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Home » Topics » Drugs » Monoclonal antibody

Monoclonal antibody
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Enflonsia

Merck wins FDA approval in pediatric RSV and steps into CDC uncertainty

June 10, 2025
By Lee Landenberger
No Comments
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.
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Elderly woman holding illustration of brain with missing puzzle piece
Neurology/psychiatric

Grant supports Mindimmune’s development of MITI-101 for Alzheimer’s disease

June 6, 2025
No Comments
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.
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Handshake with cityscape

Ligachem inks two mystery ADC deals with CSPC subsidiary Novarock

June 5, 2025
By Marian (YoonJee) Chu
No Comments
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.
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Eye wireframe illustration
Ocular

Chinese IND clearance for anti-IGF-1R antibody NTB-003 for thyroid eye disease

June 5, 2025
No Comments
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.
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Art concept for monoclonal antibody cancer treatment
Cancer

Radiopharm Theranostics reports preclinical Lu177-B7H3-mAb data

June 3, 2025
No Comments
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.
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ASCO 2025: Regeneron, Merck-Gilead drugs drop disease, death rates

June 2, 2025
By Lee Landenberger
No Comments
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.
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Vascular system
Cardiovascular

Efficacy and safety evaluation of the ANGPTL4 inhibitory antibody MAR-001 in nonhuman primates

May 29, 2025
No Comments
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.
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Immuneoncia Kosdaq debut

Cancer drug specialist Immuneoncia raises $24M in Kosdaq listing

May 27, 2025
By Marian (YoonJee) Chu
No Comments
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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ODAC Starglo vote could impact universe of trials

May 22, 2025
By Mari Serebrov
No Comments
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.
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Immuneoncia Kosdaq debut

Cancer drug specialist Immuneoncia raises $24M in Kosdaq listing

May 21, 2025
By Marian (YoonJee) Chu
No Comments
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.
Read More
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