Bayer AG’s copanlisib was approved in China for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. It is the first indication approved in the country for copanlisib, which is entering a market with room to grow but marked by some domestic competition.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allos, Astrazeneca, Bioray, Braeburn, Innoviva, Inovio, Phathom, Sarepta, Tryp.
Wuhan Endoangel Medical Technology Co. Ltd.’s artificial intelligence (AI)-assisted real-time quality control and auxiliary diagnosis system for lower gastrointestinal endoscopy has been approved by China’s NMPA.
Sequana Medical NV is considering listing in the U.S. as it builds towards the commercialization of its Alfapump, CEO Ian Crosbie told BioWorld in an interview. The company has received a U.S. FDA breakthrough device designation for Alfapump, which treats recurrent or refractory ascites due to liver cirrhosis, and it completed a pivotal study in 2022. The company intends to file the data with the FDA by the end of this year, with the hope of getting premarket approval before the end of 2024.
India has revised its policy to make quality tests by government-certified laboratories mandatory for cough syrups to be exported beginning June 1. The decision is the result of numerous safety alerts involving the death of children.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affimed, Antengene, Blueprint, Boehringer Ingelheim, Cumberland, Indivior, Junshi, Pharmabcine, Pharmessentia, Regenxbio, Rocket, Vega, Y-mabs.
A week ahead of its May 29 PDUFA date, the U.S. FDA has approved Xacduro (sulbactam for injection; durlobactam for injection) for treating one of the toughest and most deadly infections, carbapenem-resistant Acinetobacter baumannii, in adults.