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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...
Big Pharma M&A to refill oncology pipeline
Merck & Co. agreed to acquire Terns Pharmaceuticals in a roughly $6.7 billion all-cash deal, aiming to strengthen its oncology portfolio with Terns’ lead asset TERN-701, an oral BCR::ABL1 tyrosine...
FDA approvals advance rare disease and cancer settings
The FDA cleared Corcept Therapeutics’ oral relacorilant (Lifyorli) for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer—an approval arriving nearly...
Kidney disease trial readout sharpens competitive race for APOL1 inhibition
Maze Therapeutics reported Phase 2 top-line results for MZE829, its once-daily oral dual-mechanism APOL1 inhibitor in patients with broad APOL1-mediated kidney disease (AMKD). At week 12, Maze...
Gene editing update renews push for accelerated approvals in AATD
Beam Therapeutics said updated Phase 1/2 data for BEAM-302 in alpha-1 antitrypsin deficiency (AATD) showed restored functional protein production across multiple dose groups. The company reported...
Clinical-stage AI software launches to automate trial operations
PhaseV debuted an AI-driven platform, “AI Conductor,” designed to automate end-to-end clinical development workflows—from protocol development and data harmonization through ICH E9 compliance and...
Pathology + real-world data partnerships expand translational decision support
Tempus AI and Daiichi Sankyo partnered to apply multimodal AI—using Tempus foundation models including PRISM2—to improve patient selection for an oncology antibody-drug conjugate (ADC) program....
New spatial biology atlas to power disease digital twins
Bioptimus launched the Spatial Tissue Embedding Learning Atlas (STELA) with 10x Genomics and Broad Clinical Labs as a data generation initiative. Using 10x Xenium spatial transcriptomics, STELA is...
Diagnostics and bioprocess tools tighten data reliability
Countable Labs obtained CE marking for its Countable 4 single-molecule PCR platform, positioning the technology for broader European use in rare variant detection and quantification workflows. The...
FDA signals tighter enforcement on overstated claims for cancer drug
The FDA issued a warning to ImmunityBio over promotional claims connected to Anktiva. The agency cited repeated marketing assertions that the product—described in connection with bladder...
Company-level investment for liquid biopsy banking and downstream molecular testing
Virchow Medical completed a $4 million seed financing led by Cerberus Ventures to expand development of its liquid specimen biorepository, the Virchow Vault. The company plans to deploy “biopsy...
Regulatory approvals in oncology and rare disease
The FDA delivered back-to-back rare-disease and oncology wins Wednesday, highlighting a still-active accelerated-approval pathway for rare conditions. Corcept Therapeutics’ oral selective...
Competitive kidney disease pipeline and Vertex-style targeting
Maze Therapeutics reported positive mid-stage efficacy for MZE829, its oral APOL1 inhibitor for broad APOL1-mediated kidney disease (AMKD), setting up a direct race toward a pivotal program. In...