Novartis says oral BTK inhibitor remibrutinib significantly reduced relapse rates and MRI lesions versus teriflunomide in both Phase 3 REMODEL trials, with no liver safety signal and global regulatory filings now planned.
Jazz Pharmaceuticals says a second interim analysis of HERIZON-GEA-01 found statistically significant and clinically meaningful overall survival improvement with Ziihera plus chemotherapy versus trastuzumab plus chemotherapy in first-line HER2-positive advanced gastroesophageal adenocarcinoma.
Eli Lilly and Company says one-year Phase 3b data from TOGETHER-PsO and TOGETHER-PsA show sustained or deeper improvements when Zepbound and Taltz are used together in patients living with psoriatic disease and obesity.
The European Commission has approved AstraZeneca and Daiichi Sankyo’s Enhertu with pertuzumab for first-line HER2-positive metastatic breast cancer after DESTINY-Breast09 showed a 44% reduction in the risk of progression or death compared with long-standing THP therapy.
PharmaEssentia has secured FDA approval for BESREMi in adults with essential thrombocythemia after the Phase 3 SURPASS ET trial showed a 37.4% durable response rate versus 3.6% with anagrelide.
Ascletis Pharma has dosed the first participant in a 4,600-person global Phase 3 program for ASC30, a once-daily oral small-molecule GLP-1 receptor agonist that produced up to 7.7% placebo-adjusted weight loss after 13 weeks in Phase 2.
A prespecified VESALIUS-CV analysis found a 20% reduction in mortality with Amgen’s Repatha among more than 12,000 high-risk adults without a previous heart attack or stroke, strengthening the case for intensive LDL lowering before the first major cardiovascular event.
A new real-world study of sustained low-dose semaglutide and tirzepatide found measurable weight loss without escalation to standard maintenance doses, but researchers stress that prescription records do not prove intentional GLP-1 microdosing and the observational findings cannot establish cause and effect.
FDA accepts Alvotech’s AVT80 application for a subcutaneous Entyvio biosimilar, expanding its vedolizumab strategy alongside Teva.
Cadrenal Therapeutics gains FDA alignment on a Phase 3 CAD-1005 trial in HIT after encouraging thrombosis data. See the risks and next steps.