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FDA exercises flexibility in CGT chemistry, manufacturing and controls
The FDA’s Center for Biologics Evaluation and Research announced steps to modernize and provide more flexible chemical, manufacturing and control (CMC) expectations for cell and gene therapies,...
CRISPR excises NOTCH2NLC expansions: new approach targets NIID
Researchers reported a CRISPR/Cas9‑based strategy that precisely targets and excises pathogenic GGC repeat expansions in the NOTCH2NLC gene implicated in neuronal intranuclear inclusion disease...
Lilly and Nvidia: $1B lab to accelerate AI drug discovery
Eli Lilly and Nvidia announced a joint five-year investment — up to $1 billion — to establish a San Francisco lab focused on AI-driven drug discovery. Lilly will provide biological and clinical...
Basecamp’s EDEN models: AI designs programmable gene insertions
Basecamp Research, working with Nvidia and NVentures investment, disclosed EDEN — an ‘‘evolutionary AI’’ family of models that the company says can design sequences for programmable insertion of...
WHO flags equity gaps in genomic clinical research: geographic and demographic imbalances
The World Health Organization published a report highlighting imbalances in clinical genomics research: over 80% of registered genomic studies occur in high-income countries while under 5% take...
FDA eases CMC rules for cell and gene therapies – more regulatory flexibility
The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) issued guidance detailing steps to offer greater regulatory flexibility on chemistry, manufacturing and...
Tahoe, Arc and Biohub join to build massive perturbation-rich virtual‑cell dataset
Tahoe Therapeutics, the Chan‑Zuckerberg Biohub and the Arc Institute committed multi‑million dollar resources to create an open-source perturbation dataset designed to train next-generation...
Diagnostics surge: Tempus and Guardant post big preliminary revenue gains
Two diagnostics and data firms reported strong preliminary fourth-quarter results driven by testing volume growth. Tempus disclosed preliminary Q4 revenue of about $367 million, an 83%...
10x Genomics pushes diagnostics: clinical collaborations and CLIA lab plans
10x Genomics announced three clinically focused collaborations and plans to open a CLIA‑certified lab in early 2027 as it seeks to translate single‑cell and spatial platforms into diagnostic...
Targeted delivery and IND green light: Tessera cleared for in vivo gene‑editing trial
Tessera Therapeutics received FDA clearance to begin a Phase I/II clinical trial of TSRA‑196, its in‑vivo gene‑editing candidate for alpha‑1 antitrypsin deficiency, and received HREC approval in...
Big‑ticket oncology licensing: AbbVie and Novartis make strategic bets
AbbVie agreed to pay $650 million up front to license RemeGen’s PD‑1×VEGF bispecific antibody outside greater China, entering a crowded bispecific oncology field with milestone potential into the...
Data and diagnostics integration: ConcertAI adds Foundation Medicine; MeMed wins biobank grant
ConcertAI and Foundation Medicine struck a data collaboration to merge Foundation Medicine’s de‑identified genomic and multimodal data with ConcertAI’s clinically linked datasets, creating a...
AbbVie bets big on PD‑1xVEGF: $650M upfront with RemeGen
AbbVie struck a major oncology pact with China’s RemeGen, paying $650 million upfront to license a PD‑1xVEGF bispecific program. The deal formalizes AbbVie’s entry into a crowded bispecific field...
Novartis buys a brain‑shuttle ticket: $165M deal with SciNeuro
Novartis licensed a preclinical amyloid‑targeting shuttle program from SciNeuro, paying $165 million upfront with up to $1.5 billion in downstream milestones. The collaboration aims to use...
Eli Lilly, Nvidia ink AI lab pact: five years, up to $1B
Eli Lilly signed a multi‑year collaboration with Nvidia to build an AI laboratory for drug discovery and development, committing up to $1 billion over five years. The partnership will combine...
Oxford Nanopore clears CE/UKCA for GridIon Dx — clinical push begins
Oxford Nanopore received CE‑IVDR and UKCA marks for its GridIon Dx sequencer, its first IVD‑marked device in Europe and the U.K., and signaled initial clinical use through a BioMérieux partnership...
Tessera clears IND — in vivo gene editing enters clinic for AATD
The U.S. FDA cleared Tessera’s IND for TSRA‑196, its in vivo gene‑editing candidate for alpha‑1 antitrypsin deficiency, and Australia’s HREC approved the phase I/II study there. The green light...
Parabilis raises $305M to push desmoid tumor program into Phase III
Parabilis Medicines closed a $305 million Series F to advance zolucatetide (FOG‑001) toward Phase III for desmoid tumors and to support broader development. The financing was led by RA Capital,...
Mirador raises $250M — building an immunology powerhouse
Mirador Therapeutics closed a $250 million Series B to expand its precision immunology pipeline and signaled intentions to scale toward an IPO later this year. The financing will fund clinical and...
MRD and oncology testing surge: Natera and Adaptive post sharp revenue gains
Natera reported a roughly 39% jump in preliminary Q4 revenue driven by Signatera MRD test volume, processing 225,300 MRD tests in the quarter and forecasting $2.3 billion revenue for 2025....