The Korea Biotechnology Industry Organization on Oct. 30 welcomed the bilateral trade deal between the U.S. and South Korea announced during U.S. President Donald Trump’s state visit alongside the Asia-Pacific Economic Cooperation forum in Gyeongju, South Korea.

The U.S. CMS has adopted an aggressive payment policy for skin substitutes in the Medicare physician fee schedule for 2026, although the payment rate is sufficiently higher than the agency had proposed to mollify some critics.

The Office of Inspector General (OIG) said in a new report that the U.S. Medicare program had overpaid a group of providers of durable medical equipment (DME) by nearly $23 million between 2018 and 2024, an amount that is a significant drop from prior years, but which OIG said calls for further reforms for the Medicare DME program.

Pfizer Inc. has delivered on its threat of legal action against the attempt by Novo Nordisk A/S to scupper its acquisition of Metsera Inc., and has filed two lawsuits, one alleging breach of contract, and a second claiming that a merger of Novo Nordisk and Metsera would violate antitrust regulations.

The U.S. FDA once again has a leadership gap at the top of its drug center, which already has been ravaged this year by massive terminations, resignations and retirements of senior leaders. George Tidmarsh, a biopharma industry veteran who’s helmed CDER for a little more than three months, resigned effective immediately Nov. 2 after being placed on administrative leave two days earlier amid a Department of Health and Human Services probe.

Dexcom Inc. executives may have thought a $30 million beat of the consensus estimates for third quarter revenue and 20% year-over-year organic growth provided a treat to shareholders, but investors seemed to feel tricked instead. The continuous glucose monitoring powerhouse saw its share price drop a frightening 17% in the first two hours of trading on Oct. 31, pushing it down by one-third from its peak of $89.53 in late July. Investors appear to have been spooked by the company’s conservative projections for 2026, following issues with its G7 sensor, which management said have been largely resolved.

Sparrow Acoustics Inc., dba Sparrow Bioacoustics Inc., closed a C$10 million (US$7.15 million) financing round to support continued adoption of its U.S. FDA-cleared Stethophone platform, which allows bioacoustics detection of structural and rhythmic heart anomalies directly through a smartphone. Sparrow is a Software as a Medical Device and the first medically cleared product that uses smartphones to capture and decipher cardiac sounds.

John Crowley doesn’t worry about where his kids’ toys are made, but he told the Senate Health, Education, Labor and Pensions Committee that he does care where their medicines are made. His concerns, as a father and as president/CEO of the Biotechnology Innovation Organization, are becoming more urgent, he testified at an Oct. 29 HELP hearing on the future of biotech in the U.S.