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Regulatory milestones in oncology radioligand and targeted therapies
FDA has expanded the use of Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan) earlier in metastatic prostate cancer care, approving the radioligand in PSMA-positive metastatic...
Experimental oncology: tackling drug resistance and improving ADC performance
UCLA researchers reported a preclinical strategy to increase the potency of antibody-drug conjugate approaches against metastatic castration-resistant prostate cancer (mCRPC) by combining targeted...
FDA breakthrough designation for KRAS G12C pancreatic cancer
FDA granted breakthrough therapy designation to Lilly’s next-generation KRAS G12C inhibitor olomorasib for advanced pancreatic cancer with KRAS G12C mutations after at least one prior systemic...
Corporate deals reshaping pharma and radiopharma footprints
Curium moved into definitive acquisition talks, agreeing to buy Lantheus for up to about $8 billion, a deal structured around a $102.50 per-share closing price plus contingent value rights tied to...
Diagnostics and enabling platforms: whole-genome sequencing expansion
Inocras secured $31 million in a third Series B-3 financing round to expand its whole-genome sequencing (WGS) and bioinformatics platform in the United States. The company said existing investors...
Funding and market dynamics: biotech mega-round momentum
BIO International Convention programming highlighted that venture capital is increasingly able to place large bets again, with more biotech companies crossing $100 million “mega-round”...
Corporate strategy in genomic tools: Twist growth tied to AI-enabled discovery
Twist Bioscience reported fiscal Q3 revenue of $118.4 million, up 23% year over year, driven by continued double-digit growth across DNA synthesis, protein solutions, and NGS...
Tech-to-therapy pipeline: early cancer drug startups raise and move into the clinic
BlossomHill Therapeutics filed for a planned IPO targeting up to about $129 million, setting out the clinical path for BH-30643, a macrocyclic EGFR-targeting molecule positioned as a potential...
Cloud computing and clinical operations: regulatory-adjacent workflow tooling
A new report on a clinical workflow concept argues that blockchain-based “smart contracts” could help automate and audit key trial processes, including patient matching, consent acquisition, data...
AI in healthcare delivery: precision oxygen management trial
A new clinical trial suggests AI can improve the precision of oxygen delivery for hospitalized patients by keeping patients within prescribed oxygen ranges more consistently than standard...
Oncology regulatory moves for radioligand therapy and KRAS-targeted drugs
The FDA granted Priority Review to J&J’s subcutaneous RYBREVANT FASPRO (amivantamab plus hyaluronidase-lpuj) for recurrent or metastatic head and neck squamous cell carcinoma after platinum...
Dealmaking reshapes specialty pharma and radiopharma scale
Supernus and Indivior agreed to an all-stock merger of equals to form a new CNS-focused pharma, with the combined company expected to house 11 commercial CNS products. The transaction is...
Genetic and translational oncology research finds new combinability
UCLA researchers report a strategy to improve outcomes in metastatic castration-resistant prostate cancer by strengthening antibody-drug conjugates with a targeted combination approach. In...
Platform and AI-driven life science infrastructure expands
Twist Bioscience reported fiscal Q3 revenue growth of 23% year over year to $118.4 million, citing double-digit momentum across DNA synthesis, protein solutions, and NGS applications. Management...
Bioinformatics, computational validation, and translational diagnostics
Genprex and Roche Diagnostics launched collaboration plans to validate a biomarker assay in non-small cell lung cancer, centered on TROP2. Genprex said it expects to potentially integrate TROP2...
Laboratory scale and genomics expansion via new financing
Inocras raised an additional $31 million in a Series B-3 financing round to expand clinical genome sequencing operations and its proprietary bioinformatics platform. The company said it plans to...
Regulatory and health-policy pressure on U.S. drug distribution and pricing programs
HHS is reviving a 340B rebate push after a previous pilot was blocked in court, according to coverage of the administrative change. Providers said the approach would increase administrative and...
Clinical pipeline setbacks and next-step uncertainty in immune and cell therapies
Capricor’s resubmitted biologics license application for Deramiocel faced a negative advisory committee recommendation, with the FDA Cellular, Tissue, and Gene Therapies Advisory Committee voting...
Funding and IPO pipeline for emerging biotech candidates
BlossomHill Therapeutics filed for an IPO to raise about $111.7 million, earmarking funding for a potential Tagrisso challenger and additional early pipeline programs. The company’s lead asset,...
Translational microbiome and microbiology interventions
Researchers reported a combined phage therapy and fecal microbiota transplantation (FMT) approach in the first human case series for recurrent urinary tract infections (rUTIs). In three female...