Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has jumped on board the e-consent train for clinical trials, publishing a guidance for the use of electronic means for obtaining a study participant’s informed consent.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Actimed, Amneal, Artelo, Carrick, Corvus, Eloxx, Harmony, Inovio, Intensity, Maat, Merck, Pepgen.
Amsterdam-based Royal Philips NV reported that it has come to terms with customers and end users of its respiratory equipment to the tune of $479 million, which will reimburse for the cost of these systems. The problem for the company is that the settlement does not affect any personal injury cases, and thus represents only a partial closure of a controversy that has dogged the company for several years.
Nemaura Medical Inc. recently raised $6.5 million in non-dilutive funding through a clean debt facility with no warrants or convertible elements. The funding came from its existing lender and is expected to fund Nemaura’s ongoing efforts to commercialize its daily disposable, wearable glucose sensors.
Artelo Biosciences Inc. has completed a pre-IND meeting with the FDA regarding the manufacturing, preclinical and clinical development plan for ART-26.12.
While the U.S. FDA’s preclinical and clinical trial framework is generally well-suited to adapt to the use of artificial intelligence (AI) in developing new drugs, its regulatory framework for medical devices that incorporate evolving AI leaves a lot to be desired, according to Sen. Bill Cassidy (R-La.), the ranking member of the Senate Health, Education, Labor and Pension Committee.
China’s National Medical Products Administration (NMPA) has given the green light to Gloria Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody, zimberelimab (Yutuo, GLS-010), for treating second-line cervical cancer, making it the first immune checkpoint inhibitor approved in China for treating the disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Therapeutics, Astrazeneca, Atamyo, Bridgebio, Cantargia, Genentech, Gloria, Neurophth, Realta, Tango.
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