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Sun Pharmaceutical Announces FDA Approval of LEQSELVI™ for Severe Alopecia Areata

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Sun Pharmaceutical Industries Limited is thrilled to announce that the U.S. Food and Drug Administration (FDA) has approved LEQSELVI™ (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata. This approval is a significant milestone, particularly for the roughly 300,000 Americans living with this challenging condition.

LEQSELVI
Sun Pharma Headquarters

Alopecia areata is an autoimmune disorder marked by significant hair loss, often resulting in severe emotional and psychological distress. The journey to finding effective treatment options has been fraught with challenges, as the condition could be unpredictable and resistant to previous therapies.

Groundbreaking Clinical Trial Results

The FDA’s approval of LEQSELVI™ was supported by robust evidence from two Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, which collectively enrolled 1,220 patients. These studies demonstrated that LEQSELVI™ delivered substantial hair regrowth: at 24 weeks, approximately one-third of the patients achieved 80% or more scalp hair coverage, a significant improvement from an average baseline scalp hair coverage of just 13%.

How LEQSELVI™ Works

LEQSELVI™ is a cutting-edge, twice-daily oral medication that selectively inhibits Janus Kinases (JAK) JAK1 and JAK2. This mechanism targets the immune pathways believed to contribute to the hair loss seen in severe alopecia areata, offering a new hope to those who have had limited success with existing treatments.

Safety and Efficacy

The treatment has been carefully tested for safety across several studies. While the medication is generally well-tolerated, it does carry warnings for serious infections, malignancies, thrombosis, and gastrointestinal perforations, similar to other treatments in its class. Patients and healthcare providers are advised to monitor for symptoms and manage them accordingly.

Support and Accessibility

Understanding the challenges associated with treatment access, Sun Pharma is initiating a comprehensive access program. This initiative will help eligible patients begin and adhere to their treatment, ensuring that LEQSELVI™ reaches those who need it the most. More details about this program are available on the official LEQSELVI™ website.

A Step Forward for the Alopecia Community

The approval of LEQSELVI™ represents a significant advancement for the alopecia community. Abhay Gandhi, CEO North America Business, Sun Pharma, shared his enthusiasm about bringing this innovative treatment to the market, stating it “offers a new and effective solution that will significantly enhance the options for patients and their physicians.”

Moreover, organizations such as the National Alopecia Areata Foundation (NAAF) have welcomed this new treatment option. Nicole Friedland, President and CEO of NAAF, highlighted the importance of this development, underscoring the profound impact alopecia areata can have on individuals’ lives.

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Looking Ahead

With the introduction of LEQSELVI™, Sun Pharma continues to cement its position as a leader in dermatological treatments. The company’s commitment to addressing complex medical conditions through innovative solutions is evident in their rapidly expanding dermatology portfolio.

For patients suffering from severe alopecia areata, LEQSELVI™ represents not merely a new treatment option but a new hope—a possibility of regaining not just their hair, but also their confidence and quality of life.

For further details on LEQSELVI™ and patient support initiatives, visit www.LEQSELVI.com.

View the full multimedia release.

Disclaimer:
This content may include forward-looking statements, which are based on current expectations and projections about future events. Readers should not place undue reliance on these statements, as actual results may vary.

Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.

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Hal Machina is a passionate writer, blogger, and self-proclaimed journalist who explores the intersection of science, tech, and futurism. Join him on a journey into innovative ideas and groundbreaking discoveries!

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Lifestyle

Biden helped bring science out of the lab and into the community − emphasizing research focused on solutions

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Biden began his presidency in the throes of the COVID-19 pandemic. Evan Vucci/AP Photo

Arthur Daemmrich, Arizona State University

President Joe Biden was inaugurated in January 2021 amid a devastating pandemic, with over 24 million COVID-19 cases and more than 400,000 deaths in the U.S. recorded at that point.

Operation Warp Speed, initiated by the Trump administration in May 2020, meant an effective vaccine was becoming available. Biden quickly announced a plan to immunize 100 million Americans over the next three months. By the end of April 2021, 145 million Americans – nearly half the population – had received one vaccine dose, and 103 million were considered fully vaccinated. Science and technology policymakers celebrated this coordination across science, industry and government to address a real-world crisis as a 21st-century Manhattan Project.

From my perspective as a scholar of science and technology policy, Biden’s legacy includes structural, institutional and practical changes to how science is conducted. Building on approaches developed over the course of many years, the administration elevated the status of science in the government and fostered community participation in research.

Raising science’s profile in government

The U.S. has no single ministry of science and technology. Instead, agencies and offices across the executive branch carry out scientific research at several national labs and fund research by other institutions. By elevating the White House Office of Science and Technology Policy to a Cabinet-level organization for the first time in its history, Biden gave the agency greater influence in federal decision-making and coordination.

Formally established in 1976, the agency provides the president and senior staff with scientific and technical advice, bringing science to bear on executive policies. Biden’s inclusion of the agency’s director in his Cabinet was a strong signal about the elevated role science and technology would play in the administration’s solutions to major societal challenges.

Under Biden, the Office of Science and Technology Policy established guidelines that agencies across the government would follow as they implemented major legislation. This included developing technologies that remove carbon dioxide from the atmosphere to address climate change, rebuilding America’s chip industry, and managing the rollout of AI technologies.

Close-up of gloved hand holding square semiconductor chip
The CHIPS and Science Act of 2022 boosted research and manufacture of semiconductor chips in the U.S. Narumon Bowonkitwanchai/Moment via Getty Images

Instead of treating the ethical and societal dimensions of scientific and technological change as separate from research and development, the agency advocated for a more integrated approach. This was reflected in the appointment of social scientist Alondra Nelson as the agency’s first deputy director for science and society, and science policy expert Kei Koizumi as principal deputy director for policy. Ethical and societal considerations were added as evaluation criteria for grants. And initiatives such as the AI bill of rights and frameworks for research integrity and open science further encouraged all federal agencies to consider the social effects of their research.

The Office of Science and Technology Policy also introduced new ways for agencies to consult with communities, including Native Nations, rural Americans and people of color, in order to avoid known biases in science and technology research. For example, the agency issued government-wide guidance to recognize and include Indigenous knowledge in federal programs. Agencies such as the Department of Energy have incorporated public perspectives while rolling out atmospheric carbon dioxide removal technologies and building new hydrogen hubs.

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Use-inspired research

A long-standing criticism of U.S. science funding is that it often fails to answer questions of societal importance. Members of Congress and policy analysts have argued that funded projects instead overly emphasize basic research in areas that advance the careers of researchers.

In response, the Biden administration established the technology, innovation and partnerships directorate at the National Science Foundation in March 2022.

The directorate uses social science approaches to help focus scientific research and technology on their potential uses and effects on society. For example, engineers developing future energy technologies could start by consulting with the community about local needs and opportunities, rather than pitching their preferred solution after years of laboratory work. Genetic researchers could share both knowledge and financial benefits with the communities that provided the researchers with data.

Fundamentally, “use-inspired” research aims to reconnect scientists and engineers with the people and communities their work ultimately affects, going beyond publication in a journal accessible only to academics.

The technology, innovation and partnerships directorate established initiatives to support regional projects and multidisciplinary partnerships bringing together researchers, entrepreneurs and community organizations. These programs, such as the regional innovation engines and convergence accelerator, seek to balance the traditional process of grant proposals written and evaluated by academics with broader societal demand for affordable health and environmental solutions. This work is particularly key to parts of the country that have not yet seen visible gains from decades of federally sponsored research, such as regions encompassing western North Carolina, northern South Carolina, eastern Tennessee and southwest Virginia.

Community-based scientific research

The Biden administration also worked to involve communities in science not just as research consultants but also as active participants.

Scientific research and technology-based innovation are often considered the exclusive domain of experts from elite universities or national labs. Yet, many communities are eager to conduct research, and they have insights to contribute. There is a decades-long history of citizen science initiatives, such as birdwatchers contributing data to national environmental surveys and community groups collecting industrial emissions data that officials can use to make regulations more cost effective.

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Going further, the Biden administration carried out experiments to create research projects in a way that involved community members, local colleges and federal agencies as more equal partners.

Hand-drawn signs displayed on a fence against a green field, with messages about climate change around a sign that reads 'It's our future'
Collaboration between the community, academia, industry and government can lead to more effective solutions. Deb Cohn-Orbach/UCG/Universal Images Group via Getty Images

For example, the Justice40 initiative asked people from across the country, including rural and small-town Americans, to identify local environmental justice issues and potential solutions.

The National Institutes of Health’s ComPASS program funded community organizations to test and scale successful health interventions, such as identifying pregnant women with complex medical needs and connecting them to specialized care.

And the National Science Foundation’s Civic Innovation Challenge required academic researchers to work with local organizations to address local concerns, improving the community’s technical skills and knowledge.

Frontiers of science and technology policy

Researchers often cite the 1945 report Science: The Endless Frontier, written by former Office of Scientific Research and Development head Vannevar Bush, to describe the core rationales for using American taxpayer money to fund basic science. Under this model, funding science would lead to three key outcomes: a secure national defense, improved health, and economic prosperity. The report, however, says little about how to go from basic science to desired societal outcomes. It also makes no mention of scientists sharing responsibility for the direction and impact of their work.

The 80th anniversary of Bush’s report in 2025 offers an opportunity to move science out into society. At present, major government initiatives are following a technology push model that focuses efforts on only one or a few products and involves little consideration of consumer and market demand. Research has repeatedly demonstrated that consumer or societal pull, which attracts development of products that enhance quality of life, is key to successful uptake of new technologies and their longevity.

Future administrations can further advance science and address major societal challenges by considering how ready society is to take up new technologies and increasing collaboration between government and civil society.

Arthur Daemmrich, Professor of Practice in the School for the Future of Innovation in Society, Arizona State University

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This article is republished from The Conversation under a Creative Commons license. Read the original article.

The science section of our news blog STM Daily News provides readers with captivating and up-to-date information on the latest scientific discoveries, breakthroughs, and innovations across various fields. We offer engaging and accessible content, ensuring that readers with different levels of scientific knowledge can stay informed. Whether it’s exploring advancements in medicine, astronomy, technology, or environmental sciences, our science section strives to shed light on the intriguing world of scientific exploration and its profound impact on our daily lives. From thought-provoking articles to informative interviews with experts in the field, STM Daily News Science offers a harmonious blend of factual reporting, analysis, and exploration, making it a go-to source for science enthusiasts and curious minds alike. https://stmdailynews.com/category/science/


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Health

Know These 4 Core Factors to Avoid a Heart Health Syndrome

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(Family Features) In the U.S., 1 in 3 adults is at risk for a newly recognized syndrome that comes from a combination of heart disease, kidney disease, type 2 diabetes and excess body weight. This cluster of conditions, called cardiovascular-kidney-metabolic (CKM) syndrome, is an example of how problems in one part of your body can affect other parts.

To avoid CKM syndrome, health experts suggest paying close attention to four of the American Heart Association’s Life’s Essential 8 – blood pressure, lipids, body weight and blood sugar level – which are core health factors that impact your metabolic health.

Good metabolic health means your body uses energy well and keeps these factors in a normal range. However, when numbers are off in one area, it can affect others, raising your risk for heart disease, stroke, kidney disease and diabetes.

Consider these tips from the American Heart Association to help keep your core health factors under control.

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Blood Pressure
High blood pressure, also known as hypertension, happens when the force of your blood pushing against the walls of your blood vessels is too high. High blood pressure is a leading cause of heart disease, stroke and kidney disease.

Because high blood pressure doesn’t have symptoms, the only way to know you have it is to get your blood pressure checked. Healthy blood pressure is below 120/80. If your blood pressure is 130/80 or higher, talk to your doctor about checking your other core health factors.

Lifestyle changes can help reduce high blood pressure. One example is a Dietary Approaches to Stop Hypertension (DASH) eating pattern that’s low in fat and rich in fruits, vegetables, whole grains and low-fat dairy products. Losing 10 pounds and reducing alcohol consumption can also reduce blood pressure.

Cholesterol
Cholesterol is a waxy substance your liver makes then circulates in the blood where your body uses it to build cells and make vitamins and hormones. You may also get cholesterol from eating animal products. If there’s too much cholesterol circulating, your risk of type 2 diabetes, heart disease and stroke may increase.

For optimal CKM health, your LDL cholesterol should be below 100 and triglycerides below 150. Triglycerides are the most common type of fat in the body. If your triglyceride level is 135 or higher, talk to your doctor about decreasing your risk.

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Losing body weight and increasing physical activity decrease triglyceride levels. In addition, DASH and Mediterranean (plant-based, high-fiber, low-fat) eating patterns support healthy LDL and triglyceride levels.

Body Weight
Healthy weight may be determined by body mass index (BMI), a number that represents your weight in relation to your height. Extra body fat can mean a higher risk for many health problems, including heart disease, stroke, high blood pressure, high cholesterol and diabetes.

CKM syndrome starts when BMI is 25 or higher and waist circumference is 88 centimeters or higher for women and 102 centimeters or higher for men. Aim for a BMI between 18.5-25.

To lose weight and keep it off, start by setting realistic goals. Understand how much and why you eat, manage portion sizes, make smart snack substitutions and be physically active.

Blood Sugar
High blood sugar can slowly damage the kidneys. In fact, diabetes is the leading cause of kidney disease, and it increases the risk of heart attack and stroke.

Blood sugar is measured in two ways: a fasting blood glucose test (short term blood sugar) and an A1C test (long term blood sugar control). A normal fasting blood glucose level is 70-99 and a normal A1C level is below 5.7%. Fasting blood glucose above 125 and A1C of 6.5% or higher means you have diabetes.

Habits that help you avoid high blood pressure, weight gain and high cholesterol also keep your blood sugar in check. These are especially important if you have a family history of diabetes.

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Learn more about CKM syndrome and how to manage your risk at heart.org/CKMhealth.

Photos courtesy of Shutterstock

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SOURCE:
American Heart Association


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Child Health

Sesame Workshop and NewYork-Presbyterian Join Forces to Champion Children’s Health

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The two organizations will partner to foster healthy habits in young children and their families by offering free resources and videos and “Sesamatized” spaces

Sesame Workshop,

NEW YORK /PRNewswire/ — Today, Sesame Workshop, the global impact nonprofit behind Sesame Street, and NewYork-Presbyterian announced a partnership to improve health outcomes for young children by supporting their physical and emotional well-being through joyful learning moments engaging parents, caregivers, and community providers. Sesame Workshop is collaborating with NewYork-Presbyterian’s physicians and community partners on a social impact and mass media campaign featuring videos, educational materials, and “Sesamatized” physical spaces, to promote children’s health.

The partnership is launching with a six-part video series titled “Ask a Doctor,” featuring Sesame Street Muppets and NewYork-Presbyterian physicians. The videos are designed to educate and empower parents and caregivers on how to help young children stay healthy. They will cover topics including how to develop healthy sleep habits, deal with food allergies, and prepare for wellness visits. The series can be found on Sesame Workshop’s YouTube channel and will be available on NewYork-Presbyterian’s internal patient entertainment system.

“We are delighted to partner with NewYork-Presbyterian in our shared commitment to equity and health justice,” said Jeanette Betancourt, Ed.D., Senior Vice President of U.S. Social Impact at Sesame Workshop. “Our collaboration allows us to combine our expertise in healthcare, child development, and family and community engagement to make an impactful difference in the lives of those who need it most. In fostering healthy practices, especially in the early years, in ways that incorporate the perspectives and needs of parents and caregivers along with their community support networks, we are all working together to pave the way for a healthier, more equitable future.”

“We are thrilled to work with Sesame Workshop to empower parents and caregivers with important health information and meet families where they are,” said Dr. Deepa Kumaraiah, Senior Vice President and Chief Medical Officer of NewYork-Presbyterian. “Through fun learning moments that support the health and well-being of young people in our communities, we can help reduce health disparities and work toward health justice.”

A key focus of the partnership is a collaboration between Sesame Workshop and NewYork-Presbyterian’s neighboring community partners. Sesame Workshop will create educational materials with input from the children and caregivers in the communities NewYork-Presbyterian serves. Among the resources that will be available are bilingual Muppet videos, storybooks, parent guides, and activity books. “Sesamatized” physical spaces including décor featuring Sesame Street Muppets will open in the second half of 2025. The materials will be available where children and their families are, including community centers and NewYork-Presbyterian’s hospitals and clinics.

Additionally, two videos, featuring Elmo, Gabrielle, and other Sesame Street friends, that celebrate everyone of all hair and fur types complement NewYork-Presbyterian’s Dalio Center for Health Justice’s Crown Hair Care program, an initiative to provide inclusive hair care kits for pediatric and obstetric patients with curly, coiled, or tightly textured hair. These are also featured on NewYork-Presbyterian’s patient entertainment system.

About Sesame Workshop 
Sesame Workshop is the global impact nonprofit behind Sesame Street and so much more. For over 50 years, we have worked at the intersection of education, media, and research, creating joyful experiences that enrich minds and expand hearts, all in service of empowering each generation to build a better world. Our beloved characters, iconic shows, outreach in communities, and more bring playful early learning to families in more than 150 countries and advance our mission to help children everywhere grow smarter, stronger, and kinder. Learn more at www.sesame.org and follow Sesame Workshop on InstagramTikTokFacebook, and X

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About NewYork-Presbyterian
NewYork-Presbyterian is one of the nation’s most comprehensive, integrated academic healthcare systems, encompassing 10 hospitals across the Greater New York area, nearly 200 primary and specialty care clinics and medical groups, and an array of telemedicine services.

A leader in medical education, NewYork-Presbyterian Hospital is affiliated with two renowned medical schools, Weill Cornell Medicine and Columbia University Vagelos College of Physicians and Surgeons. This collaboration means patients have access to the country’s leading physicians, the full range of medical specialties, latest innovations in care, and research that is developing cures and saving lives.

Founded 250 years ago, NewYork-Presbyterian Hospital has a long legacy of medical breakthroughs and innovation, from the invention of the Pap test to pioneering the groundbreaking heart valve replacement procedure called TAVR.

NewYork-Presbyterian’s 50,000 employees and affiliated physicians are dedicated to providing the highest quality, most compassionate care to New Yorkers and patients from across the country and around the world.

For more information, visit www.nyp.org and find us on Facebook, Instagram, YouTube, LinkedIn, and Pinterest.

SOURCE NewYork-Presbyterian

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