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Xander Schauffele finally broke through. What made the difference?The gravel highway leading east from Hay River, Northwest Territories, features a relatively uniform (some might say monotonous) landscape of flat, spruce and jack pine forest. About 40 kilometers outside of the highway’s terminus at Fort Resolution, a few rock piles near the side of the highway stand out in bold relief. A quick left turn on an unmarked paved road, and one enters a grid of streets, sidewalks, and parking lots — but there are no buildings anywhere. Travel around the site, and it is not hard to stumble on one of the many large open pits that have filled with water, often coloured a brilliant azure blue. Brown grass covering abandoned fairways is all that remains of a nine-hole golf course. Although you might see the odd person, the site is completely abandoned, an industrial ruin that is a mere shadow of what was here before. From 1964 to 1988, the Pine Point lead-zinc mine operated on the site, one of the biggest and most important mineral developments in the Northwest Territories. Located on the south shore of Great Slave Lake, prospectors surveyed the site as early as 1898, but development only accelerated 50 years later, when the Canadian government granted Consolidated Mining and Smelting Company (CM&S) a 1295-km2 concession at Pine Point with exclusive exploration rights. At the time, the government regarded Pine Point as the centrepiece of its northern development program, eventually offering nearly $100 million dollars to help build a railway, highway, and hydro dam to kickstart the mine. To house the mine’s large workforce, the government and CM&S envisioned an orderly, planned town, that would be neither a hardscrabble camp nor a company-owned settlement. Instead, the government and industry would create an idyllic, suburban-style town, with high quality housing, top-notch schools, and ample recreational opportunities. Pine Point might lack the local colour of the frontier mining town, but its designers gladly traded saloons and dance halls for a stable, family-oriented town that would retain workers in a relatively remote location. The plan worked out spectacularly well. The 1200 to 1500 people who lived in Pine Point at any given time remember it as an idyllic town, so much so that an active online community of Pine Pointers has kept the town “alive” on the internet, posting photos and memorabilia to the “Pine Point Revisited” website organized by local legend Richard Cloutier, who sadly passed away in 2021. Inspired by Cloutier, media artists Paul Shoebridge and Michael Simons created a web-based interactive documentary, “Welcome to Pine Point,” that mixes photos, videos, and residents’ memories to create a nostalgic reverie for Pine Point. One former resident summed up the prevailing sentiment: “Looking in, it is hard not to think that it was a great time to be alive and up north, in a time before seatbelts and sunscreen, when you could still pull block-long wheelies without fear of judgement or consequences.” The photographs and film footage show a modern town with exceptional recreational opportunities: baseball, organized basketball, the aforementioned golf course, a curling rink, outstanding fishing, and an arena (the documentary features remarkable footage of an ice dance performance of The Wizard of Oz ). As one scrolls through “Welcome to Pine Point,” it is hard to disagree with one resident’s statement that, “most Pine Pointers think their hometown was the best place on earth to have lived.” The nearby Dene community of Fort Resolution has a somewhat more mixed recollection of Pine Point. When I participated in an oral history project about Pine Point in 2009, many in the community expressed frustration that the highway to the mine was not extended to their community until 1972, making it difficult to access employment at the mine. Others noted the lasting impact of pits, haul roads, seismic lines, and the tailings ponds on hunting and trapping activities in the Pine Point area, recalling the many ways the mine had changed the land-based culture of the Fort Resolution Dene. Despite these issues, residents of Fort Resolution who moved to Pine Point were almost unanimous in their praise for the town. Many said it had the best of the best of everything, and that they would move back “in a second” if it were ever re-built. While some remembered isolated incidents of racism, most testified to the remarkable social harmony in the town, and the fact that everybody looked out for one another. Some said it was hard to move back to Fort Resolution (a smaller town with more limited services) after the mine closed. When the mine did finally close in 1988, the company either flattened or moved all the industrial and residential buildings, leaving the ghost town that remains today. While some of the houses and other buildings could be moved elsewhere (the arena ended up in Fort Resolution, for instance), a major reason for dismantling the town was so squatters would not drift in and inhabit what was no longer an official town. For many Pine Pointers, the fact the town no longer exists accentuates the fond memories. Their former home is frozen in memory at its absolute best. As a place that has been wiped off the map, it can never change for the worse. According to many former residents, demolishing the town was better than witnessing its slow decline. For all the successes at Pine Point, the heyday of family-oriented mining towns was coming to an end by the early 1980s. The last incorporated town built specifically to support a mine was Tumbler Ridge, B.C., incorporated in 1981. Canadian mining companies have largely turned to flying workers in and out of well-serviced camps. What is lost with such arrangements is the community cohesion and the strong bond between people and place that occurs in mining towns such as Pine Point. For the “Pine Point Revisited” site, see https://www.pinepointrevisited.com/ . For the “Welcome to Pine Point” web documentary, see https://www.nfb.ca/interactive/welcome_to_pine_point/ . John Sandlos is a professor in the History Department at Memorial University of Newfoundland and the co-author (with Arn Keeling) of “Mining Country: A History of Canada’s Mines and Miners,” published by James Lorimer and Co. in 2021.His new book on the history of Giant Mine (also co-authored with Arn Keeling), will be released with McGill-Queen’s University Press in 2025.
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Savannah Guthrie introduces new family member – see the adorable announcement hereManila, 13 December 2024—To mark Human Rights Day, the U.S. Agency for International Development (USAID) and The Asia Foundation unveiled the "Cybersecurity for Human Rights in the Philippines" (C4HR-PH) initiative on 12 December. The Php16.8-million ($300,000) program aims to bolster the digital resilience of over 150 Philippine human rights organizations against cybersecurity threats like doxing, phishing, and coordinated attacks. As part of USAID and The Asia Foundation’s ongoing Initiative for Advancing Community Transformation (I-ACT) project, the "Cybersecurity for Human Rights in the Philippines" (C4HR-PH) initiative will provide tools and training to more than 150 local organizations across the country over ten months. Cybersecurity experts from The Asia Foundation will work closely with national human rights coalitions to design and deliver trainings in risk management, digital security assessments, phishing awareness, and the adoption of cybersecurity protocols such as multi-factor authentication and regular data backups. The tools and knowledge provided through C4HR-PH will help human rights defenders conduct their crucial advocacy work, safeguard private data, and advance justice and accountability without disruption or retribution. "Now more than ever, civil society organizations are reliant on technology and the internet to operate and pursue our advocacies," said Sheila Formento, National Coordinator of the Alternative Law Groups, a coalition of organizations that provide legal services to marginalized communities. "We welcome this partnership as it helps us protect our members who are constantly online and vulnerable to cyberattacks." C4HR-PH underscores USAID's commitment to fostering secure, empowered, and resilient organizations that can continue their critical work of promoting human rights and democracy. "Cyber resilience is not just about protecting data; it is about ensuring that democracy defenders can continue their vital work without fear of digital interference,” USAID Philippines Acting Mission Director Rebekah Eubanks said during the launch event attended by human rights advocates, cybersecurity experts, and other stakeholders. "This initiative reflects USAID’s commitment to fostering a safe and open digital space for civil society." "Civil society organizations are considered a high-risk community for cyberattacks because they can become under direct threat of malicious attackers but have limited defense capabilities. This crucial program will give our participants the tools and knowledge to better prevent disruptions, defend themselves, and continue to advance the work that they do," said The Asia Foundation Philippines Country Representative Sam Chittick.
The City of Prince George and the Prince George Humane Society will soon be partnering with a new location opening in 2025. It will be located at 4011 Lansdowne Rd. The partnership is under a five-year contract with the option for a three-year renewal. This agreement came after the BC SPCA's contract ended, with the city offering a $1,209,315 contract to the Humane Society. The SPCA will still continue its work in the city including working with bylaw in handling animal cruelty investigations. The new location will offer community animal shelter services that will handle stray animal intake and adoption services for both cats and dogs. The Humane Society has also decided to keep its current location on First Avenue open as well allow for an expansion of services. “We have a lot of programs and services that we believe would benefit the community as well as the city," said Humane Society president Angela McLaren. So it would be a great opportunity for us...” Explains Humane Society president Angela McLaren. “That includes working with pets with behavioural issues but also working on providing services for low-income community members. We've recognized that shelters are pretty overwhelmed with the number of animals that have been surrendered ... We felt that we needed to create solutions to prevent animals from coming into the shelters, we just couldn't continue with our old capacity. That's a program we believe that with the city we can provide some additional support to the community members." The First Avenue location will specifically be the cat adoption and humane education centre and will continue to offer the same services and programs as before with no interruption expected. As McLaren notes, this new location is expected to increase community engagement and volunteering efforts. “I know a lot of people didn't necessarily volunteer at the First Avenue location because we didn't always have dogs, but now there will be opportunities for people to get involved with socializing and walking dogs, so we want to encourage people to go to our website and put in a volunteer application," she said. If you are looking to help out the Humane Society in the new year applications can be found at www.pghumanesociety.ca .A Utah Cafe Confirms ‘Sister Wives’ Season 20 is in the WorksHeidrick & Struggles Appoints Chief Financial Officer
Mariam watches over her new born girl in the safety of her recently moved into rental home after a harrowing few years where she escaped an abusive ex-husband who beat her when she was previously pregnant and had a miscarriage. or signup to continue reading The 25-year-old Hazara Afghan woman grew up as a refugee in Pakistan and settled in Australia in 2016 as a teenager before getting married a few years later. But the relationship was marred by violence and turbulence. "When I was pregnant he started the violence again and he wanted me to have an abortion," she told AAP. She recounted how her ex-husband kicked her out of the house and she bounced around staying at her parents who were pressuring to get back with him, couch surfing with friends and even some nights sleeping in her car. "It was so hard, out of control, I didn't have any support, my relationship with my parents broke down. I was alone in this world." are a Shi'a minority in Afghanistan and have been long persecuted for their ethnicity and religion, which became even more extreme under the hardline Taliban who swept back into power in 2021 unseating the weak US-backed government after the 2001 invasion. Her ex-husband was also Hazara but he had threatened Mariam that he knew Taliban militants in Afghanistan who would kill her brother there if she did not abort the baby after she was 15 weeks pregnant. All the undue psychological pressure and physical beatings such as pushing her violently across the kitchen table took a toll on her body and she had a miscarriage in a Melbourne hospital, she said as she choked back tears. Mariam, who is providing a name she uses on social media in order not to be publicly identified for her safety, recently remarried with her husband visiting from Pakistan to be with her when she gave birth to a baby girl last month. With the help of the Melbourne-based charity Avalon Centre she was able to secure a two bedroom unit weeks ago in Dandenong, which has the highest number of homeless people of over 2300 in Victoria according to official figures. Deborah Holmes who heads the volunteer-run organisation says the grassroots provides stable furnished homes for vulnerable members of the community with ongoing casework support. "We've got a mission statement to help where we can, when we can, and in whatever way we can," she told AAP. "We're offering a hand up not a handout." The community organisation owns about 15 properties and relies entirely on donations from the public to pay off the loans. Ms Holmes said every dollar counts towards getting people off the streets and into new homes at a time when around the holidays. She and a team of volunteers worked around the clock to get the place ready for Mariam to move in with her baby earlier this month. "If that's just two cups of coffee a day and four friends then you can put a roof over somebody's head." RMIT Senior Lecturer Rojan Afrouz, who has conducted extensive research into , explains they contend with cultural barriers such as not being fluent in English as well as regressive community attitudes. "The main point that Afghan women raised was community pressure and shame and blame, and also that cultural and gender norms were stronger here (in Australia) than back in their own countries sometimes," she said. Dr Afrouz said even though domestic violence as a social phenomenon affects women of all backgrounds in Australia, it is doubly hard for refugees who carry multiple levels of trauma. "Afghan women face a lot of stigma and shame when they want to get a religious or civil divorce... sometimes it is more important than access to mainstream services. "This is because the main action that you need to do is making the decision whether you want to leave or not and the social consequences of that," the social work academic explained. She advocated for a woman-centred approach that is consultative in policymaking that ensures their agency is the prime objective. "We have to make sure that we put women's self determination experiences, not community self determination, at the forefront because sometimes minority women's voices are lost." This was Mariam's experience where she felt shunned from the tight-knit community by wanting to flee an abusive relationship. "My mental health was so bad... it was stressful and painful... everyone was blaming no matter what I said." She feels comfortable and safe in her new home with the ongoing support of her social worker and the Avalon Centre vowing to get back on her feet one day at a time. "Alhamdulillah (Thank God) everything is different now. I shut the door and feel safer than before," said Mariam. "My safety and my baby's safety is more important than anything... I don't want to lose everything again." 1800 RESPECT (1800 737 732) Lifeline 13 11 14 DAILY Today's top stories curated by our news team. WEEKDAYS Grab a quick bite of today's latest news from around the region and the nation. WEEKLY The latest news, results & expert analysis. WEEKDAYS Catch up on the news of the day and unwind with great reading for your evening. WEEKLY Get the editor's insights: what's happening & why it matters. WEEKLY Love footy? We've got all the action covered. WEEKLY Every Saturday and Tuesday, explore destinations deals, tips & travel writing to transport you around the globe. WEEKLY Going out or staying in? Find out what's on. WEEKDAYS Sharp. Close to the ground. Digging deep. Your weekday morning newsletter on national affairs, politics and more. TWICE WEEKLY Your essential national news digest: all the big issues on Wednesday and great reading every Saturday. WEEKLY Get news, reviews and expert insights every Thursday from CarExpert, ACM's exclusive motoring partner. TWICE WEEKLY Get real, Australia! Let the ACM network's editors and journalists bring you news and views from all over. AS IT HAPPENS Be the first to know when news breaks. DAILY Your digital replica of Today's Paper. Ready to read from 5am! DAILY Test your skills with interactive crosswords, sudoku & trivia. Fresh daily! Advertisement AdvertisementDonald Trump has threatened to seize the Panama Canal, revived calls to buy Greenland and joked about annexing Canada -- leaving the world guessing once again whether he is serious or not. By challenging the sovereignty of some of Washington's closest allies four weeks before he even returns to the Oval Office, the US-president elect has underscored his credentials as global disruptor-in-chief. His comments have renewed fears from his first term that Trump will end up being harsher on US friends than he is on adversaries like Russia and China. But there are also suspicions that billionaire tycoon Trump is looking for leverage as part of the "art of the deal" -- and that the former reality television star is grabbing headlines to look strong at home and abroad. "It's hard to tell how much of this he really wants, and how much is the latest soundbite that will be heard around the world," said Frank Sesno, a professor at George Washington University and former White House correspondent. "He puts other leaders in position of having to figure out what is literal and what is not," he told AFP. The idea of buying Greenland is not a new one for Trump. He also raised the prospect of purchasing the vast strategic island, a Danish territory, during his first term in office. He revived his push over the weekend when naming his ambassador to Copenhagen, saying the "ownership and control of Greenland is an absolute necessity" for US national security. But he received the same answer this time as he did then, with Greenland's Prime Minister Mute Egede saying on Monday that the resource-rich island was "not for sale." Yet his most headline-grabbing remarks have been on Panama, as he slammed what he called unfair fees for US ships passing through and threatened to demand control of the Panama Canal be returned to Washington. Trump said on Sunday that if Panama did not agree "then we will demand that the Panama Canal be returned to the United States of America -- in full, quickly and without question." He also hinted at China's growing influence around the canal, which was built by the United States in 1914 to link the Atlantic and Pacific oceans. It was returned to Panama under a 1977 deal. Panama's President Jose Raul Mulino dismissed Trump's threats, saying that "every square meter" of the canal would remain in Panamanian hands. Trump responded on TruthSocial: "We'll see about that!" Trump also teased neighboring Canada last week that it would be a "great idea" to become the 51st US state -- but against a dark backdrop of threatened tariffs. Sesno said it was hard for other countries to know how to deal with Trump's comments. "Well, it's clearly a joke. Or is it? said Sesno. "Imagine if you're the President of Panama, how do you react to something like that? You can't ignore it and your country will not let you. So the ripple effect of these comments is extraordinary." Trump's harsh treatment of US allies also stands in stark contrast to his repeated praise for the leaders of US foes -- including Russia's Vladimir Putin, who invaded Ukraine in 2022 in a bid for a land-grab. But there is still likely to be method behind Trump's rhetoric. "Maybe the message is for China" when Trump talks about buying Greenland, said Stephanie Pezard, senior political scientist with the Rand Corporation. Just as Trump expressed concern about Beijing's influence in Panama, China's growing presence in the Arctic and its ties with Russia were "something that the US is really worried about," Pezard told AFP. But there could also be a signal to Denmark that 'If you're too friendly with China, you'll find us in your way" -- even though Denmark and Greenland had been "very good NATO allies." And perhaps Trump knows the reality. Any US plan to "buy" Greenland would be unfeasible "not just in international law but more broadly in the global order that the US has been trying to uphold," she said. dk/bgsThe Kansas City Chiefs (9-1) and the Carolina Panthers (3-7) square off on Sunday at Bank of America Stadium. Tune in to TV to watch this game live. Watch live NFL games, NFL Network, other live sports and more on Fubo. What is Fubo? 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Nepra reviews new distribution code to transform power grid Code applies to Distribution Network Operators (DNOs), power generators, and bulk power consumers ISLAMABAD: The National Electric Power Regulatory Authority (Nepra) is reviewing the newly drafted Distribution Code 2024, a comprehensive regulatory framework aimed at enhancing the reliability, safety, and efficiency of Pakistan’s electricity distribution system. The code applies to Distribution Network Operators (DNOs), power generators, and bulk power consumers with connected loads exceeding 1 megawatt (MW). This reflects a broader shift toward market-based energy reforms. The updated code introduces detailed guidelines for system operations, focusing on improving communication protocols, ensuring system restoration after outages, and implementing enhanced safety measures. NEPRA has invited stakeholders and interested parties to provide their feedback on the draft within a month, emphasizing the importance of collaborative input to finalize the framework. This draft, submitted by ex-Wapda distribution companies (XW-Discos), aligns with Nepra Licensing (Distribution) Regulations 2022 and the Competitive Trading Bilateral Contract Market (CTBCM) design. It reflects significant changes in the regulatory, structural, and technological landscape of Pakistan’s electricity sector. The draft outlines protocols for restoring power after system shutdowns, emphasizing the maintenance of black start capabilities. DNOs are required to notify the System Operator of any changes to their black start facilities, ensuring effective coordination during outages. The framework also mandates that operational incidents affecting the distribution system be reported initially through verbal communication, followed by written documentation. In cases involving multiple users or operators, joint investigations will be conducted to identify and resolve issues collaboratively. Safety is a central focus of the updated code, which requires DNOs to maintain approved Safety Management Systems to protect personnel working on high-voltage equipment. These protocols aim to reduce risks at connection points and ensure compliance with stringent safety standards. Additionally, the code introduces systematic testing and monitoring requirements to maintain the safety and performance of distribution systems. The guidelines also address load management during emergencies, establishing clear procedures for equitable load shedding and effective commercial load allocation. By improving system monitoring and coordination, the code seeks to reduce disruptions and provide a more reliable energy supply to consumers. Nepra has urged all stakeholders, including power producers, DNOs, and bulk power consumers, to thoroughly review the draft and provide their input. This participatory approach is designed to ensure that the regulatory framework is practical, effective, and aligned with the evolving demands of the electricity sector. Once approved, the Distribution Code 2024 will serve as a cornerstone for ongoing energy reforms, driving the transition to a safer, more efficient, and resilient power distribution system across Pakistan.
SAN DIEGO , Dec. 13, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved CRENESSITYTM (crinecerfont) capsules and oral solution as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years of age and older with classic congenital adrenal hyperplasia (CAH), a rare, serious and lifelong genetic condition involving the adrenal glands. CRENESSITY, a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF 1 ) antagonist, is the first and only classic CAH treatment that directly reduces excess adrenocorticotropic hormone (ACTH) and downstream adrenal androgen production, allowing for glucocorticoid dose reduction. It is a breakthrough in the treatment landscape for classic CAH. "For the last three decades, Neurocrine Biosciences, together with our late founder, Wylie W. Vale , has conducted groundbreaking research uncovering the critical role of corticotropin-releasing factor and its receptor, CRF 1 , in the pathophysiology of congenital adrenal hyperplasia," said Kyle W. Gano , Ph.D., Chief Executive Officer, Neurocrine Biosciences. "The approval of CRENESSITY is a significant milestone for the CAH community, and we are grateful to the individuals who participated in our clinical trials, including their families and caregivers, and to the clinical investigators who helped advance a new therapy and class of medicines." "Patients and families struggle to achieve balance between managing the symptoms of CAH and the side effects or complications of treatment with high-dose steroids, which may impact quality of life," said Dina Matos , Executive Director, CARES Foundation. "We are grateful to Neurocrine Biosciences for engaging with our community throughout the drug development process to understand our needs and ultimately providing this new medication that can help reduce excess adrenal androgens and the need for high-dose steroid treatment for individuals living with CAH." CRENESSITY is expected to be commercially available in approximately one week. The medication will be provided through PANTHERx Rare, a specialty pharmacy, to centralize and simplify CRENESSITY prescription fulfillment. Neurocrine Biosciences is committed to supporting patients in obtaining treatment with CRENESSITY by offering Neurocrine Access Support, a free, comprehensive assistance program created for patients, caregivers and healthcare providers. It offers a range of options to make sure patients have everything they need to begin and continue taking CRENESSITY. A dedicated Care Coordinator, backed by a team, is available to help patients and caregivers navigate the insurance process and identify appropriate financial assistance options. Most patients will pay $10 or less per month for CRENESSITY*. For more information, visit www.NBIaccess.com/crenessity or call 1-855-CRNSITY (276-7489) Monday-Friday 8 am-8 pm ET . *Additional terms and conditions apply. CAHtalyst TM Clinical Program Overview: The FDA approval is supported by the largest-ever clinical trial program of classic CAH, the CAHtalyst Pediatric and Adult Phase 3 global registrational studies. CAHtalyst Phase 3 data results in pediatric and adult patients with classic CAH were published in The New England Journal of Medicine . "The clinical results across both CAHtalyst studies support the efficacy and safety profile of CRENESSITY and its ability to reduce the overproduction of adrenal androgens, allowing for a meaningful reduction in glucocorticoid dosage, while maintaining or enhancing control of these androgens," said Richard Auchus , M.D., Ph.D., Professor, University of Michigan Health, Principal Investigator. "Chronic treatment with supraphysiologic glucocorticoids can cause a number of short- and long-term health consequences, such as obesity, hypertension and osteoporosis, so the ability for patients with CAH to lower their glucocorticoid dose to a more physiologic level can have profound benefits." In both CAHtalyst studies, CRENESSITY enabled lower steroid doses and decreased androgen levels. Phase 3 CAHtalyst Pediatric Study: Phase 3 CAHtalyst Adult Study: CRENESSITY was well tolerated with few treatment-related adverse events in both CAHtalyst studies. Pediatric and adult patients taking CRENESSITY had no treatment-related serious adverse events. Adrenal insufficiency and crisis are risks of living with CAH that CRENESSITY does not address and can occur when a patient's GC dose is too low. In the CAHtalyst Pediatric study, there were no cases of adrenal crisis among patients taking CRENESSITY or placebo. In the CAHtalyst Adult study, two patients (1.6%) taking CRENESSITY experienced adrenal crisis. No patients on placebo experienced adrenal crisis. However, one patient (1.7%) on placebo experienced adrenal insufficiency. Patients should work with their healthcare provider to manage GC dosing while taking CRENESSITY. For more information about CRENESSITY, visit Crenessity.com . About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is a rare genetic condition that results in an enzyme deficiency that alters the production of adrenal steroid hormones, such as cortisol, aldosterone and adrenal androgens, which are essential for life. Approximately 95% of CAH cases are caused by variants of the CYP21A2 gene that leads to deficiency of the enzyme 21-hydroxylase (21-OH). Severe deficiency of this enzyme leads to an inability of the adrenal glands to produce enough cortisol and, in approximately 75% of cases, aldosterone. Because individuals with CAH are still able to produce androgens, the unused precursors that would normally be used to make cortisol instead result in the production of excess amounts of androgens. If left untreated, CAH can result in salt wasting, dehydration and even death. Historically, exogenous glucocorticoids (GCs) have been used not only to correct the endogenous cortisol deficiency, but doses used are higher than cortisol replacement needed (supraphysiologic) to lower the levels of adrenocorticotropic hormone (ACTH) and adrenal androgens. However, GC treatment at high doses has been associated with serious and significant complications of steroid excess, including metabolic issues such as weight gain and diabetes, cardiovascular disease and osteoporosis. Additionally, long-term treatment with high-dose GCs may have psychological and cognitive impact, such as changes in mood and memory. Adrenal androgen excess has been associated with abnormal bone growth and development in pediatric patients, female health problems such as excess facial hair growth and menstrual irregularities, testicular rest tumors in males and fertility issues in both sexes. About The CAHtalystTM Studies The Phase 3 CAHtalystTM global registrational studies were designed to evaluate the safety, efficacy and tolerability of CRENESSITY in children and adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The CAHtalyst studies were the largest-ever clinical trial program in classic CAH, including 285 pediatric and adult patients. The CAHtalyst Pediatric study included 103 pediatric patients aged four to 17 years. The study tested two questions. The first question evaluated whether four weeks of CRENESSITY treatment could improve androgen control. The second question evaluated whether an additional 24 weeks of CRENESSITY treatment enabled customized glucocorticoid (GC) down-titration while androstenedione levels were maintained or improved. The CAHtalyst Adult study included 182 adult patients aged 18 to 58 years. Similarly, the first question of the study evaluated whether four weeks of CRENESSITY treatment could improve androgen control, and the second question evaluated whether an additional 20 weeks of CRENESSITY treatment enabled GC reduction to physiologic range while androstenedione levels were maintained or improved. Data from the CAHtalyst Phase 3 studies supported approval of CRENESSITY by the U.S. Food and Drug Administration in December 2024. The open-label extension treatment portions of both studies are ongoing. About CRENESSITYTM (crinecerfont) CRENESSITYTM is a potent and selective, oral corticotropin-releasing factor type 1 receptor (CRF 1 ) antagonist developed to reduce and control excess adrenocorticotropic hormone (ACTH) and adrenal androgens through a non-glucocorticoid (GC) mechanism for the treatment of classic congenital adrenal hyperplasia (CAH). Antagonism of CRF 1 receptors in the pituitary has been shown to decrease ACTH levels, which in turn decreases the production of adrenal androgens and potentially the symptoms associated with CAH. The robust clinical study data demonstrate that lowering adrenal androgen levels with CRENESSITY enables lower, more physiologic dosing of GCs to replace missing cortisol. CRENESSITY comes in capsules and an oral solution. The capsule formulation is available in 50 mg and 100 mg doses. The oral solution is available as a 50 mg/mL strength formulation. For adults 18 years and older, the recommended dosage is 100 mg twice daily taken orally with a meal. For pediatric patients four to 17 years of age weighing less than 55 kg (121 lbs), the recommended dosage is based on body weight and is administered twice daily, taken orally with a meal. For pediatric patients weighing more than 55 kg (121 lbs), the recommended dosage is 100 mg twice daily taken orally with a meal. Healthcare providers can work with patients to determine the appropriate formulation for use depending on patient needs. Patients receiving CRENESSITY should continue GC therapy for cortisol replacement. Important Information Approved Uses CRENESSITY (crinecerfont) is a prescription medicine used together with glucocorticoids (steroids) to control androgen (testosterone-like hormone) levels in adults and children 4 years of age and older with classic congenital adrenal hyperplasia (CAH). IMPORTANT SAFETY INFORMATION Do not take CRENESSITY if you: Are allergic to crinecerfont, or any of the ingredients in CRENESSITY. CRENESSITY may cause serious side effects, including : Allergic Reactions. Symptoms of an allergic reaction include tightness of the throat, trouble breathing or swallowing, swelling of the lips, tongue, or face, and rash. If you have an allergic reaction to CRENESSITY, get emergency medical help right away and stop taking CRENESSITY. Risk of Sudden Adrenal Insufficiency or Adrenal Crisis With Too Little Glucocorticoid (Steroid) Medicine. Sudden adrenal insufficiency or adrenal crisis can happen in people with congenital adrenal hyperplasia who are not taking enough glucocorticoid (steroid) medicine. You should continue taking your glucocorticoid (steroid) medicine during treatment with CRENESSITY. Certain conditions such as infection, severe injury, or shock may increase your risk for sudden adrenal insufficiency or adrenal crisis. Tell your healthcare provider if you get a severe injury, infection, illness, or have planned surgery during treatment. Your healthcare provider may need to change your dose of glucocorticoid (steroid) medicine. Before taking CRENESSITY, tell your healthcare provider about all of your medical conditions, including if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take , including prescription and over-the counter medicines, vitamins, and herbal supplements. The most common side effects of CRENESSITY in adults include tiredness, headache, dizziness, joint pain, back pain, decreased appetite, and muscle pain. The most common side effects of CRENESSITY in children include headache, stomach pain, tiredness, nasal congestion, and nose bleeds. These are not all the possible side effects of CRENESSITY. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. Dosage Forms and Strengths: CRENESSITY is available in 50 mg and 100 mg capsules and as an oral solution of 50 mg/mL. Please see full Prescribing Information About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X (formerly Twitter) and Facebook . (*in collaboration with AbbVie) The NEUROCRINE BIOSCIENCES Logo Lockup and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. CRENESSITY and CAHtalyst are trademarks of Neurocrine Biosciences, Inc. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from CRENESSITY for the treatment of classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency; the value and benefits CRENESSITY brings to patients with CAH; the ability of Neurocrine Biosciences to ensure patients have access to CRENESSITY; and whether the results from our clinical trials of CRENESSITY are indicative of real-world results. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of CRENESSITY; whether CRENESSITY receives adequate reimbursement from third-party payors; the degree and pace of market uptake of CRENESSITY; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; risks associated with the Company's dependence on third parties for development and manufacturing activities related to CRENESSITY, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for CRENESSITY or other product candidates may not occur or be submitted in a timely manner; risks that the FDA or other regulatory authorities may make adverse decisions regarding CRENESSITY; risks that post-approval CRENESSITY commitments or requirements may be delayed; risks that CRENESSITY may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks and uncertainties relating to competitive products and technological changes that may limit demand for CRENESSITY; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2024 . Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. © 2024 Neurocrine Biosciences, Inc. All Rights Reserved. CP-CFT-US-0070 12/2024 View original content to download multimedia: https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-fda-approval-of-crenessity-crinecerfont-a-first-in-class-treatment-for-children-and-adults-with-classic-congenital-adrenal-hyperplasia-302331772.html SOURCE Neurocrine Biosciences, Inc.
Penn State preparing for hard-charging Jeanty and Boise State in CFP quarterfinalsWith that 'world champ mindset,' Helena bareback bronc rider Sam Petersen wins Chase Hawks
STATEN ISLAND, N.Y. (AP) — Zaire Williams scored 24 points and made five 3-pointers, Zavier Fitch added 21 points and Wagner beat Penn State-Scranton 120-30 on Monday. Williams added five rebounds, seven assists, and four steals for the Seahawks (8-5). Fitch had six rebounds, four assists and five steals. Di'Andre Howell-South shot 7 of 10 from the field, including 2 for 4 from 3-point range, and went 4 for 5 from the line to finish with 20 points. Jaiden Wiggins scored 16 points for Penn State-Scranton, which turned it over 29 times. The Associated Press created this story using technology provided by Data Skrive and data from Sportradar .
VANCOUVER, British Columbia, Dec. 13, 2024 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (TSX-V: RKV, the " Company ”, " Rakovina ”, or " Rakovina Therapeutics ”) a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies is pleased to announce the closing of a $3.0 million private placement. The private placement consists of 50,000,000 units (the " Units ”) at a price of $0.06 per Unit. Each Unit consists of one common share of the Company (each, a " Common Share ”) and one Common Share purchase warrant (each, a " Warrant ”). Each Warrant entitles the holder thereof to subscribe for and purchase one Common Share of the Company for a period of 24 months from the date of issue at a price of $0.10 per Common Share. Rakovina retains the right to accelerate the Warrant exercise period if, upon written notice to the holder, the 20-day volume-weighted average price of its Common Shares exceeds $0.30. In connection with the Private Placement, the Company paid cash finder's fees to Canaccord Genuity Corp., Ventum Financial Corp., Haywood Securities Inc., Research Capital Corporation, Hampton Securities Limited, Ewing Morris & Co. Investment Partners Ltd. and Leede Financial Inc. (each a " Finder ”, and collectively, the " Finders ”) in the aggregate amount of $180,841 and issued a total of 3,021,872 non-transferable finder's warrants (each, a " Finder's Warrant ') to the Finders, in accordance with the policies of the TSX Venture Exchange (the " TSXV ”). Each Finder's Warrant entitles the holder thereof to subscribe for and purchase one Common share of the Company for a period of 24 months from the date of issue at a price of $0.10 per Common Share, subject to acceleration on the same terms as the Warrants issued in connection with the private placement. The private placement is subject to the final acceptance of the TSXV and all securities issuable in connection with the private placement are subject to a hold period of four months plus one day from the date of issuance, in accordance with applicable securities laws. The proceeds of the private placement will be used to accelerate both discovery and development of the Company's proprietary drug candidates, shortlisted from the Deep Docking and Variational AI platforms. "This overwhelming response from our investors underscores the strength of our science, the extraordinary talent and dedication of our team and the transformative potential of our therapies,” said Jeffrey Bacha, Executive Chairman of Rakovina Therapeutics. "We are deeply grateful for the trust placed in us and remain resolute in our mission to utilize leading AI technologies to develop innovative solutions for cancer care.” The Company extends its heartfelt thanks to its investors, partners, and team for their unwavering support as Rakovina continues its work to bring new hope to patients and families affected by cancer. Rakovina is pleased to announce its engagement of Fairfax Partners Inc. as its Investor Relations (IR) partner. With extensive expertise in investor engagement strategies, Fairfax will implement a comprehensive six-month IR program designed to enhance Rakovina's market presence and expand its investor base. The program, which includes an option to renew for an additional six months, focuses on complementing traditional IR efforts with targeted online marketing campaigns, activation of a robust social media influencer network, and collaboration with external consultants and global wealth management channels. These initiatives will support Rakovina's strategic plan for 2025 by institutionalizing its investor base and strengthening its distribution capabilities. Under the agreement, Fairfax will receive a monthly fee of $5,000 plus GST, a one-time setup fee of $15,000 plus GST, and a marketing budget of $120,000 plus GST, disbursed as follows: $80,000 upon signing and $40,000 two months later. Services provided by Fairfax include inbound and outbound phone communications, website and social media management, marketing material preparation, news release support, and roadshow assistance, ensuring Rakovina's IR efforts align with market expectations. Fairfax Partners Inc., located at 306-1238 Seymour Street, Vancouver, BC, confirms that neither its directors nor officers hold any securities of Rakovina. For inquiries, please contact [email protected] . "We are thrilled to partner with the seasoned team at Fairfax Partners to expand our investor base and increase awareness of Rakovina Therapeutics' vision. Fairfax's creative and forward-thinking approach to investor relations will be a critical asset as we enter a pivotal year. By harnessing their extensive network and digital expertise, we aim to significantly enhance our market presence and deliver lasting value to our shareholders,” said Mr. Bacha. About Rakovina Therapeutics Inc. Rakovina Therapeutics Inc. is dedicated to developing innovative cancer therapies targeting the DNA-damage response. The company has established a development pipeline of novel DNA-damage response inhibitors by leveraging Artificial Intelligence (AI) to accelerate the identification and optimization of drug candidates. Rakovina Therapeutics aims to advance one or more of these candidates into human clinical trials in collaboration with pharmaceutical partners and secure marketing approvals from Health Canada, the U.S. Food and Drug Administration, and other international regulatory agencies. Further information may be found at www.rakovinatherapeutics.com . The TSXV has neither approved nor disapproved the content of this press release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release. Notice Regarding Forward-Looking Statements: This release includes forward-looking statements regarding the Company and its respective business, which may include, but is not limited to, statements with respect to the terms of the private placement, the closing of the private placement, the receipt of final TSXV approval, the proposed business plan of the Company; the Company's commitment to advancing new cancer therapies; the ability of the Company to extract value from its AI collaborations; the Company's ability to execute on its business plans while maintaining high standards of research; the ability of Pharma Inventor Inc. to accurately provide medicinal chemistry support; the projected timeline and effectiveness of the Company's strategy to utilize the Deep Docking AI platform; and the Company's ability to generate shareholder value. Often, but not always, forward-looking statements can be identified by the use of words such as "plans”, "is expected”, "expects”, "scheduled”, "intends”, "contemplates”, "anticipates”, "believes”, "proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events, or results "may”, "could”, "would”, "might” or "will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of the Company. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, economic factors, regulatory factors, the equity markets generally and risks associated with growth and competition. Although the Company has attempted to identify important factors that could cause actual actions, events, or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events, or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. The reader is referred to the Company's most recent filings on SEDAR for a more complete discussion of all applicable risk factors and their potential effects, copies of which may be accessed through the Company's profile page at www.sedar.com. For Further Information Contact: David Hyman, Chief Financial Officer [email protected] Invest Relations &Media Michelle Seltenrich [email protected] 778-773-5432Pakistan's first AI-enhanced virtual internship launched
A slide for market superstar Nvidia helped pull U.S. stock indexes down from their records. The S&P 500 fell 0.6% Monday, coming off its 57th all-time high of the year so far. The Dow Jones Industrial Average fell 0.5%, and the Nasdaq composite dropped 0.6% from its own record. Nvidia was the market’s heaviest weight after China said it’s probing the chip giant for potential antitrust violations. Stocks in Hong Kong jumped after top Chinese leaders agreed on a “moderately loose” monetary policy. Prices for oil and gold rose following the ouster of Syrian leader Bashar Assad. On Monday: The S&P 500 fell 37.42 points, or 0.6%, to 6,052.85. The Dow Jones Industrial Average fell 240.59 points, or 0.5%, to 44,401.93. The Nasdaq composite fell 123.08 points, or 0.6%, to 19,736.69. The Russell 2000 index of smaller companies fell 16.16 points, or 0.7%, to 2,392.84. For the year: The S&P 500 is up 1,283.02 points, or 26.9%. The Dow is up 6,712.39 points, or 17.8%. The Nasdaq is up 4,725.34 points, or 31.5%. The Russell 2000 is up 365.76 points, or 18%.
Deep-pocketed investors have adopted a bullish approach towards Monolithic Power Systems MPWR , and it's something market players shouldn't ignore. Our tracking of public options records at Benzinga unveiled this significant move today. The identity of these investors remains unknown, but such a substantial move in MPWR usually suggests something big is about to happen. We gleaned this information from our observations today when Benzinga's options scanner highlighted 14 extraordinary options activities for Monolithic Power Systems. This level of activity is out of the ordinary. The general mood among these heavyweight investors is divided, with 42% leaning bullish and 21% bearish. Among these notable options, 8 are puts, totaling $879,810, and 6 are calls, amounting to $591,900. Expected Price Movements Analyzing the Volume and Open Interest in these contracts, it seems that the big players have been eyeing a price window from $520.0 to $640.0 for Monolithic Power Systems during the past quarter. Volume & Open Interest Development Examining the volume and open interest provides crucial insights into stock research. This information is key in gauging liquidity and interest levels for Monolithic Power Systems's options at certain strike prices. Below, we present a snapshot of the trends in volume and open interest for calls and puts across Monolithic Power Systems's significant trades, within a strike price range of $520.0 to $640.0, over the past month. Monolithic Power Systems 30-Day Option Volume & Interest Snapshot Largest Options Trades Observed: Symbol PUT/CALL Trade Type Sentiment Exp. Date Ask Bid Price Strike Price Total Trade Price Open Interest Volume MPWR CALL TRADE NEUTRAL 03/21/25 $57.6 $53.0 $55.54 $640.00 $277.7K 155 50 MPWR PUT TRADE BULLISH 02/21/25 $32.6 $30.6 $30.8 $560.00 $166.3K 10 99 MPWR PUT SWEEP BEARISH 02/21/25 $19.9 $18.4 $18.4 $520.00 $149.0K 3 81 MPWR CALL TRADE BULLISH 01/17/25 $30.0 $28.0 $29.22 $610.00 $146.1K 361 54 MPWR PUT TRADE BULLISH 02/21/25 $19.7 $18.3 $18.3 $520.00 $135.4K 3 189 About Monolithic Power Systems Monolithic Power Systems is an analog and mixed-signal chipmaker, specializing in power management solutions. The firm's mission is to reduce total energy consumption in end systems, and it serves the computing, automotive, industrial, communications, and consumer end markets. MPS uses a fabless manufacturing model, partnering with third-party chip foundries to host its proprietary BCD process technology. In light of the recent options history for Monolithic Power Systems, it's now appropriate to focus on the company itself. We aim to explore its current performance. Present Market Standing of Monolithic Power Systems With a volume of 308,419, the price of MPWR is up 3.95% at $616.65. RSI indicators hint that the underlying stock may be approaching overbought. Next earnings are expected to be released in 44 days. Expert Opinions on Monolithic Power Systems Over the past month, 1 industry analysts have shared their insights on this stock, proposing an average target price of $700.0. Turn $1000 into $1270 in just 20 days? 20-year pro options trader reveals his one-line chart technique that shows when to buy and sell. Copy his trades, which have had averaged a 27% profit every 20 days. Click here for access .* In a cautious move, an analyst from Citigroup downgraded its rating to Buy, setting a price target of $700. Options trading presents higher risks and potential rewards. Astute traders manage these risks by continually educating themselves, adapting their strategies, monitoring multiple indicators, and keeping a close eye on market movements. Stay informed about the latest Monolithic Power Systems options trades with real-time alerts from Benzinga Pro . © 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.NFL NOTESInside the Gaetz Ethics Report, a Trove of New Details Alleging Payments for Sex and Drug Use
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