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.

Pfizer Inc. is threatening legal action at an attempt by Novo Nordisk A/S to scupper its acquisition of Metsera Inc., with an unsolicited $9 billion offer for the anti-obesity specialist. That trumps Pfizer’s agreed bid made in September, which valued New York-based Metsera at $7.3 billion.

With a modest $7 million up front but an ultimate payout potentially topping $1 billion on the line, Modex Therapeutics Inc. will collaborate with Regeneron Pharmaceuticals Inc. to find and develop multispecific antibodies for treating multiple indications.

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 prevalence of valvular heart disease in the U.S. is tough to peg with any great precision, but an extrapolation of data from a new study would put the number at roughly 10.6 million people, a staggering number when the clinical and fiscal implications are considered.

Ten years after the first biosimilar launched on the U.S. market, the FDA is taking steps to make biosimilar development and pharmacy substitution more like that of generics, reducing the cost of the drugs in the process. “We want to see more biosimilars. We want to see more competition,” FDA Commissioner Marty Makary said at an Oct. 29 media briefing in which he announced new guidance to streamline biosimilar development, cut through the red tape and shorten the timeline.