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HIV remission case: CCR5Δ32 transplant shows durable control
Researchers reported durable HIV remission following a heterozygous CCR5Δ32 stem-cell transplant, marking a notable advance in curative research. Case details indicate the transplant conferred...
Liquid biopsy advances: ctDNA across fluids and ultra‑sensitive sensors
A Nature Communications study mapped circulating tumor DNA (ctDNA) detectability across seven body fluids in metastatic breast cancer, revealing variable sensitivity and representativeness that...
Stem cell control and organoids: electrical steering and scaled lung models
Researchers in Melbourne reported that brief electrical pulses can steer stem-cell behavior to enhance tissue formation, suggesting electrotactic control as a tool to improve engineered nerves,...
Big pharma opens AI lab doors—collaboration replaces secrecy
Eli Lilly launched TuneLab to share proprietary AI drug-discovery models with biotech partners via federated learning, signaling a strategic shift toward open, collaborative AI infrastructure....
Regeneron backs Tessera: $150M gene-writing pact for AATD
Regeneron agreed to a $150 million collaboration with Tessera Therapeutics to co-develop TSRA-196, Tessera’s in vivo gene-writing candidate for alpha-1 antitrypsin deficiency (AATD). The pact...
Belite’s tinlarebant meets Phase III — Stargardt filing in view
Belite Bio reported positive top-line results from its 104-patient Phase III DRAGON study of oral tinlarebant in Stargardt disease type 1, meeting the primary endpoint with a statistically...
Protego closes $130M — pushes AL amyloidosis drug to pivotal run
Protego Biopharma closed an oversubscribed $130 million Series B to advance PROT‑001, its oral candidate for AL (light‑chain) amyloidosis, toward a pivotal study. The round was led by Novartis...
Generate:Biomedicines heads to Phase 3 — TSLP antibody advances
Generate:Biomedicines announced plans to start Phase 3 studies for its lead TSLP (thymic stromal lymphopoietin) antibody, marking a major clinical milestone for the AI-enabled biotech. The company...
Recursion names Najat Khan CEO — pivot to clinical proof points
Recursion replaced founder-CEO Chris Gibson with Najat Khan, PhD, its chief R&D and commercial officer, effective January 1; Gibson will become board chair. The leadership change follows...
Pfizer halts UC candidate — Tiziana to spin out IL‑6 asset
Pfizer ended development of Phase 1 ulcerative colitis candidate PF‑07899895 in a business‑driven cut, pausing the company’s early‑stage presence in that inflammatory indication. Separately,...
Leaked CBER memo roils vaccine market — policy overhaul proposed
A leaked internal CBER memo from FDA official Vinay Prasad laid out proposals to tighten vaccine approvals, urging randomized trials and expanded subgroup data, and prompting immediate market...
FDA clears intrathecal SMA gene therapy — DMD program hit by new limits
The FDA approved Novartis’ intrathecal formulation of onasemnogene abeparvovec (Itvisma), expanding access to SMA gene therapy across a broader patient age and weight range by changing the...
Singapore’s PRECISE teams with pharma to mine 100K genomes
Singapore’s PRECISE program announced precompetitive partnerships with Alnylam, Bayer, Boehringer Ingelheim and Novo Nordisk to analyze data from its PRECISE‑SG100K cohort. The collaboration will...
ICON commits $300M to AI and digital innovation over three years
ICON, the Ireland‑based CRO, announced a planned $300 million investment in AI and digital technologies over the next three years to modernize trial operations, data capture and analytics. CEO...
Regeneron bets $150M on Tessera’s gene writer: TSRA‑196 pact
Regeneron signed a multi‑year collaboration and upfront payment worth roughly $150 million to co-develop Tessera Therapeutics’ TSRA‑196, a near-clinic gene‑writing candidate for alpha‑1...
Belite’s tinlarebant clears Phase III — FDA filing next
Belite Bio posted positive top‑line results from its 104‑patient Phase III DRAGON trial: oral tinlarebant achieved the primary endpoint by slowing the growth rate of retinal lesions in Stargardt...
Protego nets $130M — pivots PROT‑001 toward pivotal study
Protego Biopharma closed an oversubscribed $130 million Series B to advance PROT‑001, its first‑in‑class oral therapy for AL (light chain) amyloidosis, into a pivotal study. The financing draws...
CBER memo roils markets: FDA vaccine rules under overhaul
An internal memo from CBER director Vinay Prasad outlining a proposed overhaul of U.S. vaccine approval policy became public, triggering market and industry reaction. The document recommends...
Cytokinetics’ first approval nears — prepares David vs. Goliath fight
Cytokinetics is approaching its first regulatory approval after nearly 30 years in business as it positions aficamten, an oral therapy for obstructive cardiomyopathy, for market entry. Wall Street...
Imvax presses FDA after mixed glioblastoma Phase 2b readout
Imvax reported Phase 2b data in glioblastoma showing no hit on the trial’s primary endpoint but a clinically meaningful overall survival benefit — roughly six months longer than standard of care —...