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BioWorld - Saturday, May 30, 2026
Home » Topics » North America » U.S.

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Three syringes illustration

CDC vaccines panel to be ‘re-established’

May 19, 2026
By Mari Serebrov
No Comments
It’s back to the drawing board for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP). After a year of Health and Human Services Secretary Robert Kennedy gutting the panel and restocking it mostly with people who share his views on vaccines, the CDC published a notice in the May 19 Federal Register saying it’s withdrawing the amended ACIP charter renewal issued April 6 and is instead “re-establishing” the committee.
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AI Agent illustration

Artificial intelligence agents get ready to take on the scientific method

May 19, 2026
By Nuala Moran
No Comments
There are real world demonstrations of how autonomous artificial intelligence agents are poised to disrupt biomedical research, according to two papers published May 19 in Nature. Each describes an AI system that assists across the piece, from generating hypotheses to designing experiments, analyzing the data and refining hypotheses in the light of new data.
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Black dollar sign on ombre blue background

Create Medicines secures $122M for in vivo CARs

May 19, 2026
By Brian Orelli
No Comments
Create Medicines Inc. closed a $122 million series B financing round to support its pipeline of therapies that use mRNAs delivered via liquid nanoparticles to express chimeric antigen receptors (CARs) in T cells, NK cells and myeloid cells inside the body of patients. The Cambridge, Mass.-based company estimates the capital will last through 2028, providing the opportunity for multiple clinical readouts of its various products.
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Blood vessels, veins and arteries

Relay’s zovegalisib hits in phase II vascular anomalies trial

May 19, 2026
By Karen Carey
No Comments
Showing a significant efficacy signal in a phase II trial, Relay Therapeutics Inc.’s zovegalisib (RLY-2608) achieved a 60% volumetric response in patients with PIK3CA-driven vascular anomalies (VAs). The isoform-selective PI3Ka inhibitor is in late-stage clinical trials with various combinations for P13Ka-mutated, HR+/HER2- advanced breast cancer, with VAs representing a second indication for which Leerink Partners analyst Andrew Berens forecasts $2.8 billion in peak revenues.
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Mirus Siegel TAVR

Boston Sci invests $1.5B in Mirus, gains option for TAVR system

May 18, 2026
No Comments
Boston Scientific Corp. has invested $1.5 billion for a 34% equity stake in Mirus LLC in a deal under which it is also gaining an exclusive option to acquire the Siegel balloon expandable transcatheter aortic valve replacement (TAVR) system.
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Health care and politics illustration

Sen. Cassidy’s primary loss increases uncertainty

May 18, 2026
By Mari Serebrov
No Comments
On the heels of the ouster of Marty Makary as the U.S. FDA commissioner and the serial leadership vacancies at the CDC and the FDA’s drugs and biologics centers, the government’s adherence to science took another blow May 16 when Sen. Bill Cassidy, R-La., lost the Louisiana primary, ending his bid for re-election.
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US flag, gavel, book

US Supreme Court swats down several biopharma IRA challenges

May 18, 2026
By Mari Serebrov
No Comments
It looks like the end of the road for many of the court challenges to the Inflation Reduction Act’s (IRA) provision requiring Medicare to negotiate prescription drug prices. The U.S. Supreme Court denied cert May 18 to petitions brought by six biopharma companies that raised questions about the constitutionality of the negotiations. All but one of the suits involved were denied in the Third Circuit; the other one was denied in the Second Circuit, so there is no circuit split – yet.
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Skin through magnifier

Regeneron’s fianlimab lags in melanoma, does $2.3B deal with Parabilis

May 18, 2026
By Brian Orelli
No Comments
Regeneron Pharmaceuticals Inc. stuck with the tradition of releasing bad news on Friday afternoon and good news on Monday morning with a pair of announcements bracketing the weekend. On May 15, 2026, the Tarrytown, N.Y.-based company announced disappointing data for its LAG-3 inhibitor fianlimab. And then on May 18, 2026, Regeneron announced better news in the form of a deal with Parabilis Medicines Inc.
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Blood pressure cuff

New hypertension option as Astrazeneca’s Baxfendy wins FDA nod

May 18, 2026
By Jennifer Boggs
No Comments
Patients on antihypertensive medications who still struggle with high blood pressure now have a new treatment option, following the U.S. FDA’s approval of Astrazeneca plc’s baxdrostat. Branded Baxfendy, the drug is a first-in-class aldosterone synthase inhibitor, though it could be joined soon by potential competitor Mineralys Therapeutics Inc., which has a December 2026 PDUFA date for its aldosterone synthase inhibitor, lorundrostat.
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Test tube and pH chart

Validity of Actelion patent hinges on temperature

May 15, 2026
By Mari Serebrov
No Comments
Temperature matters when determining pH levels. Whether that level should be measured at a standard room temperature or refrigerated matters even more, at least in Actelion Ltd.’s infringement litigation against Mylan Inc. According to Johnson & Johnson’s Actelion, the pH level in epoprostenol, the key ingredient in its hypertension drug Veletri, should be measured at a refrigerated temperature when it comes to Mylan’s generic formulation.
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