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Immunology—FcRn inhibitor momentum in rheumatoid arthritis
Immunovant’s shares jumped after early, open-label “compelling” Phase 2b data for IMVT-1402 in difficult-to-treat rheumatoid arthritis. The program enrolled patients who had already failed at...
Oncology drug expansion—BioMarin seeks Voxzogo approval for short stature
BioMarin moved to expand Voxzogo after new clinical results supporting use in children with hypochondroplasia, a skeletal disorder related to achondroplasia. In a Phase 3 trial, participants...
Genomic diagnostics—FDA nod for expanded Guardant360 Liquid CDx
The FDA approved Guardant Health’s upgraded Guardant360 Liquid CDx, expanding the test’s genomic and epigenomic coverage for comprehensive tumor profiling from a single blood draw. The new assay...
AI in drug development—BMS deploys Claude enterprise-wide
Bristol Myers Squibb partnered with Anthropic to deploy Claude AI across global operations, aiming to accelerate drug discovery and development through enterprise-wide integration. The platform is...
Clinical platform and diagnostics—Personalis expands Medicare coverage for NeXT Personal
CMS expanded Medicare coverage for Personalis’ NeXT Personal minimal residual disease test to include monitoring response to neoadjuvant therapies in stage II to III triple-negative or...
Corporate deal—Liminatus pays for InnocsAI CAR-T pipeline
Liminatus Pharma agreed to acquire InnocsAI in a share-based deal valued at about $320 million, positioning the purchase around InnocsAI’s autologous CD19xCD22 bivalent CAR-T platform IBC101. The...
M&A and platforms—Eli Lilly buys Engage Biologics for non-viral DNA delivery
Eli Lilly agreed to acquire Engage Biologics for $202 million, adding preclinical non-viral DNA delivery technology to its genetic medicines pipeline. The deal centers on Engage’s Tethosome...
Clinical development—Qihan Biotech gets FDA IND clearance for universal allogeneic CAR-T
Hangzhou Qihan Biotech received IND clearance from the FDA for QT-019C, a universal allogeneic CAR-T therapy targeting autoimmune diseases. The off-the-shelf program is engineered from healthy...
CDx scale-up
Guardant Health won FDA approval for an upgraded Guardant360 Liquid CDx, positioning the test to expand comprehensive tumor profiling beyond the company’s prior assay footprint. Guardant said the...
CAR-T M&A and early clinical momentum
Liminatus Pharma agreed to pay shares worth $320 million to acquire InnocsAI, adding an early CAR-T pipeline including IBC101, an autologous CD19xCD22 bivalent program targeting relapsed or...
Genetic medicines delivery
Eli Lilly struck a preclinical acquisition to strengthen non-viral DNA delivery for genetic medicines. Lilly will buy Engage Biologics for up to $202 million, using Engage’s Tethosome platform—a...
AI in drug discovery platforms
Qiagen and Nvidia expanded their partnership to integrate Nvidia computing and BioNeMo into Qiagen Digital Insights biomedical knowledgebases. Qiagen said the aim is to increase AI use in target...
Cancer immunotherapy engineering
Researchers reported advances in immune-cell engineering that aim to improve the performance of prime editors. In separate work, structure-informed AI and directed evolution were used to redesign...
Epigenomics tools expansion
EpiCypher and New England Biolabs expanded their epigenomics research tool partnership to develop and commercialize CUT&RUN-adjacent workflows. The companies broadened the collaboration to include...
Precision fermentation training
Prism Immersive launched BioSuite Virtual, a mixed-reality training platform designed to teach end-to-end biomanufacturing workflows via a virtual bioreactor. Built with funding from BioMADE and...
Immunology pipeline: FcRn inhibition
Immunovant’s Roivant parent disclosed early Phase 2b open-label results for IMVT-1402, a next-generation FcRn inhibitor in difficult-to-treat rheumatoid arthritis. The company said 16-week data...
Diagnostics regulation shift
US lawmakers introduced the Enhancing CLIA Act of 2026 to update oversight of laboratory-developed tests (LDTs) after a 2025 court decision said LDTs are medical services and not FDA-regulated...
Oncology investment IPO pipeline
Parabilis Medicines filed for an IPO days after signing a wide oncology collaboration with Regeneron, aiming to fund Phase 3 development of its Wnt/β-catenin pathway inhibitor zolucatetide for...
Diagnostics & reimbursement momentum
Guardant Health has won FDA approval for an upgraded liquid biopsy built to expand the clinical footprint of its Guardant360 test. The agency clearance covers a blood-based comprehensive genomic...
China biotech’s global deal signal
Bristol Myers Squibb and Jiangsu Hengrui have delivered a high-profile licensing alliance that industry sources frame as a turning point for China’s biotech influence. The multibillion-dollar deal...