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Revolution Medicines’ pancreatic cancer win and market response
Revolution Medicines said daraxonrasib met key endpoints in its pivotal Phase 3 pancreatic cancer trial, nearly doubling median overall survival versus standard chemotherapy in previously treated...
Bain Capital spinout reignites shelved Bristol Myers immunology assets
Bain Capital’s Life Sciences arm is relaunching a shelved immunology pipeline from Bristol Myers Squibb through a new startup, Beeline Medicines. The venture is structured around five licensed...
Eli Lilly buys into dual-payload ADCs via CrossBridge
Eli Lilly agreed to acquire CrossBridge Bio for up to $300 million, expanding its oncology pipeline into dual-payload antibody-drug conjugates. CrossBridge’s platform is designed to deliver two...
Regeneron and Telix enter radiopharmaceuticals with a multi-program partnership
Regeneron is entering radiopharmaceuticals through a collaboration with Telix to co-develop and co-commercialize next-generation radiopharmaceutical therapies and related diagnostics. The...
FDA sharpens expectations for gene therapy safety and trial data transparency
The FDA issued draft gene-editing safety guidance for human gene therapy products, focusing on how sponsors should use next-generation sequencing and bioinformatics to evaluate off-target risks...
FDA proposes faster Phase 1 trial approvals via a new clinical trial notification pathway
The FDA proposed a streamlined approach for first-in-human (FIH) studies by considering a new “clinical trial notification pathway.” Under the concept, sponsors with validated preclinical data and...
Thermo Fisher expands real-world data access with HealthVerity
Thermo Fisher announced a collaboration with HealthVerity to expand its real-world data capabilities for biopharmaceutical clinical development and evidence generation. The partnership grants...
Amazon launches Amazon Bio Discovery to link AI design to wet-lab execution
AWS launched Amazon Bio Discovery, an agentic AI platform intended to speed antibody drug discovery by connecting model selection, candidate evaluation, and lab-in-the-loop synthesis and testing....
TRIAL and regulatory milestone for Travere’s kidney disease therapy
Travere Therapeutics’ Filspari (sparsentan) became the first fully FDA-approved treatment for focal segmental glomerulosclerosis (FSGS). The approval expands the company’s label beyond accelerated...
New IPO and financing momentum in biopharma market
Biotech fundraising intensity continued to build as Revolution Medicines led a major capital raise and other companies moved toward public markets and new equity funding. The Revolution financing...
Regulatory acceleration for early human studies
The U.S. FDA is considering a faster regulatory pathway for first-in-human (FIH) Phase 1 trials, aiming to cut duplicative review steps for smaller biotech companies. The proposal would create a...
FDA expansion of kidney-disease approvals
Travere Therapeutics’ Filspari (sparsentan) cleared a new regulatory milestone, becoming the first FDA-approved treatment for focal segmental glomerulosclerosis (FSGS). The approval expands use...
Precision oncology dealmaking in radiopharma
Regeneron and Telix announced a major expansion into radiopharmaceuticals through a co-development and co-commercialization collaboration worth up to $2.1 billion. The partnership pairs...
Car-T manufacturing scale-up and first patient doses
Cabaletta Bio said the first two patients have been dosed with rese-cel, an investigational autologous CAR T-cell therapy manufactured using Cellares’ automated Cell Shuttle platform. The...
Targeted therapy readout that reshapes pancreatic-cancer expectations
Revolution Medicines reported “unprecedented” survival results in its Phase 3 pancreatic cancer trial for daraxonrasib, triggering expectations of rapid regulatory progress. The company said the...
Clinical progress for off-the-shelf CAR-T in lymphoma
Allogene Therapeutics provided an early view of its off-the-shelf CAR T-cell program, reporting MRD negativity in lymphoma patients at a higher rate than observation in an ongoing Phase 3 setting....
FDA validation mechanics for gene-edited products and off-target risk
The FDA released draft guidance that lays out how sponsors should use next-generation sequencing (NGS) and bioinformatics to evaluate safety risks in genome-edited human gene therapy products. The...
Major acquisition to expand ADC firepower
Eli Lilly agreed to acquire CrossBridge Bio in a deal valued at up to $300 million, strengthening Lilly’s antibody-drug conjugate (ADC) toolkit. CrossBridge develops next-generation ADCs built...
Regulatory and market reality check for trial result disclosures
The FDA reminded sponsors and researchers that many registered clinical studies still fail to post results to ClinicalTrials.gov on time. In a notice, the agency said it found delinquency in...
Cabaletta-style manufacturing automation and platform momentum in cell therapy
Automation for autologous cell therapies moved closer to scalability as Cellares’ Cell Shuttle platform produced GMP material for rese-cel, with the first two patients dosed following release...