Get the Daily Brief
Latest Biotech News
M&A and strategic partnering
AbbVie agreed to acquire Apogee Therapeutics for about $10.9 billion in cash, aiming to extend its immunology pipeline with long-acting assets, led by zumilokibart (IL-13). The deal values Apogee...
Cell therapy approvals and expansion
China approved CARsgen’s satricabtagene autoleucel (satri-cel) for solid tumors, marking what the company says is the first CAR-T authorization in the category for a specific solid-tumor target....
Oncology drug development setbacks
Pfizer’s first new antibody-drug conjugate (ADC) to read out pivotal data after its Seagen acquisition stumbled in a Phase 3 non-small cell lung cancer trial. The failure of sigvotatug vedotin in...
Obesity franchise access and policy fights
Eli Lilly’s retatrutide program is drawing attention not only for its clinical promise but also for how access is being handled before regulatory clearance. According to STAT+, Lilly and the FDA...
Digital pathology and clinical workflow infrastructure
Leica Biosystems and Versant Diagnostics expanded their collaboration as PRW Laboratories became the first lab network to deploy Leica’s Aperio GT Elite solution. The high-throughput scanner is...
AI in clinical trials operations
Medable launched its Digital Data Flow (DDF) Agent to convert static clinical trial protocols into machine-readable, standardized data in CDISC USDM 4.0 JSON format. The company says the agent can...
Antibody and immunology pipeline with major trials readouts
AbbVie’s immunology strategy moved further into clinical execution via its acquisition deal, but separate immunology progress continues across multiple companies. Merck reported a positive...
Rare disease gene therapy strategy after FDA pushback
Regenxbio said it will resubmit its Hunter syndrome gene therapy application after FDA personnel reversed an earlier position about needing a placebo-controlled component. The company said FDA...
Financing for early clinical companies
Lys Therapeutics advanced its lead candidate toward the clinic with support of more than €25 million raised since inception, including over $5 million from the Michael J. Fox Foundation. The...
AbbVie deal for Apogee lifts long-acting immunology bets
AbbVie agreed to buy Apogee Therapeutics in a roughly $10.9 billion cash deal, taking the atopic dermatitis and asthma-focused pipeline into its immunology franchise. The centerpiece is...
FDA reverses on Regenxbio’s Hunter syndrome gene therapy, signaling accelerated review path
The FDA will reconsider Regenxbio’s childhood gene therapy for Hunter syndrome after a recent rejection, according to Regenxbio. The company said the agency now acknowledges its existing Navsunli...
Insilico and SK Biopharmaceuticals launch $2.5B neuroimmune AI partnership at BIO
Insilico Medicine and SK Biopharmaceuticals announced an AI-driven collaboration worth more than $2.5 billion to discover neuroimmune disorder drug candidates for central nervous system targets....
FDA adds MRD testing guidance: Natera Signatera included for muscle-invasive bladder cancer
The National Comprehensive Cancer Network updated muscle-invasive bladder cancer guidance to include Natera’s tumor-informed Signatera minimal residual disease test. Under the update, Genentech’s...
FDA accelerates early clinical trial timelines via HHS initiative
HHS announced a plan to speed up and expand early-stage clinical trials, with the goal of reducing development timelines by 6 to 12 months. The initiative comes as the Trump administration...
Pfizer’s first Seagen ADC hits setback in Phase 3 NSCLC
Pfizer said its first new antibody-drug conjugate following the $43 billion Seagen acquisition, sigvotatug vedotin, failed a Phase 3 trial in non-small cell lung cancer. The readout marks another...
Genomics and single-cell AI advance: new framework aims at gene regulatory network inference
Researchers introduced a deep learning approach, ZINB-GRAN, designed to reconstruct gene regulatory networks from single-cell RNA sequencing data by integrating learned global network topology...
Single-cell to cell-to-cell mapping: Nature Biotechnology pushes ‘interactome’ tooling
Nature Biotechnology published work outlining technologies needed to map and engineer the human cell–cell interactome, with an emphasis on linking cellular communication to functional biology. The...
Medable launches AI agent to convert clinical protocols into machine-readable data
Medable launched its DDF Agent, a software tool that converts static clinical trial protocols into machine-readable structured data in CDISC USDM 4.0 JSON format. The company said the system...
Natera and transplant monitoring expand: Pirche and Natera collaborate on transplant risk and dd-cfDNA monitoring
Pirche announced a collaboration with Natera to connect pre-transplant risk stratification with post-transplant monitoring using Natera’s Prospera dd-cfDNA test. The companies plan to combine...
M&A: AbbVie’s $10.9B bet on IL-13 and long-acting immunology
AbbVie agreed to acquire Apogee Therapeutics for $10.9 billion in cash, paying $135.11 per share, a nearly 50% premium. The deal targets zumilokibart (APG777), a subcutaneous, half-life extended...