Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ARS, Atara, Everest, Genflow, Hepagene, Menarini, Merck, Spybiotech, Stemline, Takeda.
Genflow Biosciences plc has received correspondence from Belgium’s Federal Agency for Medicines and Health Products (FAHMP) with a recommendation to initiate a phase I/II trial of GF-1002 in patients with nonalcoholic steatohepatitis (NASH), rather than in healthy volunteers.
Leucid Bio Ltd. has received approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to commence a phase I/II trial of LEU-011 for the treatment of adults with relapsed or refractory solid tumors.
Hepagene Therapeutics Inc. has received FDA clearance of its IND application for HPG-7233 for the treatment of patients with nonalcoholic steatohepatitis (NASH) and dyslipidemia.
The U.S. FDA is going straight to final guidance with its “Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies [PHEs].”
The U.S. FDA is going straight to final guidance with its “Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies [PHEs].”
Shares of ARS Pharmaceuticals Inc. (NASDAQ:SPRY) plummeted 55.8% Sept. 20 on word that the U.S. FDA issued a complete response letter (CRL) for Neffy, despite receiving a recommendation for approval in May from the agency’s advisory committee (adcom) and following a three-month delay in action.
The U.S. FDA is still sorting through the feedback for its proposal to modestly align the Quality System Regulation with ISO 13485, but the agency has posted a draft four-year plan for regulatory harmonization that is substantially broader in scope than just quality management system considerations. While this proposal addresses a significant need for device makers working in multiple markets, the objectives include an assessment of at least nine non-FDA harmonization proposals by the end of fiscal year 2025, a clear indicator that harmonization will continue to be every bit the slog it has proven to be in recent years.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carlsmed, Choicespine.
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