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Immunotherapy biology: new targets and pathway rewiring
Researchers reported fresh mechanistic insights that could expand immunotherapy options by identifying new levers to modulate checkpoint efficacy. A study on colorectal cancer linked circulating...
Hematology oncology: epigenetic reactivation in AML models
A team from The Jackson Laboratory (JAX) and collaborators reported an epigenetic strategy to reactivate a silenced tumor suppressor in acute myeloid leukemia. The approach centers on inhibiting...
Therapeutic platform: fast-acting covalent protein drugs
Westlake University researchers unveiled a high-throughput platform for engineering fast-acting covalent protein therapeutics, published in Science. The method is designed to rapidly select...
Drug delivery: hemostatic microgel for neonatal surgeries
Biomedical engineers at UNC-Chapel Hill and North Carolina State University reported preclinical results for an injectable hemostatic microgel designed for neonatal bleeding risk. Using an animal...
Data and real-world evidence infrastructure for drug discovery
TriNetX and Regeneron agreed to link genomic and proteomic data for drug discovery and development, with TriNetX providing exclusive access to de-identified health data from roughly 300 million...
Funding and company finance: Syneron’s peptide platform buildout
Syneron Bio said it has closed a $150 million Series B to support its macrocyclic peptide development platform, following a multibillion-dollar biobucks deal with AstraZeneca and a nearly $100...
Biopharma policy: EU Biotech Act negotiations to improve market competitiveness
European biotech stakeholders are pushing for changes as the EU Biotech Act advances through negotiations, aiming to strengthen global competitiveness and make pathways to market less fragmented....
Regulatory and economic shock: renewed US tariff action on brand-name drugs
President Trump signed an executive order imposing a 100% tariff on imported patented brand-name drugs under Section 232, citing U.S. “import reliance.” The order includes exemptions for generic...
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...