With the U.S. FDA’s approval of Enflonsia (clesrovimab) to prevent respiratory syncytial virus (RSV) infection lower respiratory tract disease in newborns and infants, Merck & Co. Inc. steps into a space of competition and regulatory shifts. The preventive, long-acting monoclonal antibody (MAb)
will take its place in the market alongside the blockbuster Beyfortus (nirsevimab) from Sanofi SA and Astrazeneca plc. The MAb for pediatric use brought in about $1.77 billion in 2024.
Mindimmune Therapeutics Inc. has been awarded a grant by Rhode Island Life Science Hub to accelerate preclinical development work on MITI-101 for the treatment of mild to moderate Alzheimer’s disease. The award will accelerate development work needed to start first-in-human studies.
Ligachem Biosciences Inc. signed two license agreements with Novarock Biotherapeutics Inc., a subsidiary of CSPC Pharmaceutical Group Ltd., to bring in two of Novarock’s antibodies and create antibody-drug conjugate (ADC) candidates with novel cancer targets.
Biocytogen Pharmaceuticals (Beijing) Co. Ltd. and Nanjing Chia Tai Tianqing Pharmaceutical Co. Ltd. have announced IND clearance by China’s National Medical Products Administration (NMPA) for NTB-003 (formerly BCG-009) for thyroid eye disease.
Radiopharm Theranostics Ltd. has reported preclinical data from studies with the Lu177-B7H3-monoclonal antibody (mAb) RV-01 demonstrating favorable biodistribution and showing that RV-01 maintained high tumor uptake.
New and positive phase III cancer data for two monoclonal antibodies from two pharma giants opened the second day of the American Society of Clinical Oncology (ASCO) conference this past weekend.
Atherosclerotic cardiovascular disease (ASCVD) remains a leading cause of mortality worldwide despite advances in managing classic risk factors and therapies lowering LDL-cholesterol. Inhibiting angiopoietin-like protein 4 (ANGPTL4), a key regulator of triglyceride metabolism, is emerging as a potential strategy to treat atherogenic dyslipidemia and lower ASCVD risk.
Immuneoncia Therapeutics Inc. raised ₩33.9 billion (US$24 million) from its Kosdaq listing May 19. Shares closed at ₩7,500 – 108% higher than its offering price of ₩3,600 per share. Immuneoncia, a joint venture founded in 2016 between Seoul, South Korea-based Yuhan Corp. and San Diego-based Sorrento Therapeutics Inc., noted that the funds will support R&D operations until 2026.
The recent 8-1 adcom vote against the U.S. applicability of Genentech Inc.’s Starglo trial is being seen as a warning signal expanding beyond the confirmatory trial for Columvi (glofitamab) as a treatment for relapsed/refractory diffuse large B-cell lymphoma.
Immuneoncia Therapeutics Inc. raised ₩33.9 billion (US$24 million) from its Kosdaq listing May 19. Shares closed at ₩7,500 – 108% higher than its offering price of ₩3,600 per share. Immuneoncia, a joint venture founded in 2016 between Seoul, South Korea-based Yuhan Corp. and San Diego-based Sorrento Therapeutics Inc., noted that the funds will support R&D operations until 2026.
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