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In vivo/on-demand cellular imaging with reduced background
Researchers at the Salk Institute and Albert Einstein College of Medicine unveiled VIS-Fbs, an antigen-stabilizable fluorescent nanobody platform that lights up only when bound to target proteins...
AI-driven single-cell tumor survival prediction
NIH-backed researchers at Oregon Health & Science University (OHSU) introduced scSurvival, an AI model that forecasts cancer survival using single-cell tumor analysis. The tool is built to...
Cancer MRD expansion using whole-genome ctDNA tech
Roche moved to expand Foundation Medicine’s oncology monitoring capabilities by agreeing to acquire SAGA Diagnostics in a deal valued at up to $595 million, including milestones. Foundation...
HIV regulatory milestones: FDA approvals for Merck regimens
The FDA approved Merck’s once-daily HIV pill, a move that broadens the company’s position in a field increasingly targeted by biopharma drugmakers seeking new growth outside of shrinking pipeline...
Autoimmune CAR-T regulatory path: Kyverna targets FDA submission for stiff person syndrome
Kyverna Therapeutics reported full registrational data for miv-cel in stiff person syndrome (SPS) and said it plans to submit the therapy to the FDA by mid-year. If approved, the company expects...
Autoimmunity drug signal: low-dose IL-2 expands Treg restoration in lupus
A phase IIb trial in systemic lupus erythematosus (SLE) showed that low-dose interleukin-2 therapy can restore regulatory T cells in a dose-dependent way, according to results published in Nature...
Cell-free secretome therapy enters early clinical testing for IPF
Remedy Cell moved its secretome-based therapy, RC-0315, into first-in-human development for idiopathic pulmonary fibrosis (IPF), according to company updates. The approach uses a “secretome”...
Biotech financing: Alloy Therapeutics raises $40m Series E for tech-enabled infrastructure
Alloy Therapeutics raised $40 million in a late-stage Series E to scale its tech-enabled biotech infrastructure, the company said. Alloy plans to use the proceeds to expand discovery and...
Clinical and regulatory setbacks in oncology: TIGIT trials cut after futility
Gilead Sciences and Arcus Biosciences terminated additional trials of domvanalimab after a Phase 3 futility finding, according to disclosures. The partners ended STAR-121 in metastatic non-small...
M&A: Eli Lilly buys Kelonia to expand in vivo CAR-T pipeline
Eli Lilly agreed to acquire Kelonia Therapeutics in a deal valued at up to $7 billion, highlighted by a $3.25 billion upfront payment. Kelonia is developing in vivo CAR-T technology designed to...
Lilly and Kelonia expand in-vivo CAR-T footprint with a major acquisition
Eli Lilly agreed to buy Kelonia Therapeutics for up to $7 billion, aiming to broaden its in-vivo CAR-T strategy with a one-time intravenous therapy in multiple myeloma. The deal includes a $3.25...
FDA greenlights two-drug oral HIV regimen from Merck
The FDA approved Merck’s once-daily HIV regimen Idvynso (doravirine/islatravir) for adults with HIV-1 who are virologically suppressed, with no history of virologic treatment failure and no known...
FDA priority review accelerates Daiichi/Merck B7-H3 ADC in extensive-stage small-cell lung cancer
The FDA accepted and granted priority review to Daiichi Sankyo and Merck’s B7-H3-directed ADC ifinatamab deruxtecan. The application seeks approval for patients with advanced extensive-stage...
Merck’s Welireg combo falls short in first-line kidney cancer trial
Merck reported that adding Welireg (belzutifan) to an existing Keytruda regimen did not produce a significant improvement in newly diagnosed patients with advanced kidney cancer. The negative...
Replimune faces second FDA rejection and responds with further workforce cuts
Replimune disclosed additional layoffs in Massachusetts after the FDA issued a second rejection of its advanced melanoma candidate RP1. The company said WARN notices cover 224 employees across its...
Biotech infrastructure funding: Alloy Therapeutics scales tech-enabled platform with $40M Series E
Alloy Therapeutics raised $40 million in a late-stage Series E to expand its tech-enabled biotech infrastructure business. The company said the funds will support scaling its discovery engine,...
Clinical innovation in CAR-T: Kyverna prepares for FDA submission for stiff person syndrome
Kyverna Therapeutics plans to submit its CAR-T cell therapy for stiff person syndrome (SPS) to the FDA by mid-year after improved mobility outcomes and reduced disabilities in presented results....
Carvykti trial explores CAR-T in high-risk smoldering multiple myeloma
Dana-Farber and collaborators presented CAR-T outcomes in high-risk smoldering multiple myeloma using Carvykti (ciltacabtagene autoleucel). In the reported phase 2 CAR-PRISM trial, 20 patients...
Diagnostics and MRD: Roche to expand Foundation Medicine’s MRD offering with SAGA deal
Roche announced that Foundation Medicine will acquire SAGA Diagnostics in a transaction valued at up to $595 million to expand its molecular residual disease (MRD) portfolio. The deal is expected...
Regulatory and policy pressure: Medicare delays obesity drug coverage pilot over insurer participation risk
CMS delayed a Medicare pilot intended to cover obesity medications after insurance plans indicated they would not participate at this time. The program, described in the report as tied to a...