Get the Daily Brief
Latest Biotech News
Insilico’s AI‑made PROTAC targets PKMYT1: preclinical lead disclosed
Insilico Medicine reported the discovery of an AI‑designed PROTAC degrader, D16‑M1P2, targeting PKMYT1, a kinase implicated in cell‑cycle control and synthetic‑lethality vulnerabilities in certain...
Radboud goes live with long‑read WGS: PacBio tech deployed clinically
Radboud University Medical Center in the Netherlands began offering frontline diagnostic whole‑genome sequencing (WGS) using Pacific Biosciences long‑read technology for genetic eye diseases and...
New drug‑exposure tools: untargeted metabolomics meets clinical practice
Researchers at UC San Diego and collaborators released the GNPS Drug Library, a publicly available MS/MS reference atlas of thousands of drugs, metabolites, and analogs to detect drug exposures...
FDA props up US trials: fee hikes proposed and higher CAR‑T bar
The U.S. Food and Drug Administration proposed revisions to user‑fee structures that would raise fees for development programs that do not conduct Phase I trials in the U.S., a policy pitched as a...
Pfizer doubles down on oral GLP‑1s: $2B licensing spree
Pfizer expanded its obesity and metabolic pipeline with two licensing deals for oral GLP‑1 small molecules. The company struck a roughly $2 billion collaboration with Yaopharma (a Fosun...
FDA reopens safety review: Approved RSV antibodies scrutinized
The U.S. Food and Drug Administration has reopened a safety review of two approved monoclonal antibodies used to prevent respiratory syncytial virus (RSV) in infants. The agency informed...
Delix’s DLX‑001 shows translational effect — FDA clears Phase II with at‑home dosing
Delix Therapeutics reported positive Phase Ib biomarker and efficacy signals for zalsupindole (DLX‑001) in adults with major depressive disorder and said the FDA cleared its Phase II trial design...
Radboud UMC goes frontline: Long‑read WGS replaces multi‑test diagnostic workflow
Radboud University Medical Center has implemented long‑read whole‑genome sequencing (WGS) from Pacific Biosciences as a frontline diagnostic test for genetic eye disease and severe intellectual...
Eli Lilly bets $6B on Alabama plant — Orforglipron scale‑up underway
Eli Lilly announced plans to invest $6 billion to build a manufacturing facility in Huntsville, Alabama to produce the oral GLP‑1 candidate orforglipron. The Huntsville site is the third of four...
Pfizer doubles down on oral GLP‑1s: Two China deals add pipeline heft
Pfizer continued to expand its oral obesity pipeline via two separate deals this month. The company struck a licensing agreement for a once‑daily oral GLP‑1 from YaoPharma for $150 million upfront...
Mirum buys Bluejay for $620M — Picks up Phase‑3 hepatitis D antibody
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics for $620 million in cash and stock to obtain brelovitug, a Phase‑3 monoclonal antibody for chronic hepatitis D virus (HDV). Bluejay’s...
Teclistamab+daratumumab... Majestec‑3 posts 83% three‑year PFS
Johnson & Johnson’s combination of teclistamab (a BCMA‑targeting bispecific) with daratumumab demonstrated a large progression‑free survival benefit in the Majestec‑3 Phase‑3 trial, with an 83.4%...
FDA raises bar for CAR‑T: New push for randomized superiority trials
The FDA signaled a policy shift that will require many developers of CAR‑T therapies to demonstrate superiority over existing treatments in randomized trials, according to statements from the...
Dyne’s exon‑51 program hits pivotal goals — Company plans expedited FDA submission
Dyne Therapeutics reported that its Duchenne muscular dystrophy exon‑51 exon‑skipping candidate met the primary endpoint in a pivotal study, producing statistically significant increases in...
Insilico’s AI‑designed PROTAC targets PKMYT1 — Preclinical activity reported
Insilico Medicine published preclinical data showing an AI‑designed proteolysis‑targeting chimera (PROTAC), D16‑M1P2, selectively degrades PKMYT1 and produced anti‑tumor activity in cell lines and...
Novartis inks $1.7B AI deal: Relation to hunt atopic targets
Novartis has signed a multi-program collaboration with London-based Relation Therapeutics to discover and advance targets for atopic diseases, the companies said. The deal includes an upfront...
Mirum buys Bluejay for $620M — wins hepatitis D antibody
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics to secure brelovitug, a monoclonal antibody in late‑stage testing for chronic hepatitis D virus (HDV), the companies announced. The...
FDA raises bar: CAR‑T developers told to prove superiority
The FDA’s biologics leadership signaled a policy shift requiring many new CAR‑T applications to demonstrate superiority versus existing therapies, the agency’s guidance and commentary show....
Teclistamab+daratumumab: Majestec‑3 posts dramatic PFS gain
Data from the Majestec‑3 trial presented at ASH showed the combination of Janssen’s teclistamab and daratumumab produced an 83.4% three‑year progression‑free survival rate versus 29.7% for...
Terns’ TERN‑701 shakes up CML: 64% MMR at 24 weeks
Terns Pharmaceuticals reported early ASH data showing its next‑generation chronic myeloid leukemia candidate TERN‑701 achieved a 64% major molecular response rate at 24 weeks across four...