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Tag: approves

  • In a switch, Trump approves Fed’s decision to hold interest rates steady


    U.S. President Donald Trump looks on as he signs an executive order in the Oval Office at the White House in Washington, U.S., Jan. 31, 2025. 

    Carlos Barria | Reuters

    President Donald Trump agreed with the Federal Reserve for its decision last week to leave interest rates unchanged, an early pivot from his previous demand that the central bank ease “immediately.”

    In an exchange with reporters Sunday, Trump said holding its key borrowing level in a range between 4.25%-4.5% was the correct move for the Fed.

    “I’m not surprised,” he said regarding the decision, according to multiple reports. “Holding the rates at this point was the right thing to do.”

    The statement stood in stark contrast to one Trump delivered when speaking remotely to the World Economic Forum in Davos, Switzerland. In a Jan. 23 appearance, Trump said he would “demand that interest rates drop immediately.”

    The president has no direct authority over the Fed, though he does nominate the chairman as well as other board members. Current Chair Jerome Powell is a Trump nominee, and a frequent target of the president’s criticism.

    Markets don’t expect the Fed to lower rates until at least June. In his post-meeting news conference last Wednesday, Powell repeatedly asserted that the Fed doesn’t need to be in a “hurry” to lower further after shaving a full percentage point off the fed funds rate from September to December in 2024.

    The Fed’s decision-making got potentially more complicated after Trump on Saturday said he would impose aggressive tariffs against Canada, Mexico and China, the three largest U.S. trading partners. Economists worry that the tariffs will drive up prices at a time when inflation has shown signs of easing.

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    In a surprising turn of events, President Trump has approved the Federal Reserve’s decision to keep interest rates steady. This decision comes after months of criticizing the Fed for raising rates too quickly, causing tensions between the President and the central bank.

    Trump’s approval of the Fed’s decision signals a shift in his stance on monetary policy, as he has previously called for lower interest rates to stimulate economic growth. This change in attitude could be a sign that the President is beginning to trust the Fed’s judgment and is willing to work with them to achieve economic stability.

    The decision to hold interest rates steady was made at the Fed’s recent meeting, where they cited concerns about slowing global growth and trade tensions as reasons for their cautious approach. Trump’s approval of this decision could help ease concerns about potential interference in the Fed’s independence and provide reassurance to investors and markets.

    Overall, this unexpected move by President Trump to support the Fed’s decision to keep interest rates steady could be a positive development for the economy and financial markets. It will be interesting to see how this newfound cooperation between the White House and the Federal Reserve plays out in the coming months.

    Tags:

    1. Trump administration
    2. Federal Reserve
    3. Interest rates
    4. Monetary policy
    5. Economic decisions
    6. President Trump
    7. Federal Reserve decision
    8. Financial markets
    9. Economic stability
    10. Federal Reserve interest rates

    #switch #Trump #approves #Feds #decision #hold #interest #rates #steady

  • Tampa City Council approves more money for storm drainage


    The Tampa City Council voted to support spending an additional $500,000 a year on storm drain maintenance as residents called for more information about why so much flooding occurred this past hurricane season and getting updates on what’s being done about it monthly.

    During a presentation about short-term solutions to flooding, city Mobility Director Vik Bhide said the department planned to ask for $10.5 million next week to upgrade the city’s 16 pump stations, adding back-up generators to power them where they don’t exist as well as monitoring equipment.

    Bhide said it could take up to two years to implement the upgrades. In the interim, the city will switch to generator power the day before a storm arrives to avoid power outages taking them out of commission, an issue during Hurricane Milton in October.

    The division also asked for the additional $500,000 to address maintenance and improve its pipe inspection system.

    The department is working on longer-term solutions with seven consultants that include looking at each drainage basin within the city, Bhide said. That work will begin in February and include modeling using current data and standards, which would allow the department to create a list of capital needs and costs.

    But some residents were not put at ease.

    Steve Michelini, general manager of the Soho Business Alliance, called the solutions “a day late and a dollar short.

    “All of a sudden it’s a crisis that they’ve ignored for many years, not just this mayor,” he said. “It goes back several years. Back then we didn’t have a problem because we didn’t have storms of this significant magnitude.”

    He said near his own South Tampa house, every rain brings floods because of poorly designed drainage systems.

    Michelini said the council didn’t need new plans but needed to execute ones already in place and focus on maintenance. He said the department would need an immediate appropriation.

    “Get the ditches and the retention ponds and the culverts cleaned out,” he said. “And that will solve a lot of problems. It won’t solve an 100% but it’ll be a good first step.”

    Other residents spoke of cracks in pipes, poorly maintained retention ponds, culverts, ditches and drains — with trees growing out of some. They spoke of the flooding that came to their neighborhoods as a result.

    Pam Cannella, who lives on San Rafael Street in South Tampa, held up binders of photos to show the council.

    Anneliese Meier with the Historic Parkland Estates Preservation Society, who is working with neighborhood groups in Concordia Park, Bayshore Gardens, Palma Ceia Pines, Beach Park, Virginia Park and Forrest Hills, said residents want to know where the stormwater assessment fees they pay are going.

    “We also want to know what equipment the department has (for) stormwater maintenance, because I don’t think they have enough,” she told the council.

    Bhide said the maintenance assessment funds 62 positions in stormwater operations. He also said in the Parkland Estates neighborhood, the Mobility Department removed more than six tons of debris over the past year. He said the department also inspected and cleaned over 7,000 miles of pipe.

    “Was it enough to make sure everything was great?” he asked rhetorically. “We feel we’ve done everything we can within the resources we have.” The area, he said, needs more capital infrastructure.

    David Laxer, president of Bern’s Steakhouse Co. sent an email to the City Council the night before the meeting, calling the verbal report from the Mobility Department “absurd.”

    “Please pay close attention to the items being discussed, Stormwater and Flooding, and note that ALL THESE ITEMS DO NOT HAVE ANY WRITTEN BACK-UP REPORTS!” he wrote. “… No written documents, no maps, no photos, nothing to review in advance. …The lack of transparency and candor to the citizens of Tampa and City Council should disturb you.”

    “Management failures and processes/procedures are not in place to properly maintain our current stormwater systems, thus putting our neighborhoods and citizens at risk,” his email said.

    Council member Lynn Hurtak agreed with the calls for a breakdown in spending and for monthly reports.

    “Just part of what will make people feel better is a continual reminder of where we are, what we’re doing, the types of movement, of movement that’s coming,” she said.



    In a recent decision, the Tampa City Council has approved additional funding for storm drainage infrastructure. This move comes in response to the increasing frequency and severity of storms in the area, which have caused significant flooding and damage to properties.

    The approved funds will be used to upgrade and expand the city’s storm drainage system, including the installation of larger pipes, improved drainage channels, and enhanced water storage capabilities. This investment is expected to help alleviate flooding issues and better protect residents and businesses from future storm events.

    Council members emphasized the importance of proactively addressing storm drainage concerns to mitigate the impact of severe weather on the community. By allocating more resources to this critical infrastructure, the city aims to improve resilience and ensure the safety and well-being of its residents.

    Overall, the decision to allocate additional funding for storm drainage reflects the city’s commitment to proactive planning and investment in infrastructure to enhance the overall quality of life for its residents.

    Tags:

    1. Tampa City Council
    2. Storm drainage
    3. Tampa news
    4. City council funding
    5. Tampa infrastructure
    6. Drainage improvements
    7. Tampa city development
    8. Stormwater management
    9. Tampa government funding
    10. Urban planning in Tampa

    #Tampa #City #Council #approves #money #storm #drainage

  • Tampa City Council approves more money for storm drainage


    The Tampa City Council voted to support spending an additional $500,000 a year on storm drain maintenance as residents called for more information about why so much flooding occurred this past hurricane season and getting updates on what’s being done about it monthly.

    During a presentation about short-term solutions to flooding, city Mobility Director Vik Bhide said the department planned to ask for $10.5 million next week to upgrade the city’s 16 pump stations, adding back-up generators to power them where they don’t exist as well as monitoring equipment.

    Bhide said it could take up to two years to implement the upgrades. In the interim, the city will switch to generator power the day before a storm arrives to avoid power outages taking them out of commission, an issue during Hurricane Milton in October.

    The division also asked for the additional $500,000 to address maintenance and improve its pipe inspection system.

    The department is working on longer-term solutions with seven consultants that include looking at each drainage basin within the city, Bhide said. That work will begin in February and include modeling using current data and standards, which would allow the department to create a list of capital needs and costs.

    But some residents were not put at ease.

    Steve Michelini, general manager of the Soho Business Alliance, called the solutions “a day late and a dollar short.

    “All of a sudden it’s a crisis that they’ve ignored for many years, not just this mayor,” he said. “It goes back several years. Back then we didn’t have a problem because we didn’t have storms of this significant magnitude.”

    He said near his own South Tampa house, every rain brings floods because of poorly designed drainage systems.

    Michelini said the council didn’t need new plans but needed to execute ones already in place and focus on maintenance. He said the department would need an immediate appropriation.

    “Get the ditches and the retention ponds and the culverts cleaned out,” he said. “And that will solve a lot of problems. It won’t solve an 100% but it’ll be a good first step.”

    Other residents spoke of cracks in pipes, poorly maintained retention ponds, culverts, ditches and drains — with trees growing out of some. They spoke of the flooding that came to their neighborhoods as a result.

    Pam Cannella, who lives on San Rafael Street in South Tampa, held up binders of photos to show the council.

    Anneliese Meier with the Historic Parkland Estates Preservation Society, who is working with neighborhood groups in Concordia Park, Bayshore Gardens, Palma Ceia Pines, Beach Park, Virginia Park and Forrest Hills, said residents want to know where the stormwater assessment fees they pay are going.

    “We also want to know what equipment the department has (for) stormwater maintenance, because I don’t think they have enough,” she told the council.

    Bhide said the maintenance assessment funds 62 positions in stormwater operations. He also said in the Parkland Estates neighborhood, the Mobility Department removed more than six tons of debris over the past year. He said the department also inspected and cleaned over 7,000 miles of pipe.

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    “Was it enough to make sure everything was great?” he asked rhetorically. “We feel we’ve done everything we can within the resources we have.” The area, he said, needs more capital infrastructure.

    David Laxer, president of Bern’s Steakhouse Co. sent an email to the City Council the night before the meeting, calling the verbal report from the Mobility Department “absurd.”

    “Please pay close attention to the items being discussed, Stormwater and Flooding, and note that ALL THESE ITEMS DO NOT HAVE ANY WRITTEN BACK-UP REPORTS!” he wrote. “… No written documents, no maps, no photos, nothing to review in advance. …The lack of transparency and candor to the citizens of Tampa and City Council should disturb you.”

    “Management failures and processes/procedures are not in place to properly maintain our current stormwater systems, thus putting our neighborhoods and citizens at risk,” his email said.

    Council member Lynn Hurtak agreed with the calls for a breakdown in spending and for monthly reports.

    “Just part of what will make people feel better is a continual reminder of where we are, what we’re doing, the types of movement, of movement that’s coming,” she said.



    The Tampa City Council has approved additional funding for storm drainage improvements in the city. This decision comes after recent storms caused flooding in several areas, highlighting the need for better drainage systems.

    The approved funding will go towards upgrading existing stormwater infrastructure, including adding more retention ponds and improving drainage channels. This investment aims to reduce the risk of flooding and protect homes and businesses from water damage during heavy rain events.

    City officials are also working on long-term solutions to address drainage issues in Tampa, as the city continues to grow and develop. By prioritizing storm drainage improvements, the City Council is taking proactive steps to ensure the safety and well-being of residents and businesses in Tampa.

    Stay tuned for updates on the progress of these storm drainage projects and how they will benefit the community. Let’s work together to build a more resilient and sustainable city for all.

    Tags:

    1. Tampa City Council
    2. Storm drainage
    3. Tampa news
    4. City council approval
    5. Infrastructure funding
    6. Tampa flood prevention
    7. Local government decisions
    8. Tampa public works
    9. Stormwater management
    10. Tampa city finances

    #Tampa #City #Council #approves #money #storm #drainage

  • FDA approves Vertex non-opioid painkiller drug Journavx


    A sign hangs in front of the world headquarters of Vertex Pharmaceuticals in Boston.

    Brian Snyder | Reuters

    The Food and Drug Administration on Thursday approved Vertex Pharmaceuticals‘ non-opioid painkiller pill, a new alternative for pain relief that comes without the risk of addiction. 

    Vertex is now the first drugmaker in decades to gain U.S. approval for a new type of pain medicine. It’s a milestone after a long history of mostly unsuccessful efforts to develop painkillers without the destructive dependency of cheap and widely available opioids, which have caused a horrific epidemic of abuse and overdose in the U.S.

    Vertex’s drug, Journavx, is specifically approved for the treatment of moderate-to-severe acute pain, which is usually caused by injury, surgery, illness, trauma or painful medical procedures and likely eases with time. Around 80 million patients are prescribed a medicine for their moderate-to-severe acute pain every year in the U.S., according to Vertex. 

    Wall Street analysts have said that the medication could become a blockbuster drug if it wins approval from regulators, estimating its annual sales could exceed $1 billion. 

    The experience of pain starts in a nerve ending, and the body detects the pressure and sends a signal to the spinal cord and then the brain. Vertex’s treatment works by blocking pain signals at their origin before they reach the brain. That’s different from opioids, which act directly on the brain to block pain, triggering the brain’s rewards centers in a way that can feed addiction.

    The approval underscores the “FDA’s commitment to approving safe and effective alternatives to opioids for pain management,” said Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, in a release.

    Vertex’s painkiller was more effective than placebo at reducing the intensity of pain after 48 hours in two late-stage studies on more than 1,000 patients who had abdominoplasties, also known as “tummy tucks,” and roughly another thousand in people who had bunion surgery. Those two procedures are commonly used in studies of people with acute pain.

    The painkiller, however, failed to meet the secondary goal in both trials of reducing pain when compared to a combination of the opioid drug hydrocodone, which is frequently abused, and acetaminophen, the basis for popular pain medications such as Tylenol.

    In both trials, rates of adverse side effects were lower in those who received Vertex’s drug compared to people who took a placebo. The most commonly reported adverse events among people who received Journavx were itching, muscle spasms and rash, among others, according to the FDA.

    In a separate phase three study, more than 83% of patients said in a survey that the drug was good, very good or excellent at easing pain. Those people had undergone various surgical or non-surgical procedures.

    The bigger opportunity for Vertex may be to win FDA approval in chronic pain. That’s an area where the risk of addiction to prescription opioids can be greater, according to the Centers for Disease Control and Prevention. 

    In 2023, the company’s painkiller produced positive results in a mid-stage trial in diabetes patients suffering from a chronic nerve condition.



    The FDA has just approved a groundbreaking new non-opioid painkiller drug called Journavx, developed by Vertex Pharmaceuticals. This is a major milestone in the fight against the opioid epidemic, as Journavx offers a much-needed alternative for pain management without the risk of addiction or overdose.

    Journavx works by targeting specific receptors in the brain that are involved in the perception of pain, providing effective relief without the side effects commonly associated with traditional opioid medications. Clinical trials have shown promising results, with patients reporting significant reductions in pain levels and improved quality of life.

    The approval of Journavx represents a significant step forward in the development of safer and more effective pain management options. This new drug has the potential to revolutionize the way we treat pain, offering hope for millions of patients who struggle with chronic pain on a daily basis.

    Vertex Pharmaceuticals is committed to bringing innovative solutions to market, and Journavx is a prime example of their dedication to improving patient care. With the FDA’s stamp of approval, this new non-opioid painkiller is set to make a positive impact on the lives of countless individuals.

    Tags:

    1. FDA approval
    2. Vertex Pharmaceuticals
    3. Non-opioid
    4. Painkiller
    5. Drug approval
    6. Journavx
    7. Pain management
    8. Pharmaceutical news
    9. Health updates
    10. Vertex pain relief

    #FDA #approves #Vertex #nonopioid #painkiller #drug #Journavx

  • FDA approves first new type of pain medication in 25 years




    CNN
     — 

    The US Food and Drug Administration signed off Thursday on the first new type of pain reliever to be approved in more than two decades.

    The drug, suzetrigine, is a 50-milligram prescription pill that’s taken every 12 hours after a larger starter dose. It will be sold under the brand name Journavx.

    “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option,” Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, said in a news release. “This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management.”

    Government surveys show that analgesics, or medications that control pain, are the most commonly prescribed type of drug in hospitals.

    About 80 million Americans fill prescriptions each year for medications to treat new instances of moderate to severe pain, according to a study by Vertex Pharmaceuticals, the company that developed the new drug; about half those prescriptions are written for opioid medications, which can lead to dependence and addiction.

    Suzetrigine is the first new painkiller approved in the US since Celebrex, a type of nonsteroidal anti-inflammatory drug called a Cox-2 inhibitor, which was approved in 1998.

    Multiple parts of the body are involved in the sensation of pain, explains Dr. Sergio Bergese, an anesthesiologist at Stony Brook University’s Renaissance School of Medicine. Nerve cells carry an electrical signal from the site of tissue damage up to the brain, which perceives the signal as pain.

    Unlike opioid medications, which dull the sensation of pain in the brain, suzetrigine works by preventing pain-signaling nerves around the body from firing in the first place.

    “This drug, what it is doing is interrupting that path, so even though the tissue injury exists, the brain doesn’t know,” Bergese said.

    And crucially, suzetrigine creates no euphoria or high like opioids sometimes can, so doctors believe there’s no potential for it to create addition or dependence in people who use it.

    The medication was discovered after researchers learned about a family of fire walkers in Pakistan and discovered that they lacked a gene allowing pain signals fire in their skin. Members of this family could walk over hot coals without flinching.

    “They knew that they were on something hot; they knew they could feel the coals. So it’s not impacting the nerves that do heat and touch and stuff like that. It is just these pain-conducting nerves,” said Stuart Arbuckle, chief operating officer of Vertex Pharmaceuticals. “They were, in every other way, normal.”

    Still, it took scientists 25 years to figure out how to exploit that pain-conducting mechanism to develop a medication.

    “Neurons talk to each other by producing series of nerve impulses, like a Morse code,” said Dr. Stephen Waxman, who directs the Center for Neuroscience and Regeneration Research at the Yale School of Medicine. “And nerve impulses are produced by tiny molecular batteries within the membranes of neurons. The molecular batteries are called sodium channels.”

    Suzetrigine works by closing one sodium channel that conducts only pain signals.

    There have been many false starts along the way to finding a drug that could block one specific sodium channel. Suzetrigine’s approval means other drugs that could work even better are likely to follow, Waxman said.

    “It is an important step forward, because it provides proof of concept that a [sodium-channel blocker] can reduce pain in humans,” said Waxman, who has no financial ties to the new drug. “That opens up the door to a second generation of even more effective [medications].”

    Suzetrigine is a pill that’s given in two dosages. In studies, participants got an initial dose of 100 milligrams, followed by 50 milligrams every 12 hours.

    Doctors stress that it may not be the right drug for everyone or for every type of pain.

    In two clinical trials that included almost 600 participants, suzetrigine controlled pain after abdominal and foot surgeries better than an inactive placebo pill. About as many people said suzetrigine reduced their pain by at least half after surgery as those who took Vicodin, which is a combination of acetaminophen and the opioid hydrocodone. The research wasn’t designed to directly compare suzetrigine to Vicodin, however, so it’s hard to know whether one worked better than the other.

    On a well-known rating scale that runs from 0 to 10, the study participants started with pain of about seven, on average, and suzetrigine reduced it roughly 3.5 points.

    “It’s not like eliminating all pain,” Arbuckle said. “It’s reducing pain by about 50%.”

    In a third study, of people who had back pain caused by sciatica, suzetrigine reduced pain by about 2 points, the same amount reported by people taking a placebo, suggesting that this drug might not be a standout for chronic pain.

    Vertex disagrees, saying that it has tested the drug in different types of chronic pain and that it seems to work for long-term pain, too. The company is continuing to test it in people who have diabetic neuropathy, in which high blood sugar levels damage nerves over time, leading to symptoms such as numbness, tingling, pain and muscle weakness.

    The sciatica study was smaller than the others, with about 100 people in the suzetrigine arm and in the placebo group, so there may not have been enough participants to show clear differences between the groups. Placebos tend to have large effects in pain studies too, which complicates their interpretation.

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    “In our opinion, the drug did what we expected to do in terms of the amount of pain relief,” Arbuckle said. “But unfortunately, as often happens in studies in pain, there is quite a large placebo response.”

    Doctors who help people manage pain said they were excited to have a new option.

    “The more options we have, the better we’re able to treat each and every patient,” said Dr. Kimberley Mauer, an anesthesiologist at Oregon Health and Science University.

    Mauer said cost might be a big factor in how the drug is used. Vertex said that it has set a wholesale cost of $15.50 per 50-mg pill but that patient assistance programs would be available.

    Mauer said doctors and patients would have to wait to learn what insurance companies might do in terms of coverage.

    “It might limit some patients getting it. So we just have to kind of see, and it’s hard to tell until it kind of gets out on the market,” she said.



    Exciting News: FDA Approves First New Type of Pain Medication in 25 Years!

    In a groundbreaking decision, the Food and Drug Administration (FDA) has approved a new type of pain medication for the first time in a quarter of a century. This innovative drug offers hope for millions of individuals suffering from chronic pain, providing a much-needed alternative to traditional pain management options.

    The approval of this new medication marks a significant milestone in the field of pain management, as researchers have been working tirelessly to develop new and more effective treatments for those in need. With the opioid epidemic still looming large, the introduction of this non-opioid pain medication is a much-welcomed development.

    While the specifics of the new medication have not been disclosed, its approval signals a new era in pain relief and a step forward in addressing the diverse needs of patients. This groundbreaking achievement will undoubtedly pave the way for further advancements in pain management and improve the quality of life for countless individuals.

    Stay tuned for more updates on this exciting development and the potential impact it may have on the field of pain management. The approval of this new type of pain medication is a promising step towards a safer and more effective future for those struggling with chronic pain.

    Tags:

    1. FDA approval
    2. new pain medication
    3. pain relief
    4. medical breakthrough
    5. healthcare news
    6. pharmaceutical industry
    7. pain management
    8. FDA regulations
    9. drug approval process
    10. pain medication development

    #FDA #approves #type #pain #medication #years

  • Washoe County School Board approves major changes to Pine and Traner middle school


    RENO, Nev. (KOLO) – The Washoe County School Board of Trustees unanimously approved to close Pine and Traner middle schools to build two new PreK to 5th grade schools.

    This proposal stems from the 2023 Facility Modernization Plan. The District wants to modernize old buildings, limit gap years between elementary to middle school and improve English and Math scores.

    The new schools will house Smithridge, Dodson, Duncan, Lemelson and/or neighboring schools.

    The new school, that will be built where Pine is now, would be open in 2028.

    Concerns point to fewer course options, possible enrollment decline and teacher credential barriers.

    Shareholders heard from Principals, students, teachers, families and community members leading up to this decision. The public also gave feedback about the PreK-8 study.

    The district says this is a major step forward. “Change is scary and hard, and we respect the history of community and pine but this hopefully is met with a sense of enthusiasm that, hey, I want to be a part of writing the script of my future, for my students and my community,” said Adam Searcy with WCSD.

    More details about the PreK-8 study report and results can be found, here.

    To watch the live stream, click here.

    Copyright 2025 KOLO. All rights reserved.



    The Washoe County School Board has approved significant changes to Pine and Traner middle schools. These changes come as part of a larger effort to improve academic performance and overall student experience at both schools.

    One of the major changes approved by the school board is the implementation of a new curriculum focusing on STEM (science, technology, engineering, and mathematics) education. This will provide students with more opportunities to engage in hands-on, project-based learning that is relevant to real-world applications.

    Additionally, both schools will be receiving funding for updated technology and resources to support this new curriculum. This includes new computers, software, and equipment to enhance student learning and prepare them for future success in STEM-related fields.

    Furthermore, Pine and Traner middle schools will be implementing new extracurricular programs and clubs to further engage students outside of the classroom. This will provide students with a well-rounded educational experience that fosters their interests and talents.

    Overall, these changes are aimed at creating a more dynamic and engaging learning environment for students at Pine and Traner middle schools. The school board is confident that these improvements will have a positive impact on student achievement and help prepare them for success in high school and beyond.

    Tags:

    1. Washoe County School Board
    2. Pine Middle School
    3. Traner Middle School
    4. School board approval
    5. Education updates
    6. Washoe County schools
    7. Middle school changes
    8. School board decisions
    9. Educational reforms
    10. Washoe County education

    #Washoe #County #School #Board #approves #major #Pine #Traner #middle #school

  • FDA approves Ozempic to reduce risks from chronic kidney disease in diabetes patients




    CNN
     — 

    Ozempic, the blockbuster GLP-1 drug that was originally approved to treat type 2 diabetes, has now also been approved by the US Food and Drug Administration to reduce certain risks associated with chronic kidney disease, drugmaker Novo Nordisk said Tuesday.

    A Phase 3 clinical trial found that injections of the semaglutide medication once weekly reduced the risk of kidney disease worsening by 24% in people who also had diabetes. It also reduced the risk of kidney failure and cut the risk of death from heart disease by about 5% in adults with both type 2 diabetes and chronic kidney disease, the company said in a news release.

    Chronic kidney disease is a common complication for people living with type 2 diabetes. Diabetes is the leading cause of kidney failure, which is one of the leading causes of death in the US and worldwide; about a third of adults with diabetes also have chronic kidney disease, according to the US Centers for Disease Control and Prevention

    The clinical trial tested the efficacy of Ozempic when added to the standard of care, not as a replacement for other treatments for disease management such as medicines to manage blood pressure, including ACE inhibitors and ARBs. About 3,500 adults across 28 countries were enrolled in the trial, which started in 2019 and followed participants for an average of about 3½ years.

    The new indications, approved Tuesday by the FDA, make Ozempic the most broadly indicated drug in its class, with the largest set of specific medical conditions that it may be prescribed to treat.

    Novo Nordisk is conducting a different study to understand how and why semgalutide seems to reduce the progression of kidney disease, said Stephen Gough, global chief medical officer and senior vice president at Novo Nordisk. But even though scientists don’t fully understand the mechanisms behind them, the positive effects are strong: The clinical study was stopped early after reaching positive endpoints sooner than expected, and no new safety risks were identified in this trial, he said.

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    “This really means something to the patients,” Gough told CNN. “The impact on not just kidney disease but also cardiovascular disease and on all-cause death.”

    Ozempic and other semaglutide injections such as Wegovy have been in short supply for years due to their rapid popularity. The FDA now lists Ozempic as “available,” but there is still high demand.

    “This is a medicine that’s already available, both in diabetes clinics and now in renal clinics, so I would hope the uptake would start pretty quickly,” Gough said, adding that he hopes the confidence that comes with the data behind this approval will aid clinicians who are making daily decisions about how and when to use different treatments.

    “It does help clinicians with their decision-making process, and it helps them focus those medicines to the patients who will benefit the most,” he said.



    The FDA has recently approved the use of Ozempic for reducing the risks associated with chronic kidney disease in patients with diabetes. This is a significant development in the field of diabetes management, as chronic kidney disease is a common complication of diabetes and can lead to serious health issues if not properly addressed.

    Ozempic, also known as semaglutide, is a once-weekly injectable medication that helps lower blood sugar levels in patients with type 2 diabetes. In addition to its blood sugar-lowering effects, studies have shown that Ozempic can also help reduce the risk of kidney damage in diabetic patients.

    Chronic kidney disease is a serious complication of diabetes that can lead to kidney failure if not properly managed. By reducing the risks associated with kidney disease, Ozempic has the potential to improve the overall health and quality of life for diabetes patients.

    The approval of Ozempic for reducing the risks of chronic kidney disease in diabetes patients is a significant milestone in the field of diabetes management. It provides healthcare providers with another tool to help prevent and manage complications associated with diabetes, ultimately improving patient outcomes and quality of life.

    Tags:

    1. FDA approval
    2. Ozempic
    3. Chronic kidney disease
    4. Diabetes patients
    5. Risk reduction
    6. FDA regulations
    7. Diabetes management
    8. Kidney health
    9. Health news
    10. Medical breakthrough

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  • Whitmer approves new Michigan gun, school safety laws




    Governor Gretchen Whitmer has approved a new set of gun and school safety laws in Michigan, aimed at promoting responsible gun ownership and protecting students.

    The new laws include measures such as requiring background checks for all firearm purchases, implementing a red flag law that allows for the temporary removal of firearms from individuals deemed a threat to themselves or others, and increasing penalties for individuals who fail to properly secure their firearms from minors.

    In addition to these gun control measures, the new laws also focus on improving school safety. This includes funding for mental health resources in schools, requiring active shooter drills, and implementing technology to improve communication during emergencies.

    Governor Whitmer stated that these laws are a crucial step towards creating a safer and more secure environment for all Michigan residents, especially students. She emphasized the importance of balancing Second Amendment rights with the need for common-sense gun regulations to prevent gun violence.

    Overall, these new laws represent a significant milestone in Michigan’s efforts to address gun violence and enhance school safety. It is hoped that these measures will help prevent tragic incidents and protect the well-being of all residents in the state.

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    #Whitmer #approves #Michigan #gun #school #safety #laws

  • Michigan panel approves electricity rate increase for DTE Energy




    The Michigan Public Service Commission has approved a rate increase for DTE Energy, one of the state’s largest electric utility companies. The rate hike, which will go into effect in the coming months, is expected to raise the average residential customer’s bill by about 4.2%.

    The decision to approve the rate increase came after a thorough review of DTE Energy’s request, which cited the need for additional funds to invest in infrastructure improvements and upgrade their grid system. The company has also committed to increasing investment in renewable energy sources and reducing their carbon footprint.

    While the rate increase may be unwelcome news for customers, the Public Service Commission assured that it was necessary to ensure the reliability and sustainability of DTE Energy’s services. They also emphasized that the company is subject to regular oversight to prevent excessive rate increases.

    Overall, the approval of the rate increase reflects the ongoing challenges facing utilities as they work to modernize their systems and meet the demands of a changing energy landscape. Customers can expect to see the new rates reflected in their bills soon, with DTE Energy promising to continue providing reliable service to all of its customers in Michigan.

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    Michigan panel, electricity rate increase, DTE Energy, Michigan energy news, rate hike approval, Michigan utilities, DTE rate change, energy bill increase, Michigan electricity update

    #Michigan #panel #approves #electricity #rate #increase #DTE #Energy

  • FDA approves Johnson & Johnson nasal spray Spravato for depression


    This photo provided by Janssen Global Services shows Spravato nasal spray.

    Janssen Global Services via AP

    The Food and Drug Administration on Tuesday approved Johnson & Johnson‘s nasal spray to be used alone in adults with a major depressive disorder that is difficult to treat, as sales of the drug grow. 

    The spray, called Spravato, is now the first-ever stand-alone therapy for treatment-resistant depression, which is when trying at least two standard treatments does little to nothing to improve depression symptoms in a patient. 

    Previously, Spravato was cleared in the U.S. to use together with an oral antidepressant for both treatment-resistant depression and for people with major depressive disorder who are experiencing thoughts of suicide or harm. The drug first entered the U.S. market in 2019. 

    “We want to recognize that this is a medicine that treats a disease that [when] left untreated, depression is potentially fatal,” Bill Martin, J&J’s global therapeutic area head of neuroscience, said in an interview. 

    Around one-third of the estimated 21 million U.S. adults with major depression battle symptoms — such as persistent feelings of sadness, sleep disturbances, low energy, and thoughts of death or suicide — that don’t respond to treatment, according to some estimates. 

    “For the first time ever, we now have an option that gives patients freedom,” said Dr. Gregory Mattingly, a physician and president of the Midwest Research Group who was involved in Spravato’s original clinical trials. 

    His center in St. Louis has treated more than 6,000 patients with the drug, and currently just over 100 people are taking it there. That is one of 3,000 outpatient treatment centers in the U.S. that are certified to administer Spravato, according to J&J’s tally.

    Mattingly said patients can now choose to take Spravato with or without an oral antidepressant, especially if those pills aren’t improving their symptoms and are causing undesirable side effects, such as weight gain and sexual issues. 

    J&J’s Martin said the approval provides “an avenue for caregivers and their patients to really optimize, personalize the treatment paradigm for each individual” and determine the best way for them to manage the disease. 

    That could potentially “open up the number of patients who could benefit” from Spravato, according to Martin. 

    More CNBC health coverage

    Spravato is on its way to becoming a blockbuster product, with the drug bringing in $780 million in sales during the first nine months of 2024 as doctors grow more comfortable using it, according to J&J’s third-quarter earnings. The company has even higher expectations for its growth, telling investors in December that it expects sales will increase to between $1 billion and $5 billion annually. 

    That is a boon to J&J as it prepares for an upcoming patent expiration and new negotiated prices with Medicare to pressure sales of its top-selling inflammatory treatment, Stelara. 

    The approval is based on a phase four trial, which showed Spravato alone improved depressive symptoms beginning about 24 hours after treatment and lasting through at least one month. The company has said that the safety profile was consistent with previous clinical data on Spravato’s use in combination with oral antidepressants.

    Martin said that demonstrates “not only rapid symptom relief, but also a durable symptom relief” when patients take Spravato by itself. 

    Spravato’s long road to rapid growth

    Spravato blazed a trail in 2019 as the first new major depression treatment to win FDA approval in more than three decades. The drug is related to ketamine, a common anesthetic that can have hallucinogenic effects and is sometimes misused recreationally. J&J made it into a nasal spray to get it into the brain quickly. 

    Spravato “turns on neural networks in a way that’s different,” said Mattingly. 

    “Our standard oral antidepressants took weeks to months to see if they’re going to work,” he added. “Quite often with the same day, the very next day, people can already start to feel they’re feeling somewhat better” with Spravato.

    Spravato’s warning label cautions about the risk of sedation and dissociation, respiratory depression, suicidal thoughts, and abuse or misuse of the drug, among other potential side effects. Because of that, Spravato is only available through a restricted program, meaning it can’t be purchased at a pharmacy and is only administered in certified health-care settings under strict supervision. 

    Users of the medication must also be monitored by a health-care professional for two hours following administration.

    Spravato’s launch had a sluggish start, especially as pandemic-related challenges complicated arrangements for the drug’s necessary medical supervision. But J&J began to market Spravato more heavily after in-person doctor visits became the norm again, and physicians became more aware of its benefits. 

    “The mental health community wasn’t really used to doing procedures at that point. We weren’t used to having a space set aside. We weren’t used to thinking about how to do Spravato,” Mattingly said. “I think the good news is now we’ve all seen the benefits to our patients. So many of us have become really strong advocates” for it. 

    Five years of real-world data on the drug and a head-to-head study demonstrating Spravato’s superior efficacy to an oral antidepressant also gave doctors higher confidence in the treatment, according to J&J’s Martin.

    If you are having suicidal thoughts or are in distress, contact the Suicide & Crisis Lifeline at 988 for support and assistance from a trained counselor.

    Don’t miss these insights from CNBC PRO



    Great news for those struggling with treatment-resistant depression! The FDA has recently approved Johnson & Johnson’s nasal spray called Spravato for use in patients with depression. This new medication offers hope for individuals who have not found relief with traditional antidepressants.

    Spravato, which contains the active ingredient esketamine, has shown promising results in clinical trials for its ability to rapidly reduce symptoms of depression. This breakthrough treatment is administered under the supervision of a healthcare provider and has been found to be effective in improving mood and overall well-being.

    If you or someone you know is dealing with treatment-resistant depression, be sure to speak with a healthcare provider about the potential benefits of Spravato. This new nasal spray could be a game-changer in the treatment of depression and offer new hope for those in need.

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