Get the Daily Brief
Latest Biotech News
Radboud goes live with PacBio long‑read WGS as frontline diagnostic test
Radboud University Medical Center launched long‑read whole‑genome sequencing (WGS) using Pacific Biosciences technology as a frontline diagnostic test for genetic eye disease and severe...
Roche oral SERD: 30% cut in post‑surgery recurrence
Roche disclosed interim adjuvant data showing its oral selective estrogen receptor degrader (SERD) reduced the risk of invasive disease recurrence or death by about 30% versus standard of care....
FDA pivots on CAR‑T: randomized trials now expected
The FDA’s Center for Biologics Evaluation and Research (CBER) signaled a policy shift: most chimeric antigen receptor (CAR‑T) cell therapy approvals will now be supported by randomized controlled...
Lilly picks Huntsville – $6B API plant for GLP‑1 pill
Eli Lilly announced Huntsville, Alabama, as the site for a $6 billion active pharmaceutical ingredient (API) facility that will support peptide and small‑molecule medicines including its oral...
Pfizer doubles down on oral GLP‑1s – China deals add heft
Pfizer continued to expand its obesity portfolio with two separate deals for oral GLP‑1 candidates from China: a $150 million upfront license for YaoPharma’s once‑daily oral GLP‑1 and a broader $2...
Mirum buys Bluejay... adds late‑stage HDV antibody
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics in a deal valuing the transaction at roughly $820 million, bringing brelovitug, a late‑stage monoclonal antibody for chronic hepatitis...
Kelonia’s in‑body CAR‑T: deep remissions in early MM readout
Kelonia Therapeutics reported early clinical data showing efficacy for its in‑vivo CAR‑T approach in multiple myeloma, with single‑infusion results producing deep responses in a small cohort. The...
Continuous fermentation goes commercial – Pow.Bio joins Bühler
Pow.Bio and the Bühler Group said they are ready to market an integrated continuous precision fermentation platform that combines Pow.Bio’s AI‑enabled continuous fermentation technology with...
Radboud goes long: PacBio long‑read WGS frontline diagnostic
Radboud University Medical Center has deployed Pacific Biosciences long‑read whole‑genome sequencing (WGS) as a frontline diagnostic test for selected genetic indications, replacing a basket of...
Ginkgo, Deep Origin win $31.7M ARPA‑H contract for non‑animal safety
Ginkgo Bioworks and AI drug‑discovery firm Deep Origin lead a multi‑partner consortium that secured up to $31.7 million from ARPA‑H to develop non‑animal models for drug safety and ADME‑Tox...
Dyne reports pivotal Duchenne win — FDA submission ahead
Dyne Therapeutics announced that its Duchenne muscular dystrophy candidate met the primary endpoint in a pivotal study, positioning the company to pursue accelerated approval with the U.S. FDA....
FDA demands randomized trials for CAR‑T approvals
The FDA signaled a policy shift by saying it will generally require randomized controlled trials (RCTs) to support approvals of CAR‑T cell therapies, except in narrowly defined circumstances such...
Tec‑dara combo posts landmark PFS at ASH — bispecifics vs CAR‑T
Late‑breaking results from the Majestec‑3 trial showed the teclistamab plus daratumumab combination produced an 83.4% three‑year progression‑free survival (PFS) rate versus 29.7% for standard...
Mirum snaps up Bluejay to add late‑stage HDV antibody
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics in a cash‑and‑stock deal to add brelovitug, a late‑stage monoclonal antibody for chronic hepatitis D virus (HDV), to its rare‑liver...
Lilly pins Huntsville for $6B API plant — onshore GLP‑1 supply
Eli Lilly selected Huntsville, Alabama, as the site for a $6 billion active pharmaceutical ingredient (API) plant focused on peptide and small‑molecule medicines, including the oral GLP‑1...
AI‑designed degrader and SciSciGPT push human–AI science integration
Insilico Medicine reported the AI‑generated discovery of a bifunctional PROTAC degrader targeting PKMYT1, with preclinical activity in biomarker‑selected cancer models; the work was detailed in...
Wireless BCI milestone: 65,536 electrodes on a single implant
Teams from Columbia, Stanford, Penn and NewYork‑Presbyterian reported an ultra‑high‑density, wireless subdural brain‑computer interface integrating 65,536 electrodes and 1,024 recording channels...
Pfizer doubles down on oral GLP‑1s with China licensing deals
Pfizer expanded its obesity pipeline with multiple licensing deals for oral GLP‑1 candidates from China: a $150 million upfront license for a Fosun subsidiary’s once‑daily small molecule and...
Radboud UMC launches PacBio long‑read WGS as frontline diagnostic
Radboud University Medical Center in Nijmegen went live with diagnostic whole‑genome sequencing (WGS) based on PacBio long‑read technology as a frontline test for genetic eye disease and severe...
GNPS library and online tool let labs detect hidden drug exposures
Researchers at UC San Diego and collaborators released the GNPS Drug Library, an MS/MS reference resource linking thousands of drugs, metabolites and analogs with exposure sources, pharmacologic...