The U.S. FDA said postmarketing reports of neutralizing antibodies to ADAMTS13, including one reported patient death, have prompted an investigation into Takeda Pharmaceutical Ltd.’s Adzynma (apadamtase alfa), a recombinant protein product approved in 2023 for use in adults and pediatric patients with congenital thrombotic thrombocytopenic purpura.
Otsuka Pharmaceutical Co. Ltd. filed an NDA with the U.S. FDA for centanafadine (formerly EB-1020), a new nonstimulant therapy for treating attention-deficit hyperactivity disorder (ADHD) in children, adolescents and adults. Centanafadine is a norepinephrine, dopamine and serotonin reuptake inhibito formulated as a once-daily extended-release capsule.
Phrontline Biopharma Suzhou Co. Ltd. closed a $60 million pre-A+ financing round led by Lapam Investment, with participation from nine other investors. The funds raised will support Phrontline’s development of next-generation antibody-drug conjugate (ADC) candidates.
Two South Korean conglomerates – Samyang Holdings Corp. and Samsung Biologics Co. Ltd. – listed their newly spun-off biopharmaceutical units on Korea Exchange’s (KRX) main trading board Nov. 24.
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.
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