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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alveofit, Boston Scientific, Implantica.
Two U.S. federal government departments recently issued a series of guidelines for their handling of mergers and acquisitions in a draft that has provoked both support and opposition from observers. Barry Nigro of the George Washington University School of Law said he is concerned that the presumption that a transaction is necessarily anticompetitive will prompt litigation over that presumption and thus bog down the process of reviewing these transactions.
Pepgen Inc. has received a no objection letter from Health Canada for its clinical trial application (CTA) to initiate a phase I study of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1). Initial data from the study are expected next year.
The FDA has awarded orphan drug designation to Healx Ltd.’s HLX-1502 for the treatment of neurofibromatosis type 1 (NF1). HLX-1502, discovered through the company’s proprietary artificial intelligence (AI) drug discovery platform, has a first-in-class mechanism and supporting data that indicate the potential for a good safety profile.
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