Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Alnylam, Alvotech, Astrazeneca, Boehringer Ingelheim, Compugen, Eli Lilly, Medi&Gene, Medipost, Nxera Pharma, Peptidream, Prism Biolab, Protalix Biotherapeutics, Regeneron, Secarna Pharmaceuticals, Talux, Teikoku Seyaku, Teva.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Actimed, Aptose, Austrianova, Avant, Celltrion, Cytomed, Hanmi, Kazia, Klothea, Klothonova, Mankind Pharma, Microbiotix, Nxera, TC Biopharm, Trioar.
Immunotherapy-focused biotech company LTZ Therapetics Inc. and GSK plc are partnering to develop up to four potential first-in-class myeloid cell engagers using LTZ’s immune-engager platform to target blood cancers and solid tumors.
With phase I/II data in hand, Taiho Pharmaceutical Co. Ltd. and Cullinan Therapeutics Inc. began filing a rolling NDA to the U.S. FDA for accelerated approval of zipalertinib to treat patients with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations who previously received platinum-based chemotherapy.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Celltrion, Henlius, Obi Pharma.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Actimed, Aptose, Austrianova, Avant, Celltrion, Cytomed, Hanmi, Kazia, Klothea, Klothonova, Mankind Pharma, Microbiotix, Nxera, TC Biopharm, Trioar.
The U.S. FDA gave the thumbs up to Kura Oncology Inc./Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, to treat relapsed, refractory (r/r) nucleophosmin1 (NMP1)-mutant acute myeloid leukemia (AML). The approval of the drug, branded Komzifti, came more than two weeks ahead of the Nov. 30 PDUFA date.