Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Blueprint, BMS, Can-Fite, Clovis, Deciphera, Kancera, Leading Biosciences, Neuraptive, Seelos.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Aim Immunotech, Cellphire, Enzychem, Immunic, Nordic Nanovector, Pharmazz, Restem, Sanofi, Scimount, Seattle Genetics, Takeda, Verona, Zealand.
BEIJING – Shandong, China-based Luoxin Pharmaceuticals Group Stock Co. Ltd. said its PIK3α inhibitor, LX-086, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for advanced solid tumors, two weeks after Novartis AG’s alpelisib, which aims at the same target, was also granted IND clearance in China.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arbor, Ascletis, Bluebird, BMS, Cytodyn, Dcprime, Ferring, Novocure, Rhythm, Sunovion, Zai Lab.
BEIJING – Canbridge Pharmaceuticals Inc. is to add another source of income after Chinese regulators approved Nerlynx (neratinib) to be marketed for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpha Cognition, Histogen, Moderna, Seattle Genetics.
Three biopharma drugs are up for FDA approval this week, including one new chemical entity, dasotraline, from Sunovion Pharmaceuticals Inc. to treat binge eating disorder, and two other candidates that are part of supplemental filings for expanded indications.
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