Latest news with #669
Boston Globe
04-05-2025
- Health
- Boston Globe
Trump administration slashes research into LGBTQ+ health
Of the 669 grants that the National Institutes of Health had canceled in whole or in part as of early May, at least 323 — nearly half of them — related to LGBTQ+ health, according to a review by the Times of every terminated grant. Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up Federal officials had earmarked $806 million for the canceled projects, many of which had been expected to draw more funding in the years to come. Advertisement Scores of research institutions lost funding, a list that includes not only White House targets such as Johns Hopkins University and Columbia University, but also public universities in the South and the Midwest, including Ohio State University and the University of Alabama at Birmingham. At Florida State University, $41 million worth of research was canceled, including a major effort to prevent HIV in adolescents and young adults, who experience one-fifth of new infections in the United States each year. Advertisement In termination letters over the past two months, the NIH justified the cuts by telling scientists that their LGBTQ+ work 'no longer effectuates agency priorities.' In some cases, the agency said canceled research had been 'based on gender identity,' which gave rise to 'unscientific' results that ignored 'biological realities.' Other termination letters told scientists their studies erred by being 'based primarily on artificial and nonscientific categories, including amorphous equity objectives.' The cuts follow a surge in federal funding for LGBTQ+ research over the past decade, and active encouragement from the NIH for grant proposals focused on sexual and gender minority groups that began during the Obama administration. President Trump's allies have argued that the research is shot through with ideological bias. 'There's been a train of abuses of the science to fit a preconceived conclusion,' said Roger Severino of the Heritage Foundation, the conservative think tank that helped formulate some Trump administration policies. 'And that was based on an unscientific premise that biology is effectively irrelevant, and a political project of trying to mainstream the notion that people could change their sex.' Scientists said canceling research on such a broad range of illnesses related to sexual and gender minority groups effectively created a hierarchy of patients, some more worthy than others. 'Certain people in the United States shouldn't be getting treated as second-class research subjects,' said Simon Rosser, a professor at the University of Minnesota whose lab was studying cancer in LGBTQ+ people before significant funding was pulled. 'That, I think, is anyone's definition of bigotry,' he added. 'Bigotry in science.' The White House and the Department of Health and Human Services did not respond to requests for comment. Advertisement Andrew Nixon, a spokesperson for the health department, told The Daily Signal, a conservative publication, last month that the move 'away from politicized DEI and gender ideology studies' was in 'accordance with the president's executive orders.' The NIH said in a statement: 'NIH is taking action to terminate research funding that is not aligned with NIH and HHS priorities. We remain dedicated to restoring our agency to its tradition of upholding gold-standard, evidence-based science.' The LGBTQ+ cuts ended studies on antibiotic resistance, undiagnosed autism in sexual minority groups, and certain throat and other cancers that disproportionately affect those groups. Funding losses have led to firings at some LGBTQ+-focused labs that had only recently been preparing to expand. The NIH used to reserve grant cancellations for rare cases of research misconduct or possible harm to participants. The latest cuts, far from protecting research participants, are instead putting them in harm's way, scientists said. They cited the jettisoning of clinical trials, which have now been left without federal funding to care for volunteer participants. 'We're stopping things that are preventing suicide and preventing sexual violence,' said Katie Edwards, a professor at the University of Michigan, whose funding for several clinical trials involving LGBTQ+ people was canceled. The Times sought to understand the scale of terminated funding for LGBTQ+ medical research by reviewing the titles and, in many cases, research summaries for each of the 669 grants that the Trump administration said it had canceled in whole or in part as of early May. Advertisement Beyond grants related to LGBTQ+ people and the diseases and treatments that take a disproportionate toll on them, the Times included in its count studies that were designed to recruit participants from sexual and gender minority groups. It excluded grants related to illnesses like HIV that were focused on non-LGBTQ+ patients. While the Times examined only NIH research grants, the Trump administration is also ending or considering ending LGBTQ+ programs elsewhere in the federal health system. It has proposed, for example, scrapping a specialized suicide hotline for LGBTQ+ young people. The research cuts stand to hollow out a field that in the last decade had not only grown larger, but also come to encompass a wider range of disease threats beyond HIV. Already, scientists said, younger researchers are losing jobs in sexual and gender minority research and scrubbing their online biographies of evidence that they ever worked in the field. Five grants obtained by Brittany Charlton, a professor at the Harvard School of Public Health, have been canceled, including one looking at sharply elevated rates of stillbirths among LGBTQ+ women. Ending research on disease threats to gender and sexual minority groups, she said, would inevitably rebound on the entire population. 'When other people are sick around you, it does impact you, even if you may think it doesn't,' she said. This article originally appeared in
Business Wire
29-04-2025
- Health
- Business Wire
AUA 2025: New Data from Post-Hoc Analyses Shared on Ultra-Low Prostate-Specific Antigen (PSA) Response in Patients with Metastatic Hormone-Sensitive Prostate Cancer Receiving NUBEQA ® (darolutamide) plus Androgen Deprivation Therapy (ADT)
WHIPPANY, N.J.--(BUSINESS WIRE)--New post-hoc analyses from the investigational Phase III ARANOTE trial showed that patients receiving NUBEQA ® (darolutamide) plus androgen deprivation therapy (ADT) were more likely to experience an ultra-low (<0.02 ng/mL) prostate specific androgen (PSA) response (42.6%) at any time versus patients receiving placebo plus ADT (7.8%), with ultra-low response rates in the NUBEQA group being higher than in the placebo group regardless of baseline PSA. 1 The post-hoc analyses from the pivotal ARANOTE trial also showed that in patients receiving NUBEQA plus ADT, achieving ultra-low PSA response correlated with prolonged radiographic progression-free survival (rPFS) time (HR 0.09; 95% CI: 0.05–0.16), time to metastatic castration-resistant prostate cancer (mCRPC) (HR 0.07; 95% CI: 0.04–0.11) and time to PSA progression (HR 0.02; 95% CI: 0.01–0.05). 1 The safety profile of NUBEQA was independent of PSA response, with lower treatment discontinuation rates due to treatment emergent adverse events (TEAEs) in patients receiving NUBEQA plus ADT versus placebo. 1 The results were presented today at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada. NUBEQA is indicated in the U.S. for the treatment of adult patients with mHSPC in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC). 2 Prostate cancer is the second most common cancer in men. 3 Only 30% of those diagnosed with mHSPC will survive five years or more after diagnosis. 4 Most people with mHSPC eventually progress to mCRPC, a condition with limited long-term survival. 5,6 'The subgroup analyses of the ARANOTE trial contribute to the valuable insights of the management of metastatic hormone-sensitive prostate cancer and equip physicians with additional data to help inform treatment options,' said Dr. Neal Shore, Medical Director, Carolina Urologic Research Center and Urologist at AUC Urology Specialists, Myrtle Beach, South Carolina. "At Bayer, we are committed to redefining prostate cancer care and enhancing patient outcomes at various stages of the disease. The growing evidence supporting NUBEQA reinforces its potential to meet the needs of men with prostate cancer," said Christine Roth, Global Head of Product Strategy and Commercialization at Bayer's Pharmaceuticals Division. 'These data add to the meaningful insights from the ARANOTE trial which can be leveraged by physicians to inform clinical decisions, helping them to identify the right treatment options for their patients living with prostate cancer.' About the ARANOTE Trial 7 The ARANOTE trial (NCT04736199) is a Phase III, randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of NUBEQA in combination with standard ADT in patients with mHSPC. A total of 669 patients were randomized 2:1 to receive either 600 mg of NUBEQA (n=446) or placebo (n=223) twice daily in addition to ADT. The primary endpoint of the ARANOTE trial was rPFS, which was statistically significant for the NUBEQA arm vs placebo arm (HR: 0.54; 95% CI: 0.41-0.71; P < 0.0001), measured as time from randomization to date of first documented radiological disease progression or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (OS; time to death from any cause), time to first castration-resistant event, time to initiation of subsequent anti-cancer therapy, time to PSA progression, PSA undetectable rates, time to pain progression, and safety assessments. Initial results from pivotal Phase III ARANOTE trial (n=669), published in The Journal of Clinical Oncology and presented at the 2024 European Society for Medical Oncology (ESMO) Congress, demonstrated a statistically significant improvement in rPFS with a 46% reduction in the risk of radiologic progression or death (HR 0.54; 95% CI: 0.41-0.71; P<0.0001) compared to placebo plus ADT. 8 About NUBEQA ® (darolutamide) 2 NUBEQA ® (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. NUBEQA is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: Non-metastatic castration-resistant prostate cancer (nmCRPC) Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel IMPORTANT SAFETY INFORMATION Warnings & Precautions Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA vs. 0.2% receiving placebo. In a study of patients with mHSPC (ARASENS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel vs. 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel vs. 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease. Seizure – In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving NUBEQA vs. 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of patients receiving NUBEQA with docetaxel, including one Grade 3 event, vs. 0.2% receiving placebo with docetaxel. Seizure occurred 38 to 340 days after initiation of NUBEQA. It is unknown whether antiepileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment. Embryo-Fetal Toxicity – Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose. Adverse Reactions In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA vs. 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA vs. 3.2% of patients receiving placebo. Fatal adverse reactions in patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common adverse reactions (>2% with a ≥2% increase over placebo), including laboratory test abnormalities, were increased AST, decreased neutrophil count, fatigue, increased bilirubin, pain in extremity and rash. Clinically relevant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease and heart failure. In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel vs. 42% of patients receiving placebo with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), decreased neutrophil count (2.8%), musculoskeletal pain (2.6%), and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel vs. 4% of patients receiving placebo with docetaxel. Fatal adverse reactions in patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with docetaxel) were constipation, rash, decreased appetite, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures, ischemic heart disease, seizures, and drug-induced liver injury. Drug Interactions Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use. Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed. Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate. NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates. Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA. For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information. About Metastatic Hormone-Sensitive Prostate Cancer Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide. 3.9 In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, including almost 300,000 cases in the U.S., and about 375,000 died from the disease worldwide. 10,11 At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately 10% of men will already present with mHSPC when first diagnosed. 12,13,14 Men with mHSPC will start their treatment with hormone therapy, such as ADT, androgen receptor inhibitor (ARi) plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mHSPC will eventually progress to mCRPC, a condition with limited survival. 5,6 About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 'Health for all, Hunger for none,' the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to © 2025 Bayer BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer. Find more information at Our online press service is just a click away: Follow us on Facebook: Follow us on X: Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References Shore N et al. Ultra-low PSA Response (<0.02 ng/mL) With Darolutamide Plus ADT in ARANOTE Correlates With Greatly Improved Clinical Outcomes. Abstract IP26-07. Presented at AUA 2025. NUBEQA® (darolutamide) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; October 2023. Bray F et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. Accessed: March 2025. Ng, K et al. Oncol Ther. 2020;8:209–230. Siegel DA et al. MMWR Morb Mortal Wkly Rep. 2020;69:1473–1480. Hahn AW et al. Am Soc Clin Oncol Educ Book. 2018 May 23;38:363-371. NCT04736199. Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE). Accessed: March 2025. Journal of Clinical Oncology ( Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial. September 2024. Hyuna S et al. Ca Cancer J Clin 2021; 71:209–249. Prostate Cancer: Statistic. Accessed: March 2025. American Cancer Society. Cancer Facts & Figures 2024. Accessed: March 2025 Piombino C et al. Cancers (Basel). 2023 Oct 11;15(20):4945. Helgstrand JT et al. Cancer. 2018;124(14):2931-2938. Buzzoni C et al. Eur. Urol. 2015;68:885–890.
Gulf Today
24-03-2025
- Business
- Gulf Today
Enoc achieves Dhs395 million in energy savings
Enoc Group recorded remarkable success in energy reduction through comprehensive Energy & Resource Management (E&RM) activities across its operations. Driving resilience through sustainable economic growth, the Group saved Dhs395 million in total energy from 2014 to 2024, mitigating 703,840 metric tonnes of greenhouse gas emissions. As part of its long-term commitment to environmental responsibility, Enoc joined millions around the world in observing Earth Hour 2025, switching off non-essential lights at its headquarters, operational facilities, and service stations on March 22nd from 8.30pmto 9.30pm. Saif Humaid Al Falasi, Group CEO of Enoc, said, 'Earth Hour is a powerful reminder of the urgency for collective action to ensure tangible results in combating environmental challenges. Enoc Group remains steadfast in its commitment to promoting sustainable development initiatives and raising awareness about optimising energy consumption in the UAE and beyond.' In 2024, Enoc business units achieved substantial savings through targeted energy efficiency initiatives. Enoc Processing Company (EPCL) spearheaded these efforts, saving Dhs2,314,669 through various energy and resource management initiatives. The Retail unit made a significant contribution with the implementation of key projects such as the integration of Solar PV LED Lights in the Retail Operations Management & AutoPro sites, resulting in a combined saving of Dhs3,115,294. Enoc's Corporate Real Estate (CRE), and Emirates Gas further contributed to the Group's success, respectively achieving savings of Dhs539,448 and Dhs139,409. Enoc's commitment to sustainability is evident in its portfolio of successful initiatives spanning water conservation, renewable energy, and energy efficiency. These include Solar PV implementation across facilities, LED lighting installation throughout operations, and advanced water management solutions. WAM
Al Etihad
23-03-2025
- Business
- Al Etihad
ENOC Group achieves Dh395 million in energy efficiency savings over decade
23 Mar 2025 21:37 DUBAI (WAM) ENOC Group recorded remarkable success in energy reduction through comprehensive Energy & Resource Management (E&RM) activities across its resilience through sustainable economic growth, the Group saved Dh395 million in total energy from 2014 to 2024, mitigating 703,840 metric tonnes of greenhouse gas part of its long-term commitment to environmental responsibility, ENOC joined millions around the world in observing Earth Hour 2025, switching off non-essential lights at its headquarters, operational facilities, and service stations on March 22 from 8:30 pm to 9:30 CEO of ENOC, Saif Humaid Al Falasi, said, 'Earth Hour is a powerful reminder of the urgency for collective action to ensure tangible results in combating environmental challenges. ENOC Group remains steadfast in its commitment to promoting sustainable development initiatives and raising awareness about optimising energy consumption in the UAE and beyond.'In 2024, ENOC business units achieved substantial savings through targeted energy efficiency initiatives. ENOC Processing Company (EPCL) spearheaded these efforts, saving Dh2,314,669 through various energy and resource management initiatives. The Retail unit made a significant contribution with the implementation of key projects such as the integration of Solar PV LED Lights in the Retail Operations Management & AutoPro sites, resulting in a combined saving of Dh3,115,294. ENOC's Corporate Real Estate (CRE), and Emirates Gas further contributed to the Group's success, respectively achieving savings of Dh539,448 and Dh139, commitment to sustainability is evident in its portfolio of successful initiatives spanning water conservation, renewable energy, and energy efficiency.|These include Solar PV implementation across facilities, LED lighting installation throughout operations, and advanced water management prioritises high-quality green procurement standards that help significantly reduce energy demand and minimise emissions across the supply chain. These achievements align with ENOC's broader sustainability strategy and demonstrate the Group's proactive resource management and environmental protection approach.
