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Vaccine policy shake‑up looms — FDA memo and scientists clash ahead of ACIP vote
Internal FDA guidance and leaked memos have ignited a policy fight over U.S. vaccine approval standards and schedules. CBER leadership outlined proposals that would require randomized trial...
Imvax reports survival signal in glioblastoma Phase 2b — FDA meeting planned
Imvax released Phase 2b data showing a survival benefit for its glioblastoma cell‑therapy program despite missing the trial’s primary endpoint. The company reported a median overall survival...
FDA drug czar exits: Pazdur files for retirement
Richard Pazdur, director of the FDA’s Center for Drug Evaluation and Research (CDER), has filed paperwork to retire at month’s end, creating immediate uncertainty at the agency’s drug-review helm....
FDA narrows primate testing for antibodies: new draft guidance
The FDA unveiled draft guidance enabling biopharma developers to reduce or eliminate nonhuman primate testing for certain monoclonal antibodies (mAbs), signaling a policy shift in preclinical...
Regeneron bets $150M on Tessera gene writing—rare disease target
Regeneron and Tessera Therapeutics signed a global collaboration to develop TSRA-196, an in vivo gene-writing candidate for alpha-1 antitrypsin deficiency (AATD), with Regeneron committing $150...
Belite’s tinlarebant wins Phase III—first Stargardt success
Belite Bio reported positive top-line results from its Phase III DRAGON study: oral tinlarebant met the primary endpoint by slowing progression of retinal lesions in Stargardt disease type 1. The...
Protego raises $130M to push AL amyloidosis drug to pivotal
Protego Biopharma closed an oversubscribed $130 million Series B to advance PROT-001, a first-in-class oral candidate for AL (light chain) amyloidosis, toward a pivotal study. The financing was...
Vaccine rule fight: scientists push to keep newborn hep B shot timing
A coalition of vaccine scientists released a comprehensive review supporting universal hepatitis B vaccination within 24 hours of birth, submitting the evidence days ahead of a pivotal CDC...
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...