The 2012 safe harbour for 3Rs data was barely used. The replacement is a voluntary pilot that takes submissions independently of a marketing application, running until the third quarter of 2027.
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ANALYSISAcross 24 official German licensing exams, the best model answered 99.31% of first-exam items correctly. On items containing an image, the error rate rose several-fold, against 1.24x for students.
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WHAT THE STUDY ACTUALLY SAYSA 740,744-child natural experiment tested a decade-old hypothesis that rotavirus vaccine might prevent type 1 diabetes. It found no protective effect — and no evidence of harm either.
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WHAT THE STUDY ACTUALLY SAYSA 293-woman Dutch trial found more women reported improvement at 12 months with perioperative oestriol cream than placebo. Anatomical success, surgical success and reintervention were unchanged.
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ANALYSISA UK survey of 26,322 urban adults finds a small but consistent life-satisfaction gain from neighbourhood greenery. A Stockholm study of 46,282 shows who ends up living without it.
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WHAT THE STUDY ACTUALLY SAYSThe ODDESSI trial ran in 30 clusters across five NHS trusts in England. Time to relapse was unchanged; inpatient admission, re-referral and service-user ratings all moved in Open Dialogue's favour.
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A national survey finds treatment volumes above 2021 levels and linear accelerators replacing cobalt-60 units. Nearly every department still using cobalt says replacing the source is now unfeasible.
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England's A&E departments handled 2.5 million attendances in July alone. Nursing staff say wards without air conditioning are becoming an occupational-safety problem, not just a patient-comfort one.
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429 cases across nine countries, and a mosquito species that transmits two other viruses now established in 16 European countries — double the number from twelve years ago.
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THE HEAT MAPResearchers modelled 854 European cities under the climate that exists and the one that would have existed without human warming. The attributable share rose from 45% to 64%.
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ECDC data show near-zero hepatitis B in under-fives and vertical transmission below 2%, alongside five million chronic infections and only seven countries meeting the harm-reduction benchmark.
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ANALYSISA comparative survey finds four European countries still rely on opportunistic screening, and that where family doctors are most involved, participation tends to be lower — not higher.
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WHAT THE STUDY ACTUALLY SAYSA registry study spanning 4.9 million people separates where the most deaths occur from where the inequality is largest. Heart disease and lung disease give different answers.
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THE DRUG DOCKETThe CHMP's June meeting recommended pulling avacopan from the EU market on data-integrity grounds, refused three cell and biological therapies, and reversed itself on a Rett syndrome drug it had earlier rejected.
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WHAT THE STUDY ACTUALLY SAYSA registry snapshot of 13,455 adults measures how far the biologic era has moved severe asthma toward remission, and finds the inflammation these drugs target still detectable in most patients.
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WHAT THE STUDY ACTUALLY SAYSA burden-of-disease calculation built on EU noise-mapping data puts numbers on two outcomes that noise research has mostly ignored. The confidence intervals are as informative as the estimates.
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WHAT THE STUDY ACTUALLY SAYSData from 20 European countries covering 2014 to 2024 tracks lung function, nutrition and infection through the arrival of triple modulator therapy — and the new complications arriving with age.
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WHAT THE STUDY ACTUALLY SAYSSwitzerland allows limited psilocybin use for treatment-resistant depression. A review of 19 patients found meaningful improvement, but remission in barely a fifth to a quarter.
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ANALYSISThe ESC Atlas reports 68 million disability-adjusted life years and more than three million cardiovascular deaths a year, with middle-income countries carrying roughly double the mortality of high-income ones.
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ANALYSISA cross-sectional analysis of NICE evaluations found 78 supporting studies behind 30 technologies — and consistent holes in comparators, cost of delivery and adverse-event reporting.
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ANALYSISAn econometric analysis of the 2019 European Health Interview Survey prices smoking-attributable inpatient and daycare hospitalisation across the EU — deliberately excluding every other kind of care.
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THE DRUG DOCKETThe CHMP backed tolebrutinib for non-relapsing secondary progressive multiple sclerosis, a population with no prior disability-targeting treatment. The trial showed a 31% delay in progression.
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An analysis across the Premier League, La Liga, Serie A, Bundesliga and Ligue 1 found economic losses from player injuries topped 730 million euros in a season, with hamstrings hit hardest.
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WHAT THE STUDY ACTUALLY SAYSThe LiverScreen project ran transient elastography across nine countries, then sent everyone who screened positive to a hepatologist. The gap between the two numbers is the interesting part.
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THE DRUG DOCKETThe European Medicines Agency's March meeting produced five positive opinions, three of them for orphan-designated cancer and rare-disease treatments already available in some other markets.
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WHAT THE STUDY ACTUALLY SAYSA survey-based analysis of the European Health Interview Survey puts a price on Europe's obesity-related hospital use, and finds the strongest single association is not with obesity at all.
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ANALYSISTen years of national anti-doping reports show NSAID declarations flat at about 45%, a significant shift away from COX-2 selective drugs, and glucocorticoids making up around 13% of all prohibited-substance findings.
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WHAT THE STUDY ACTUALLY SAYSA Swedish birth cohort of 2.76 million people found the cumulative male-to-female ratio for autism incidence had fallen to 1.2 by age 20 — and projects parity by 2024.
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WHAT THE STUDY ACTUALLY SAYSSeven seasons of records on 569 students found 9.0 injuries per 1,000 exposure days in the upper school. Most injuries came on gradually, and a quarter were recurrences.
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ANALYSISThe PROP OA trial found a 3.39-point gain on a 100-point score at six months. The effect on pain was larger than the effect overall, and both diminished by twelve months.
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ANALYSISIn 105,260 people followed for 7.6 years, higher intakes of sorbates, sulfites, nitrates and acetates tracked with modestly higher cancer incidence. This is an observational study of self-reported diets.
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ANALYSISAn 11,018-measurement study in 24 English intensive care units found false negative rates up to 35.3 percentage points higher in patients with darker skin tones. A neonatal study published two days later did not.
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ANALYSISHousehold cure rates were 88.5 percent with permethrin against 71.8 percent with ivermectin. The trial set out to show ivermectin was non-inferior and found the opposite.
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Twelve years of English primary care records put a price on weather. The heat effect is loud and short; the cold effect is quiet, cumulative, and much larger.
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WHAT THE STUDY ACTUALLY SAYSA ten-season analysis of 3,750 matches quantifies the load argument footballers have been making. It also states plainly what it cannot show: anything about injury.
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ANALYSISGermany's DINKS trial is one of the largest randomised tests of a reimbursable digital therapeutic. The effect is big, the comparator is usual care alone, and the sponsor made the app.
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ANALYSISEngland ran the closest thing to a national test of clinical AI anyone has published. The software sites gained more, but the comparison sites were improving on their own, and that gap is the whole result.
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WHAT THE STUDY ACTUALLY SAYSNearly a million conscripts followed for three decades: obesity carried a 3.1-fold hazard for sepsis, and high cardiorespiratory fitness was associated with a 42% lower risk of dying from bacterial infection.
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THE DRUG DOCKETThe CHMP's November meeting produced ten positive opinions. Two of them — teplizumab and a Telethon-sponsored gene therapy — address conditions the EU has had no authorised treatment for.
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WHAT THE STUDY ACTUALLY SAYSA within-individual analysis of 505,474 people in Finland and Sweden found lower psychiatric hospitalisation on clozapine in every disorder studied except borderline personality disorder, with no excess mortality signal.
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THE HEAT MAPResearchers tested heat-mortality forecasts against the European summers of 2022 and 2023. The skill pattern is not the one a warning system designer would have guessed.
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ANALYSISThe trial was designed to test non-inferiority against traditional dietary advice. It found superiority instead, with 62% versus 42% achieving a clinical response over six weeks.
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THE DRUG DOCKETTwo trials showed more deaths on voxelotor than placebo. The registry data that triggered the 2024 precautionary suspension did not confirm the original signal — the trials did something worse.
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THE DRUG DOCKETBrensocatib cleared CHMP on an accelerated timetable with a 19.4% cut in exacerbation rate. The same October meeting issued a negative opinion on belumosudil and kept a sickle cell drug suspended.
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WHAT THE STUDY ACTUALLY SAYSIn 24,223 Swedish workers followed to 2018, insomnia and long sleep raised cardiovascular risk only when accompanied by daytime impairment — and rising sleep duration preceded disease.
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WHAT THE STUDY ACTUALLY SAYSFourteen Swedish primary care patients were interviewed alongside a trial of nurse-led group sleep restriction therapy. Depression and life circumstances were what got in the way.
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WHAT THE STUDY ACTUALLY SAYSLoneliness tracked with depression, perceived stress, psychotic-like experiences and suicidal ideation. A prevalence that high raises a question about what the measure is capturing.
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WHAT THE STUDY ACTUALLY SAYSOver 17.4 years, high ultra-processed food intake was linked to a 24% higher colorectal cancer risk overall — and a 58% higher risk for right-sided colon cancer specifically.
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WHAT THE STUDY ACTUALLY SAYSAcross 20,121 adults and 25 years of registry data, morningness markers predicted lower educational attainment but also lower odds of the bottom income quintile. Effects were absent in women.
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Seven of those nine were denosumab. The committee's September opinions also covered an RSV antibody for infants, a first EU treatment for IgG4-related disease, and four withdrawn applications.
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WHAT THE STUDY ACTUALLY SAYSIn 99 men hospitalised for stress-related disorders, roughly four in five met probable criteria for trauma-associated sleep disorder — a condition that is not yet a recognised diagnosis.
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THE HEAT MAPA 50-year attribution study separates two trends that usually get modelled as one: rising temperatures and a population that has become less likely to die in them.
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WHAT THE STUDY ACTUALLY SAYSA UK-wide survey found cognitive and psychological symptoms outranked the ones menopause care is organised around, with higher ratings among Asian and Black respondents.
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WHAT THE STUDY ACTUALLY SAYSA French prospective cohort followed adults with rare genetic obesity treated with the MC4R agonist in routine care. Weight fell about 20% in the first year and hunger scores dropped 62%.
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EXPLAINERAn EMAS clinical guide sets out how to manage endometriosis after menopause, advising against oestrogen-only hormone therapy even in women who have had a hysterectomy.
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ANALYSISA Spanish trial in 4,746 adults compared an energy-reduced Mediterranean diet plus exercise against the same diet eaten freely. Over six years the absolute gap was 12.0% versus 9.5%.
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ANALYSISA 15-city study found a pooled relative risk of exactly 1.00 for heat warnings. Adjusting for green space, population and density turned it into 0.85. Both numbers are in the same paper.
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ANALYSISFifty-five English adults ate two eight-week diets that both followed the UK Eatwell Guide. Both produced weight loss. The minimally processed version produced about one percentage point more.
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ANALYSISTwo BMJ reviews found high-risk usability problems in 18 of 30 tests, and use judged contrary to evidence-based guidance for 11 of the 19 conditions covered.
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WHAT THE STUDY ACTUALLY SAYSIn 270 patients whose voices persisted despite antipsychotics, the therapy beat matched clinical contact on hallucination severity by 2.26 points — significant, with a Cohen's d of 0.27.
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