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BioWorld - Monday, June 5, 2023
Home » Topics » Regulatory

Regulatory
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Bayer’s PI3K inhibitor cleared in China for follicular lymphoma

May 25, 2023
By Doris Yu
No Comments
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.
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Regulatory actions for May 25, 2023

May 25, 2023
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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.
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Regulatory actions for May 25, 2023

May 24, 2023
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kane Biotech.
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Regulatory actions for May 24, 2023

May 24, 2023
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Zoll Medical.
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Endoangel’s AI-based diagnosis system for endoscopy is approved in China

May 24, 2023
By Doris Yu
No Comments
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.
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Sequana---Alfapump,-Cathether,-charger.jpg

Sequana considers listing in the US as it looks for growth for Alfapump

May 24, 2023
By Shani Alexander
No Comments
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.
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US CMS flexes muscle in proposing Medicaid Rx pricing tools

May 24, 2023
By Mari Serebrov
No Comments
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.
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India ramps up testing requirements after contaminated cough syrup exports

May 24, 2023
By T.V. Padma
No Comments
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.
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Regulatory actions for May 24, 2023

May 24, 2023
No Comments
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.
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Xacduro

Entasis’ bacterial infection drug receives FDA approval

May 24, 2023
By Lee Landenberger
No Comments
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.
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