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Gene therapy in Duchenne pushes toward an FDA submission
Regenxbio reported that its Duchenne muscular dystrophy gene therapy RGX-202 met a pivotal clinical bar, setting the stage for an FDA submission and accelerating the company’s path toward...
Car-T manufacturing and delivery scale-up via funding and automation
Create Medicines raised $122 million to expand its in vivo CAR-T platform, focusing on faster, one-day manufacturing using an mRNA-lipid nanoparticle approach to reprogram T cells, NK cells and...
FDA clears broader solid tumor genomic profiling
FDA cleared Datar Cancer Genetics’ CellDx-Tissue assay for comprehensive genomic profiling of solid tumors, enabling DNA and RNA testing on formalin-fixed, paraffin-embedded tissue. The...
AI-driven clinical operations compress trial readouts
Veristat launched InStat, an automated biostatistics platform designed to cut clinical trial data readout timelines from weeks to days. The company said the system can produce submission-ready...
Big oncology trial news in bladder cancer combinations
AstraZeneca reported a Phase 3 win in bladder cancer using a combination built around Imfinzi. The company said combining Imfinzi with Pfizer’s Padcev improved outcomes versus standard of care,...
Antipsychotics and oncology meet new chemistry IP (patents)
Multiple patent disclosures pointed to new small-molecule chemistry for both central nervous system and oncology targets. Vivozon reported new heterocyclic dual 5-HT2A/dopamine D2 receptor...
Biopharma dealmaking expands Alzheimer’s and oncology collaborations
Fosun secured rights to AriBio’s oral Phase 3 Alzheimer’s therapy AR-1001 in a structured option deal that totals potential consideration of up to $4.7 billion, according to reporting. Fosun will...
AI drug discovery funding accelerates again
Google-backed Isomorphic Labs closed a $2.1 billion Series B to scale its AI drug-design engine and expand toward the clinic. The company positioned the engine as a unified design-and-development...
Diagnostics and reimbursement expand for MRD monitoring and cancer testing
Medicare expanded coverage for Personalis’ NeXT Personal minimal residual disease assay to include immunotherapy monitoring across late-stage solid tumors, following earlier coverage for...
CAR-T related access and delivery models expand beyond the US
A Spanish public-sector model aims to improve patient access to CAR-T therapy using hospital exemption manufacturing pathways, targeting faster delivery for eligible patients. Presenters described...
In vivo CAR-T funding and first clinical expansion into autoimmune disease
Create Medicines raised $122 million to expand its in vivo CAR-T platform targeting cancers and autoimmune indications, the company said. The Series B round was co-led by Arch Venture Partners,...
Billion-dollar pharma dealmaking for global immuno-oncology pipelines
Bristol Myers Squibb and Hengrui Pharma agreed to collaborate across 13 early-stage programs spanning oncology, hematology, and immunology, with deal economics that could reach more than $15.2...
FDA approval for BeOne’s BCL2 inhibitor in mantle cell lymphoma
BeOne Medicines received US FDA accelerated approval for sonrotoclax, now marketed as Beqalzi, for patients with relapsed or refractory mantle cell lymphoma after treatment with a BTK inhibitor....
Regenxbio’s Duchenne gene therapy clears pivotal bar for FDA submission path
Regenxbio said its Duchenne muscular dystrophy gene therapy met the bar in a pivotal study, setting up an FDA submission expected in 2027. The company reported the therapy produced sufficiently...
Cell therapy manufacturing automation for progenitor T-cell therapy
Cellares and ProTgen announced a partnership to automate manufacturing and quality control for ProT-096, a personalized progenitor T-cell therapy aimed at refractory leukemia and other hematologic...
BeOne/Biopharma compliance and reimbursement pressures shaping diagnostics and lab economics
MDxHealth reported Q1 revenue rose 13% year over year while the company discontinued its Resolve UTI test and lab operations in Plano, Texas. The company cited a reimbursement landscape it...
EU diagnostic regulation milestone: Cepheid multiplex GI panel gains IVDR CE marking
Cepheid received CE marking under the EU IVDR framework for its Xpert GI Panel, a multiplex PCR test intended to identify 11 gastrointestinal pathogens from a single stool sample in about 74...
AI-backed liquid biopsy diagnostics for immunotherapy-response prediction
LiquidCell Dx said it is developing LiquidTME, a cfDNA-based methylation profiling liquid biopsy assay designed to predict response to immune checkpoint inhibition by identifying tumor...
Gene therapy safety question in Dravet: steroids may blunt efficacy in Encoded trial data
A study from Encoded Therapeutics suggested that a medicine commonly used to reduce gene-therapy immune responses could also reduce effectiveness. In a Dravet syndrome gene-therapy trial, most of...
Rebuild at the FDA after commissioner resignation and leadership handoff
Marty Makary resigned as FDA commissioner, ending a politically turbulent tenure as Kyle Diamantas, previously the agency’s top food regulator, moved in as acting commissioner. The transition...