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FDA gene therapy approval and pediatric priority review voucher
FDA approved Rocket Pharmaceuticals’ gene therapy Kresladi (marne-cel) for leukocyte adhesion deficiency type I, according to the company’s March approvals update. FDA also issued a rare pediatric...
AZD2811 biomarker analytics for relapsed/refractory SCLC
Phase I dose-expansion findings tied biomarker analysis to clinical monitoring for AZD2811 in relapsed or refractory small-cell lung cancer (SCLC), researchers reported in a featured update. The...
Epigenetic reactivation strategy in AML models
Researchers at The Jackson Laboratory (JAX), working with collaborators, reported that inhibiting KDM4 can epigenetically reactivate the tumor suppressor ZBTB7A in acute myeloid leukemia (AML)...
Macrocyclic peptide funding push for platform scale-up
Syneron Bio closed a $150 million Series B to support its macrocyclic peptide development platform, after earlier funding and a multibillion-dollar biobucks deal with AstraZeneca. The round...
Immunotherapy in advanced thyroid cancer using dual checkpoint inhibition
A phase II GETNE-DUTHY trial tested a combination of durvalumab and tremelimumab in advanced thyroid cancer, according to a reported study update. The trial, led by Capdevila, Hernando,...
AI and multi-omics data collaboration for drug discovery
TriNetX will link genomic and proteomic data for drug discovery and development with Regeneron through exclusive, secure access to de-identified health data from about 300 million individuals. The...
Diabetes drug safety evidence in older adults
A real-world study published in Nature Communications evaluated comparative safety of second-line antihyperglycemic agents in older adults with type 2 diabetes. Kim, Bu, Blacketer and colleagues...
New hemostatic injectable microgel for neonatal surgery
Researchers at the University of North Carolina at Chapel Hill and North Carolina State University developed an injectable microgel intended to reduce bleeding in infants during surgery. In...
Pharma policy shocks: Trump’s 100% drug tariff order and MFN exemptions
Trump signed an executive order imposing a 100% ad valorem tariff on imported brand-name patented pharmaceuticals and associated ingredients under Section 232, citing U.S. import reliance. The...
MCED trial controversy in NHS pathway after endpoint miss
Clinicians and researchers offering early access to Grail’s multi-cancer early detection (MCED) test are waiting for the full NHS trial readout after the endpoint miss, according to the report....
Gene therapy approval and regulatory milestone
FDA has approved Rocket Pharmaceuticals’ gene therapy Kresladi (marne-cel) for leukocyte adhesion deficiency type I, and the therapy has earned a rare pediatric disease priority review voucher...
Biomarker and precision oncology in SCLC and GI cancer
New oncology findings highlight how biomarker analysis is moving from retrospective validation toward real-time decision support. In relapsed or refractory small-cell lung cancer, a phase I...
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...