Biomedicine Daily · Friday, 25 September 2026
CBA FRONTIER INSIGHTS
FDA advisors back Grail's Galleri multi-cancer blood test despite efficacy doubts
An FDA advisory committee voted on September 23 that the benefits of Galleri, Grail's blood test for early detection of multiple cancers, outweigh its risks — a key step toward formal FDA review of the product. The panel voted 10 to 0 that there is reasonable assurance the test is safe, split 6 to 4 on effectiveness, and voted 7 to 2 with one abstention that benefits outweigh risks for patients meeting the proposed indication's criteria. The endorsement came despite a major trial setback earlier this year and ongoing questions over efficacy. The FDA is not obliged to follow the panel's advice but often does, leaving Grail positioned for a potential approval. Also this day: the FDA approved Eli Lilly's once-weekly basal insulin Onswik for adults with type 2 diabetes, and Merck's remigromig hit its primary endpoint in the phase 2b/3 Brunello trial in diabetic macular edema.
Clinical readouts and safety
Merck sees pivotal victory for $3B eye disease prospect
Merck's remigromig, a trispecific Wnt-pathway agonist for diabetic macular edema, hit the primary endpoint in the phase 2b/3 Brunello trial: both doses were noninferior to ranibizumab at Week 52 on change in best-corrected visual acuity and were well tolerated. Rates of proliferative diabetic retinopathy, vitreous hemorrhage and discontinuations due to adverse events were higher on remigromig, and Merck is running further analyses. The candidate came with Merck's $3 billion acquisition of EyeBio.
Evorpacept plus trastuzumab, ramucirumab and paclitaxel in HER2-positive gastric cancer: a randomized phase 2 trial
Adding the CD47 inhibitor evorpacept to trastuzumab, ramucirumab and paclitaxel (TRP) produced a higher objective response rate than TRP alone in patients with HER2-positive advanced gastric cancer that had progressed on anti-HER2 treatment. The finding comes from the phase 2 part of the randomized ASPEN-06 trial. Response was associated with CD47 and HER2 expression.
[Articles] Faecal microbiota transplantation in irritable bowel syndrome (REFIT2): a randomised, double-blind, placebo-controlled, phase 3 trial
Faecal microbiota transplantation provided no clinical benefit over placebo in patients with irritable bowel syndrome in REFIT2, a randomised, double-blind, placebo-controlled phase 3 trial. The results suggest that modulating the microbiota alone may be insufficient to improve IBS symptoms. The finding shifts attention away from microbiota-only strategies for this condition.
Regulatory and policy
FDA Approves Eli Lilly Once-Weekly Basal Insulin Onswik for Type 2 Diabetes
The FDA has approved Eli Lilly's once-weekly long-acting basal insulin Onswik (insulin efsitora alfa) for adults with type 2 diabetes, offering an alternative to daily insulin injections. The approval reflects a broader effort across insulin and GLP-1 drugs to extend dosing intervals for long-term treatment. Onswik now becomes a new treatment option for adult patients in the United States.
Eli Lilly Adds SUMMIT Data to Tirzepatide China Label for Obese HFpEF Patients
On September 21, Eli Lilly said China's NMPA approved an update to the label for Mufengda (tirzepatide injection), its GIP/GLP-1 dual-target weekly injection, adding clinical study data in adults with heart failure with preserved ejection fraction and obesity. The update incorporates SUMMIT study results showing a 38% reduction in the risk of worsening in these patients. The drug was previously positioned for glucose lowering and weight reduction.
FDA Advisory Panel Backs GRAIL's Galleri Multi-Cancer Blood Test
An FDA expert committee voted on September 23 that the clinical benefits of Galleri, a multi-cancer early-detection blood test, outweigh its risks. The vote marks a key step toward formal FDA review of the product, which is positioned as a blood draw for early cancer screening. The agency's decision process now moves forward following the panel's endorsement.
STAT+: FDA advisory panel endorses Grail blood test for cancer, saying benefits outweigh risks
An FDA advisory panel endorsed Galleri, Grail's blood test to screen for multiple types of cancer, voting 10 to 0 that there is reasonable assurance the test is safe. The panel split 6 to 4 on effectiveness and voted 7 to 2 with one abstention that benefits outweigh risks for patients meeting the proposed indication's criteria. The FDA is not obliged to follow the panel's advice but often does.
Grail survives adcomm vote as it awaits FDA decision for cancer blood test
FDA advisors have voted to recommend Grail's multi-cancer blood test Galleri, despite a major trial setback earlier this year and ongoing questions over its efficacy. Grail now awaits an FDA decision on the test. The outcome leaves the company positioned for a potential approval ahead.
White House plan to increase control of NIH grants appears ‘dead’
A drafted executive order that would have given a commission of political appointees, including OMB Director Russell Vought, veto power over NIH grant awards is “looking dead” after bipartisan pushback in Congress. Sen. Susan Collins, the Appropriations Committee chair, wrote to Vought and NIH Director Jay Bhattacharya urging the plan be dropped, and other lawmakers in both chambers objected. The White House has not commented.
STAT+: Indonesian ruling against ‘patent evergreening’ by pharma industry sends critical message, patient advocates say
Indonesia's Constitutional Court struck down a two-year-old amendment that had removed a prohibition on 'patent evergreening', ruling the original restriction is needed to balance patent holders' rights with public health. Patients and advocacy groups brought the case. Advocates say the decision signals that other countries can challenge the practice of filing patents with minor tweaks to delay competition.
FDA slams GLP-1 compounder over risk of contaminating drugs ‘with filth’
The FDA sent Empower Clinic Services, which does business as Empower Pharmacy, a warning letter dated Sept. 18 citing insanitary conditions at a Houston site inspected in November 2025 and evidence that its compounded tirzepatide and semaglutide products are essentially copies of FDA-approved drugs in violation of Section 503A. As of Sept. 24, Empower still listed both products for sale. The company has 15 working days to respond in writing with steps taken to correct and prevent the violations.
Industry and deals
Roche pens backloaded $2B deal with Atavistik to discover allosteric CVRM drugs
Roche has struck a licensing deal worth up to $2 billion with Atavistik Bio to discover allosteric small molecules for cardiovascular, renal and metabolic diseases. Roche pays $70 million up front, with up to $1.9 billion in milestones; the partners will use Atavistik's AMPS platform, with Atavistik handling discovery and Roche taking over preclinical work and beyond. The deal extends Roche's CVRM push, which includes the zilebesiran partnership with Alnylam, the $3.5 billion purchase of 89bio and the $2.7 billion Carmot takeover.
Lilly puts up $100M, plus billions on the backend, to form 5-target deal with China's InnoCare
Eli Lilly will pay InnoCare Pharma $100 million in upfront and near-term payments for a five-target drug discovery collaboration, with up to $3.25 billion in potential milestones plus single-digit tiered royalties on net sales. Beijing-based InnoCare will apply its drug discovery platform to targets the partners have not disclosed, beyond saying the programs address critical unmet medical needs. The deal extends a Lilly deal spree funded by GLP-1 cash.
Research papers
Senescence-directed nanotherapy ameliorates fibrosis and overcomes immune exclusion in cancer
A pericyte-to-myofibroblast transition links APOE4 to cerebrovascular degeneration
APOE4 drives pericytes to become myofibroblasts, producing cerebrovascular fibrosis and perivascular amyloid accumulation. Inhibiting TGF-β reverses this remodeling, pointing to a strategy for restoring cerebrovascular homeostasis in APOE4 carriers at high risk of cerebrovascular degeneration.
Tissue-resident macrophages feed pancreatic cancer cells Selenop to sustain invasiveness
Tissue-resident macrophages enriched at the tumor boundary deliver the selenoprotein Selenop to highly invasive pancreatic ductal adenocarcinoma cells, helping them evade ferroptosis and maintain their invasive state. The finding reframes immune cells in the tumor microenvironment as nutrient and metabolic donors that directly sustain malignant cell behavior, not only as sources of cytokines and immune signals.
Single-cell multi-omics reveals brain cell types and regions age at different rates
Single-cell multi-omics profiling shows brain aging proceeds unevenly across cell types and regions. The DNA methylation analysis covered 132551 single-cell profiles and three-dimensional chromatin conformation data covered 72666 cells. Oligodendrocyte progenitor cells and oligodendrocytes carried far more age-related differentially methylated regions than neurons.
Ceramide synthesis mediates colorectal cancer metastasis through a YAP-driven regenerative program
PHGDH-Deficient Pancreatic Cancer Activates Hepatocyte Serine Synthesis to Drive Liver Metastasis
Pancreatic ductal adenocarcinoma frequently spreads to the liver, and about 40% of PDAC tumors lack PHGDH, the rate-limiting enzyme of de novo serine synthesis, making them dependent on external serine. Analysis of human PDAC liver metastasis specimens showed marked upregulation of PHGDH in surrounding hepatocytes, and a mouse liver metastasis model confirmed that PHGDH-deficient pancreatic cancer cells activate the serine synthesis pathway in neighboring hepatocytes.
Zhejiang University Team Identifies MFF as a Ferroptosis Regulator in Nature
A Zhejiang University team publishing in Nature used a phosphoproteomics screen to identify MFF as a regulator of ferroptosis, tracing how mitochondrial and peroxisome dynamics jointly govern execution of this cell-death pathway. The work ran from omics screening through in vivo pharmacological validation and offers a reusable target-screening framework for ferroptosis-centered cancer research.
Fibroblasts restrain gut inflammation by IGF1-dependent regulation of innate lymphocytes
Escape of the BC200 gene to a human poxvirus reveals its persistent transposition in primates
Resident tissue macrophages transfer selenium transporter protein to protect pancreatic cancer from ferroptosis
Mammals produce cyclo-octasulfur to suppress lipid peroxidation and ferroptosis
Conformal oxides decouple chemical stability and energetics at NiOx/perovskite interfaces
Single wildfire smoke exposure causes lasting harm, natural experiment in monkeys hints
CMAC: A deep learning framework for absolute cardiomyocyte transcriptional age estimation
CMAC, a deep learning framework built from 18 murine single-cell RNA-seq datasets, assigns absolute transcriptional maturation age to cardiomyocytes across platforms and experimental conditions. An XGBoost regressor on its batch-invariant latent space predicted chronological age with leave-one-dataset-out MAE of 4.09 days (Pearson r = 0.903), and in an independent P14 cohort of 98,163 cells achieved mouse-level MAE of 0.33 days. Applied to PGC1/beta double-knockout mice, it quantified maturation deficits of 4.77 to 8.60 days across P7 to P28.
Convergent evolutionary loss of chemosensory and blood-feeding pathways in non-blood-feeding mosquitoes
Comparing chromosome-level genomes and whole-brain reconstructions across seven mosquito species, including three independent non-blood-feeding lineages, reveals convergent loss of blood-feeding genes: Aegyptin, blood-activated serine proteases Chymotrypsin-1 and 2, a carboxylesterase, and multiple chemosensory receptor clades. Non-blood-feeding females also show reduced female-biased head gene expression and smaller antennal lobes. The work defines a compact gene set underlying a complex trait lost three times over roughly 200 million years.
Methods and resources
Advancing sarcoma diagnostics with expanded DNA methylation-based classification
An expanded DNA methylation-based sarcoma classifier (v13.1) was trained on 4377 methylation profiles covering 116 tumor sub-classes, 4 control groups and 93 distinct methylation classes, and validated in 1547 mesenchymal tumors from four independent cohorts. Five-fold nested cross-validation yielded 98% class-level accuracy with a Brier score of 0.017. Predictions were obtained in 73% of validation cases, 91% matched the histopathology diagnosis, and 6% of inconclusive or ambiguous cases gained a definitive molecular diagnosis or reclassification.
Simplifying in silico protein evolution with minimal screening by unZipro
unZipro is a geometric deep learning framework that adapts general protein design models to specific protein families using meta-learning to navigate family-specific fitness landscapes. It enabled rapid in silico protein evolution across gene editing, luciferase reporting, transcriptional regulation, and antiviral resistance with minimal experimental screening. The work simplifies protein evolution by cutting the screening burden required to tailor designs to a chosen family.
AlphaFold ‘goes viral’: database adds protein complexes of common viruses
The AlphaFold Protein Structure Database has added more than 8,000 virus protein dimers from 23 virus families that infect humans, including monkeypox, measles and hepatitis B viruses. Researchers analysed sequences of 41,774 proteins from around 2,800 viruses and used AlphaFold2 to predict roughly 40,746 homodimers and nearly 1.7 million heterodimers, of which only 2,749 homodimers and 5,279 heterodimers met accuracy standards for inclusion. The update, launched on 24 September with a pandemic preparedness portal, fills a viral blind spot in a resource with more than three million users.
AI system helps lab devices ‘talk’ with each other — streamlining research
A software framework called the Model Hardware Standard (MHS), developed by Anthropic and the Howard Hughes Medical Institute's Janelia Research Campus, connects laboratory instruments from different vendors into a single system that AI agents can control to run experiments. A team testing it at Carnegie Mellon University set up a functioning experiment in hours, a process that can easily take months. Unlike the SiLA consortium's existing standard, MHS links instruments directly to AI agents.
Opinion and commentary
GLP-1 drugs fail to help some people lose weight — scientists are on a quest for answers
While most users of GLP-1 obesity drugs lose an average of one-quarter of their body weight, 10–15% lose minimal weight or none, and researchers are investigating why, with biological sex, genetics and behavioural factors under study. The Endocrine Society has made individualized responses a field priority but says precision medicine for obesity remains largely aspirational. Studies of semaglutide and tirzepatide suggest oestrogen given with hormone-replacement therapy may enhance the drugs' effects.
In brief
Also today
3 events that did not make today's daily, one table per category, one row per event. Open a category to expand.
OtherSTAT+ · Enveda Therapeutics · Otsuka JV recalls one lot of sodium chloride over labeling issue3 ▾▴
Everything else with a concrete event that did not make the daily.