Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Zoll Medical.
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.
The U.S. Centers for Medicare & Medicaid Services (CMS) is flexing its new authority in a proposed rule intended to clamp down on drug prices by providing more transparency in the Medicaid program.
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.
Blueprint Medicines Corp. scored a broader label from the U.S. FDA for Ayvakit (avapritinib), which became the first approved therapy to treat adults with indolent systemic mastocytosis (ISM).
When it comes to cutting health care costs in the U.S., last year’s Inflation Reduction Act, with its inflationary rebates and direct Medicare negotiations, was just Act 1. Now lawmakers, in both the House and Senate, are feverishly working on bipartisan scripts for Act 2 that go beyond biopharma’s role in drug prices to taking on pricing issues across the health care sector.
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