12h ago
Caribou Biosciences to shut down after failing to fund late-stage trial for lymphoma CAR-T therapy
Caribou Biosciences said it will shut down after it was unable to raise enough money to support a late-stage clinical trial of its CAR-T therapy for lymphoma. The Berkeley, California-based biotech, which traces its roots to Nobel laureate Jennifer Doudna’s CRISPR research lab, will stop clinical development of two CRISPR-based CAR-T programs, including vispa-cel for advanced B-cell non-Hodgkin lymphoma. The company had finalized a Phase 3 trial design with the U.S. Food and Drug Administration, but financing the study proved too difficult, STAT reported.
12h ago
10-2
Medicare Advantage insurers cut 2027 benefits and raise seniors’ out-of-pocket costs
Federal data show Medicare Advantage insurers are trimming 2027 plan benefits, sharply reducing extras such as dental coverage and dropping some options with broad hospital and doctor networks. At the same time, enrollees are being asked to pay more out of pocket. That could leave older adults facing unexpected costs when the annual enrollment period for 2027 plans begins on Oct. 15. The data were reviewed by STAT and several investment firms.
10-2
9-29
UniQure says AMT-130 slowed Huntington’s disease progression 44% at four years, missing statistical significance
UniQure reported four-year follow-up data showing its gene therapy AMT-130 reduced Huntington’s disease progression by 44% in a high-dose group, though the result was not statistically significant. The size of the benefit was smaller than in a comparable analysis conducted one year earlier, prompting renewed questions about durability. The update comes as the U.S. Food and Drug Administration begins reviewing UniQure’s marketing application.
9-29
8-28
AstraZeneca explains Phase 3 ATTR-CM miss, raising questions for rival biotechs
AstraZeneca said its Phase 3 trial of an ATTR-CM drug developed with Ionis Pharmaceuticals failed to show additional benefit. Most patients in the study were already taking an oral “stabilizer,” and results showed the injectable “silencer” did not improve outcomes, weighing heavily on the overall trial. The setback is rippling beyond the two partners to other companies in the space, prompting a fresh reassessment of how injectable silencers stack up against oral stabilizers.
8-28
8-14
FDA approves Bristol Myers Squibb’s Zenbexus for multiple myeloma, introducing a new drug class
The U.S. Food and Drug Administration has approved Bristol Myers Squibb’s oral multiple myeloma therapy iberdomide, sold as Zenbexus, for use in combination with Darzalex and dexamethasone. The regimen is indicated for patients who have received at least one prior line of therapy. The approval marks the first clearance of a new drug class for multiple myeloma and the FDA’s first decision based on a more stringent measure of remission.
8-14
8-3
Sandoz agrees to pay $478.5 million to settle generic-drug price-fixing allegations
Sandoz, Novartis’ generics unit, agreed to pay $478.5 million to settle antitrust allegations from dozens of U.S. states and drug distributors over alleged price-fixing. The deal includes $400 million to be paid over seven years starting in 2027, plus about $50 million for states that previously reached settlements. It also sets aside $28.5 million to resolve remaining class-action litigation brought by indirect resellers, and Sandoz did not admit wrongdoing.
8-3
7-27
FDA says Capricor’s Duchenne stem cell therapy missed Phase 3 trial goals
The U.S. Food and Drug Administration said Capricor Therapeutics’ stem cell treatment for Duchenne muscular dystrophy, deramiocel, did not meet the objectives of its Phase 3 trial. That contrasts with Capricor’s December statement that the therapy met both the primary and secondary endpoints in a large randomized study. The drug had been aimed at teenagers and young men who have already lost the ability to walk, a group with limited treatment options.
7-27