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uniQure-FDA standoff: agency presses for sham-surgery trial
The FDA escalated scrutiny of uniQure’s AMT‑130 Huntington’s disease gene therapy by urging a prospective, randomized, double‑blind, sham‑surgery‑controlled trial, prompting fierce public dispute...
Roche’s pivotal miss — breast‑cancer pill fails first‑line trial
Roche announced that its oral breast‑cancer candidate failed a crucial Phase 3 first‑line study, dashing expectations that the drug could become a major revenue driver. The company had previously...
Daraxonrasib posts 47% ORR — Revolution targets Phase 3 in RAS PDAC
Revolution Medicines reported daraxonrasib produced a 47% objective response rate (ORR) in a treatment‑naïve cohort of RAS‑mutant metastatic pancreatic ductal adenocarcinoma (PDAC), prompting...
Wireless eye implant... blind patients read again
A wireless subretinal implant (PRIMA) restored functional central vision in a clinical study of patients with geographic atrophy, enabling reading of short words and numbers after years of...
Petrelintide meets endpoints — but weight loss lags expectations
Roche and Zealand Pharma reported Phase 2 results for petrelintide, an amylin receptor‑targeting peptide, meeting trial endpoints with tolerability comparable to placebo but producing average...
Study maps new HIV‑1 resistance routes to lenacapavir
Researchers published novel pathways by which HIV‑1 can evolve resistance to lenacapavir, a long‑acting capsid inhibitor, documenting recurrent and unique mutational routes in Nature...
High‑throughput DnD assay reveals hidden antibiotic resistances
A team led by Ma and Kim published a dilution‑and‑delay (DnD) susceptibility assay in Nature Communications that detects low‑frequency or time‑dependent antibiotic resistance missed by standard...
ITK targeting ramps up anti‑CD19 CAR‑T potency
Researchers disclosed that targeting interleukin‑2‑inducible T‑cell kinase (ITK) enhances the efficacy of anti‑CD19 CAR‑T cells by remodeling T‑cell signaling and function. The preclinical work...
DNA‑repair defects alter chemotherapy outcomes in metastatic PDAC
New research links DNA repair gene alterations to differential efficacy of combination chemotherapies in metastatic pancreatic ductal adenocarcinoma (PDAC). The study shows that tumors with...
Video AI quantifies Parkinson’s finger‑tapping motor signs
Researchers introduced a video‑based system that quantifies finger‑tapping performance in Parkinson’s disease using interpretable computer vision and machine‑learning readouts. The tool delivers...
uniQure and FDA... Sham-surgery demand fuels stock roller-coaster
uniQure’s experimental Huntington’s gene therapy AMT-130 remains at the center of an escalating regulatory standoff with the U.S. Food and Drug Administration. The FDA signaled that data from...
Daraxonrasib... 47–55% ORR pushes RAS drug toward Phase 3
Revolution Medicines’ daraxonrasib (RMC-6236) produced objective response rates near 47% in a first-line cohort of RAS-mutant metastatic pancreatic ductal adenocarcinoma (PDAC), according to...
Roche, Zealand: Obesity peptide meets Phase 2 goals – weight loss under expectations
Roche and Zealand Pharma reported that petrelintide, a peptide amylin-receptor agonist, met the primary endpoints in a Phase 2 obesity study with tolerability comparable to placebo. The trial...
Lenacapavir resistance pathways mapped: HIV finds new escape routes
Researchers published a Nature Communications study mapping recurrent and novel HIV-1 evolutionary pathways that confer resistance to lenacapavir, the long-acting capsid inhibitor. The team, led...
Dilution-and-delay assay... High-throughput detection exposes hidden antibiotic resistance
A Nature Communications paper from Ma and Kim introduces the dilution-and-delay (DnD) susceptibility assay, a high-resolution, high-throughput method designed to detect low-frequency or inducible...
ITK targeting... Rewiring T cells to boost anti‑CD19 CAR‑T potency
Researchers reported that inhibition or genetic targeting of interleukin-2–inducible T-cell kinase (ITK) improves the potency and persistence of anti-CD19 CAR‑T cells in preclinical models. The...
DNA repair mutations reshape PDAC chemo response — biomarker implications
A new study shows that tumor-intrinsic DNA repair gene alterations modulate response to combination chemotherapy in metastatic pancreatic ductal adenocarcinoma (PDAC). Investigators analyzed...
AI mines mammograms: routine screens flag future heart disease risk
A study in the European Heart Journal adapted AI to quantify breast arterial calcification (BAC) on routine mammograms and demonstrated that BAC measurements predict cardiovascular disease risk,...
World’s tiniest robot... sub‑millimeter machines promise biomedical applications
University of Pennsylvania researchers built a sub-millimeter robot with onboard sensors, an actuator, and a microcontroller; the devices are solar-powered, can move through fluids via...
The age of animal experiments may be waning: NAMs scale up
Policy moves from the UK, the U.S. FDA and the NIH, alongside major investments in China, are accelerating a shift away from traditional animal testing toward new-approach methodologies (NAMs)...