Biomedicine Daily · Wednesday, 7 October 2026

AbbVie, Genmab's Epkinly sets ‘new standard of care’ in first-line lymphoma in Phase 3

Adding AbbVie and Genmab's Epkinly to R-CHOP cut the risk of disease progression or death by 51% in newly diagnosed diffuse large B cell lymphoma, hitting the primary endpoint of the 900-patient Phase 3 EPCORE DLBCL-2 trial. The benefit exceeded analyst expectations of 30-35%, was consistent across high-risk and low- to intermediate-risk disease, and beats the 27% and 25% reductions reported for Polivy and Monjuvi regimens, positioning Epkinly as a potential first-line standard of care.

Obexelimab for the Treatment of IgG4-Related Disease.

Weekly subcutaneous obexelimab, 250 mg for 52 weeks, cut the risk of IgG4-related disease flare requiring rescue therapy by more than half in a phase 3 trial of 194 patients (hazard ratio 0.44; flares in 26.8% vs. 54.6% with placebo). Complete remission at week 52 was reached by 37.1% versus 19.6%, and cumulative glucocorticoid rescue dose was 329.5 mg versus 929.8 mg. The results position this non-depleting anti-CD19/FcγRIIb antibody as an alternative to glucocorticoid-dependent management.

TAISHAN-302 Phase 3 Data on YL201 Versus Topotecan in Recurrent SCLC Presented at WCLC and Published in NEJM

The phase 3 TAISHAN-302 trial tested the anti-B7-H3 antibody-drug conjugate econtambetamab tazepibody (Tam-Peli, YL201) against topotecan in patients with recurrent small cell lung cancer. Professor Zhang Li of Sun Yat-sen University Cancer Center presented the efficacy and safety results in a plenary session at the 2026 World Conference on Lung Cancer in Seoul on September 13, 2026, with simultaneous publication in the New England Journal of Medicine. The data position this ADC against standard topotecan in recurrent SCLC.

MATTERHORN and ASTRUM-006 establish perioperative immunochemotherapy in gastroesophageal cancer

Final MATTERHORN data show that perioperative durvalumab plus FLOT, previously shown to significantly improve event-free survival over FLOT alone in gastroesophageal cancer, also converts that benefit into an overall survival benefit. The Chinese ASTRUM-006 trial separately validates perioperative serplulimab plus SOX in PD-L1-positive disease, establishing perioperative immunochemotherapy globally.

Trials Test Phage Therapy for UTIs

FDA Authorizes First Autonomous Robotic Blood Draw Device

Walmart, Inc. - 736557 - 10/01/2026

FDA's Center for Drug Evaluation and Research issued a warning letter dated October 1, 2026 to Walmart President and CEO John Furner over three products sold on walmart.com: HClear for him, Herstat GST, and Terragen HG Formula. Purchased by FDA in July 2026 and shipped via Walmart Fulfillment Services, the products are marketed for genital herpes and genital sore symptoms and are unapproved new drugs under section 505(a) of the FD&C Act. FDA notes no OTC drug product is approved for treating any STI and warns that failure to correct the violations may bring seizure or injunction without further notice.

HHS Launches SURPASS Program Through ARPA-H to Speed Clinical Trials

On September 30, the US Department of Health and Human Services announced the launch of SURPASS (Simulation-augmented, Real-time Platform Adaptive Seamless Trials) through ARPA-H, along with three supporting programs. The initiative aims to redesign how clinical trials are run, streamline trial processes and speed products to market. Congress has authorized ARPA-H to pursue breakthrough technologies that conventional research and commercial activity cannot achieve.

Pine Pharmaceuticals, LLC - 728537 - 08/07/2026

FDA issued a warning letter dated August 7, 2026 to Pine Pharmaceuticals, LLC, a section 503B outsourcing facility in Tonawanda, New York, after a November 4-14, 2025 inspection found insanitary conditions and CGMP violations that rendered sterile drug products adulterated. Cited failures include inadequate disinfection of materials entering the ISO 5 hood, deficient environmental monitoring of staging trays, and incomplete batch failure investigations. The letter follows the firm's December 8, 2025 response to a Form FDA 483, and FDA expects corrective action.

Novo Nordisk Mim8 hemophilia A approval stalled in US over plant issue

Novo Nordisk said on October 2 that FDA review of Mim8, its hemophilia A drug, has stalled. The company submitted the marketing application in September 2025 and had expected a decision in the third quarter of this year. The delay stems from an issue at a manufacturing facility, not from the drug itself.

GE HealthCare to acquire Sofie Biosciences for $945M

GE HealthCare has agreed to buy Sofie Biosciences for $945 million in cash to expand its U.S. radiopharmaceutical manufacturing and distribution. Sofie, a contract manufacturing organization with 15 U.S. CMO sites making PET radiopharmaceuticals, will join GE HealthCare's pharmaceutical diagnostics business PDx, with the deal expected to close in the first half of 2027. GE HealthCare also gains U.S. rights to FAPI-74, a pan-cancer PET radiotracer, and expects the acquisition to add to revenue growth and adjusted EPS in the first full year of ownership.

Compliance concerns hinder rollout of AI in drug manufacturing: Survey

Fewer than 10% of drugmakers are scaling AI in clinical or commercial manufacturing, according to a CRB survey of more than 400 R&D and manufacturing professionals for its 2026 Horizons report. Use is concentrated in nonregulated areas such as administrative workflows (56%) and drug discovery (45%), with accuracy and quality concerns and insufficient validation standards cited as the main barriers. CRB found that 31% of respondents plan to use AI in regulated manufacturing within three years, and another 31% are considering it without a formal plan.

Cancer competition for vitamin B2 creates metabolic checkpoint for T cell ferroptosis

T cells take up vitamin B2 through the transporter SLC52A3, while tumors rely on SLC52A2 to outcompete them for the vitamin, driving T cell ferroptosis. A CRISPR screen of solute carriers identified this transport split. Enforcing SLC52A3 overexpression in T cells reversed the competition and enhanced their antitumor activity.

Cryo-electron tomography reveals in situ maturation pathway of human pre-ribosomes in the nucleolus

Cryo-electron tomography has visualized human pre-ribosome maturation inside the nucleolus in situ, moving beyond the single-particle structures obtained from purified extracellular samples. The work reveals the positions and intermediates of ribosomal RNA processing and assembly factor binding within real cellular space. It defines a native maturation pathway for human ribosome precursors.

Mitochondrial proteome of Acanthamoeba delineates aerobic and anaerobic pathways dynamically regulated by oxygen.

The Acanthamoeba castellanii mitochondrial proteome has been mapped into AcMitoCarta, a 1,122-protein inventory built by immunoprecipitation, density gradient purification, mass spectrometry, protein correlation profiling and microscopy, with 381 proteins lacking obvious homologs in human and yeast mitochondria. Complexome analysis defines 20 macromolecular assemblies, and proteomic and transcriptomic profiling shows oxygen extensively rewires the organelle's bioenergetics, including induction of an anaerobic pyruvate:ferredoxin oxidoreductase-to-hydrogenase pathway under anoxia. Acanthamoeba is shown to produce H2 gas under anoxic conditions via a mitochondria-localized, oxygen-labile hydrogenase.

Cargo Crosslinking Nucleates AP-1 Lattice Formation, Cell Study Shows

Cargo proteins play an active role in assembling the coat that transports them: a study from West China Hospital of Sichuan University and West China Second University Hospital, published in Cell, shows that a single cargo molecule bearing tandem sorting motifs can bridge two neighboring AP-1 adaptor complexes. Cryo-electron microscopy revealed a previously undescribed mu1-sigma1 cross-complex interface through which cargo crosslinking drives AP-1 oligomerization and formation of AP-1-clathrin cages.

Cell Study Maps Spatial Evolution of Cachexia-Promoting Microenvironment in Pancreatic Cancer

More than 80% of pancreatic cancer patients develop cachexia, the progressive loss of skeletal muscle and adipose tissue that progresses from a pre-cachexia stage. A team led by Xu Jingyong at Beijing Hospital and the National Center of Gerontology, with the Cancer Institute and Hospital of CAMS and the University of Oklahoma, mapped how a cachexia-promoting microenvironment evolves spatially in pancreatic cancer to drive skeletal muscle wasting. The work appears in Cell as "Spatial evolution of a cachexia-promoting microenvironment in pancreatic cancer."

AlphaFold Structure Mining Reveals GPCR-like Protein TM184C Regulates Vesicle Transport and Autophagy

AlphaFold-based structure mining has identified TM184C, a GPCR-like protein from the poorly characterized "dark proteome," as a regulator of intercellular vesicle transport and autophagy. Database protein sequences vastly outnumber those with experimental validation, and this work shows structure-led searching of that uncharacterized space can assign function to unknown proteins. It points to unexplored biology and potential therapeutic targets.

Cranial bone marrow-derived monocytes promote neuroinflammation in chronic traumatic brain injury.

Cranial bone marrow-derived inflammatory monocytes/macrophages migrate into the brain and drive chronic neuroinflammation and neurological deficits after traumatic brain injury, with the effect worsening with age. Age-related PPARα deficiency caused lipid metabolism dysfunction in these cells, promoting inflammatory chromatin states. In a randomized trial of 40 older adult patients with cTBI, fenofibrate reduced plasma neurofilament light chain levels and improved cognitive function.

medicalxpress.com

One dose of protein-targeting CAR-T cells shrinks solid tumors in preclinical tests

CAR-T cells engineered to recognize MPZL1, a surface protein overexpressed because its gene sits in a chromosomal region often amplified in solid tumors, shrank tumors in mice after a single dose. Analysis of 2,200 tumor samples showed cancer cells often express high levels of MPZL1 while healthy tissue expresses much less. In vitro, the CAR-T cells killed liver, breast, lung and pancreatic cancer cells and glioblastoma cells with high MPZL1 density, and infiltrated patient tumor tissue while showing less activity in healthy tissue.

Highly multiplexed mammalian metabolic engineering with a shotgun approach

Shotgun genetic engineering (SGE) delivers barcoded individual transcription units at high multiplicity of infection so each mammalian cell carries a unique pathway combination, letting a far larger design space be sampled in parallel than serial design-build-test cycles allow. After selection, sequencing of cells with the desired phenotype reveals which combinations of promoters, localization signals, enzymes, stoichiometry and copy number conferred the function. The method also generates large-scale synthetic datasets for training predictive machine learning models of pathway design.

SPARCS enables scalable recovery of complex image-based phenotypes for genetic screening

SPARCS automates laser microdissection to run pooled forward genetic screens that scale to large mutant libraries while measuring complex image-based phenotypes. It physically recovers individual mutants, so hits can be profiled beyond genotyping, including by mass spectrometry-based proteomics. This removes the trade-off between library scale and information-rich phenotype measurement in genetic screening.

Brain organoids grafted into cortex-free mice will advance human brain research

Kaganovsky et al. report in Nature an engraftment model in which human stem-cell-derived brain organoids are transplanted into living mice. The approach produces neurons that cannot be obtained in vitro and may let researchers connect brain injury to behaviour, overcoming limits of organoids that cannot mature, lack interaction with other brain structures and give no behavioural output. Marty G. Yang and Aparna Bhaduri of UCLA discuss the work in a News and Views piece.