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FDA authorization brings new blood-based pharmacogenomic testing for opioid use disorder
Solvd Health received FDA approval to use blood samples for its AvertD pharmacogenomic test for opioid use disorder (OUD), extending prior approval that relied on cheek swab collection. The test...
Cancer diagnostics: whole-genome methylation and cfDNA multimodal screening advances
Researchers reported an enhanced multicancer screening assay that combines whole-genome methylation sequencing with multimodal cell-free DNA (cfDNA) analysis, aiming to improve sensitivity and...
Epigenomic workflow partnership boosts methylation and fragmentomic profiling
Claret Bioscience and New England Biolabs agreed to copromote a combined sample-preparation workflow for DNA methylation and fragmentation analysis. The arrangement links ClaretBio’s SRSLY...
CAR-T front line moves earlier: Dana-Farber Phase 2 CAR-PRISM responses in high-risk SMM
Dana-Farber Cancer Institute presented Phase 2 CAR-PRISM results using CAR T-cell therapy in high-risk smoldering multiple myeloma (SMM), reporting durable and profound responses across...
Cancer epigenetics: methylation classifiers target cancers of unknown primary
Researchers presented methylation-based machine learning models that aim to identify the tissue of origin for cancers of unknown primary (CUP) by using CpG DNA methylation signatures. The work...
Oncology drug development setback: Merck’s Welireg combo misses in first-line kidney cancer
Merck disclosed that adding Welireg (belzutifan) to an existing Keytruda regimen did not produce a significant improvement in newly diagnosed patients with advanced kidney cancer. The company...
FDA regulatory shift: priority review granted for Merck-Daiichi B7-H3 ADC
The FDA granted priority review to Daiichi Sankyo and Merck’s B7-H3-directed antibody-drug conjugate ifinatamab deruxtecan, supported by a BLA submission for extensive-stage small-cell lung...
Digital health: DiMe launches initiative to scale direct-to-patient pathways
The Digital Medicine Society (DiMe) launched an initiative aimed at building an operational, regulatory and evidence framework to scale direct-to-patient (DTP) care pathways. The effort, titled...
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...