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ATTR-CM antisense setbacks at Roche and Ionis
Roche has moved to end two Huntington’s disease antisense programs with Ionis, citing data-driven decisions after key efficacy setbacks and new stopping information. The Phase 2 GENERATION HD2...
FDA continues to issue CRLs amid manufacturing and transparency pushback
The FDA has resumed posting complete response letters (CRLs), adding another batch of rejection notices as regulators emphasize “commitment to transparency.” The latest wave includes multiple...
GSK’s B7-H3 ADC extends survival in Phase 3 small-cell lung cancer
GSK reported that its B7-H3 antibody-drug conjugate risvutatug rezetecan (ris-rez) met a primary endpoint in a Phase 3 trial in advanced or relapsed small cell lung cancer in China. The study...
New blood test validation: Freenome SimpleScreen CRC update hits CRC screening endpoints
Freenome disclosed validation results for an updated version of its SimpleScreen CRC blood test, reporting that the assay met primary and secondary endpoints in a large clinical validation dataset...
Nanopore RNA liquid biopsy for early cancer detection
UCSC researchers are developing a nanopore-based RNA liquid biopsy approach for early cancer detection using their Locate-seq method, and the program is receiving validation support from Oxford...
Diagnostics funding push for neonatal sepsis: CARB-X and CGD launch NeoTest market design
CARB-X is backing a Center for Global Development (CGD) effort—NeoTest—to accelerate neonatal sepsis diagnostics toward market. The initiative is designed to reduce the gap between diagnostic...
Gut-immune and microbiome signals in cancer and infectious disease R&D
Two separate studies spotlight how microbiome-linked mechanisms are increasingly shaping translational R&D in oncology and diagnostics. In one report, researchers summarize evidence that microbial...
German drug pricing bill doubles manufacturer rebates to 15.5%
Germany’s lower parliament has voted to advance a cost-saving bill that would raise mandatory rebates on most brand-name prescription drugs from 7% to 15.5%, affecting manufacturer net pricing...
First-in-class home deep-sleep modulation study expands Parkinson’s feasibility signal
A long-term extension study reported in npj Parkinson’s Disease explores home-based deep sleep modulation in people with Parkinson’s disease, extending feasibility and assessing sustained effects...
AI operating model debate: closed-loop R&D as requirement for compounding learning
A McKinsey report argues that biopharma companies will not fully capture AI benefits without a “structural redesign” of R&D operations. The consultancy says AI can make individual steps more...
Regulatory setbacks in late-stage neurodegeneration programs
Roche has halted two Huntington’s disease antisense therapy studies in collaboration with Ionis Pharmaceuticals after disappointing efficacy signals and new safety-related data. In a letter to the...
FDA reverses course on CRL transparency and resumes new complete response letter releases
The FDA has resumed posting complete response letters (CRLs) after a pause in new CRL releases earlier in the week, pointing to its “commitment to transparency.” The restart comes as multiple...
Third FDA rejection escalates manufacturing risk for liver cancer immunotherapy combo
The FDA has rejected a liver cancer regimen from HLB and Hengrui for the third time, extending uncertainty over the rivoceranib plus camrelizumab program. The reported basis for the continued...
Checkpoint to clinical readout in oncology: GSK’s B7-H3 ADC posts Phase 3 survival win in China
GSK and Hansoh Pharmaceutical reported that risvutatug rezetecan (ris-rez), a B7-H3 targeted antibody-drug conjugate, met its primary endpoint of overall survival in a Phase 3 small cell lung...
Colorectal cancer screening: Freenome’s updated SimpleScreen CRC test meets validation endpoints with tighter precancer sensitivity
Freenome reported that an updated version of its SimpleScreen CRC blood test met primary and secondary endpoints in a clinical validation study, drawing mixed industry reaction. The analysis used...
Liquid biopsy innovation: Oxford Nanopore-backed RNA approach targets early cancer detection
A UCSC team is developing a nanopore-based RNA liquid biopsy approach for early cancer detection using its Locate-seq method, with validation support from Oxford Nanopore Technologies. The work...
Synthetic biology milestone: SpudCell claims first synthetic cell assembled from purified non-living components
Researchers announced the creation of SpudCell, described as the first synthetic cell built from purified, non-living components. The reported system is presented as cell-like, performing core...
Immunotherapy delivery platform: Nanotechnology switch halts cancer growth and boosts immune attack
A research team led by Yoosoo Yang at Sungkyunkwan University, with partners including the Korea Institute of Science and Technology and Incheon National University, reported a...
Diagnostics and antimicrobial resistance: CARB-X backs NeoTest market-shaping funding for neonatal sepsis
CARB-X is backing a Center for Global Development program, NeoTest, to accelerate the development and market uptake of neonatal sepsis diagnostics through a combined push-and-pull funding...
Oncology immunology mechanism: TP53 mutations drive CD8+ T cell exhaustion in therapy-resistant urothelial cancer
A British Journal of Cancer study has linked TP53 mutations to CD8+ T cell exhaustion in urothelial carcinoma, describing how altered tumor biology can bias immune cells into a dysfunctional...