BioPharm Weekly News Roundup—Week of Sept. 15, 2025

Welcome to the BioPharm International® weekly news roundup for the week of Sept. 15, 2025. In this new video feature, the editors will highlight each week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week. And be sure to check the links below for more in-depth coverage of each story.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended separating the combined MMRV vaccine (marketed as Merck & Co.’s ProQuad) from the separate MMR and varicella vaccines for children under four to reduce the risk of febrile seizures.

The CPHI Pharma Awards 2025 shortlist showcased bio/pharma advancements across 14 categories, featuring technologies like Lonza’s Design2Optimize, TriLink Biotechnologies’ GMP-Grade CleanCap M6 analog, Accord Healthcare’s Orgovyx, and Evonik Industries’ EUDRACAP colon, emphasizing synthetic biology, AI-driven formulation, and sustainability.

CSL entered a strategic collaboration and exclusive option agreement with VarmX to fully fund the global Phase III trial (EquilibriX-S) and manufacturing scale-up for VMX-C001, a recombinant modified Factor X protein developed to restore blood coagulation in patients taking FXa DOACs.

FDA issued warning letters to Eli Lilly and Company regarding misleading safety information about tirzepatide injections Mounjaro and Zepbound, and also sent warnings to Novo Nordisk concerning its semaglutide injections (Ozempic, Wegovy) and Hims & Hers Health for its compounded semaglutide products, highlighting failures in adequate risk disclosure.

Gyala Therapeutics published preclinical results for its CD84-targeting CAR-T therapy, GYA-01, demonstrating specific and potent cytotoxicity against hard-to-treat hematological malignancies including acute myeloid leukemia and T-cell acute lymphoblastic leukemia, with clinical trials planned in Spain by the end of 2025.

SynaptixBio CEO Dan Williams discussed how small biotechs drive innovation for ultra-rare, primarily genetic, diseases by leveraging agility, fast decision-making, and collaborations with academic institutions and larger pharmaceutical companies to overcome funding and development challenges.

Limula and Institut Paoli-Calmettes (IPC) announced a collaboration to explore the cell-processing capabilities of Limula’s LimONE technology, an automated and closed system, for hematopoietic stem cell transplantation applications to improve product quality and consistency by refining cryoprotectant removal.

Former CDC Director Susan Monarez testified that Health Secretary Robert F. Kennedy Jr. fired her for resisting pressure to replace scientific evidence with ideology and pre-approve vaccine recommendations, creating regulatory instability that affects manufacturers of products like the MMRV, hepatitis B, and COVID-19 vaccines.

Monte Rosa Therapeutics and Novartis expanded their collaboration to develop novel molecular glue degraders (MGDs) for immune-mediated diseases, utilizing Monte Rosa’s AI/ML-enabled QuEEN product engine, with Novartis providing a $120 million upfront payment and assuming responsibility for later-stage development.

Japan-based Nxera Pharma and Cancer Research UK announced the first patient dosing in a Phase IIa clinical trial for the investigational small-molecule immunotherapy HTL0039732 (NXE0039732), designed to block the EP4 receptor and treat advanced, immunotherapy-resistant solid tumors including microsatellite stable colorectal cancer.