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GT Biopharma files IND for GTB‑5550 TriKE – NK engager targets B7‑H3 in solid tumors
GT Biopharma submitted an IND to the FDA for GTB‑5550, a TriKE (tri‑specific killer engager) targeting B7‑H3 for B7‑H3‑expressing solid tumors. The company plans a Phase 1 subcutaneous basket...
Bispecific antibody‑oligo conjugate offers neuron‑specific delivery…proof in vivo
Researchers at the University of Michigan presented preclinical data for a three‑part antibody‑oligonucleotide conjugate that ferries antisense oligonucleotides into neurons after crossing the...
FDA signals and process shifts: Phase‑1 rule tweaks and delayed voucher reviews
FDA leadership is signaling regulatory adjustments to speed early‑phase trials and respond to global competition, with Commissioner Marty Makary describing agency plans to rework Phase 1...
Big money heads to biotech: Novo Nordisk Foundation $850M pledge and JPM funding surge
The Novo Nordisk Foundation committed up to $850 million to scale Denmark’s BioInnovation Institute across Europe, expanding an innovation engine that has supported 131 startups to date. The move...
Epkinly misses overall survival in DLBCL — AbbVie, Genmab disclose
AbbVie and Genmab reported that Epkinly (tafasitamab-cxix) failed to prolong overall survival in a Phase 3 trial for diffuse large B‑cell lymphoma (DLBCL). The study enrolled patients who had...
UC San Diego wins $25.8M ARPA‑H award to 3D‑print patient livers
UC San Diego received up to $25,771,771 from ARPA‑H to develop a patient‑specific, fully functional 3D‑bioprinted liver under the PRINT program. The multidisciplinary effort, led by Shaochen Chen...
Off‑the‑shelf CAR‑NK yields durable CRs in Waldenström’s — ImmunityBio
Early Phase 1 data from ImmunityBio’s off‑the‑shelf allogeneic CD19 CAR‑NK therapy, given with rituximab, produced durable complete responses in four patients with Waldenström’s macroglobulinemia...
Enterococcus faecalis uses redox metabolism to stall wound healing — NTU‑led study
An international team led by Nanyang Technological University and the University of Geneva identified extracellular electron transport (EET) in Enterococcus faecalis as a mechanism that generates...
Two‑step genome editing creates full‑length humanized mice — new model
Researchers described a two‑step genome‑editing strategy that enables construction of full‑length humanized mouse models, overcoming limitations tied to divergent regulatory landscapes between...
Cells rewired as RNA recorders: new intracellular recording devices
A multidisciplinary team reported a platform that converts enigmatic intracellular structures into devices capable of recording RNA activity over time, providing an unbiased record of a cell’s...
Retrons drive synthetic DNA systems for protein targeting in cells
Researchers used bacterial retrons to build synthetic, non‑genetic DNA systems inside cells that bind specific proteins, creating programmable protein‑binding DNA constructs without altering the...
Foli Bio builds stool RNA panels to predict IBD drug response — Columbia spinout
Foli Bio, a Columbia University spinout, is developing stool‑based RNA‑seq panels from exfoliated fecal RNA to predict drug response in inflammatory bowel disease and reduce reliance on endoscopy...
Vedanta cuts staff, refocuses cash on VE303 phase‑3 push
Vedanta Biosciences said it significantly reduced headcount and refocused resources on advancing VE303, an eight‑strain live bacterial consortium aimed at preventing recurrent Clostridioides...
Novo Nordisk Foundation pledges up to $850M to scale European biotech incubator
The Novo Nordisk Foundation committed up to $850 million to expand Denmark’s BioInnovation Institute into a pan‑European innovation engine. The funding will let the institute broaden its support...
ImmunityBio CAR‑NK: durable complete responses in Waldenström’s lymphoma
ImmunityBio reported durable complete responses in an off‑the‑shelf CD19 CAR‑NK program for Waldenström’s macroglobulinemia, with responses sustained through seven and 15 months in the first...
Epkinly misses overall survival: AbbVie, Genmab disclose Phase 3 failure in DLBCL
AbbVie and Genmab reported that Epkinly (their antibody‑drug conjugate) failed to prolong overall survival in a Phase 3 trial for diffuse large B‑cell lymphoma (DLBCL). The companies said the...
UC San Diego wins ARPA‑H grant: $25.8M drive to 3D‑print patient livers
UC San Diego secured a $25,771,771 ARPA‑H award to develop patient‑specific, 3D‑bioprinted whole livers over a 60‑month program aimed at scalable, immunocompetent organ manufacture. The...
Vedanta trims workforce, narrows focus to VE303: phase‑3 push for C. difficile
Vedanta Biosciences said it significantly reduced headcount to concentrate remaining resources on VE303, its lead live‑biotherapeutic bacterial consortium for prevention of recurrent...
Labcorp expands MRD portfolio: Plasma Detect ID and Genome go nationwide
Labcorp launched two assays—Plasma Detect ID and Plasma Detect Genome—expanding its molecular residual disease (MRD) testing suite nationwide. The personalized whole‑exome sequencing‑guided Plasma...
Delfi eyes FDA: FirstLook Lung pivotal readouts and reimbursement push in 2026
Delfi Diagnostics outlined a 2026 roadmap of multiple pivotal data readouts for its FirstLook Lung liquid biopsy, aiming to support regulatory submission and commercial reimbursement. CEO Susan...