicines programs.

Launched out of 5AM Ventures’ 4:59 Initiative, Renasant Bio Inc. has secured $54.5 million in seed funding to support development of treatments for autosomal dominant polycystic kidney disease (ADPKD), a genetic disease caused by mutations in the PKD1 and PKD2 genes, which encode polycystin proteins PC1 and PC2 that come together to form a calcium ion channel vital for kidney function.

Three months earlier than an expected update on a deal, Becton, Dickinson and Co. reported its biosciences and diagnostic solutions business will combine with Waters Corp. in a transaction valued at $17.5 billion. The resulting enterprise will operate under the Waters name and use its trading symbol (NYSE:WAT). Waters CEO Udit Batra will head the combined company.

Zimmer Biomet Holdings Inc. reported it is buying orthopedic robotics maker Monogram Technologies Inc. for an upfront payment of $4.04 per share in cash, corresponding to an equity value of approximately $177 million and an enterprise value of about $168 million.

The continuing proliferation of U.S. state privacy law drew the attention of developers of med-tech wearables for some time, but a recent Senate hearing delivered the news to Congress that a failure to preempt it will slow digital health innovation to a crawl.