Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABK Biomedical, Clordisys Solutions, Exactech, West Pharmaceutical.
Simcere Pharmaceutical Group Ltd.’s subsidiary Simcere Zaiming Pharmaceutical Co. Ltd. has received FDA clearance of an IND application for SIM-0501, an oral small-molecule inhibitor of ubiquitin-specific peptidase 1 (USP1), for advanced solid tumors.
Mission Therapeutics Ltd. has reported clinical trial authorization (CTA) by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for a first-in-human phase I study of MTX-325 for the treatment of Parkinson’s disease. Dosing is expected to commence in the first quarter of next year, with preliminary data to follow later in the year.
Eli Lilly and Co., through its Loxo@Lilly oncology unit, secured its second accelerated approval for non-covalent Bruton’s tyrosine kinase (BTK) inhibitor Jaypirca (pirtobrutinib), this time to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. The U.S. FDA approval of 100-mg and 50-mg tablets is for patients who have received two prior lines of therapy, including another BTK inhibitor and a BCL-2 inhibitor. It is based on phase I/II data from a subset of 108 patients participating in the open-label, single-arm, multi-cohort Bruin trial.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neuronetics.
The U.S. FDA opted not to pursue one form of medical device harmonization via the Global Harmonization Working Party (GHWP), as it reported it will withdraw from the organization.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Transit Scientific.
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