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FDA clears first-of-its-kind campus-developed CAR T for IND review
The University of Colorado Anschutz Gates Institute received U.S. FDA Investigational New Drug (IND) clearance for a novel CAR T-cell therapy, marking the first time the agency has cleared a CAR T...
Epigenetic reactivation of a tumor suppressor re-frames AML biology
Researchers at The Jackson Laboratory (JAX) and collaborators identified an epigenetic strategy to restore the tumor suppressor ZBTB7A in acute myeloid leukemia (AML) models. Their mouse data,...
Manufacturing surge for immune checkpoint oncology: Lonza to supply PD-L1 antibody
ImmuneOncia Therapeutics and Lonza signed an agreement for late-stage clinical manufacturing of Danburstotug (IMC-001), a fully human PD-L1 immune checkpoint antibody in development for...
Oncology supportive care: COCOON trial reports 50% dermatologic toxicity reduction
Interim results from the phase II COCOON trial show a proactive skincare approach can cut dermatologic adverse events by 50% in patients receiving frontline therapy for EGFR-mutant non-small cell...
TriNetX and Regeneron expand data linkage for discovery and development
TriNetX will link and provide Regeneron exclusive access to de-identified genomic and proteomic data for drug discovery and development. The agreement gives Regeneron secure, licensed access to...
Gene therapy secures rare pediatric priority review voucher alongside FDA March approvals
Rocket Pharmaceuticals’ gene therapy Kresladi (marne-cel) for leukocyte adhesion deficiency type I was among FDA’s March approvals and earned a rare pediatric disease priority review voucher....
Syneron returns to the clinic pipeline with new Series B to scale macrocyclic peptides
Syneron Bio closed a $150 million Series B to support its macrocyclic peptide development platform, following a multibillion-dollar AstraZeneca biobucks deal and nearly $100 million raised last...
Immune-enabled ‘cervix-on-a-chip’ targets STI biology with a new ex vivo model
University of Maryland researchers, in collaboration with the University of Delaware and the University of Virginia, engineered the first immune-capable “cervix-on-a-chip” model to study sexually...
Diabetes cell therapy gets Canadian government backing to keep manufacturing roots local
Aspect Biosystems, a Vancouver startup pursuing a diabetes cell therapy, received $79 million from the Canadian government. The award is framed as a way to preserve the company’s Canadian...
EU policy push: EU Biotech Act aims to boost manufacturing and harmonize market access
The European Union’s proposed Biotech Act is advancing as a strategy to restore global competitiveness, with stakeholders emphasizing two practical goals: harmonizing pathways to market and...
Regulatory momentum for gene therapy as FDA approves Rocket program
FDA approved Rocket Pharmaceuticals’ gene therapy Kresladi (marne-cel), delivering MAC-1, and the company said it expects to launch by year-end. Rocket also disclosed that Kresladi earned a rare...
Obesity and cardiometabolic strategy intensifies with oral GLP-1 approvals
FDA approval of Eli Lilly’s oral obesity pill Foundayo set up an immediate competitive face-off with Novo Nordisk’s oral Wegovy strategy. Analysts framed the market impact around differences in...
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,...