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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...
Kymera degrader signals biologic‑like activity; pill posts Dupixent‑style drop
Kymera reported Phase Ib biomarker activity for an oral STAT6 degrader and separately disclosed Phase 1b BroADen results for KT‑621, an oral pill for atopic dermatitis, that produced a mean 63%...
Dyne targets FDA: Duchenne exon‑51 drug hits pivotal endpoint
Dyne Therapeutics announced that its Duchenne muscular dystrophy candidate met the primary endpoint in a pivotal study and that the company plans to seek accelerated FDA approval. Company releases...
Oral GLP‑1 race heats: Structure posts double‑digit weight loss
Structure Therapeutics reported Phase IIb data showing its oral GLP‑1 candidate aleniglipron produced up to 15% weight loss in mid‑stage testing, while China’s Ascletis posted 7.7%...
AI designs PROTAC: Insilico reports PKMYT1 degrader; NeurIPS flags biology models
Insilico Medicine published a Nature Communications paper describing D16‑M1P2, an AI‑designed PROTAC that targets PKMYT1 and showed preclinical activity in CCNE1‑amplified and FBXW7‑mutant tumor...