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FDA payment transparency and clinical evidence scrutiny for MCED testing
Clinicians offering early access to Grail’s multi-cancer early detection (MCED) test are now waiting for the full NHS trial readout after an endpoint miss. Providers and researchers are weighing...
Biotech financing backs oral obesity and peptide platforms toward the clinic
Syneron Bio closed a $150 million Series B to fund its macrocyclic peptide development platform, building on earlier AstraZeneca-linked activity and a nearly $100 million prior raise. Separately,...
Company and data partnership: TriNetX links genomic and proteomic data to Regeneron
TriNetX will link its de-identified real-world health data—covering roughly 300 million individuals—with Regeneron’s discovery and development efforts, adding genomics and proteomics to accelerate...
Oncology supportive care trial reports dermatologic toxicity reduction in EGFR-mutant NSCLC
Interim phase II results from the COCOON trial suggest a 50% reduction in dermatologic toxicity with proactive skincare for patients receiving frontline therapy for EGFR-mutant non-small cell lung...
Preclinical immuno-oncology breakthrough with dual HIF inhibition plus immunotherapy
Researchers at Johns Hopkins University and the University of Maryland School of Pharmacy report that novel small molecules inhibiting HIF-1 and HIF-2 can eradicate multiple tumor types in mice...
Diagnostics and therapeutics: RADx Tech funding targets non-invasive endometriosis biomarker assay
Northwell Health’s Feinstein Institutes for Medical Research received a $500,000 RADx Tech award to develop a non-invasive endometriosis biomarker test using menstrual samples. The project—part of...
Cell therapy pipeline: University of Colorado earns first-ever FDA approval for campus-developed CAR T
The University of Colorado Anschutz Gates Institute received IND clearance from the U.S. FDA for a campus-developed CAR T-cell therapy, marking the first time a CAR T was cleared that was...
Neuro-oncology and neuroscience engineering: hydrogel axon models improve testing for MS remyelination drugs
UCL researchers developed a hydrogel-based axon model using tunable micropillar arrays to better mimic the geometry and softness of native axons in multiple sclerosis. Published in Nature Methods,...
FDA clears Rocket gene therapy and grants a rare pediatric priority review voucher
FDA approved Rocket Pharmaceuticals’ gene therapy Kresladi (marnetegragene autotemcel) for leukocyte adhesion deficiency type I, according to the company’s March update. Rocket said the...
TriNetX and Regeneron sign a data linkage deal spanning genomic and proteomic cohorts
TriNetX will provide Regeneron exclusive, secure, licensed access to de-identified real-world health data covering about 300 million individuals, with TriNetX linking genomic and proteomic...
Alto’s Phase 2 miss forces program shelving in cognitive impairment in schizophrenia
Alto Neuroscience shelved its schizophrenia-related cognitive impairment program after a Phase 2 failure of its PDE4 inhibitor, the company said. The decision pauses further development and...
Trump revives 100% pharma tariffs with carveouts and manufacturing-linked reductions
The Trump administration announced 100% tariffs on imported brand-name drugs, while building in carveouts for drugmakers that strike most-favored nation-style agreements or pledge domestic...
Rocket gene therapy PRV and other pipeline signals land alongside new FDA PDUFA schedule
FDA’s April calendar includes remaining PDUFA decisions, including a pending call on an oncolytic virus and updates tied to delayed biologics. Replimune’s oncolytic virus Vusolimogen oderparepvec...
Ambrosia raises fresh Series B to fund oral obesity pipeline and moves toward Phase 1
Ambrosia Biosciences secured an oversubscribed $100 million Series B to advance its oral obesity drug pipeline, including its lead oral small-molecule GLP-1 candidate. The company plans to move...
Syneron closes $150M Series B to scale macrocyclic peptide discovery platform
Syneron Bio closed a $150 million Series B to support development of its macrocyclic peptide discovery platform. The company previously raised nearly $100 million and also secured a...
Biogen moves into nephrology via $5.6B acquisition of Apellis Pharmaceuticals
Biogen agreed to acquire Apellis Pharmaceuticals for $5.6 billion, aiming to accelerate its nephrology expansion. The deal comes after Biogen’s immunology push and is tied to an HI-Bio drug in...
FDA clears investigational sequencing platform rollout through AIM/organ models narrative
The industry spotlight continued on FDA’s evolving approach to reduce reliance on animal efficacy proof-of-concept, with emphasis on organoid-based preclinical evidence. SillaJen’s vascularized...
Injectable hemostatic microgels show at least 50% bleeding reduction in neonate surgery models
Researchers at UNC–NC State developed an injectable microgel designed to reduce bleeding in infants undergoing surgery, reporting at least a 50% reduction in an animal model. The hemostatic...
Regulatory approvals and expansion of gene therapy marketing pathways
FDA’s March approval of Rocket Pharmaceuticals’ gene therapy Kresladi (marne-cel) marked a notable regulatory milestone, with the drug earning a rare pediatric disease priority review voucher....
Funding to advance oral obesity and peptide platform programs
Ambrosia Biosciences raised an oversubscribed $100 million Series B to advance its preclinical oral obesity pipeline into Phase I. The round co-led by Blue Owl Healthcare Opportunities, Redmile...