1 دن پہلے
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.
1 دن پہلے
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