Ultragenyx Pharmaceutical Inc. and Mereo Biopharma Group plc, along with investors, had hoped for an early halt to the phase III study of setrusumab in treating brittle bones. They didn’t get it, as the clinical trial’s data monitoring committee wants the study to roll on through its final analysis.
China’s National Medical Products Administration gave the green light to Simcere Pharmaceutical Group Ltd.’s Enzeshu (suvemcitug) for treating recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in combination with paclitaxel, liposomal doxorubicin, or topotecan in adults who have received at least one systemic therapy after platinum resistance.
Despite the controversies swirling around the June meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP), the reconstituted committee delivered good news to Merck & Co. Inc. when it voted 5-2 June 26 to recommend that infants younger than 8 months who are not protected by maternal vaccination get one dose of a monoclonal as they head into their first respiratory syncytial virus season.
Abion Inc. signed a potential $1.315 billion deal with an anonymous partner June 22, granting the counterparty exclusive global rights to a preclinical claudin 3-targeting monoclonal antibody, ABN-501, and the potential to license four more protein targeting antibodies.
Keymed Biosciences Co. Ltd. has raised HK$982 million (US$125 million) in a placement on the Hong Kong Stock Exchange (HKEX:2162) to commercialize its IL-4Rα monoclonal antibody CM-310 branded as Stapokibart, and to advance its larger pipeline.
Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa monoclonal antibody, garadacimab (CSL-312), to prevent hereditary angioedema attacks.
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.
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.
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.
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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