Having suffered a setback last year when deficiencies at a third-party manufacturer scuppered hopes of a quick US approval of sutimlimab for cold agglutinin disease, Sanofi has released more promising data on its C1s inhibitor at the European Hematology Association meeting.
Seven months after a surprise rejection from regulators in the US, Sanofi has presented new late-stage data on its rare blood disorder drug sutimlimab which will provide the basis for a submission in Europe and a resubmission Stateside in the coming months.
The French giant has presented data at the European Hematology Association meeting on sutimlimab from a second Phase III study...
Analysts see the new strategy as a way to address pressure from the Trump administration’s most favored nation drug pricing proposals.
CMS said that 33 US states plus the District of Columbia and Puerto Rico had joined a program whereby the agency negotiates outcomes-based contracts on their behalf.
Roctavian shows durable bleed control and safety over five years, but high costs and access hurdles limit its commercial outlook.
The drugmaker announced positive topline results for the drug in hemophilia A and B patients with inhibitors, on top of the existing approval for patients without inhibitors.
The drug, combined with Merck’s Keytruda, was successful among certain chemotherapy-ineligible MIBC patients, with another Phase III readout expected by March 2026.
The US FDA approved Hernexeos for previously treated HER2-mutant NSCLC, making it the first oral option in a setting where drugs like AstraZeneca/Daiichi Sankyo’s Enhertu dominate.
Novartis has strengthened its argument that ianalumab, its BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate, has PIP potential with successful topline results in two Phase III Sjögren’s syndrome trials, after recently dropping the product in hidradenitis suppurativa.
