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In vivo CAR-T expansion via Kelonia deal
Eli Lilly moved further into in vivo CAR-T with an agreement to acquire Kelonia Therapeutics for up to $7 billion, adding early-stage lentiviral in vivo CAR-T development to its oncology pipeline....
AACR clinical readouts for next-gen KRAS and RAS-pathway oncology
Revolution Medicines unveiled additional early data for daraxonrasib, its RAS-pathway targeted therapy, including tumor control signals when dosed early in first-line pancreatic cancer and in...
FDA review and safety signal for Merck’s Welireg combo in kidney cancer
Merck reported that adding Welireg to an existing Keytruda-based regimen failed to deliver a significant survival benefit in first-line advanced kidney cancer. The setback reduces the strategic...
Company financing and scaling: Serif Biomedicines launches modified DNA platform
Flagship Pioneering launched Serif Biomedicines with a modified DNA platform intended to combine features of gene therapy, mRNA, and siRNA while aiming to improve durability and re-dosing. The...
Biotech funding: Alloy Therapeutics raises for tech-enabled biotech infrastructure
Alloy Therapeutics raised $40 million in a late-stage Series E funding round to scale its tech-enabled biotech infrastructure. The company said it will use the capital across discovery engine...
Lilly’s immunology and CAR-T M&A/portfolio consolidation theme
Beyond Kelonia, the latest deal coverage reinforced how large pharma is reshaping pipelines toward cell therapies and in-body engineering. The reporting placed Kelonia within a broader pattern of...
Clinical diagnostics innovation: ClearNote pancreatic cancer assay performance update
ClearNote Health presented updated validation data for its Avantect Pancreatic Cancer test at the American Association for Cancer Research annual meeting. The company reported that adding a glycan...
Biomarker and CDx validation: Solvd Health wins FDA OK for blood-sample OUD test
Solvd Health received FDA approval to use its AvertD pharmacogenomic test for opioid use disorder with blood samples, expanding beyond cheek swabs. The test analyzes 15 genetic variants linked to...
Autoimmune cell therapy toward FDA submission: Kyverna stiff person syndrome CAR-T
Kyverna Therapeutics reported positive registrational trial results for miv-cel in stiff person syndrome, reinforcing the company’s plan to pursue an FDA submission in mid-year. The company framed...
Clinical trial and regulatory pipeline: FDA fast track for B7-H3 ADC ifinatamab deruxtecan
The FDA granted priority review to Daiichi Sankyo and Merck’s B7-H3-directed antibody-drug conjugate ifinatamab deruxtecan. The BLA acceptance and priority review apply to patients with advanced...
In-vivo CAR T expansion accelerates with Eli Lilly’s Kelonia move
Eli Lilly agreed to buy Kelonia Therapeutics in a deal valued at up to $7 billion, pairing Lilly’s oncology footprint with Kelonia’s lentiviral in-vivo CAR T approach. The transaction includes a...
Biogen consolidates Greater China rights for CD38 antibody felzartamab
Biogen secured exclusive Greater China rights to felzartamab through an $850 million agreement with TJ Biopharma, adding a $100 million upfront payment plus milestone-based consideration and...
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...