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M&A
Merck has agreed to acquire Terns Pharmaceuticals for about $6.7 billion, securing TERN-701, an oral BCR::ABL tyrosine kinase inhibitor in phase 1/2 for Philadelphia chromosome-positive...
M&A & Immunology Bispecifics
Gilead announced it will acquire Ouro Medicines for about $2.17 billion, adding the autoimmune-stage BCMAxCD3 T-cell engager gamgertamig (OM336). The front-loaded structure includes $1.675 billion...
Regulatory Approvals – Oncology
The FDA approved Corcept Therapeutics’ Lifyorli (relacorilant) in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal...
Regulatory Approvals – Rare Disease
The FDA granted Denali Therapeutics accelerated approval for Avlayah (tividenofusp alfa), a Hunter syndrome gene therapy, in a decision that runs counter to recent rare-disease rejection patterns...
Clinical Development – NK Cell Engagement Shutdown
Innate Pharma discontinued its phase 1/2 NK cell engager program IPH6501, ending the B-cell non-Hodgkin lymphoma study as part of a strategic pipeline prioritization. Innate had been evaluating...
Clinical Development – Gene Editing in Rare Liver/Lung Disease
Beam Therapeutics reported positive proof-of-concept readouts for its base editing therapy BEAM-302 in alpha-1 antitrypsin deficiency, showing restored functional protein production and meaningful...
Clinical Development – Kidney Disease Proteinuria Reduction
Maze Therapeutics said its phase 2 program for MZE829, an oral dual-mechanism APOL1 inhibitor, achieved a clinically meaningful mean reduction in urine protein levels in APOL1-mediated kidney...
Diagnostics – CE Mark for Single-Molecule PCR
Countable Labs secured CE marking for its Countable 4 single-molecule PCR platform, positioning the instrument for European biopharma and contract manufacturing customers. The company says its...
AI for Drug Development – Clinical Trial Automation
PhaseV debuted AI Conductor, an AI-driven clinical development offering aimed at automating trial execution tasks from protocol development through regulatory submission readiness. The platform is...
Biomanufacturing & Analytical Methods – Targeted HCP Proteomics
Researchers from Université Claude Bernard Lyon’s Institut des Sciences Analytiques reported a targeted proteomics workflow to improve host-cell protein (HCP) monitoring across variable...
M&A: Merck-Terns deal reshapes targeted oncology pipeline
Merck & Co. has agreed to buy Terns Pharmaceuticals for about $6.7 billion, securing Terns’ lead oral BCR::ABL1 tyrosine kinase inhibitor TERN-701 as it prepares for major patent expirations...
Regulatory: FDA greenlights Denali’s Avlayah for Hunter syndrome
The FDA approved Denali Therapeutics’ Avlayah (tividenofusp alfa) for Hunter syndrome (mucopolysaccharidosis II) under the accelerated approval pathway, a notable win amid scrutiny that has...
Regulatory: Corcept wins early FDA approval for Lifyorli in ovarian cancer
The FDA approved Corcept Therapeutics’ Lifyorli (relacorilant) in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal...
Clinical update: Beam reports positive base-editing data in AATD
Beam Therapeutics reported updated proof-of-concept data for its base-editing therapy BEAM-302 in alpha-1 antitrypsin deficiency (AATD), saying treatment restored functional protein production and...
Clinical update: Maze reports proteinuria reduction in Phase 2 AMKD program
Maze Therapeutics disclosed positive mid-stage topline results for MZE829, an oral APOL1 inhibitor targeting a broad set of APOL1-mediated kidney diseases (AMKD), reporting a clinically meaningful...
Deals: Gilead buys Ouro Medicines, expands autoimmune bispecific platform
Gilead Sciences agreed to acquire Ouro Medicines in a deal valued at about $2.17 billion, adding gamgertamig (OM336), a BCMAxCD3 T-cell engager, to its autoimmune pipeline. The transaction...
Diagnostics/Quality: Countable Labs secures CE mark for single-molecule PCR
Countable Labs announced it has obtained CE marking for its Countable 4 platform, a single-molecule PCR instrument designed to detect rare variants with low variant allele frequencies and deliver...
Proteomics & manufacturing analytics: scout-triggered MRM improves HCP control
Researchers at Université Claude Bernard Lyon’s Institut des Sciences Analytiques reported scout-triggered MRM (st-MRM), a targeted proteomics workflow designed to improve host-cell protein (HCP)...
AI platform in clinical trials: PhaseV launches AI Conductor with $54M backing
PhaseV debuted an AI offering called AI Conductor to automate clinical development tasks, aiming to harmonize data across studies and make submissions “submission-ready from the start.” The...
Funding: ProteomEdge secures seed round for absolute quantitation proteomics
ProteomEdge, a Sweden-based SciLifeLab and KTH spinout, secured SEK 8 million in a seed financing to expand its absolute quantitation workflow for mass spectrometry-based proteomics. The...