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Forget Main Street Capital, 12%-Yielding Capital Southwest Is The Better BuySome Centralia area residents living in the Fords Prairie neighborhood near Centralia High School and the banks of the Chehalis River are now questioning whether it's safe to drink the water coming from their own taps. Recent testing from wells in the area has shown dangerously high levels of nitrates in the water, but questions now remain, specifically what is causing it and how it can be remedied. More than a dozen residents were in attendance at the Centralia City Council meeting on Tuesday, Dec. 10, to voice their concerns over the contamination as both city and Lewis County staff were on hand for a presentation on the issue. The neighborhood is in Centralia’s urban growth area, meaning the city is in an interlocal agreement with Lewis County for jurisdiction in the area. The county is ultimately responsible under the current agreement. Currently, both city and county officials are working with neighborhood residents to test more wells on private property throughout the neighborhood, trying to pinpoint the source of the nitrate contamination in the area’s ground water. High nitrate levels in water are dangerous, especially to infants and adults with pre-existing health issues, as the nitrates can cause methemoglobinemia, also known as blue baby syndrome, according to the Cleveland Clinic. With blue baby syndrome, the nitrates are converted to nitrite in the stomach, which prevents red blood cells from carrying oxygen, leading to bluish skin discoloration due to low blood oxygen levels. This can cause a number of symptoms ranging from neurological development issues for infants to pale skin, fatigue, headaches, nausea, vomiting and more for adults. Chronic nitrate exposure can also lead to increased cancer risk and possible birth defects. As for what can cause high nitrate levels in water, it can be triggered by a range of factors from industrial waste, fertilizers, animal waste, wastewater and more. And while many of the residents in Fords Prairie do have septic tanks, they believe there is another source aside from the possibility of wastewater leaking from their septic tanks, as resident Amy White told the council during the public comment session. Through her own investigation, White stated city staff told her they had actually been seeing increasing nitrate levels in a monitoring well northwest of Fords Prairie going back to 2015. “The wells at (Fort) Borst Park are pure, I was told, so that showed city water that the contamination source was to the west of the park,” White said. “What large source could there possibly be on Fords Prairie? Well how about a 240-acre game farm, raising 40-to-45,000 birds every year. Do the math. That many birds produce around 200 pounds of poop every day.” White was referring to the Washington state Department of Fish and Wildlife’s (WDFW) Bob Oke Game Farm, which is located south of Centralia High School along Mt. Vista Road. She claimed staff told her the likely cause of the nitrate levels was leaking septic tanks, but stated her own was well-maintained and not leaking. White also recalled how shortly after she moved to the neighborhood in 2004, the game farm euthanized its entire flock to prevent the spread of disease to wild birds in the area, and the tens of thousands of dead birds were simply “buried on site,” on top of other questionable farming practices she’s observed. The game farm breeds and raises pheasants for hunters. It is named after the late Washington state Sen. Bob Oke. Originally opened in the 1950s as the Lewis County Game Farm, it was renamed the Bob Oke Game Farm in 2006 and is almost completely funded by WDFW pheasant hunting license fees, according to previous reporting by The Chronicle. Following public comment, Centralia Public Works Director Kim Ashmore and Lewis County Public Health & Social Services Director Meja Handlen gave a presentation addressing what the city and county know about the nitrate problem so far and what the next steps are in addressing this issue. According to Ashmore, Centralia staff have been testing wells in Fords Prairie since 1981 and did notice nitrate levels increasing in the area from 2017 to 2019 — where an increase of 2.8 to 3.42 milligrams per liter was observed. The maximum allowable limit of nitrate levels in water is 10 milligrams per liter, according to the federal Safe Drinking Water Act, while state law mandates increased monitoring be conducted if the level rises above 5 milligrams per liter. “We started looking at what are potential contaminants out there besides septic tanks and stormwater catch basins, things like that,” Ashmore said. Then a monitoring well on Mt. Vista Road directly next to the Bob Oke Game Farm showed much higher levels starting in 2023 — first at 8.0 milligrams per liter and rising to 9.18 milligrams per liter. The city also drilled another monitoring well at the corner of Mt. Vista and Eshom roads in late 2023. Test results from that well have ranged from 9.12 milligrams per liter to well above the allowable limit at 30.8 milligrams per liter this year. “That’s when we invited Lewis County into this discussion,” Ashmore said. He added wells on private property have also been tested in the neighborhood, all with nitrate levels above 10 milligrams per liter. According to Handlen, the main areas of concern the county has are residences located on Mayberry, Rancho, Eshom, Prill, Mt. Vista, Cowlitz and Pheasant roads along with some residences on Borst Avenue. “This is an area of concern and impact of about 70 homes,” Handlen said. “When we look at this map, we want to be really cognizant of a plume zone.” Tests on Centralia High School’s water supply did not find high levels of nitrates. Handlen stated that Centralia’s drinking water aquifer is shallow with loose overlaying soils, making it vulnerable to nitrate contamination, and historically nitrate has always been present throughout the entire aquifer. As for what happens next, Handlen said she is working to try to get more residents in the area to allow for testing in private wells. So far, they have notified 70 private well owners in the area, tested 28 wells and are now monitoring 20 wells in Fords Prairie, with “about 10 that are private wells that have very high (nitrate) levels.” While results were still inconclusive, high nitrate levels appear to be clustered in an area generally downgradient of the monitoring well at the corner of Mt. Vista and Eshom roads — mainly from residences on Mayberry Road. “We don’t have all the data for everybody on, say Mayberry (Road), and that’s what we really need, to show all the homes together,” Handlen said. Once more testing is conducted and the contamination source is identified, then work can begin on remedying this issue, Handlen added. In addition to more testing to pinpoint the source of the nitrate contamination, county and city staff are working to fund installation of under-sink nitrate filters for residents, with $41,600 coming from a Washington state Department of Health grant, pending grant approval next month. Ashmore added the city has been in contact with both state legislators and the WDFW about this issue, and is planning a community town hall meeting next week. “Everybody’s aware of the issue and we’re all trying to find what is the right solution, but as Meja said, we need a little bit more data,” Ashmore said. While he didn’t announce the exact time, Ashmore said he was in talks with Centralia High School staff to utilize a room on Thursday, Dec. 19, for the town hall meeting, “sometime around 6:30 p.m.” An announcement will be made once the town hall meeting details have been finalized.The Mall at Greece Ridge, located near Rochester, closed early Thursday due to concerns about “large and disorderly groups of teens and young adults.” It was shut down shortly after 6 p.m. on the day after Christmas, also known as Boxing Day, by police and mall security. According to WHAM, the Greece Police Department said it was expecting a large influx of teens after seeing posts on social media. Greece Police said the mall was cleared without incident, but fights between several groups of teenagers broke out in the surrounding area outside the mall shortly afterwards. Two 16-year-old Rochester residents were arrested for disorderly conduct. No other crimes were reported, police said, and there was no damage to stores within the mall or surrounding businesses. WROC reports an area Chick-fil-A refused dine-in service, only offering drive-thru, and shoppers at a nearby Target said they were asked by police to leave. According to WHAM, a curfew was enforced at the mall last year after large fights occurred in 2023. Police developed a plan with mall security to quickly shut down the area to prevent future incidents. In a statement, The Mall at Greece Ridge said a large number of teens were running throughout the mall creating disruptions and refusing to leave. Similar disruptions were allegedly promoted on social media at a mall near Buffalo, officials said. WKBW reports Cheektowaga police swept the Walden Galleria around 7 p.m. Thursday as part of a “coordinated and planned effort to sweep the mall at closing time.” The preventative measure comes after the shopping center previously saw fights on the day after Christmas in 2018, 2021 and 2023. In a separate incident, a man was arrested on Monday for allegedly starting a fight at Crossgates Mall near Albany. WNYT reports a 27-year-old man was charged with disorderly conduct. Guilderland Police said he was intoxicated in the Dec. 23 incident; no one was seriously hurt and no weapons were involved.
As the end of the college football season approaches, many teams are beginning to eye which bowl they will be playing in. It also marks the time when coaches that have not met expectations are being fired. The list of fired coaches is already long and growing, likely to be in line with the number of coaches who changed schools or positions in 2023. The schools affected included several from the Bowl Championship Series. Mack Brown, the University of North Carolina (UNC) coach, was let go on Nov. 26. His record of 44-33 over six seasons during his most recent tenure at North Carolina was respectable. He also took his team to bowl games every season, though his 1-4 record in these games was less than stellar. Neal Brown, the West Virginia Mountaineers coach, was let go on Dec. 1. His record of 37-35 over six seasons, with three bowl game appearances (and a 2-1 record), was insufficient to keep his job. Speculations on his successor abound, with former Mountaineer coach Rich Rodriguez certainly in the mix. Ryan Walters, the Purdue Boilermakers coach, was also let go on Dec. 1. His record of 5-19 over just two seasons, including season ending embarrassing losses to Notre Dame and Indiana, likely played into his dismissal. Before feeling sorry for these men, they will all receive handsome buyouts. Neal Brown will walk away with nearly $10 million. Ryan Walters will take home over $9 million. Mack Brown will receive a rather modest $2.8 million. What gets forgotten at these times are the students who had developed close ties to these men. Given how the transfer portal functions, many will look for a new school next season, possibly following their fired coach to his new home. This benefited Indiana this season, when first year coach Curt Cignetti was able to attract several of his best players from James Madison University where he previously coached. There are a number of issues that should be addressed when coaches are fired and paid ridiculous amounts of money for not coaching. These figures not only top faculty salaries, they are well over the salaries earned by every university president and chancellor. The UNC chancellor, Lee Roberts, takes home around $600,000. Gordon Gee, the chancellor of West Virginia University, has a base salary of $800,000. Mung Chiang, president of Purdue, has a salary over $600,000. Yet none of these high-ranking university official salaries come close to the buyouts for the dismissed coaches. It is common knowledge that big time college sports involve big time money. That is why the major television networks pay billions of dollars for the rights to broadcast high profile games involving teams in high profile conferences. So who will pay for these buyouts? The simple answer is all of us. Television contracts are paid for by advertisers. The cost of these advertisements is recouped in the products and services that we purchase. People who never watch a football game are paying for some of these buyouts. When buyouts, let alone salaries paid to employed coaches, become excessive, one must begin to question whether the “tail is (inappropriately) wagging the dog”? Athletic departments often argue that they are self-sustaining, not using general university funds targeted for education. Research suggests that this is not the case. Athletic departments also argue that college sports build school spirit and alumni engagement. The question is at what price are such benefits accrued. Without revenue sports like football and basketball, the professional leagues would need to spend a significant amount of money to build minor league systems to keep their talent pipelines stocked. Names, Images and Likeness (NIL) endorsements have made these revenue sports into minor league feeder systems. Some college students are now earning millions of dollars for being a student and playing on the school team. Of course, such high-profile athletes are the exception, not the rule, with most student-athletes earning a few thousand dollars. What has become clear is that in high profile revenue sports, student athletics are no longer about students. They are about a financial arms race that has driven coach salaries and performance expectations ever higher. When Ryan Day, the Ohio State football coach lost to Michigan for the fourth consecutive year, speculation about his dismissal abounded. Fortunately, he was given a vote of confidence by the institution. Nearly every school would welcome him on their sidelines if Ohio State was foolish enough to listen to their vocal fans and fire him, given his 66-10 record since 2018 and five top-10 rankings in the final Coaches and AP polls. Athletics has a place on college campuses. Yet the financial optics tarnish its image. Most turn a blind eye, hoping to win this financial athletic arms race with national championships. Yet with only one national champion crowned each year, nearly all schools end up disappointed, except perhaps the coaches who end up being let go. They walk away with a treasure trove for failing to meet unrealistic expectations in a no-win situation. Sheldon H. Jacobson, Ph.D., is a professor of Computer Science at the University of Illinois at Urbana-Champaign. He applies his expertise in data-driven risk-based decision-making to evaluate and inform public policy.Trump asks US Supreme Court to pause law threatening TikTok ban
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(BPT) - The holidays are almost here! It means parties and events, hustle and bustle ... and figuring out what to buy for everyone on your list. Sometimes it's hard to get inspired with great ideas that your nears and dears will love at a price you can afford, right? The good news? Inspiration + savings are covered this year. One of the top gifts of Holiday 2024 is technology, and there are a lot of deals out there right now. Done and done! Here are 5 ideas for hot tech gifts for everyone on your list. Smartphones for the family T-Mobile is running a hot deal right now. Get four new smartphones at T-Mobile — this includes Samsung Galaxy S24 and other eligible devices — and four lines for just $100/month . It doesn't get better than that! These new Galaxy phones are tech-tastic, too, with features like AI, Circle to Search with Google, which can be used to help solve math problems and translate entire pages of text in a different language, and Note Assist with Galaxy AI, which lets you focus on capturing your notes and then Note Assist will summarize, format and even translate them for you. High tech spiral notebook for students We've got to admit, this is pretty cool. The Rocketbook looks (a bit) like a regular spiral, paper notebook. Here's the high tech twist: You can take notes, capture ideas, brainstorm, draw — whatever you do on paper — on the pad, and the Rocketbook digitizes your doodles and saves to the cloud device of your choice. Then you simply wipe the pad clean and it's good to go. Look for Black Friday and Cyber Monday sales at your favorite online retailer. Wrist-worthy smartwatches for athletes (or those who want to be) Everyone loves smartwatches (if you're not already tracking your sleep and heart rate, where have you been?) and the Google Pixel Watch 3 (41mm & 45mm) takes it to the next level with features for athletes or anyone who may be setting fitness goals for the coming year. The watch has workout prompts like Real Time Guidance — audio and haptic cues for when to sprint, cool down or maintain pace. It gives you the ability to program your workouts and even monitors your cadence and stride. It also has Offline Maps, with driving navigation, search and maps. Here's the deal of the century: Get it for free at T-Mobile when adding a qualifying watch line. Cute wireless keyboard for people who are all thumbs Who else is annoyed by typing email or texts or social posts on a smartphone? The Logitech Multi-Device Wireless Bluetooth Keyboard solves that problem with style! It comes in sweet colors like lavender, it's wireless, it's small and portable, and it works with just about any device. Pop it into your backpack or purse and you'll never have to thumb-out a message again. Speakers perfect for hosting and giving Have a music lover in your life or need the perfect hosting gift? T-Mobile has you covered. For a limited time, you can get the JBL Clip 5 for free when you pick up a Harman Kardon Onyx Studio 9 . The JBL Clip 5 is an ultra-portable Bluetooth speaker perfect for those on the go and the Onyx Studio 9's sleek design and booming sound will take care of all your holiday hosting needs. For more tech-tastic holiday gift inspiration, check out T-Mobile's holiday gift guide at t-mobile.com/devices/tech-gifts . Best trending stories from the week. Success! An email has been sent to with a link to confirm list signup. Error! There was an error processing your request. You may occasionally receive promotions exclusive discounted subscription offers from the Roswell Daily Record. Feel free to cancel any time via the unsubscribe link in the newsletter you received. You can also control your newsletter options via your user dashboard by signing in.
(PRNewsfoto/Neurocrine Biosciences, Inc.) Logo (PRNewsfoto/Neurocrine Biosciences, Inc.) Logo 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.
SAD or Winter Blues?Supreme Court will take up a challenge related to California's tough vehicle emissions standards WASHINGTON (AP) — The Supreme Court says it will take up a business-backed appeal that could make it easier to challenge federal regulations, acting in a dispute related to California’s nation-leading standards for vehicle emissions. The justices agreed Friday to hear an appeal filed by fuel producers who object to a waiver granted to California in 2022 by the Environmental Protection Agency during Joe Biden’s presidency. The waiver allows California to set more stringent emissions limits than the national standard. The case won’t be argued until the spring, when the Trump administration is certain to take a more industry-friendly approach to the issue. Musk says US is demanding he pay penalty over disclosures of his Twitter stock purchases DETROIT (AP) — Elon Musk says the Securities and Exchange Commission wants him to pay a penalty or face charges involving what he disclosed — or failed to disclose — about his purchases of Twitter stock before he bought the social media platform in 2022. In a letter, Musk’s lawyer Alex Spiro tells the outgoing SEC chairman, Gary Gensler, that the commission’s demand for a monetary payment is a “misguided scheme” that won’t intimidate Musk. The letter also alleges that the commission reopened an investigation this week into Neuralink, Musk’s computer-to-human brain interface company. The SEC has not released the letter. Nor would it comment on it or confirm whether it has issued such a demand to Musk. Senate begins final push to expand Social Security benefits for millions of people WASHINGTON (AP) — The Senate is pushing toward a vote on legislation that would provide full Social Security benefits to millions of people. Senate Majority Leader Chuck Schumer began the process on Thursday for a final vote on the bill, known as the Social Security Fairness Act. It would eliminate policies that currently limit Social Security payouts for roughly 2.8 million people. The legislation has passed the House. The bill would add more strain on the Social Security Trust funds, which are already estimated to be unable to pay out full benefits beginning in 2035. The measure would add an estimated $195 billion to federal deficits over 10 years, according to the Congressional Budget Office. Saudi Arabia banned film for 35 years. The Red Sea festival is just one sign of the industry's rise JEDDAH, Saudi Arabia (AP) — “My Driver and I” was supposed to be made in 2016, but was scuttled amid Saudi Arabia’s decades-long cinema ban. Eight years later, the landscape for film in the kingdom looks much different. And the star of “My Driver and I” now has an award. Roula Dakheelallah was named the winner of the Chopard Emerging Saudi Talent award at the Red Sea International Film Festival on Thursday. Both the award and the glitzy festival itself are signs of Saudi Arabia’s commitment to shaping a new film industry. The reopening of cinemas in 2018 after 35 years marked a cultural turning point for Saudi Arabia. Trump offers support for dockworkers union by saying ports shouldn't install more automated systems WASHINGTON (AP) — President-elect Donald Trump is offering his support for the dockworkers union before their contract expires next month at Eastern and Gulf Coast ports. He posted on social media Thursday that he met with union leaders and that any further “automation” of the ports would harm workers. He wrote that the “amount of money saved is nowhere near the distress, hurt, and harm it causes for American Workers.” 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. The Maritime Alliance says the technology will improve worker safety and strengthen our supply chains, among other things. IRS recovers $4.7 billion in back taxes and braces for cuts with Trump and GOP in power WASHINGTON (AP) — IRS leadership on Thursday announced that the agency has recovered $4.7 billion in back taxes and proceeds from a variety of crimes. The announcement comes under the backdrop of a promised reckoning from Republicans who will hold a majority over both chambers of the next Congress and have long called for rescinding the tens of billions of dollars in funding provided to the agency by Democrats. IRS Commissioner Danny Werfel said improvements made to the agency will help the incoming administration and new Republican majority congress achieve its goals of administering an extension of the 2017 Tax Cuts and Jobs Act. Unique among 'Person of the Year' designees, Donald Trump gets a fact-check from Time magazine Donald Trump got something this year that no other person designed Time magazine's Person of the Year had ever received. He got a fact-check of claims that the president-elect made in the interview accompanying the magazine's piece. Trump earned the recognition of the year's biggest newsmaker for the second time, also winning it in 2016 the first time he was elected president. But in a piece described as a “12-minute” read, Time called into question more than a dozen statements Trump made when speaking to the magazine's reporters, on issues like border size, autism and crowd size at a rally. Time said it has fact-checked other interviews in the past, but not for this annual feature. OpenAI's legal battle with Elon Musk reveals internal turmoil over avoiding AI 'dictatorship' A 7-year-old rivalry between tech leaders Elon Musk and Sam Altman over who should run OpenAI and best avoid an artificial intelligence ‘dictatorship’ is now heading to a federal judge. The development comes as Musk seeks to halt the ChatGPT maker’s ongoing conversion into a for-profit company. Musk was an early OpenAI investor and board member. But he sued the artificial intelligence company earlier this year. He has since escalated the dispute, adding new claims and asking for a court order that would stop OpenAI’s plans to convert itself into a for-profit business more fully. OpenAI filed its response in court Friday. OpenAI's Altman will donate $1 million to Trump's inaugural fund LOS ANGELES (AP) — OpenAI CEO Sam Altman is planning to make a $1 million personal donation to President-Elect Donald Trump’s inauguration fund, joining a number of tech companies and executives who are working to improve their relationships the incoming administration. A spokesperson for OpenAI confirmed the move on Friday. The announcement comes one day after Meta, the parent company of Facebook and Instagram, said it donated $1 million to the same fund. Amazon also said it plans to donate $1 million. China signals it's prepared to double down on support for the economy as Trump tariffs loom BANGKOK (AP) — Chinese leaders met this week to plot economic policy for the coming year and sketched out plans to raise government spending and relax Beijing's monetary policy. Analysts said the broad-brush plans from the annual Central Economic Work Conference were more of a recap of current policy than ambitious new initiatives at a time when the outlook is clouded by the President-elect Donald Trump's threats to sharply raise tariffs once he takes office. The ruling Communist Party did commit to raising China's deficit and to doing more to encourage consumer spending by bringing wage increases in line with the pace of economic growth. Here's a look at China's main priorities and their potential implications.Authored by Tom Mitchelhill via CoinTelegraph.com, Ethereum’s Ether has been marred by under-performance over the last 18 months, seeing Bitcoin and a swathe of other alternative layer-1 coins, including the likes of Solana and Sui, dramatically outperforming it. While ETH has gained 88% in the last 18 months, SOL has posted a 1,040% gain, and SUI has rallied 448% in the same timeframe. “ETH got sandwiched in 2024 between two shiny objects: Bitcoin, which attracted a huge amount of institutional interest, and Solana, which gained traction with retail investors. ETH was the odd man out,” Bitwise chief investment officer Matt Hougan told Cointelegraph. However, many crypto pundits believe the election of Donald Trump in the United States and the expected crypto-friendly stance of key agencies under his new administration could mark the turning point for the performance of Ether in the crypto market. After all, the incoming president’s family launched its own decentralized finance (DeFi) project, World Liberty Financial, on the chain. Experts are looking at a swathe of new developments for a bullish stance on ETH heading into 2025, ranging from the demise of “financial nihilism” to a complete overhaul of the US Securities and Exchange Commission, positive regulatory developments, Ether exchange-traded fund (ETF) staking, and increased Commodity Futures Trading Commission (CFTC) oversight of crypto. Alternative layer-1 coins like SOL and SUI have drastically outperformed ETH. Source: TradingView “Ethereum is poised to benefit more [from a Trump win] than other protocols, especially since it’s just a lot bigger and more mature than all the other ecosystems other than Bitcoin, which is mature but narrow in its purview,” Consensys CEO Joe Lubin told Cointelegraph at Devcon 2024 . At the same time, the gloss has started to come off Solana, whose SOL token peaked at an all-time high of $264 a month ago but has since retreated to $192 amid concerns over looming token unlocks. One of the big factors weighing heavily on Ethereum’s price has been the aggressive approach of regulators toward alleged securities violations by ecosystem projects including Uniswap, Consensys, Lido and Rocket Pool. Memecoin projects, meanwhile, have been largely overlooked by the SEC. A related issue is the disillusionment of crypto natives who were dumped on by venture capitalists during the brutal bear market. Many have turned to fair-launch memecoins and other hyper-speculative assets with little utility. Ikigai Asset Management founder and chief investment officer Travis Kling calls this phenomenon “financial nihilism.” In a March 12 essay , Kling said financial nihilism gives little if any importance to “fundamentals” or any notion of an underlying “value proposition.” “Financial Nihilism goes hand in hand with Populism – a political approach that strives to appeal to ordinary people who feel that their concerns are disregarded by established elite groups.” “The underlying drivers of Financial Nihilism and Populism are the same – this system is not working for me, so I want to try something very different (e.g., buy SHIB or vote for Trump),” wrote Kling. However, Ethereum is sold almost entirely on its fundamentals and utility. Advocates repeatedly make the claim that the blockchain network and its ecosystem of layer 2s stand as the future of legitimate, programmable digital money, smart contracts and decentralized financial activity. Saul Rejwan, managing partner of crypto venture capital firm Masterkey, says Trump’s pro-crypto stance could see financial nihilism fall out of favor as legitimate projects are encouraged by regulators rather than hit with endless Wells notices from the SEC. On Dec. 4, Trump tapped pro-crypto businessman and former SEC Commissioner Paul Atkins as his nominee for the next SEC chair , with current Chair Gary Gensler set to resign from the agency on Jan. 20. The SEC will be losing three of its Democratic commissioners under Trump, with Jaime Lizarraga set to leave the agency on Jan. 17 and, more recently, the Senate Banking Committee canceling the renomination vote of crypto-skeptic commissioner Caroline Crenshaw on Dec. 17. As the ruling party, the Republicans would typically appoint a majority of three commissioners, but the rapid-fire resignations and cancellations open the SEC up to a possible line-up of four Republican-appointed, crypto-friendly commissioners if Trump breaks protocol. Rejwan told Cointelegraph that legitimate sectors of the crypto industry, specifically DeFi and decentralized physical infrastructure (DePIN), stand to benefit most from the new administration and a more crypto-friendly SEC. “DeFi projects will thrive under a more favorable regulatory environment. Sectors like restaking just need a little regulatory push to hook institutional investors,” he said. “We expect this new leadership to lower barriers to entry and make it easier for early-stage crypto entrepreneurs and resilient firms to innovate and thrive.” The Gensler-led SEC under the Biden administration has been famously hostile to DeFi, with the regulator bringing Uniswap, the largest decentralized exchange on Ethereum, into its sights earlier this year. The SEC has proposed expanding the definition of what qualifies as an exchange in the Exchange Act of 1934, explicitly arguing it should include crypto market participants in DeFi. Anoop Nannra, CEO of Trugard Labs, said he expects the SEC to undergo a complete overhaul of its enforcement actions and policy directions, saying crypto assets are slated to be classified as “property” under the new administration. “I’ve heard from several people within Trump’s orbit that property rights are a critical issue for this administration and that this is actually going to be the calling card for the Republican party’s position on crypto,” he said. “I expect to see a complete revamp of the SEC's position based on this.” On Dec. 19, the Token Alliance — which incoming SEC Chair Paul Atkins was co-chair of — met with staffers for SEC Commissioners Hester Peirce and Mark Uyeda and issued its list of priorities. It requested that the agency denounce the controversial 2018 “Hinman speech” and formally withdraw a series of rules that deemed DeFi players to be seen as “exchanges” by law. The Token Alliance has asked the SEC to walk back a swathe of anti-crypto policies. Source: The Digital Chamber Nannra said he also expects the CFTC will soften to digital assets as well and that the SEC will engage in more discussions with the CFTC moving forward. “I expect to see the CFTC take a more progressive position on crypto as well, further re-aligning the oversight powers between the SEC and the CFTC,” Nannra said. Many pundits believe that the Financial Innovation and Technology for the 21st Century Act (FIT21) — a bill that was passed through the House in May — would be central to the alignment of the CFTC and the SEC on crypto. In short, the bill sought to introduce a federal framework for crypto regulation, pull back some of the SEC’s authority over digital assets, and hand over regulation of spot crypto markets to the CFTC instead. Because Ether has also been deemed a commodity by the CFTC, several pundits have previously asserted that FIT21 could be highly beneficial for Ethereum from a policy perspective. But now, with the change in the regulatory landscape, it raises the question of whether or not the FIT21 bill would be necessary or even desirable anymore. The bill may end up becoming just an unnecessary policy bargain made during a hostile time for crypto assets. In a Nov. 15 client alert, lawyers from legal firm Brownstein noted the bill had stalled but would likely “serve as the starting point for legislative efforts in the new Congress.” Regardless of whether FIT21 passes, Trump is reportedly considering handing the CFTC oversight over crypto during his upcoming term, which would also classify most crypto projects as commodities if they meet certain criteria. If the CFTC is given regulatory control of crypto, it could come as a win for the industry, which has long signaled that the agency would be its preferred regulator — with the CFTC widely seen as having a “lighter touch” on regulation. Crypto lawyer Robert Nupp told Cointelegraph that the launch of the Trump dynasty’s World Liberty Financial was one the biggest “soft” endorsements of Ethereum, DeFi and real-world crypto projects. It has already purchased millions of dollars worth of ETH, Chainlink LINK $22.18 and Aave AAVE $326.14 . Nupp believes many within crypto are actually underestimating the positive impact of Trump on the industry. Source: Lookonchain According to Nupp, Trump is using World Liberty Financial as a beacon to show the world exactly how he intends to deal with crypto when he becomes president. “He’s basically signaling to the world that it’s okay to do this going forward in his administration,” he said. Nupp also tipped the Trump administration to move extremely quickly on crypto, pointing out Trump’s close ties with Elon Musk and the appointment of David Sacks as crypto and AI czar as evidence of the pace he will set. SEC Commissioner Peirce has already flagged the potential of revisiting decisions to block in-kind redemptions for crypto ETFs and to add staking for the Ether ETFs. “If it changes from a majority of commissioners who don’t want things to go through to a majority of commissioners who do want things to go through, then yeah, it’s easier,” she said . The ETF issuers — including Fidelity, 21Shares, and Franklin Templeton — have all requested the addition of staking, which currently yields approximately 3.1% per year, according to Staking Rewards. “We believe, under a new Trump 2.0 crypto-friendly SEC, ETH staking yield will likely be approved,” Bernstein said , predicting that growing network activity on Ethereum could see rewards “juice up” to 4%–5%. Ethereum boasts a 3.11% staking reward rate as of Dec. 24. Source: Staking Rewards It doesn’t take much to connect the dots on why an ETF offering native yield would be bullish for the underlying asset, particularly in an economic landscape where the US Federal Reserve is looking to drop interest rates further in 2025. “In a declining rate environment, ETH yield can be quite attractive. The yield feature in ETFs would also leave some spread for asset managers,” Bernstein said, adding that this would improve ETH’s economics and introduce further incentives to push ETH ETFs to institutional investors.
Trump names David Sacks as White House AI and crypto czar
