The U.S. FDA once again has a leadership gap at the top of its drug center. George Tidmarsh, a biopharma industry veteran who’s helmed CDER for a little more than three months, resigned yesterday after being placed on administrative leave two days earlier amid a Health and Human Services probe into concerns about his conduct. Those concerns became public knowledge when Aurinia Pharmaceuticals Inc. filed a defamation complaint against Tidmarsh yesterday in the U.S. District Court for the District of Maryland. Prior to Tidmarsh’s July 21 appointment as CDER director, Jacqueline Corrigan-Curay, an eight-year FDA veteran and the center’s principal deputy director, was serving as acting CDER director. Tidmarsh’s appointment coincided with her retirement. Currently, no one holds the principal deputy director title at CDER, according to the FDA’s leadership roster. The center has been ravaged this year by layoffs, retirements and resignations, resulting in regulatory uncertainty.

Uniqure stock plunges on FDA opinion change regarding Huntington’s BLA

Shares of Uniqure NV (NASDAQ:QURE) were trading at $29.54, down $38.16, or 56%, on word that the U.S. FDA apparently no longer agrees that data from the phase I/II studies of AMT-130 vs. external control in Huntington’s disease are adequate for a BLA submission. Lexington, Mass.-based Uniqure said that prespecified protocols and statistical analysis plans were shared before analyses with regulators, who seemed to have endorsed the setup. The company expects to receive final minutes within 30 days of the pre-BLA meeting and will “urgently interact” with the FDA to seek a path forward.

Pfizer files two lawsuits to stop Novo's $9B buyout of Metsera

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 first lawsuit, against both Metsera and Novo Nordisk, filed on Oct. 31, asks for a temporary restraining order to prevent Metsera from terminating its merger agreement with Pfizer. The second lawsuit on Nov. 3, accusing Metsera and Novo Nordisk of “an anticompetitive conspiracy,” also points a finger at Metsera’s controlling shareholders, Arch Venture Partners and Validae Health, claiming they are part of the conspiracy.

Stock turns sharply higher with Terns’ leukemia data

Early stage data from Terns Pharmaceuticals Inc.’s lead candidate showed a large reduction in the number of leukemia cells in those with previously treated chronic myeloid leukemia. Results from the ongoing phase I Cardinal study of TERN-701, an oral, allosteric BCR-ABL tyrosine kinase inhibitor, were “unprecedented,” according to Terns. The dose escalation and expansion portion of the clinical trial produced a 75% overall cumulative major molecular response (MMR) rate at 24 weeks, as 64% – 14 out of 22 patients – achieved MMR, and 10 of 10 participants maintained their MMR. The company’s stock (NASDAQ:TERN) had risen sharply at midday, with shares going for $15.53 each, a jump of 88%. The data is part of the first abstracts to be released for the 67^th American Society of Hematology Annual Meeting and Exposition in Orlando on Dec. 6-9.

UK MHRA sets out reforms to speed rare disease therapy approvals

The U.K. Medicines and Healthcare products Agency (MHRA) has committed to major reforms of how it regulates drugs for rare diseases, making it easier to run clinical trials and get approvals. The new rules will be published in full early in 2026 and come into effect later in the year, but following consultation with industry, academic and patient groups, the agency has released a position paper setting out its plans. One proposed change is to simultaneously grant approval for a clinical trial and for a product to be put on the market under an “investigational marketing authorization” that would require a strict safety monitoring plan and frequent reviews of real-world evidence of benefit.

Scientists rehabilitate disease-causing T cells into tolerance builders

For 75 years, the standard tools for autoimmune disease have consisted of steroids, cytotoxics and broad biologics that tamp down the entire immune system. They can help, but they are rarely curative. “They’re blunt instruments,” Regcell Inc. CEO Mike McCullar told BioWorld. “They can’t distinguish good immune cells and bad immune cells,” which is why many carry black-box warnings and must be taken for years, sometimes for life. In a new study published in Science Translational Medicine, Nobel prize winner Shimon Sakaguchi and his team at Osaka University map out how to reprogram the problem itself into the solution. Instead of globally suppressing immunity, the researchers convert disease-causing T cells into stable, antigen-specific regulatory T cells (Tregs) that can patrol the same tissues, recognize the same antigens and switch off destructive responses at their source.

Biopharma nonprofit dealmaking and grants stabilize in a new normal

The value of biopharma nonprofit deals and grants has declined sharply since peaking during the pandemic. Nonprofit deal value surged to $21.44 billion in 2021, before falling to $7.99 billion in 2022 and $754.6 million in 2024. So far in 2025, nonprofit deal value totals $126 million through the third quarter (Q3). Meanwhile, the value of grants awarded to biopharmas climbed to $12.97 billion in 2020, and stands at $1.67 billion through Q3 2025.

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4D Molecular, Ajinomoto, Arcus, Astellas, Astrazeneca, Boost, Calluna, Celldex, Compass, Corbus, DBV, Galapagos, Gilead, Hightide, Hookipa, Karolinska, Liminatus, Nanobiotix, Neurokaire, Otsuka, Parabilis, Phio, Stallergenes Greer, Vesper