Tag: Japan

REYKJAVIK, Iceland, June 08, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio^® (vedolizumab) lyophilized vial for intravenous administration.

THE INFORMATION CONTAINED HEREIN IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN OR INTO AUSTRALIA, CANADA, ITALY, DENMARK, JAPAN, THE UNITED STATES, OR TO ANY NATIONAL OF SUCH JURISDICTIONS

Transaction Establishes a Large-Scale Pharmaceutical Platform in Japan and Strengthens Commercial Capabilities Across Key Therapeutic Areas

Ingelheim, Germany - Boehringer Ingelheim today announced positive results from two global Phase III trials of its glucagon/GLP-1 dual agonist survodutide (BI 456906), SYNCHRONIZE-1 and SYNCHRONIZE-MASLD.^2,4 The results demonstrate survodutide’s potential to reduce weight and therefore improve metabolic health in two distinct populations: adults living with obesity or overweight, without type 2 diabetes (SYNCHRONIZE-1),² and adults with overweight or obesity with metabolic dysfunction-associated steatotic liver disease (MASLD) with evidence of inflammation and or fibrosis (SYNCHRONIZE-MASLD).⁴ Full results from SYNCHRONIZE-1 and SYNCHRONIZE-MASLD were presented today at the American Diabetes Association’s (ADA) 2026 Scientific Sessions and published simultaneously in The New England Journal of Medicine and Nature Medicine respectively.^5,6

Montrouge, June 8, 2026

Clinical benefit, including remissions, demonstrated in both systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) patients following a single target dose of CLN-978