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Regulatory approval – radioligand expansion in prostate cancer
The FDA has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in combination with an androgen receptor pathway inhibitor for patients with PSMA-positive metastatic hormone-sensitive...
FDA panel and clinical-path reset – viral-vector melanoma therapy
Replimune’s RP1 (vusolimogene oderparepvec) moved back toward the clinical spotlight after an FDA advisory committee vote. The update centers on the panel’s support for RP1 in combination with...
Phase 3 cardiovascular failure – anti-inflammatory IL-6 strategy
Novo Nordisk’s phase 3 Zeus trial suffered a negative result for ziltivekimab, an IL-6 pathway inhibitor being tested for cardiovascular risk reduction in people with atherosclerotic...
Phase 3 oncology failure and strategic runway – cash crunch at Karyopharm
Karyopharm Therapeutics’ shares plunged after phase 3 results for Xpovio (selinexor) in endometrial cancer failed to meet the progression-free survival primary endpoint. The Newton, Mass.-based...
Big biotech deal – acquisition to move beyond wound care
Mimedx agreed to buy Sanara Medtech in a cash-and-stock deal valued at about $350 million as it tries to reposition away from a wound-care business pressured by CMS reimbursement changes for skin...
Radiopharma financing – new capital for clinical development
Ratio Therapeutics raised $70 million for its radiopharmaceutical trial program, according to the reported Series C terms. The funding includes participation from existing investors Duquesne...
FDA pilot policy – 340B rebate framework changes
Pharma industry groups backed proposed changes to the HHS 340B rebate pilot, according to reporting tied to Health Resources and Services Administration (HRSA) updates. The revised pilot would let...
Regulatory compliance and lab capability – EU IVD rollout for HIV and respiratory panels
ABL Diagnostics secured CE-IVD registration for multiple molecular tests covering HIV-1, respiratory pathogens, and viral meningitis. The French company also amended an equity line and share loan...
Imaging and diagnostics workflow – long-read WGS integration into reporting
GenomOncology said it will integrate Pacific Biosciences’ HiFi whole-genome sequencing secondary analysis pipeline into its Pathology Workbench reporting platform. The stated goal is to translate...
Biotech market and deal pressure – takeover jockeying in proteomics
Seer’s stock jumped in July as the company became the target of competing takeover bids, prompting additional investor-driven offers and board resistance. GenomeWeb reporting highlighted a 34%...
FDA advisory committee and melanoma resubmission momentum
Replimune’s RP1 vusolimogene oderparepvec program got a lift after an FDA panel vote that supported advancing the therapy despite negative materials in the agency’s briefing package. The...
Cardiovascular inflammation drug setback in late-stage trial
Novo Nordisk’s Phase 3 Zeus trial for ziltivekimab, an IL-6 inhibitor aimed at reducing cardiovascular events via inflammation, failed to improve the primary endpoint versus placebo. In an update...
Oncology setbacks and rapid cash pressure in endometrial cancer
Karyopharm Therapeutics’ effort to expand selinexor (Xpovio) into endometrial cancer suffered another setback as top-line Phase 3 data missed the progression-free survival primary endpoint. The...
Clinical immunotherapy bioengineering and cell-killing mechanisms
Researchers reported a high-throughput strategy to engineer bispecific antibodies intended to strengthen macrophage-mediated killing of B-cell lymphoma cells. The approach, described in Nature...
In vivo CAR T expands toward autoimmune indications in Australia
Create Medicines received Australian HREC approval to begin a first-in-human study of CRT-402, its lead in vivo CAR T candidate for autoimmune diseases. The clearance sets up early clinical...
Precision sequencing workflow integration for blood cancer reporting
GenomOncology announced it will integrate Pacific Biosciences’ HiFi whole-genome sequencing secondary analysis pipeline into its Pathology Workbench reporting platform. The workflow combines...
AI drug discovery evaluation benchmark launch
Insilico Medicine launched what it describes as the first Drug Discovery and Development Benchmark-as-a-Service targeting frontier AI and foundation models. The framework is built as a “blind...
Radiopharma funding for trials and pipeline execution
Ratio Therapeutics raised $70 million to support radiopharmaceutical trials, according to the company’s Series C update. The financing includes participation from existing investors Duquesne...
Genomic diagnostics company expands with CE-IVD registrations
ABL Diagnostics obtained CE-IVD registration for a set of molecular tests spanning HIV-1 genotyping, respiratory pathogens, and viral meningitis. The PCR-based DeepChek Whole Genome HIV-1...
Immunotherapy commercialization momentum and partnership push
Regeneron reported a strong quarter for Dupixent as label expansions and ongoing demand fueled sales growth, lifting global Dupixent revenue to $6 billion for the first time in a quarter. The...