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Medscape
3 hours ago
- Medscape
Could Consumption of UPFs Up Lung Cancer Risk?
Individuals who ate more ultra-processed foods (UPFs) had a significantly higher risk for lung cancer over 12 years than those who ate fewer UPFs, based on new data from more than 100,000 adults in an observational study. Cigarette smoking is a known contributor to lung cancer, but diet also is known to play a role; however, data on the impact of UPFs in particular on lung cancer risk remain unclear, Kanran Wang, MD, of Chongqing Cancer Hospital, Chongqing, China, and colleagues wrote. In a study published in Thorax, the researchers reviewed data from 101,732 adults enrolled in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial, a randomized trial of screening tests for lung, prostate, colorectal, and ovarian cancers from 10 centers across the US. The primary endpoint was the incidence of lung cancer. In a multivariate analysis, individuals in the highest quartile of UPF consumption were 41% more likely to develop lung cancer than those in the lowest quartile of consumption (hazard ratio [HR], 1.41); risk also was higher for both non-small cell lung cancer (NSCLC) (HR, 1.37) and small cell lung cancer (SCLC) (HR, 1.44). These results remained statistically significant after a large range of subgroup and sensitivity analyses, including age, sex, and family history of lung cancer. UPF consumption was based on the Food Frequency Questionnaire, and foods were classified by dietitians into four categories of processing as unprocessed or minimally processed, processed culinary ingredients, processed foods, and UPF, based on the NOVA criteria. The mean age of the study population at baseline was 62.5 years. The mean energy-adjusted UPF consumption was 2.8 servings/d, with mean servings for the lowest and highest intake quarters of 0.5 and 6.0, respectively. Approximately half of the participants in each quarter were current or ever-smokers. The researchers identified 1706 lung cancer cases over a mean follow-up of 12.2 years, including 1473 cases of NSCLC and 233 cases of SCLC. Potential explanations for the association between UPF and lung cancer include the impact of nutritional components of UPF including high sodium, saturated fats, added sugar, and low fiber, the researchers noted. Overall, lunchmeat was the greatest contributor to UPF (11%) following by caffeinated soft drinks (diet and regular) and decaffeinated soft drinks (diet and regular), which each accounted for approximately 7% of UPF intake. The researchers acknowledged the study limitations, including the observational design, limited number of incident events, relatively homogenous study population, and use of self-reports. However, they concluded that if the findings are confirmed in other studies, limiting trends of UPF intake globally could help reduce the overall burden of lung cancer. In addition, 'future studies should elucidate potential molecular mechanisms and increase understanding of the observed associations,' the researchers wrote. Caveats Abound, Experts Say Several experts weighed in with comments that were published online in the Science Media Centre. Although the study was well-conducted, limitations include the study population of only adults aged 55-74 years in the US, therefore the results may not be relevant to younger individuals in other countries, said Rachel Richardson, acting head of methods support, The Cochrane Collaboration, in an editorial section accompanying the study. In addition, dietary habits also change considerably over the course of long-term studies; therefore, 'it is difficult to directly conclude that lung cancer is related to the level of UPF consumption alone given it was only declared at the start of the study,' wrote Sam Hare, MD, a consultant chest radiologist at Royal Free London NHD Trust. 'The most obvious confounding factor here is smoking, which is well-known to cause a greatly increased risk of lung cancer,' wrote Adam Jacobs, MD, executive director and strategic consultant, biostatistics, Ergomed. 'If people with high UPF consumption smoked more than people with low UPF consumption, then that difference in smoking could easily lead to the observed results,' he said. The researchers' efforts to adjust for smoking was limited by the use of only two categories (current/former smokers and nonsmokers) and the use of self-reports, he said. Study Has Merit, but More Work Is Needed There was ample justification to conduct a study on the link between UPF and lung cancer, as prior evidence on this association was limited and inconsistent, said Jamie Garfield, MD, professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview. 'Given the global rise in UPF consumption and the high burden of lung cancer, clarifying this relationship is important for public health and cancer prevention strategies,' said Garfield, who was not involved in the study. Strengths of this study include the large, well-characterized population, pathologic confirmation of lung cancer, and comprehensive adjustment for confounders such as smoking, diet quality, and demographic factors, she said. The findings of a statistically significant association between higher UPF intake and increased risk for lung cancer (including both NSCLC and SCLC), were not surprising, as similar associations have been observed for other cancer types and chronic diseases, Garfield told Medscape Medical News . 'However, the magnitude and consistency of the association across subgroups, and the observation that the risk persisted after adjustment for smoking and diet quality, are notable and reinforce the plausibility of a direct link,' she said. The findings were limited by the observational design that prevents conclusions of causality, especially from unmeasured smoking intensity, said Garfield. Additionally, the single dietary assessment at baseline only may not capture dietary changes over time and could lead to misclassification of UPF intake bias, she noted. Other limitations included the use of a validated food frequency questionnaire not designed to align with the NOVA classifications, and the use of a mainly non-Hispanic White study population, Garfield said. Despite the limitations, the study findings are worthwhile and have potential implications for clinical practice, Garfield told Medscape Medical News . 'They support dietary counseling to limit UPF intake as part of cancer prevention,' she said. However, 'Further research in more diverse populations and with repeated dietary measures is needed to confirm causality and clarify mechanisms,' she added. This study was funded by the Chongqing University Cancer Hospital, Chongqing, China, and received grants from the Chongqing Talent Plan, Chongqing Shapingba District Technological Innovation Project. The researchers disclosed no financial conflicts of interest. The Science Media Centre commentators disclosed no financial conflicts of interest.
Yahoo
4 hours ago
- Yahoo
Ocugen, Inc. Announces Positive Scientific Advice from the European Medicines Agency Related to the Approval Pathway for OCU410ST—Modifier Gene Therapy for Stargardt Disease
MALVERN, Pa., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the study design, endpoints and planned statistical analysis of the ongoing pivotal confirmatory OCU410ST Phase 2/3 GARDian3 clinical trial for Stargardt disease and provided acceptability of a single U.S.-based trial for submission of a Marketing Authorization Application (MAA). EMA provided this opinion based on safety and tolerability that OCU410ST demonstrated in the Phase 1 GARDian trial, including 48% slower lesion growth and statistically significant (p=0.031) and clinically meaningful improvement of nearly 2-line/9-letter gain in best corrected visual acuity (BCVA) at 12-month follow-up in evaluable treated eyes compared to untreated eyes. The Phase 2/3 study will enroll 51 participants diagnosed with Stargardt disease. Of these, 34 will receive a one-time subretinal injection of OCU410ST (200 μL at a concentration of 1.5 × 10¹¹ vector genomes/mL) in the eye with poorer visual acuity, while 17 will be assigned to an untreated control group. The unique adaptive design of this trial includes a masked interim analysis of 24 subjects in the study (16 in treatment group and 8 in control group) at 8 months. The primary objective of the trial is to evaluate the reduction in atrophic lesion size. Key secondary endpoints include improvements in BCVA and low luminance visual acuity (LLVA), compared to controls. Data from the one-year follow-up will be used to support the Company's planned Biologics License Application (BLA) and MAA in the EU. 'This positive opinion endorses a single trial as the basis for both BLA and MAA submissions and brings us closer to providing a one-time, modifier gene therapy to approximately 100,000 Stargardt patients in the U.S. and Europe combined,' said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. 'We are very encouraged about the prospect of addressing the unmet medical need that exists for these patients who currently have no approved treatment options available to them.' The EMA opinion is an extremely favorable outcome, as it will potentially reduce the time and cost to gain marketing authorization in the EU. Alignment with the EMA follows recent important milestones for the OCU410ST program, including Rare Pediatric Disease Designation (RPDD) in May, IND clearance in June, and first patient dosing in July. With enrollment scheduled to be complete in the first quarter of 2026 the Company remains on track for a BLA filing in the first half of 2027, aligned with its goal of three BLAs in the next three OCU410STOCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR-Related Orphan Receptor A) gene. It represents Ocugen's modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathophysiological pathways linked to Stargardt disease, such as lipofuscin formation, oxidative stress, complement formation, inflammation, and cell survival networks. About Stargardt DiseaseStargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula. Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease. About Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient's lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at and follow us on X and LinkedIn. Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as 'predicts,' 'believes,' 'potential,' 'proposed,' 'continue,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'intends,' 'may,' 'could,' 'might,' 'will,' 'should,' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled 'Risk Factors' in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release. Contact:Tiffany HamiltonAVP, Head of in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Bloomberg
5 hours ago
- Bloomberg
Zero: The Race to Shrink Reactors, Grow Nuclear Power
Electricity demand is soaring, and some think the answer isn't building bigger, but smaller. That's the idea behind small modular reactors (SMRs): shrink a large and hard-to-build reactor to something that is, in theory, more manageable, cheaper and easier to replicate. These are early days for SMRs, with only two in commercial operation in Russia and China. Can SMRs ever become a solution for our energy needs and climate goals? Nuclear scientist and venture capitalist Rachel Slaybaugh joins Akshat Rathi on Zero to discuss.
