When dockworkers walked the picket line in October, the strike lasted for 3 days. And if a new contract between their 45,000 member union and the U.S. Maritime Alliance isn't signed by mid-January — a longer strike could send inflation going in the wrong direction. Just months after a strike at Gulf and East Coast ports ended, operators and union members are now at an impasse — once again — over automation. Port operators say they need more technology to increase port efficiency, improve safety and to control costs. But union members say no, because some workers will lose their jobs. A new strike could come if an agreement isn't reached by January 15. And if that happens inflation could increase, when goods aren't flowing in an out of ports as quickly. Thursday union leaders met with President-elect Donald trump at Mar-a-Lago and walked away with his support. Writing about automation on Truth social, Trump said "the amount of money saved is nowhere near the distress, hurt, and harm it causes for American workers," and that foreign countries "...shouldn't be looking for every last penny knowing how many families are hurt." RELATED STORY | Billions of dollars of U.S. economic activity halted as port workers enter day two of their strike Professor Todd Belt of George Washington University called it Trump striking a different path than he did during his first term. "During the first Trump term you had Donald Trump, surrounded by a lot of people who were suggested to him by incumbent Republicans who had really a Republican orthodoxy on free trade. Donald trump now is going to be surrounded by a lot of people who support his ideas of interventionism and tariffs, as well as other trade policies that will protect working people at the expense of, of course, inflation," Belt said. The International Longshoremen's Association has until Jan. 15 to negotiate a new contract with the U.S. Maritime Alliance, which represents ports and shipping companies. At the heart of the dispute is whether ports can install automated gates, cranes and container-moving trucks that could make it faster to unload and load ships. The union argues that automation would lead to fewer jobs, even though higher levels of productivity could do more to boost the salaries of remaining workers. The Maritime Alliance said in a statement that the contract goes beyond ports to "supporting American consumers and giving American businesses access to the global marketplace — from farmers, to manufacturers, to small businesses, and innovative start-ups looking for new markets to sell their products." "To achieve this, we need modern technology that is proven to improve worker safety, boost port efficiency, increase port capacity, and strengthen our supply chains," said the alliance, adding that it looks forward to working with Trump. In October, the union representing 45,000 dockworkers went on strike for three days, raising the risk that a prolonged shutdown could push up inflation by making it difficult to unload container ships and export American products overseas. The issue pits an incoming president who won November's election on the promise of bringing down prices against commitments to support blue-collar workers along with the kinds of advanced technology that drew him support from Silicon Valley elite such as billionaire Elon Musk. Trump sought to portray the dispute as being between U.S. workers and foreign companies, but advanced ports are also key for staying globally competitive. China is opening a $1.3 billion port in Peru that could accommodate ships too large for the Panama Canal. There is a risk that shippers could move to other ports, which could also lead to job losses. Mexico is constructing a port that is highly automated, while Dubai, Singapore and Rotterdam already have more advanced ports. "For the great privilege of accessing our markets, these foreign companies should hire our incredible American Workers, instead of laying them off, and sending those profits back to foreign countries," Trump posted. "It is time to put AMERICA FIRST!" The Associated Press contributed to this report.
Paper Boat Creative The rise of Bitcoin to new all-time highs has created numerous winners, but perhaps none more so than MicroStrategy Incorporated ( MSTR ). The stock is up over 400% so far this year, even including a sizable draw-down If you liked this idea, sign up for a no-obligation free trial of my Seeking Alpha Marketplace service, Timely Trader ! I sift through various asset classes to find the best places for your capital, helping you maximize your returns. Timely Trader seeks to find winners before they become winners, and keep you out of losers. In addition, you get access to our community via chat, direct access to me, real-time price alerts, a model portfolio, and more. Sign up today! Josh Arnold has been covering financial markets for a decade, utilizing a combination of technical and fundamental analysis to identify potential winners early on in their growth cycles. Josh's focus is mainly on growth stocks. His goal is efficient and profitable use of capital, which overly rigid buy-and-hold strategies do not allow. Timely Trader Learn more. Analyst’s Disclosure: I/we have a beneficial long position in the shares of MSTR either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.It's All BananasSpecified Technologies Inc. Unveils Firestop Clash Management and Locator Updates
Aspen Technology stock hits 52-week high at $249.94The RCMP will create a new aerial intelligence task force to provide round-the-clock surveillance of Canada’s border using helicopters, drones and surveillance towers. The move is part of the federal government’s $1.3-billion upgrade to border security and monitoring to appease concerns of U.S. president-elect Donald Trump about the flow of migrants and illegal drugs. Trump has threatened to impose a 25 per cent tariff on all Canadian and Mexican exports to the U.S. as soon as he is inaugurated next month unless both countries move to improve border security. Public Safety Minister Dominic LeBlanc says he has discussed parts of the plan with American officials and that he is optimistic about its reception. Canada will also propose to the United States to create a North American “joint strike force” to target organized crime groups that work across borders. The government also intends to provide new technology, tools and resources to the Canada Border Services Agency to seek out fentanyl using chemical detection, artificial intelligence and canine teams. The union representing rank-and-file Mounties is welcoming the federal plan unveiled in the fall economic update Monday. Money, to be spread over six fiscal years, is earmarked for the RCMP, Public Safety Canada, the Canada Border Services Agency and the cyberspies at the Communications Security Establishment. RCMP members enforce laws between official points of entry and investigate criminal activities related to the border. National Police Federation president Brian Sauvé says members have been protecting the border with limited resources, and the new money will allow them to continue delivering on their mandate. Aaron McCrorie, the border services agency’s vice-president of intelligence and enforcement, said in a recent interview that irregular migration and smuggling of drugs such as fentanyl are common concerns for Canada and the United States. “These aren’t concerns that are unique to the United States. We share those same concerns,” he said. “In that sense, it really speaks to the need for us to work collaboratively.” McCrorie said the Canadian border agency is working closely with U.S. counterparts including Customs and Border Protection, the Drug Enforcement Administration and Homeland Security, as well as with agencies in Britain, Australia and New Zealand. “Criminal enterprises, organized crime, they don’t respect international boundaries. They collaborate, they exploit weaknesses in the system,” McCrorie said. “And so the best way to confront them is to is to collaborate on our side, fill those gaps, support each other’s efforts.” He said Canada’s border agency has two targeting officers embedded with U.S. Customs and Border Protection, and the American agency plans to soon send a targeting officer to Canada.
The Indian Space Research Organisation (ISRO) announced that it has reached a significant milestone in the Gaganyaan Programme, with the first solid motor segment moved from the production plant to the launch complex. The space agency said, "India's human spaceflight dreams are taking shape!" In a post on the social media platform X, ISRO stated, "A significant milestone for the Gaganyaan Programme! The first solid motor segment has been moved from the production plant to the launch complex, marking a key step towards the HLVM3 G1 flight." In September, ISRO Chairman S Somanath said that efforts were underway to launch India's first human spaceflight programme, Gaganyaan, by the end of this year. "Gaganyaan is ready for launch; we are trying to launch it by the end of this year," Somanath had said. The Gaganyaan Programme, approved in December 2018, envisages human spaceflight to Low Earth Orbit (LEO) and the establishment of technologies required for a long-term Indian human space exploration endeavour. On 18 September, the Cabinet approved the Chandrayaan-4 mission to the Moon. This mission aims to develop and demonstrate technologies to return to Earth after a successful lunar landing, as well as collect and analyse Moon samples on Earth. The Chandrayaan-4 mission will achieve foundational technologies and capabilities needed for an eventual Indian landing on the Moon (planned by 2040) and a safe return to Earth. Key technologies for docking, undocking, landing, safe return, and lunar sample collection and analysis will be demonstrated. The central government's expanded vision for the Indian space programme during the Amrit Kaal includes an Indian Space Station (Bharatiya Antariksh Station) by 2035 and an Indian landing on the Moon by 2040. (Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)The Dallas Cowboys ruled out right guard Zack Martin and cornerback Trevon Diggs with injuries on Saturday, one day prior to a road game against the Washington Commanders. Martin has been dealing with ankle and shoulder injuries and didn't practice at all this week before initially being listed as doubtful to play on Friday. He also physically struggled during Monday night's loss to the Houston Texans. Martin, who turned 34 on Wednesday, has started all 162 games played in 11 seasons with the Cowboys. He's a nine-time Pro Bowl selection and a seven-time first-team All-Pro. Diggs has been dealing with groin and knee injuries. He was listed as questionable on Friday before being downgraded Saturday. Diggs, 26, has 37 tackles and two interceptions in 10 games this season. The two-time Pro Bowl pick led the NFL with 11 picks in 2021 and has 20 in 57 games. The Cowboys elected not to activate receiver Brandin Cooks (knee) for the game. He returned to practice earlier this week and he was listed as questionable on Friday. Dallas activated offensive tackle Chuma Edoga (toe) and defensive end Marshawn Kneeland (knee) off injured reserve Saturday, placed safety Markquese Bell (shoulder) on IR and released defensive end KJ Henry. Tight end Jake Ferguson (concussion) was previously ruled out. Tight end Princeton Fant was elevated from the practice squad to replace him. Cornerback Kemon Hall also was elevated from the practice squad. --Field Level Media
Stocks closed higher on Wall Street ahead of the Christmas holiday, led by gains in Big Tech stocks. The S&P 500 added 1.1% Tuesday. Trading closed early ahead of the holiday. Tech companies including Apple, Amazon and chip company Broadcom helped pull the market higher. The Dow Jones Industrial Average rose 0.9%, and the Nasdaq composite climbed 1.3%. American Airlines shook off an early loss and ended mostly higher after the airline briefly grounded flights nationwide due to a technical issue. Treasury yields held steady in the bond market. On Tuesday: The S&P 500 rose 65.97 points, or 1.1%, to 6,040.04. The Dow Jones Industrial Average rose 390.08 points, or 0.9%, to 43,297.03. The Nasdaq composite rose 266.24 points, or 1.3%, to 20,031.13. The Russell 2000 index of smaller companies rose 22.42 points, or 1%, to 2,259.85 For the week: The S&P 500 is up 109.19 points, or 1.8%. The Dow is up 456.77 points, or 1.1%. The Nasdaq is up 458.53 points, or 2.3%. The Russell 2000 is up 17.48 points, or 0.8%. For the year: The S&P 500 is up 1,270.21 points, or 26.3%. The Dow is up 5,607.49 points, or 14.9%. The Nasdaq is up 5,019.77 points, or 33.4%. The Russell 2000 is up 232.78 points, or 11.5%.
Dialog Enterprise, the corporate ICT solutions arm of Dialog Axiata PLC, in collaboration with Dell Technologies and Pinnacle Distribution Lanka, unveiled an advanced AI-driven Video Surveillance and Analytics as a Service (VSaaS) solution at the ‘Sight Beyond Sight’ event held on October 30, in Colombo. The event was attended by key industry professionals from various sectors, marking a significant leap forward in transforming physical security operations across Sri Lanka. The ‘Sight Beyond Sight’ event highlighted the integration of Dialog’s AI-powered Video Surveillance and Analytics solution, powered by Dell Technologies’ reliable infrastructure. This collaboration brings together Dialog’s ICT expertise and Dell’s robust infrastructure, creating a secure and intelligent ecosystem for businesses to enhance physical security operations and streamline efficiency. The AI-driven solution offers businesses real-time threat intelligence and proactive security management, setting a new standard for the industry. A key highlight of the event was the live Proof of Concept (POC), where attendees had the unique opportunity to experience firsthand the power of AI-driven video analytics in real time. Presenters demonstrated how the solution effectively detects threats and accelerates investigations, revolutionising how businesses approach security management. The live demonstration showcased how AI can automate workflows, optimise resources, and enhance return on investment (ROI) on Video Surveillance, empowering businesses to enhance operational efficiency while strengthening security. “Dialog Enterprise is committed to empowering businesses with innovative solutions that redefine the future of security. Our collaboration with Dell Technologies enhances the capabilities of our video surveillance and analytics systems, offering businesses a proactive approach to managing security,” said Navin Pieris, Group Chief Officer Dialog Enterprise, Dialog Axiata PLC. “The event was a landmark moment for the industry. The integration of AI-powered video surveillance and video analytics opens new doors for businesses to revolutionise their security infrastructure. We are proud to be part of this journey with Dialog and Dell Technologies,” said Saman Perera, Managing Director, Pinnacle Distribution Lanka. As businesses face increasingly complex physical security challenges, the collaboration between Dialog Enterprise and Dell Technologies is paving the way for a comprehensive, scalable solution. This AI-powered video surveillance solution ensures real-time threat detection and enhanced operational efficiency, helping businesses stay ahead in the rapidly evolving security landscape. The event demonstrated the future of security, offering businesses in Sri Lanka a glimpse into the potential of intelligent, AI-powered video surveillance and analytics.
By DAVID BAUDER Time magazine gave Donald Trump something it has never done for a Person of the Year designee: a lengthy fact-check of claims he made in an accompanying interview. Related Articles National Politics | Trump’s lawyers rebuff DA’s idea for upholding his hush money conviction, calling it ‘absurd’ National Politics | Ruling by a conservative Supreme Court could help blue states resist Trump policies National Politics | A nonprofit leader, a social worker: Here are the stories of the people on Biden’s clemency list National Politics | Nancy Pelosi hospitalized after she ‘sustained an injury’ on official trip to Luxembourg National Politics | Veteran Daniel Penny, acquitted in NYC subway chokehold, will join Trump’s suite at football game The fact-check accompanies a transcript of what the president-elect told the newsmagazine’s journalists. Described as a “12 minute read,” it calls into question 15 separate statements that Trump made. It was the second time Trump earned the Time accolade; he also won in 2016, the first year he was elected president. Time editors said it wasn’t a particularly hard choice over other finalists Kamala Harris, Elon Musk, Benjamin Netanyahu and Kate Middleton. Time said Friday that no other Person of the Year has been fact-checked in the near-century that the magazine has annually written about the figure that has had the greatest impact on the news. But it has done the same for past interviews with the likes of Joe Biden, Netanyahu and Trump. Such corrections have been a sticking point for Trump and his team in the past, most notably when ABC News did it during his only debate with Democrat Kamala Harris this fall. There was no immediate response to a request for comment on Friday. In the piece, Time called into question statements Trump made about border security, autism and the size of a crowd at one of his rallies. When the president-elect talked about the “massive” mandate he had received from voters, Time pointed out that former President Barack Obama won more electoral votes the two times he had run for president. The magazine also questioned Trump’s claim that he would do interviews with anyone who asked during the campaign, if he had the time. The candidate rejected a request to speak to CBS’ “60 Minutes,” the magazine said. “In the final months of his campaign, Trump prioritized interviews with podcasts over mainstream media,” reporters Simmone Shah and Leslie Dickstein wrote. David Bauder writes about media for the AP. Follow him at http://x.com/dbauder and https://bsky.app/profile/dbauder.bsky.social.CRENESSITY, the first new treatment available in 70 years to the classic congenital adrenal hyperplasia (CAH) community, offers a paradigm-shifting treatment approach FDA approval supported by data from the largest-ever clinical trial program in pediatric and adult patients with classic CAH CRENESSITY is expected to be commercially available in approximately one week Rare Pediatric Disease Priority Review Voucher granted in connection with approval 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: The CAHtalyst Pediatric study met its primary endpoint, with CRENESSITY significantly decreasing androstenedione levels from baseline to Week 4 versus patients taking placebo who experienced a substantial increase in androstenedione levels. Children taking CRENESSITY were also able to significantly reduce their GC doses at Week 28 while maintaining or improving androgen levels, a key secondary endpoint. Children taking CRENESSITY saw approximately four times greater reduction in androstenedione compared with those taking placebo. Approximately four times greater steroid dose reduction in children taking CRENESSITY was seen compared with those taking placebo. Children taking CRENESSITY saw approximately 12 times greater reduction in 17-hydroxyprogesterone (17-OHP) compared with those taking placebo. Headache, abdominal pain, fatigue, nasal congestion and nosebleed were the most common adverse drug reactions (ADRs) among the pediatric population treated with CRENESSITY. Most side effects were temporary and mild to moderate in severity. Phase 3 CAHtalyst Adult Study: The CAHtalyst Adult study met its primary endpoint with CRENESSITY enabling significant GC dose reductions at Week 24 (while maintaining or improving baseline androstenedione levels) and key secondary endpoint of decreasing androstenedione levels at Week 4. A significantly higher number of patients taking CRENESSITY (63%) achieved a GC dose in the physiologic range while androstenedione was maintained or improved compared with patients taking placebo (18%). Approximately two times greater steroid dose reduction was seen in people taking CRENESSITY compared with those taking placebo. People taking CRENESSITY saw an eight times greater reduction in androstenedione compared with those taking placebo. People taking CRENESSITY saw a 37 times greater reduction in 17-OHP compared with those taking placebo. Fatigue, headache, dizziness, joint pain, back pain, decreased appetite and muscle pain were the most common ADRs in the CRENESSITY treatment group. Most side effects were temporary and mild to moderate in severity. 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.
Representative image MUMBAI: Three large IPOs, all of which closed on Friday, have collectively attracted investor interest worth about Rs 2.2 lakh crore. The three companies - Vishal Mega Mart, Sai Life Sciences and One Mobikwik - had set out to mobilise Rs 11,615 crore from the public, data from the exchanges showed. Of these three IPOs, the offer for One Mobikwik - the tech-driven payments enabler - saw a nearly 120 times demand, making it the most subscribed Rs 500-crore-plus IPO of 2024. Retail investors were the most active lot in the Mobikwik IPO. The Rs 8,000-crore offer for Vishal Mega Mart too witnessed strong investor demand. It was subscribed a little over 27 times, garnering total demand worth Rs 1.6 lakh crore. Sai Life Sciences' IPO, which was aiming to get Rs 3,043 crore, was subscribed 10.3 times. The offer saw a demand worth Rs 21,881 crore, exchange data showed. So far in the year, IPOs have mobilised nearly Rs 2 lakh crore, making it the biggest grossing year for such offers. Prior to this, in 2021, nearly Rs 1.2 lakh crore was raised from the capital market through 63 offers, data from Chittorgarh showed. Ready to Master Stock Valuation? ET’s Workshop is just around the corner!Scotland star scores a Serie A screamer from 45 yards out as fans rave about his ‘crazy idea’
White House National Security Communications Advisor John Kirby responds to more questions over the aerial systems on 'The Story.' White House National Security Communications Advisor John Kirby maintained that the government still lacks definitive answers regarding the nature of reported drone sightings as public frustration intensifies. "Many of the corroborated sightings have turned out to be piloted aircraft. I didn't say all of them, and what I said was those are the ones we were able to corroborate," Kirby said on " The Story ." "There certainly is ones that we have not been able to, and we don't know the answer to it, and I strongly recommend that for folks that are seeing these things and documenting them to share that as they can with the Department of Homeland Security and the FBI." DRONE MYSTERY: NEW JERSEY HOMEOWNERS THREATEN TO TAKE MATTERS INTO THEIR OWN HANDS IF GOVERNMENT DOESN'T ACT In a Wednesday letter to Biden, New Jersey Gov. Phil Murphy asked the president for more federal resources to address drone sightings, noting that the federal law limits the ability of state and local law enforcement to counter drones. "... it has become apparent that more resources are needed to fully understand what is behind this activity," Murphy wrote. "The continued reporting of UAS (unmanned aircraft systems) activity has raised more questions than answers and prompted an outcropping of conspiracy theories across social media and other platforms." A map showing drone sightings around New Jersey. Kirby addressed the possibility that the reported drone sightings could be linked to a private company, saying that they "could very well be" commercially developed drones of some kind. "Why don't we know? I wish I could tell you exactly why we don't have an answer for you here in the afternoon on the 13th of December," Kirby said. "But I can tell you that we are working on it very, very hard to know, because we want to answer those questions the same as those folks in New Jersey want answers to them." Kirby disclosed that there was an inter-agency conversation Friday morning about the topic. "We have now decided to employ some additional technology to New Jersey and some additional personnel to try to get a better sense of what these things are," he said. New Jersey State Assemblyman Paul Kanitra took a photo of what appears to be multiple drones hovering in the New Jersey sky on Thursday, Dec. 13. (Paul Kanitra / "Fox News @ Night") Monmouth County, N.J., Sheriff Shaun Golden urged officials to declare a state of emergency over the drone sightings, issuing a statement Wednesday evening. The release included a heat map showing the density of drones spotted across his county: A heat map indicating drone activity in Monmouth County, New Jersey. (Courtesy: Monmouth County Sheriff's Office) FOLLOW ALONG HERE FOR THE LATEST UPDATES ON THE NJ DRONE MYSTERY Rep. Chris Smith, R-N.J., whose district includes parts of Monmouth and Ocean Counties, recounted spending Monday night on a beach where he spoke with several individuals, including a U.S. Coast Guard commanding officer stationed in Barnegat Light. According to the commander, he said, a 47-foot Coast Guard vessel had been closely followed by more than a dozen drones the previous night. Monmouth and Burlington Counties are home to several military installations, including Naval Weapons Station Earle in Colts Neck and Joint Base McGuire-Dix-Lakehurst. On Thursday, Middletown, N.J., Mayor Tony Perry expressed his "concerns" to Fox News regarding the drone sightings near Naval Weapons Station Earle's waterfront site in his town, 14 miles north of the Colts Neck installation. CLICK HERE TO GET THE FOX NEWS APP "I'm not going to lie to you or to the American people, and I'm not going to say we know something when we don't," Kirby said. "We would never, ever stoop to think that an American citizen was crazy or nuts because of what they're seeing and what they're documenting. We're taking that imagery seriously, and we're doing the best we can to analyze it, and we encourage people to come forward if they have additional sightings and imagery." Joshua Comins is an associate editor for Fox News Digital. He covers media , politics , breaking news and current events. Story tips can be sent to joshua.comins@fox.com .Prospera Financial Services Inc Sells 797 Shares of ARK Innovation ETF (NYSEARCA:ARKK)
( MENAFN - media OutReach Newswire) HO CHI MINH, VIETNAM - Media OutReach Newswire - 18 December 2024 - LiveIn, Southeast Asia's leading long-stay provider dedicated to converting surplus properties into modern homes for young people, has formed a strategic alliance with JinJoo Home, Vietnam's pioneer in co-living for young professionals. Together, they aim to unify and strengthen Vietnam's co-living market by offering solutions for local operators that blend international standards and local relevance. Keek Wen Khai, CEO & Co-founder of LiveIn (left), and Jason Wong, CEO & Founder of JinJoo Home (right), at the alliance signing ceremony. Vietnam's urbanization rate is expected to surpass 50% by 2025, and with over 50% of the population being millennials and Gen Z, the demand for co-living spaces in major cities like Ho Chi Minh City is set to rise. However, the market remains fragmented, and local operators face challenges, such as high vacancies, maintenance costs, and inconsistent service. Keek Wen Khai, CEO & Co-founder of LiveIn, said: "Vietnam's long-stay market remains highly fragmented, but we see great potential in driving sustainable growth through collaboration. By forming a strategic alliance with JinJoo Home, we aim to bring operators together, address their challenges, and elevate standards to deliver a better living experience for the next generation." Jason Wong, CEO & Founder of JinJoo Home, said: "We're excited to join forces with LiveIn, a leading player in Southeast Asia. Our shared passion for improving young people's living experience makes this alliance a natural fit. Together, we can combine our strengths and create a more dynamic and high-quality co-living market in Vietnam." The strategic alliance comes at a time when Vietnam's residential real estate market is projected to reach USD 45.62 billion by 2029, with co-living playing a pivotal role. As many fragmented operators struggle to scale due to limited resources, LiveIn and JinJoo Home are focused on helping them seize this growth opportunity by combining LiveIn's international standards with JinJoo Home's extensive local expertise. LiveIn continually refines its product standards to address changing consumer preferences and ensure compliance with local regulatory requirements. With 10,500 rooms across 200 buildings in 4 Southeast Asian countries, LiveIn brings its proven regional expertise in technology, operational management, and demand generation. Meanwhile, JinJoo Home's deep local knowledge and strong presence in Ho Chi Minh City will help consolidate and support operators in adopting these best practices, tailored to meet the unique needs of the Vietnamese market. The strategic alliance with JinJoo Home builds on LiveIn's earlier strategic alliance with Hive, a regional leader in co-living renovations, to establish the LiveIn Global Renovation Division. Through this new division, LiveIn delivers thoughtfully designed homes that inspire growth and new experiences across all the markets it serves, including Malaysia, Thailand, Vietnam, and Indonesia. Both synergies further cement LiveIn's position as a leading flexible housing provider in Southeast Asia. MENAFN17122024003551001712ID1109005181 Legal Disclaimer: MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.
LOUISVILLE, Ky. (AP) — Pittsburgh quarterback Eli Holstein was carted off the field and taken to a hospital with a left leg injury sustained while being sacked in the first quarter of Saturday's Atlantic Coast Conference game at Louisville. The redshirt freshman's left ankle was caught at an awkward angle beneath Louisville defensive end Ashton Gillotte's hip on a twisting tackle for a 4-yard loss at midfield. Panthers medical personnel rushed to Holstein's aid, with a cart arriving quickly on the field within minutes. Javascript is required for you to be able to read premium content. Please enable it in your browser settings. Get the latest sports news delivered right to your inbox six days a week.Osamu Suzuki, who ran automaker across several decades, dies at 94