Latest news with #ARCH
Medscape
7 days ago
- Health
- Medscape
Does Romosozumab Deserve Its Black Box Warning?
Osteoporosis drug romosozumab showed no increased risk for the development of cardiovascular (CV) events compared with anabolic osteoporosis drugs, contrary to its black box warning, new research found. 'These findings suggest there is no heightened risk for major adverse cardiovascular events in patients with osteoporosis treated with romosozumab compared to the anabolic agents teriparatide or abaloparatide,' the authors reported at ENDO 2025: The Endocrine Society Annual Meeting. 'Further observational data is required to concur with such findings, which may lead to a discontinuation of the black box warning,' they said. Romosozumab, a monoclonal antibody targeting sclerostin, has a unique dual action of anabolic properties (increasing bone formation while reducing resorption and improving bone mineral density while reducing vertebral fracture risk). The drug is injected monthly for 12 months, after which time its anabolic effects decline and patients must transition to other antiresorptive therapies, such as bisphosphonates or denosumab, to maintain gains in bone density. Although the FDA approved romosozumab for osteoporosis management, it has given a black box warning after clinical trials (including the ARCH study) comparing romosozumab with alendronate suggested an increased risk for serious CV events, including myocardial infarction, stroke, and CV death. The drug is therefore contraindicated in patients with hypocalcemia and those who have had a myocardial infarction or stroke within the previous year. However, data on those risks has been highly inconsistent, first author Maxim John Levy Barnett, MD, of Jefferson-Einstein Hospital, Philadelphia, told Medscape Medical News . 'Most previous studies on this issue show a nonsignificant trend toward a higher risk but do not reach statistical significance,' he said. Even the ARCH trial 'showed a trend of higher incidence of adverse outcomes, but it was not statistically significant,' he noted. New Findings To further investigate the risks, Barnett and colleagues evaluated data on patients with osteoporosis in the TriNetX database, including 14,760 patients treated with romosozumab and 45,302 treated with either teriparatide or abaloparatide anabolic agents. For the propensity score analysis, patients in the two groups were matched for age, sex, race, glycated hemoglobin, hypertension, chronic kidney disease, ischemic heart disease, cerebrovascular disease, diabetes, and other factors. After matching, the romosozumab group had 14,288 patients compared with 14,362 in the anabolic agent group. Patients had a mean age at baseline of 70.5 years, 94% were women — as the drug is approved in the US for women only — and 71% were White. With a mean follow-up of 5 years (including the 1-year treatment with romosozumab), there was a nonsignificant trend toward a reduced risk for CV incidents among those treated with romosozumab (relative risk [RR], 0.601; P = .0692). The romosozumab group also had significantly lower ischemic heart disease rates than the anabolic agent group (RR, 0.848; P = .0017). In addition, those receiving romosozumab had a lower risk of acute myocardial infarction (RR, 0.654; P < .0001). Likewise, acute heart failure, either systolic or diastolic, was also significantly lower in the romosozumab group (RR, 0.664; P = .0029). 'After propensity-score matching, there was still a significant reduction [with romosozumab], which was a surprise,' Barnett said. 'Three out of the 4 outcomes actually showed a significant decrease in risk with romosozumab.' 'To the best of my knowledge, similar trends have not been noted in other studies,' he said, adding that there have been no significant changes to romosozumab's treatment regimen or other factors that might explain differences in risk since the issuance of the black box warning. 'It is important to note that this was not the primary objective of the noninferiority study, and it was not powered for this endpoint,' Barnett said. The findings nevertheless add to evidence from others showing results that call into question the concerns behind the black box warning. 'There is no substantial evidence for cardiovascular risk and this medication; nonetheless, the black box warning is present,' Barnett said. Commenting on the study, Tiffany Kim, MD, of the University of California, San Francisco, who co-moderated the session, agreed that 'these are definitely interesting findings that add to growing data that romosozumab may not be associated with increased cardiovascular risk.' She noted that, as intended, 'any black box warning has a big effect on how clinicians consider and talk to a patient about the risks of a medication.' 'From a medico-legal perspective, I always inform my patient so they aren't surprised if they read this later, and so that I can document that they accept the benefits outweigh the risk for their individual situation.' 'This study adds to the reassuring literature that romosozumab may not be associated with increased risk of cardiovascular disease,' Kim said. 'In my clinical practice, I only consider anabolic therapy for my patients with severe osteoporosis at high fracture risk who really need treatment, so having more data about the CV risk helps with my clinical decision-making and with discussions with my patients about the risks and benefits of this drug.' In terms of caveats, Kim noted that 'the study did a good job of matching for medical comorbidities, but there may be other factors that cause a clinician to prescribe the drugs that are associated with cardiovascular disease.' 'This study is a helpful addition to the literature, but it's hard to be definitive in an observational study,' she added.
Cision Canada
19-06-2025
- Business
- Cision Canada
The federal government supports construction of supportive housing for individuals recovering from addiction and homelessness Français
POUCE COUPE, BC, June 19, 2025 /CNW/ - Solving Canada's housing crisis requires immediate action to address the urgent needs of Canadians. To provide Canadians with increased access to supportive housing, the government today announced an investment of $3 million to expand the North Wind Wellness Centre (NWWC) in Pouce Coupe from 10 beds to 15 beds for addiction treatment and 40 units of supportive housing. The project will provide five early recovery beds, 15 beds in addiction treatment housing, and 40 self-contained supportive homes. The facility will also include The Junction, a recovery-based community centre at the heart of the complex that will serve as a resource hub for those in treatment. The NWWC will deliver a full continuum of addictions recovery services, combining detox, early recovery housing, treatment, and supportive housing through the Addictions Recovery Community Housing (ARCH) model. This model combines First Nations healing traditions with western medicine practices, including coordinated access, live-in treatment supports, and post-recovery supports. Funding provided for this housing project includes: $3 million from the federal government, through Canada Mortgage and Housing Corporation under the Affordable Housing Fund (AHF) $19.8 million from the Province through BC Housing's Supportive Housing Fund (SHF) and $1.2 million in annual operating funding. $12 million from a Tripartite investment made by BC Ministry of Health, the First Nations Health Authority (FNHA), and the federal government through Indigenous Services Canada $4 million from the Northern Health Authority Up to $1 million from the North Wind Wellness Centre through a combination of funding and land contribution $800,000 from the Streetohome Foundation $800,000 from the Streetohome Foundation Other community support was provided by the Treaty 8 Tribal Association, the Peace River Regional District and the Village of Pouce Coupe. Quotes: "Our government is committed to supporting housing for the most vulnerable Canadians. Working with organizations such as the North Wind Wellness Centre ensures that individuals have access to the safe and supportive housing they need on their journey to recovery." – Jake Sawatzky, Member of Parliament for New Westminster—Burnaby—Maillardville, on behalf of The Honourable Gregor Robertson, Minister of Housing and Infrastructure "This groundbreaking marks a meaningful step forward in building a more inclusive and culturally safe health-care system. The North Wind Wellness Centre will provide vital, comprehensive support for people on their healing journey, closer to home and community. The North Wind Wellness Centre will provide vital, comprehensive support for people on their healing journey, closer to home and community. It's a powerful example of how we can work together to build services that are rooted in community and focused on wellness." – The Honourable Josie Osborne, Minister of Health for British Columbia " At the North Wind Wellness Centre, people near and around Pouce Couple will be able to get the care and housing they need locally, in the community they know. The centre offers stable, safe homes and continued support after treatment, helping people build a foundation for a healthier life. At the same time, cutting-edge care and services will honour and deepen connections to family, First Nations culture and community." – The Honourable Ravi Kahlon, Minister of Housing for British Columbia "Too many people in rural and Indigenous communities face barriers to accessing appropriate addiction care. By building a centre that blends traditional Indigenous wellness with clinical supports, we are helping people heal in a place that feels like home, close to culture, community and care." – Amna Shah, Parliamentary Secretary for Mental Health and Addictions for British Columbia "With the generous support of our funders, the NWWC is proud to establish Canada's first Health and Wellness Centre, pioneering an innovative approach that unites the full continuum of care under one roof with the ARCH model. This integrated model combines withdrawal management, addiction treatment, and assisted recovery housing, providing comprehensive support for individuals on their healing journey. The Northeast Junction—a peer-led central hub—connects all components, fostering a strong sense of community and holistic support." – Isaac Hernandez, Executive Director, North Winds Wellness Centre "This project reflects nearly a decade of cross-sector collaboration, vision, and heart. It began with a commitment to do better—for individuals, for communities, and for future generations. With the collective support of funders including BC Housing, CMHC, FNHA, Northern Health, and Streetohome, we're not just building a facility—we're creating a lifeline, rooted in respect, culture, and long-term recovery." – Rob Turnbull, President and Chief Executive Officer, Streetohome "Treaty 8 Tribal Association has proudly supported NWWC, recognizing that having this facility is a crucial and vital step forward in addressing the needs of our communities. As we continue to navigate this toxic drug crisis together, this facility will represent a shared commitment to resilience, support, and healing. Situated in Pouce Coupe, the Centre will stand on the traditional, ancestral territory of the Treaty 8 First Nations, fostering healing and support for those in need." – Marlene Roy, Executive Director, Treaty 8 Tribal Association "The new North Wind Wellness Centre brings hope to our region. Many families have suffered unendurable losses due to the toxic drug epidemic in our communities. This facility offers a second chance to those struggling with addiction, and reassurance to families that help is close to home." – Danielle Veach, Mayor of Pouce Coupe "The Peace River Regional District is pleased to support the NWWC's new Health and Wellness Centre. This facility will bring a unique approach to addiction recovery services to our region, helping those who have previously had to travel far for this essential support. It will serve people throughout the province as well. We're excited to see this project move forward - it's going to make a real difference for people who need help." Leonard Hiebert, Board Chair, Peace River Regional District Quick facts: The Affordable Housing Fund (AHF) provides funding through low-interest and/or forgivable loans or contributions to partner organizations for new affordable housing and the renovation and repair of existing affordable and community housing. The AHF is a $14.6-billion National Housing Strategy program that prioritizes housing projects for those who need it most: women and children fleeing family violence, seniors, Indigenous people, people living with disabilities, those with mental health or addiction issues, veterans and young adults. As of March 2025, the federal government had committed $11.99 billion to support the creation of close to 46,000 units and the repair of over 174,000 units through the AHF. Budget 2024 announced enhancements to the AHF which includes the program being extended from 2025 – 2026 to 2028 – 2029. The existing New Construction stream is now subdivided into two dedicated sub-streams: a Rapid Housing sub-stream to create shelters, supportive and transitional housing for those in greatest need, and a Community Housing sub-stream to support affordable and mixed-market housing where there are both affordable and market-rent units in a project. The Repair and Renewal stream, has replaced minimum requirements with an approach where projects supporting accessibility and energy efficiency will be prioritized. NWWC was established in 1996 to serve Indigenous communities in BC Treaty 8 Territory. The new Centre represents a significant advancement in addiction recovery in Canada, by integrating the entire continuum of care under one roof and combining Western medical practices with Traditional Indigenous healing. Additional information: Visit for the most-requested Government of Canada housing information. CMHC plays a critical role as a national facilitator to promote stability and sustainability in Canada's housing finance system. Our mortgage insurance products support access to homeownership and the creation and maintenance of rental supply. We also actively support the Government of Canada in delivering on its commitment to make housing more affordable. Our research and data help inform housing policy. By facilitating cooperation between all levels of government, private and non-profit sectors, we contribute to advancing housing affordability, equity, and climate compatibility. Follow us on X (formerly Twitter), YouTube, LinkedIn, Facebook and Instagram. Progress on programs and initiatives is updated quarterly on the Housing, Infrastructure and Communities Canada (HICC) website. The Housing and Infrastructure Project Map shows the affordable housing projects developed so far. To learn more about NWWC, visit: SOURCE Canada Mortgage and Housing Corporation (CMHC)
Daily Mail
25-04-2025
- General
- Daily Mail
Helicopter crashes into suburban street during routine training drill
A helicopter crashed into a suburban Illinois street on Thursday night and burst into flames during a routine training session, creating a chaotic scene for onlookers. MMB-BK 117 plummeted into the street after taking off from a fire station in Hartford, which is about half an hour from St. Louis, Missouri. A pilot and two passengers were on board when the helicopter fell from the sky just after 9 pm, the Federal Aviation Administration confirmed. All three were transported to a local hospital for their injuries. Video footage captured by residents in the area depicts the helicopter taking off and seemingly clipping a tree before falling to the ground. Additional video captured by witnesses show the helicopter engulfed in flames on the ground. Before the crash, the Harford Fire Department warned residents on social media that ARCH, an air medical service based in Missouri and Illinois, would be conducting a training session in an empty lot. 'Please do not be alarmed. This is for training purposes only. If you would like to see the Helicopter up close, please DO NOT approach the Helicopter without authorization from ARCH,' the statement read. 'Helicopters can be Very Dangerous and this is one of the reasons for training,' the department added. Video footage captured by residents in the area depicted the helicopter take off and then plummet to the ground after it seemingly clipped a tree ARCH later announced that the Illinois crew was involved in the incident and the crash occurred after they departed from a local fire station. 'We continue to support our teammates and are working with the authorities in support of the investigation,' the statement read. The shocking scene alarmed suburban residents in the area, who were quick to respond to the crash. Ashley Quigley, who witnessed the event and told local Fox affiliate, KTVI, '[The helicopter] went up maybe a foot, it started hitting the trees, and stuff was flying. 'It was twisting all over, all of a sudden it came down with a big boom and started catching fire.' 'The fire truck came around and started trying to put it out. The fire went out a little bit, but then it started going back up in big smoke again, and they were just trying to grab the people who were on the ground, trying to help them,' she continued. 'It was literally the craziest thing I've ever seen.' The FAA is currently investigating the incident with ARCH Air Methods, and local authorities are working to determine what led to the crash. The three crew members survived but the extent of their injuries hasn't been released.
Daily Maverick
24-04-2025
- Business
- Daily Maverick
Patrice Motsepe's ARC delisting faces R3.6bn cross-border collision
As Patrice Motsepe's investment vehicle prepares to exit the JSE, an escalating legal battle in Tanzania threatens to follow it across borders. When African Rainbow Capital (ARC) issued a SENS statement on 18 March 2025 announcing its intention to delist from the Johannesburg Stock Exchange and A2X, the message was clear: the move was reportedly about streamlining costs and correcting a mismatch between market value and actual asset worth. Several thousand kilometres to the north in Tanzania, that announcement sent alarm bells ringing. There, ARC and its affiliates — including African Rainbow Minerals (ARM), ARCH Sustainable Resources GPCo, and Motsepe himself — are facing a $195-million (about R3.6-billion) lawsuit brought by US-based investment firm Pula Group. The timing of ARC's delisting, Pula alleges, is far from incidental. Judgment day approaches The Tanzanian High Court has taken the matter seriously. After ARC and several co-defendants failed to appear in court in December 2023, Pula applied for a default judgment. A default judgment is a legal ruling made in favour of one party when the other fails to respond or appear in court. ARC and its co-defendants argued that they had been improperly served — a claim the court rejected on 12 July 2024. As a result, the Commercial Court of Tanzania is set to hear the case on 7 May 2025. The hearing comes just weeks before ARC's expected exit from the JSE and A2X, scheduled for early June. A neighbour too close for comfort Initially filed in November 2023, the lawsuit accuses ARC and its affiliates of breaching a confidentiality and non-compete agreement over a graphite project in Tanzania's mineral-rich Ruangwa District. It accuses the companies of using privileged information shared by Pula to back a competing graphite venture, Evolution Energy Minerals. In its 2024 annual report, Evolution describes ARCH as the company's 'cornerstone investor' with a 24.7% interest in the company. 'Out of more than 50 graphite projects in Africa that ARCH could have invested in, they decided to invest in the project adjacent to Pula's graphite operations,' Ambassador Charles Stith, executive chairman of Pula Group, said. The fallout, Stith claims, was strategic. 'The delisting has profound financial implications and significantly affects the profile of ARC,' he added. '[Pula] submitted to the court that the delisting materially affects that status quo.' No comment, no clarity ARC declined to respond to Daily Maverick's queries about the lawsuit or its delisting. Nor has it publicly commented on the pending mediation process ordered by the Tanzanian court. ARM only responded that it is not in a position to comment as the matter is currently before the Tanzanian court. ARCH, for its part, denied any wrongdoing or obligation. '[ARCH] was not a party and has no obligations to Pula pursuant to the terms of the confidentiality agreement,' the company said in a written statement. It further stressed that it 'did not receive any confidential information on the Pula Graphite Project from ARM.' ARCH did, however, confirm the basics of the dispute. 'ARM concluded a confidentiality agreement with [Pula] to consider a potential investment in the Pula Graphite Project,' it said. 'We understand that ARM subsequently did not proceed with the proposed investment.' Graphite, power, and precedent At stake is a resource increasingly coveted by battery manufacturers and governments alike: graphite. Tanzania's Ruangwa District is home to some of the world's top-ranked graphite deposits, and Pula holds four licences in the area. The group told Daily Maverick that it had hopes of the lawsuit setting a precedent in protecting the rights of Tanzanian mining companies competing against international counterparts. 'Seventy percent of mineral exploration in Tanzania is conducted by Australian and Canadian companies,' Pula said in a press advisory statement in November 2024. 'It is the unfair, prejudicial, and predatory practices of companies like ARM and Motsepe's associated companies that perpetuate the disparity in the mining sector.' How does this affect you? ARC's delisting may seem like a distant boardroom decision, but its implications ripple far beyond Sandton. For Africans invested in ARC, delisting means reduced transparency and fewer investor protections. Meanwhile, the Pula lawsuit raises questions about how South African firms conduct business across borders and the potential legal fallout when deals sour. If local companies can quietly pull back from public accountability while facing serious legal claims abroad, it sets a precedent that chips away at corporate transparency. A delisting with baggage ARC's reasons for delisting, detailed in its most recent circular to shareholders, centre on cost, tax inefficiencies and low market liquidity. It also noted that its international fundraising ambitions via a Mauritian structure failed to materialise, and that nearly all shareholders were South African. ARC may be preparing its corporate exit, but for now, the courtroom in Dar es Salaam might be the only place it can't quietly walk away from. DM
Yahoo
07-03-2025
- Health
- Yahoo
UAMS scientist awarded $1.9 million to study air pollution, breast cancer
LITTLE ROCK, Ark. (KNWA/KFTA) — A researcher at the Winthrop P. Rockefeller Cancer Institute at the University of Arkansas for Medical Sciences received a $1.9 million grant from the National Institute of Environmental Health Sciences to study the role of environmental exposures in the development of early onset breast cancer in Arkansas women. According to a press release, Ping-Ching Hsu, Ph.D., is the first UAMS researcher to receive federal funding for a large, population-based study on environmental exposure and cancer in rural Arkansas communities. Hsu is an associate professor of Environmental Health Sciences in the UAMS Fay W. Boozman College of Public Health and a member of the Cancer Institute's Cancer Prevention and Population Sciences Research Group. The release says the five-year NIEHS grant will advance Hsu's study of 26,000 Arkansas women, who have been study participants in the UAMS Arkansas Rural Community Health Study since 2007. University of Arkansas for Medical Sciences faces potential funding cuts According to the release, ARCH is a large group of women ages 18 to 95 from every county in Arkansas that began as Spit for the Cure. The release says Hsu has already found that ARCH has high proportions of women younger than 50 who were healthy when they enrolled and later developed breast cancer. 'We already know that among women in the cohort who joined that had breast cancer, 45.6% of them have early-onset breast cancer; among those who were healthy when they joined and now have breast cancer, 20% of them have early-onset breast cancer, which is very high,' said Hsu. 'We have identified 709 mother-daughter pairs in the cohort — about 1,400 women — and we plan to follow them up, especially those who live close to communities that have high environmental exposures.' Hsu will use data from the EPA National Air Toxins Assessment, U.S. Geological Survey, and the Arkansas Cancer Registry. The release says the grant will pay for follow-up and outreach to as many as 850 participants among the mother-daughter pairs for additional data with the potential to examine individual levels of heavy metals. According to the release, Hsu published the results of an initial study of ARCH in the Journal 'Environmental Pollution' and found several significant associations between air pollutants and breast cancer risk. 'We need to raise awareness about the health risks of environmental exposure,' said Hsu. 'Arkansas is feeding everyone in the nation, and we suffer from the exposure.' Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
