Today, a brief rundown of news involving the Food and Drug Administration and Takeda, as well as updates from BeOne Medicines, AstraZeneca and Alumis that you may have missed.
More than 300 biotechnology executives, investors and patient advocates have signed a petition calling for President Donald Trump to nominate Rick Pazdur as the next commissioner of the Food and Drug Administration. A longtime FDA veteran and cancer drug reviewer, Pazdur is a proven leader with a “track record of credibility, rigor, and results” whose appointment would “secure and strengthen” the agency at what’s now a “pivotal moment,” the coalition argued. Pazdur left the FDA over reported frustrations with politically driven decisionmaking under former commissioner Martin Makary. His and other departures have “created a crisis of confidence in America’s ability to remain a leader in biomedical progress,” the group warned in its petition. — Ben Fidler
Takeda will lay off 4,500 workers as part of an ongoing restructuring meant to shed $1.3 billion in annual costs by 2028. The Japanese pharmaceutical giant has been working to cut spending for a few years now in response to a broader profit decline catalyzed by patent losses. The latest planned cuts are part of a "transformation program" the company outlined in March and that, according to an earnings presentation Wednesday, will "reduce management layers" and streamline corporate functions ahead of multiple crucial drug launches. Takeda is preparing for approvals of medicines for narcolepsy, psoriasis and polycythemia vera over the next 12 to 18 months. All three have "blockbuster potential," wrote Jefferies analyst Stephen Barker. — Ben Fidler
The Food and Drug Administration on Wednesday granted an accelerated approval to BeOne Medicines’ Beqalzi for certain people with the rare, aggressive blood cancer mantle cell lymphoma. The clearance covers patients whose disease has progressed after two treatment lines, including a “BTK inhibitor” like BeOne’s own Brukinsa. Beqalzi’s clearance was based on study results showing 52% of drug recipients responded to treatment and 16% achieved a complete remission. A so-called BCL-2 inhibitor, Beqalzi is in the same class as Roche and AbbVie’s Venclexta, which is available in three different leukemia and lymphoma settings but not mantle cell disease. A confirmatory trial of Beqalzi in mantle cell is underway, as well as studies testing the drug directly against Venclexta in other settings. — Jonathan Gardner
A combination of AstraZeneca’s immunotherapy Imfinzi and Pfizer and Astellas Pharma’s antibody-drug conjugate Padcev helped people with bladder cancer live longer than those who didn’t when administered before and after surgery in a Phase 3 trial, AstraZeneca said Thursday. The company didn’t provide specifics, but said the drug combination resulted in “statistically significant and clinically meaningful improvements” in both event-free survival and overall survival compared to standard treatment for tumors that have penetrated the bladder’s muscle walls. AstraZeneca will share the results with regulators. — Jonathan Gardner
Alumis will offload a drug it picked up in a merger with Acelyrin in 2025, the company said Thursday in its first-quarter earnings report. The drug, lonigutamab, was being positioned as a competitor to Amgen’s thyroid eye disease drug Tepezza and was Acelyrin’s main focus prior to the deal. But Alumis noted last year that it intended to re-evalute the program to “confirm its differentiation” and revealed Thursday that it now intends to “explore strategic alternatives” for the program. Alumis’ stock price has soared in recent months on positive study data for its plaque psoriasis prospect envudeucitinib, which the biotech plans to submit for regulatory approval by the end of the year. — Gwendolyn Wu
