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.
KSQ Therapeutics Inc., in collaboration with The University of Texas MD Anderson Cancer Center and the Cell Therapy Manufacturing Center (CTMC), have announced FDA clearance of an IND application for a phase I/II study of KSQ-001EX, KSQ’s lead engineered tumor-infiltrating lymphocyte (eTIL) program.
CSPC Pharmaceutical Group Ltd.’s SYH-2053 injection has obtained clearance from China’s National Medical Products Administration (NMPA) to enter clinical trials in China.
Pasithea Therapeutics Corp. has received written responses from the FDA to questions submitted for a type 2 pre-IND meeting regarding the clinical development plan for PAS-004 (CIP-137401).
Redhill Biopharma Ltd.’s stock (NASDAQ:RDHL) has soared in recent days following news that the U.S. FDA granted five years of market exclusivity for Talicia, a first-line therapy for eradication of Helicobacter pylori infection, which affects about 35% of the U.S. adult population.
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