U.S. and European organ-on-a-chip specialty biotechnology companies are driving development of organ-on-a-chip technologies, fueled by the U.S. FDA’s decision to phase out animal testing for investigational new drugs.

Tempest Therapeutics Inc. entered definitive agreements approved by its board to acquire certain dual-targeting CAR T programs from Factor Bioscience Inc. and its affiliates in an all-stock transaction expected to close in early 2026.

In a verbal sparring over who can deliver the lowest drug prices in the U.S., several Senate Democrats are urging President Donald Trump to immediately release the list of second-round Medicare-negotiated drug prices, instead of doing what they characterize as “ambiguous” and “opaque” pricing deals with individual biopharma companies.

“Our goal is that by the end of this call, you’ll share our conviction in the totality of the data.” So said Agios Pharmaceuticals Inc. CEO Brian Goff as the company reported top-line data from its 52-week Rise Up trial testing mitapivat in sickle cell disease showing the oral pyruvate kinase activator hit statistical significance on one of two primary endpoints and two of three key secondary endpoints.

Dexcom Inc. received U.S. FDA clearance for its Smart Basal CGM-integrated basal insulin dosing optimizer. Designed for adults with type 2 diabetes using glargine U-100 long-acting insulin therapy, Smart Basal uses data from Dexcom’s G7 15 Day sensor with doses logged by the user to personalize recommendations and adjust long-acting insulin doses, with direction from the patient’s health care provider.

The recent strategic partnership Siemens Healthineers AG recently entered into with Boston Scientific Corp. to develop and commercialize an Acunav 4D intracardiac echocardiography catheter could drive “significant growth” for the company, Jochen Schmitz, CFO, at Siemens, told delegates at the Jefferies Global Healthcare Conference, in London.

U.S. and European organ-on-a-chip specialty biotechnology companies are driving development of organ-on-a-chip technologies, fueled by the U.S. FDA’s decision to phase out animal testing for investigational new drugs.

Arrowhead Pharmaceuticals Inc. won U.S. FDA approval of plozasiran in familial chylomicronemia syndrome (FCS), the second drug to gain clearance for use in the rare genetic disease following the late 2024 nod for Ionis Pharmaceuticals Inc.’s Tryngolza (olezarsen), setting up a battle in the marketplace even as the firms wage a patent dispute regarding the two RNA-based therapies.

The U.S. FDA gave the thumbs up to Kura Oncology Inc./Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, to treat relapsed, refractory (r/r) nucleophosmin1 (NMP1)-mutant acute myeloid leukemia (AML). The approval of the drug, branded Komzifti, came more than two weeks ahead of the Nov. 30 PDUFA date.

Shanghai Henlius Biotech Inc. and Organon & Co. announced Nov. 17 that the U.S. FDA cleared Poherdy (pertuzumab-dpzb) as the first and only interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc./Roche Holding AG).