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Personalized mRNA cancer vaccines in late-stage readouts
Merck and Moderna reported Phase 3 success for their personalized mRNA cancer vaccine, intismeran autogene, in adjuvant melanoma when combined with Merck’s Keytruda. The companies said the trial...
GLP-1 receptor antagonist moves toward approval for post-bariatric hypoglycemia
Amylyx said its GLP-1 receptor antagonist avexitide delivered a Phase 3 success in post-bariatric hypoglycemia (PBH), cutting serious hypoglycemic events by 55% versus placebo in the pivotal...
China regulatory progress: Harbour Biomed’s HBM-7004 reaches the clinic
Harbour Biomed said China’s National Medical Products Administration (NMPA) cleared its IND submission for HBM-7004, enabling the program to enter the clinic for advanced solid tumors. The...
Rare disease dealmaking: BioMarin acquires Alesta program for skeletal pipeline
BioMarin agreed to buy Alesta Therapeutics in a deal valued at $275 million upfront, bringing the hypophosphatasia program into BioMarin’s skeletal disease portfolio. The transaction is designed...
Oncology trial updates in China: Akeso and Summit face shrinking benefit for ivonescimab
Akeso and Summit Therapeutics disclosed updated data from the China-based Harmoni-6 trial for ivonescimab, a PD-1/VEGF bispecific antibody. Updated follow-up showed the progression-free survival...
Partnered drug discovery platform: OmniAb inks up to $370M Lilly ion-channel collaboration
OmniAb secured a global collaboration and licensing agreement with Eli Lilly for an undisclosed ion channel discovery program. The deal includes an undisclosed upfront payment and potential...
Diagnostics expansion: Craif pushes urine-based pancreatic cancer test toward U.S. trial
Craif raised $33 million in a Series D round and said it will accelerate its U.S. clinical trial plans for a urine-based pancreatic cancer assay built on microRNA analysis from exosomes. The...
Neuroscience technology: live-cell Ras activity biosensor enters drug research workflows
Researchers published a new chemigenetic biosensor, HaloRasAR, that tracks endogenous Ras activity in living cells during drug research. The study in Nature Chemical Biology reports a live-cell...
FDA policy on generative AI devices: agency solicits input on regulating medical tools
The FDA asked for public input on approaches to regulating generative AI-enabled medical devices. The agency said it is exploring issues including risk assessment, premarket evaluation, and...
Biotech startup funding and compute partnerships: Network Bio launches with Nvidia-backed cfRNA foundation model
Network Bio launched with $50 million in financing and a collaboration valued at $30 million with Nvidia to develop a cell-free RNA (cfRNA) foundation model. The Palo Alto startup plans to...
Post-bariatric hypoglycemia drug readouts
Amylyx Pharmaceuticals said its GLP-1 receptor antagonist avexitide hit the primary endpoint in a pivotal Phase 3 trial in post-bariatric hypoglycemia (PBH), with a statistically significant...
U.S. FDA moves on generative AI medical device oversight
The FDA is seeking input on how to regulate generative AI-enabled medical devices, outlining questions it says will shape future policy on risk assessment, premarket evaluation and postmarketing...
Protein biomarkers and trial endpoints in autoimmune myositis
Argenx reported a Phase 3 win for Vyvgart Hytrulo, a subcutaneous FcRn antagonist version of its blockbuster efgartigimod alfa, in immune-mediated necrotizing myopathy. The company said the drug...
Gene editing safety scrutiny tied to Huidagene trial decisions
STAT+ convened independent gene editing experts to review decision-making around Huidagene’s muscle gene editing trial after the death of a young boy. The analysis revisited actions taken months...
CAR T portfolio reshuffling at Janssen
Janssen Biotech ended development of its CD20/CD19 CAR T therapy, prizloncabtagene autoleucel (C-CAR039), transferring the program’s rights back to Abelzeta Pharma. Abelzeta previously had...
Deal: BioMarin expands rare bone pipeline with Alesta buyout
BioMarin agreed to acquire Alesta Therapeutics in a $275 million deal to bring a rare bone disorder asset into its skeletal disease portfolio. The company framed the transaction as a way to...
Leo Pharma licensing for oral rare photosensitivity drug
Leo Pharma said it will acquire worldwide rights to Tanabe Pharma’s rare disease drug dersimelagon, in a deal potentially worth up to $435 million including upfront and milestone payments. The...
Precision oncology infrastructure: NAVINCI and BrainZell spatial proteomics
Navinci and BrainZell announced a collaboration to apply spatial proteomics workflows to brain organoids, using Navinci’s in situ proximity ligation assay (PLA) technology. The effort aims to...
Cancer immunotherapy platform: delayed STING activation with mRNA vaccines
A Nature Biotechnology paper reports that mRNA vaccine efficacy can be enhanced by bioorthogonal-like delayed activation of an exogenous STING adjuvant. The approach aims to separate timing...
Liquid biopsy coverage push for Freenome
TD Cowen initiated coverage of Freenome with a Buy rating and a $17 price target, citing the company’s liquid biopsy chemistry and commercial partnerships with Abbott and Roche. The analyst...