Topic
Staged human studies that establish whether a drug, device or diagnostic works well enough to be used in routine care.
argenx says its intravenous drug FB102 preserved more intestinal lining than placebo in a 126-patient phase 2 celiac disease trial. The readout is topline and not yet peer-reviewed, and ScienceAlert's report does not say how large the difference was.
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Merck and Moderna are preparing to file their personalized mRNA melanoma vaccine after a Phase 3 trial showed it delayed recurrence. At the STAT Summit, executives said the next task is showing it works in other tumors, and that they must pick where to look first.
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USC Norris Comprehensive Cancer Center has started a Phase 1 trial of a blood test used alongside mammograms to find breast cancer as early as Stage I. No results have been reported, and the stated measure is accuracy against patients' diagnoses.
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Four of eight patients tested consistently detected a notebook through optogenetic goggles after one gene injection, a 10-person NEJM trial reports. The therapy targets surviving ganglion cells, so it need not match any of 100-plus disease genes, but ScienceAlert's account does not break results out by gene.
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Laurel Morris's team at Mount Sinai reported that one neurofeedback session improved mood in people with depression more than sham feedback did. It lasted into the next day, was gone at one week, and came without a significant difference in activity in the targeted region.
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Retatrutide's 12 mg dose cut body weight 25% over 80 weeks, versus 3.9% on placebo, in a 2,339-adult phase 3 trial in NEJM. Its near-30% two-year figure comes from 532 completers, and because placebo was the only comparator, the trial cannot rank the drug against Ozempic.
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Eli Lilly's retatrutide cut body weight by more than 20% on average at its top dose in an 80-week phase 3 trial of 1,152 people with type 2 diabetes. Lilly calls that a first for the field, and it gives the four- and five-receptor drugs now in development a figure to beat in patients with diabetes.
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Nature's editors want AI medical devices tested in real clinics, noting that just 19 of some 4,600 clinical AI papers were prospective randomized trials. Until the FDA decides, hospitals need to check whether a vendor's accuracy figure came from real patients or from a simulation.
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United Therapeutics is sponsoring the first xenotransplant clinical trial. Its first patient got a 10-edit pig kidney at NYU Langone in November. The longest a gene-edited pig kidney has worked in a person is 271 days, against years or decades for a human donor organ.
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A Beijing team turned one woman's fat cells into pancreatic islets, and within two months she stopped needing insulin injections. Nearly three years of steady blood sugar is the longest result reported, in a single patient.
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Two former commissioners, writing before Heidi Overton's Senate hearing on Thursday, argue that FDA review capacity now decides where new medicines reach patients first. Their evidence is a count of trial starts.
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Researchers at Mount Sinai counted drug trials collecting wearable data on ClinicalTrials.gov, and ten years of growth turned out to be gradual, with the researchers quoted by Nature split on whether sensor capability or validation work is the holdup.
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A City of Hope team reports catching stage 1 and 2 pancreatic cancer from a three-marker blood score. The trial does not settle what a positive means in the high-risk groups a screening programme would enrol first.
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