logo
#

Latest news with #FDA-authorized

How Mounjaro Injections Help to Manage Weight Loss in Dubai?
How Mounjaro Injections Help to Manage Weight Loss in Dubai?

Time Business News

time3 days ago

  • Health
  • Time Business News

How Mounjaro Injections Help to Manage Weight Loss in Dubai?

In the ever-evolving international ultra-modern weight reduction solutions, Mounjaro Dubai have emerged as a promising treatment for individuals suffering from obesity or overweight situations. Dubai, a metropolis recognized for its advanced healthcare centres and well-being projects, is rapidly embracing this modern approach. However, what precisely are Mounjaro injections, and How Mounjaro Injections Help to Manage weight loss in Dubai? let's dive into the info. Mounjaro, scientifically known as tirzepatide, is an FDA-authorized injectable medication frequently developed to treat type 2 diabetes. but it has won a reputation for its giant effects on weight loss. The remedy works by way of mimicking the pastime of present-day hormones involved in regulating blood sugar and appetite, which include glucagon-like peptide-1 (GLP-1) and glucose-structured insulinotropic polypeptide (GIP). This twin motion makes Mounjaro specific in comparison to other weight loss medicines. using focusing on more than one pathway, it effectively reduces starvation, complements emotions, and brings brand new fullness and helps the body's metabolic methods. Dubai is a hub for scientific remedies and attracts sufferers from all over the world in search of modern advanced solutions for weight management. Choosing Mounjaro injections in Dubai gives numerous benefits: noticeably skilled practitioners: Clinics in Dubai employ skilled endocrinologists and weight control specialists who ensure sure safe and powerful administration of the latest treatment. facilities: Dubai's healthcare system is renowned for its modern-day infrastructure and adherence to global clinical standards. complete health applications: Many clinics offer holistic weight reduction packages that combine Mounjaro injections with eating regimens, exercise, and modern-day counselling. Mounjaro injections are performed through a multi-faceted approach to weight loss. here's how: Appetite Suppression: with the aid of mimicking GLP-1 and GIP hormones, Mounjaro slows gastric emptying, reducing hunger and selling a feeling of cutting-edge fullness. more suitable Insulin Sensitivity: The remedy improves the frame's response to insulin, stabilizing blood sugar tiers and preventing energy crashes that brand new cause overeating. Boosted Metabolism: Mounjaro's movement on metabolic pathways encourages the body to burn energy more successfully. Moreover, sufferers of modern-day revel in a reduction in cravings for bad ingredients, making it simpler to undertake and maintain more healthy eating habits. The advantages of Mounjaro injections at Enfield Royal Clinicenlarge beyond dropping extra kilos. Some key advantages encompass: sizable weight loss: clinical trials have proven that Mounjaro can cause huge weight reduction, with some sufferers losing up to fifteen to 20% of their body weight through the years. Progressed metabolic health: by means of regulating blood sugar stages, the remedy reduces the chance of developing type 2 diabetes and other metabolic issues. more desirable fine today's existence: weight reduction accomplished through Mounjaro can alleviate obesity-associated conditions, which include joint pain, sleep apnea, and high blood pressure. Non-surgical alternative: Not like bariatric surgery, Mounjaro provides a minimally invasive solution for weight reduction without the risks and recovery time related to surgery. Sustainable effects: Blended with modern state changes, Mounjaro facilitates sufferers to maintain their weight loss in the long term. Even as Mounjaro injections Dubai are tremendously powerful, they're now not suitable for the present day. generally, the appropriate applicants are: Adults with a BMI state-of-the-art 30 or better (obesity). individuals with a BMI of 27 or better who have weight-related health conditions that include type 2 diabetes, excessive blood pressure, or sleep apnea. sufferers who've now not done favoured effects through weight loss programs and exercising on their own. those without a record of state-of-the-art sure medical conditions, such as thyroid cancer or pancreatitis. A radical session with a healthcare company is crucial to determine if Mounjaro injections are right for you. Your journey begins with an in-depth consultation with a healthcare expert. Throughout this session, your medical history, current fitness popularity, and weight reduction dreams can be evaluated. The practitioner may also explain the remedy plan and cope with any questions or concerns. Mounjaro is run as a once-weekly injection, usually in the abdomen, thigh, or higher arm. The dosage starts off low and is regularly extended, primarily based on your reaction and tolerance. Normal follow-up appointments are vital to monitor your progress, adjust the dosage if vital, and make sure of the treatment's effectiveness. These test-ins also provide an opportunity to receive extra steerage on nutrients and physical activity. To maximize the effectiveness of modern Mounjaro injections, recall these pre-remedy suggestions: consult an expert: make sure you go through a comprehensive assessment to rule out contraindications. adopt healthful conduct: begin incorporating a balanced food regimen and regular exercising into your routine to complement the treatment. Stay Hydrated: Proper hydration helps standard fitness and enhances the body's capacity to manage the medication. Keep away from smoking and alcohol: each can interfere with the medicine's efficacy and put off progress. After beginning Mounjaro injections, observe these tips to make certain of the most efficient results: Keep on with your timetable: Administer the injections on the same day each week to keep steady consequences. monitor side effects: While maximum sufferers tolerate Mounjaro properly, a few may additionally enjoy mild side consequences, which include nausea, diarrhoea, or reduced urge for food. Record any severe or persistent signs in your health practitioner right now. Adopt a holistic technique: integrate the remedy with a healthy contemporary, including a nutrient-wealthy weight loss plan and normal physical activity, for sustainable weight loss. Attend follow-ups: Regular test-ins with your healthcare provider assist in tracking progress and addressing any worries promptly. Normally, Mounjaro is nicely tolerated. However, some sufferers may experience slight gastrointestinal issues, which normally subside as the body adjusts to the drugs. maximum patients start noticing weight reduction within the first few weeks of the brand-new remedy. huge consequences are normally executed after several months of ultra-modern, consistent use. Yes, whilst used below scientific supervision, Mounjaro is safe for extended intervals. Normal tracking ensures that any potential risks are minimized. While effective, Mounjaro works high-quality whilst mixing with a healthy lifestyle. It is not a replacement for proper nutrition and bodily activity. Mounjaro injections constitute a groundbreaking advancement in weight loss control, offering desire to people struggling with weight problems and associated conditions. In Dubai, with its internationally magnificent medical understanding and customized care, sufferers can embark on a transformative journey, present-day stepped forward health and well-being. By addressing the basic causes of present-day weight gain and helping sustainable lifestyle changes, Mounjaro injections empower sufferers to gain lasting effects. If you're geared up to manipulate cutting-edge weight reduction adventure, seek advice from a certified healthcare provider in Dubai to explore how Mounjaro injections will let you acquire your dreams. TIME BUSINESS NEWS

A Landmark Global Trial Led from Lebanon: Mitapivat in NTDT Published in The Lancet
A Landmark Global Trial Led from Lebanon: Mitapivat in NTDT Published in The Lancet

Web Release

time04-07-2025

  • Health
  • Web Release

A Landmark Global Trial Led from Lebanon: Mitapivat in NTDT Published in The Lancet

In a major advancement for global thalassemia care, the results of a landmark global phase 3 clinical trial of mitapivat in non-transfusion-dependent thalassemia (NTDT) led by the American University of Beirut (AUB) and the Chronic Care Center, the thalassemia center in Lebanon, have been published in The Lancet, one of the world's leading medical journals. The study, titled 'Phase 3 trial of mitapivat in non-transfusion-dependent alpha- or beta-thalassemia,' led by Dr. Ali Taher, professor of medicine at the Division of Hematology and Oncology, director of the Naef K. Basile Cancer Institute, and consultant at the Chronic Care Center served as both global principal investigator and first and corresponding author. It is the first to demonstrate the efficacy of an oral, disease-modifying therapy for both beta and alpha forms of NTDT, positioning mitapivat as a potential game changer in the treatment of this lifelong blood disorder. 'This publication is more than a scientific milestone,' said Dr. Taher. 'It's proof that Lebanon, even in its hardest times, can lead groundbreaking medical advances that change global standards of care. I'm proud this trial was conceived, led, and delivered from AUB and the Chronic Care Center.' NTDT is a lifelong inherited blood disorder that results in chronic anemia. Patients with NTDT do not require blood transfusions, but still suffer from chronic anemia and associated complications, including iron overload and reduced quality of life. Until now, therapeutic options for these patients have been limited. Mitapivat is currently under review by the United States Food and Drug Administration (FDA) for potential marketing authorization. If approved, it would become the first FDA-authorized oral disease-modifying treatment for NTDT, offering a transformative option for thousands of patients worldwide. The phase 3 trial met all of its primary and secondary endpoints, demonstrating statistically and clinically significant improvements in hemoglobin levels, alongside favorable safety and tolerability profiles. This work represents the culmination of over a decade of research, beginning with redefining the disease and understanding the morbidity and mortality risks of untreated anemia and iron overload. It builds on prior global efforts led from AUB that resulted in the approval of key therapies, including iron chelation through the THALASSA trial and luspatercept through the BEYOND trial. Both studies were led by Dr. Ali Taher, whose vision and leadership have been instrumental in transforming the global approach to thalassemia care. Widely recognized as one of the foremost experts in the field, Dr. Taher has played a central role in advancing treatment standards and improving outcomes for patients worldwide. His long-standing commitment to thalassemia research has not only shaped the current therapeutic landscape, but has also positioned Lebanon and AUB at the forefront of international medical innovation. This achievement serves as a powerful affirmation of AUB's role as a beacon of academic and clinical excellence, firmly committed to advancing health through research, education, and patient-centered innovation. It also reflects the resilience and determination of Lebanon's medical and scientific communities to contribute meaningfully to global health, despite the formidable challenges faced at home.

Invested in America: Philip Morris International Highlights Bold Commitment to America Through New National Ad Campaign
Invested in America: Philip Morris International Highlights Bold Commitment to America Through New National Ad Campaign

Business Wire

time03-07-2025

  • Business
  • Business Wire

Invested in America: Philip Morris International Highlights Bold Commitment to America Through New National Ad Campaign

STAMFORD, Conn.--(BUSINESS WIRE)--Today, Philip Morris International's U.S. businesses ('PMI U.S.') unveiled 'Invested in America,' a bold advertising campaign that brings to life the company's deep-rooted commitment and increased contributions to America and Americans. The campaign's message is grounded in the role PMI U.S. is playing in powering job growth, revitalizing manufacturing, improving public health by offering adults 21+ who smoke better choices, and strengthening communities across the nation. 'Philip Morris International is invested in America's future—and we have a proud story to tell,' said Stacey Kennedy, CEO of PMI U.S. 'From building our advanced manufacturing facilities to contributing to progress within communities nationwide, the people of PMI U.S. are helping to write America's next chapter. Our story is part of the story of America, unfolding from our global headquarters in Stamford, Connecticut, to our operations across America's heartland, where we will continue to create high-quality, high-paying jobs and invest in innovation for generations to come.' The ad campaign captures PMI U.S.'s vision of what responsible business leadership looks like in today's America, grounded in the places it calls home. It is rooted in concrete actions that deliver tangible benefits to American workers, communities, and the economy. The campaign will launch on July 3 with full-page print advertisements, and a corresponding digital campaign will follow. Together, the ads will introduce PMI U.S.'s vision to decision-makers and opinion leaders across the business, policy, and civic spheres, inviting them to join a coalition of stakeholders dedicated to the country's success. It will also tell the PMI U.S. story to Americans, who want to see corporations step up to the challenges they see in their lives and communities. 'Invested in America' will highlight the four pillars of PMI U.S.'s American commitment: America's Manufacturing Comeback: With announced plans to invest over $800 million in new and expanded U.S. manufacturing facilities to produce smoke-free products, PMI U.S. isn't just growing American manufacturing—it's supporting a renaissance, creating high-skilled, high-paying jobs that contribute to thriving communities. Advancing Public Health: PMI, which has never sold cigarettes in the U.S., is on a mission to help America's ~30 million legal-age adults who smoke replace combustible cigarettes—by far the most harmful way to consume nicotine—with FDA-authorized, smoke-free alternatives that are scientifically substantiated to be a better choice for adults 21+ who would otherwise smoke. Strengthening Communities: PMI U.S.'s approach to corporate citizenship involves strategic investment in communities where its employees and 21+ adult consumers live and work, focusing on sustainable impact rather than short-term interventions. It is committed to causes that matter to Americans, including supporting military veterans and their families, promoting economic empowerment, and responding to natural disasters. Purpose-Driven Performance: With $14+ billion invested globally in smoke-free innovation since 2008, PMI is driving transformative solutions while delivering strong business results. Philip Morris International is headquartered in Stamford, Connecticut, and PMI U.S. has multiple operations in Virginia, Colorado, North Carolina, and Kentucky. As it opens and expands facilities, the business is generating hundreds of high-quality jobs and millions of dollars in direct investment in communities around the country. PMI U.S. has also contributed approximately $25 million to charitable causes since 2022. In 2024 alone—the first official year of its philanthropy program—PMI U.S. and its employees contributed more than $10 million to 327 nonprofits in 35 states. 'This campaign embodies our innovation and determination to reshape an entire industry and strengthen America,' Kennedy added. 'It also reflects our commitment to meaningful investments that create genuine value for our business, our workforce, and our communities. In every state where we operate, we're not just doing business—we're creating opportunities that will define the America of tomorrow.' Invested in America Philip Morris International Inc.'s U.S. businesses (collectively, 'PMI U.S.') are on a mission to improve public health in America by providing the ~30 million legal-age consumers who still smoke traditional cigarettes with better, smoke-free alternatives. PMI U.S. is committed to responsible marketing practices that help prevent access to its products by people under the age of 21. PMI U.S. businesses employ more than 2,500 people across America and operate product manufacturing facilities, including in Owensboro, Kentucky, and Wilson, North Carolina. Since 2022, PMI U.S. has contributed approximately $25 million to charitable causes, amplifying the good work of organizations already active within communities through financial contributions and volunteering. For more information, please visit and Forward-Looking and Cautionary Statements This press release contains projections of future results and goals and other forward-looking statements, including statements regarding expected operational performance; capital expenditures; and business plans and strategies. Achievement of future results is subject to risks, uncertainties and inaccurate assumptions. In the event that risks or uncertainties materialize, or underlying assumptions prove inaccurate, actual results could vary materially from those contained in such forward-looking statements. Pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995, PMI is identifying important factors that, individually or in the aggregate, could cause actual results and outcomes to differ materially from those contained in any forward-looking statements made by PMI. PMI's business risks include: excise tax increases and discriminatory tax structures; increasing marketing and regulatory restrictions that could reduce our competitiveness, eliminate our ability to communicate with adult consumers, or ban certain of our products in certain markets or countries; health concerns relating to the use of tobacco and other nicotine-containing products and exposure to environmental tobacco smoke; litigation related to tobacco and/or nicotine use and intellectual property; intense competition; the effects of global and individual country economic, regulatory and political developments, natural disasters and conflicts; the impact and consequences of Russia's invasion of Ukraine; changes in adult smoker behavior; the impact of natural disasters and pandemics on PMI's business; lost revenues as a result of counterfeiting, contraband and cross-border purchases; governmental investigations; unfavorable currency exchange rates and currency devaluations, and limitations on the ability to repatriate funds; adverse changes in applicable corporate tax laws; recent and potential future tariffs imposed by the U.S. and other countries; adverse changes in the cost, availability, and quality of tobacco and other agricultural products and raw materials, as well as components and materials for our electronic devices; and the integrity of its information systems and effectiveness of its data privacy policies. PMI's future profitability may also be adversely affected should it be unsuccessful in its attempts to introduce, commercialize, and grow smoke-free products or if regulation or taxation do not differentiate between such products and cigarettes; if it is unable to successfully introduce new products, promote brand equity, enter new markets or improve its margins through increased prices and productivity gains; if it is unable to expand its brand portfolio internally or through acquisitions and the development of strategic business relationships; if it is unable to attract and retain the best global talent, including women or diverse candidates; or if it is unable to successfully integrate and realize the expected benefits from recent transactions and acquisitions. Future results are also subject to the lower predictability of our smoke-free products performance. PMI is further subject to other risks detailed from time to time in its publicly filed documents, including PMI's Annual Report on Form 10-K for the fourth quarter and year ended December 31, 2024, and the Quarterly Report on Form 10-Q for the first quarter ended March 31, 2025. PMI cautions that the foregoing list of important factors is not a complete discussion of all potential risks and uncertainties. PMI does not undertake to update any forward-looking statement that it may make from time to time, except in the normal course of its public disclosure obligations. References to 'PMI' mean the Philip Morris International family of companies. 'PMI U.S.,' 'we,' 'our,' and 'us' refer to PMI U.S. businesses.

TISSIUM Receives FDA De Novo Authorization for COAPTIUM® CONNECT in Atraumatic Sutureless Peripheral Nerve Repair
TISSIUM Receives FDA De Novo Authorization for COAPTIUM® CONNECT in Atraumatic Sutureless Peripheral Nerve Repair

Business Upturn

time24-06-2025

  • Business
  • Business Upturn

TISSIUM Receives FDA De Novo Authorization for COAPTIUM® CONNECT in Atraumatic Sutureless Peripheral Nerve Repair

This regulatory milestone marks TISSIUM's entry into the U.S. market and establishes the foundation of the TISSIUM polymer platform for atraumatic tissue repair Paris, France, Cambridge, USA, June 24, 2025 – TISSIUM, a MedTech company pioneering biomorphic programmable polymers for tissue reconstruction, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for COAPTIUM® CONNECT with TISSIUM Light, a first-of-its-kind atraumatic sutureless solution for peripheral nerve repair. This authorization represents a pivotal regulatory milestone for TISSIUM, further validating its biopolymer platform and enabling U.S. commercialization of its first product. COAPTIUM® CONNECT is now the only FDA-authorized system designed for atraumatic sutureless nerve coaptation. Christophe Bancel, Co-Founder and CEO of TISSIUM said: 'This FDA marketing authorization validates over a decade of scientific and clinical commitment to developing next-generation solutions in tissue reconstruction. COAPTIUM® CONNECT is the first demonstration of the transformative potential of our polymer platform and an important step in making atraumatic tissue repair available to patients.' Peripheral nerve injuries affect hundreds of thousands of patients annually and are typically repaired using microsurgical sutures. However, this approach presents limitations—including technical complexity, risk of additional trauma, and variable outcomes. COAPTIUM® CONNECT addresses these challenges by offering a reproducible, atraumatic sutureless alternative that preserves nerve integrity and simplifies the coaptation process1. In a recent clinical study on 12 patients with digital nerve injuries, COAPTIUM® CONNECT achieved 100% procedural success, defined as successful atraumatic sutureless coaptation using the polymer-assisted coaptation device, with all patients regaining full flexion and extension of the injured digit and reporting no pain 12 months after the procedure1. TISSIUM plans to initiate commercial rollout of COAPTIUM® CONNECT in the coming months. The COAPTIUM® CONNECT System leverages TISSIUM's unique biopolymer platform, invented by Maria Pereira, Jeffrey Karp and Robert Langer at the MIT and Brigham & Women's Hospital, using its bioresorbable light-activated surgical polymer and its 3D-printed polymer chamber. Maria Pereira, Co-Founder and Chief Innovation Officer, said: 'This first product illustrates the technical versatility and the potential of the TISSIUM polymer platform, not only in peripheral nerve repair where other solutions are currently under development, but also in other surgical applications, such as atraumatic hernia repair and cardiovascular sealing.' *** About TISSIUM TISSIUM is a clinical and commercial stage MedTech company based in Paris, France, Cambridge, USA, and with a manufacturing site in Roncq, France. The company is pioneering a proprietary platform of fully biosynthetic, biomorphic, programmable, elastomeric polymers designed to address critical unmet needs in atraumatic tissue repair and tissue reconstruction. TISSIUM's diversified pipeline includes seven products across three core verticals: sutureless nerve repair, atraumatic hernia repair, and cardiovascular sealants. Each solution is designed to optimize tissue repair through controlled and consistent procedures with specialized delivery and activation devices to maximize the performance and usability of its products. Founded in 2013, TISSIUM is built on breakthrough research and intellectual property originating from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Women's Hospital). For more information, please visit and follow us on LinkedIn: TISSIUM. *** Contacts Investor relationsRomain Attard – Chief Financial Officer [email protected]

TISSIUM Receives FDA De Novo Authorization for COAPTIUM® CONNECT in Atraumatic Sutureless Peripheral Nerve Repair
TISSIUM Receives FDA De Novo Authorization for COAPTIUM® CONNECT in Atraumatic Sutureless Peripheral Nerve Repair

Yahoo

time23-06-2025

  • Business
  • Yahoo

TISSIUM Receives FDA De Novo Authorization for COAPTIUM® CONNECT in Atraumatic Sutureless Peripheral Nerve Repair

This regulatory milestone marks TISSIUM's entry into the U.S. market and establishes the foundation of the TISSIUM polymer platform for atraumatic tissue repairParis, France, Cambridge, USA, June 24, 2025 - TISSIUM, a MedTech company pioneering biomorphic programmable polymers for tissue reconstruction, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for COAPTIUM® CONNECT with TISSIUM Light, a first-of-its-kind atraumatic sutureless solution for peripheral nerve repair. This authorization represents a pivotal regulatory milestone for TISSIUM, further validating its biopolymer platform and enabling U.S. commercialization of its first product. COAPTIUM® CONNECT is now the only FDA-authorized system designed for atraumatic sutureless nerve coaptation. Christophe Bancel, Co-Founder and CEO of TISSIUM said: 'This FDA marketing authorization validates over a decade of scientific and clinical commitment to developing next-generation solutions in tissue reconstruction. COAPTIUM® CONNECT is the first demonstration of the transformative potential of our polymer platform and an important step in making atraumatic tissue repair available to patients.' Peripheral nerve injuries affect hundreds of thousands of patients annually and are typically repaired using microsurgical sutures. However, this approach presents limitations—including technical complexity, risk of additional trauma, and variable outcomes. COAPTIUM® CONNECT addresses these challenges by offering a reproducible, atraumatic sutureless alternative that preserves nerve integrity and simplifies the coaptation process1. In a recent clinical study on 12 patients with digital nerve injuries, COAPTIUM® CONNECT achieved 100% procedural success, defined as successful atraumatic sutureless coaptation using the polymer-assisted coaptation device, with all patients regaining full flexion and extension of the injured digit and reporting no pain 12 months after the procedure1. TISSIUM plans to initiate commercial rollout of COAPTIUM® CONNECT in the coming months. The COAPTIUM® CONNECT System leverages TISSIUM's unique biopolymer platform, invented by Maria Pereira, Jeffrey Karp and Robert Langer at the MIT and Brigham & Women's Hospital, using its bioresorbable light-activated surgical polymer and its 3D-printed polymer chamber. Maria Pereira, Co-Founder and Chief Innovation Officer, said: 'This first product illustrates the technical versatility and the potential of the TISSIUM polymer platform, not only in peripheral nerve repair where other solutions are currently under development, but also in other surgical applications, such as atraumatic hernia repair and cardiovascular sealing.' *** About TISSIUM TISSIUM is a clinical and commercial stage MedTech company based in Paris, France, Cambridge, USA, and with a manufacturing site in Roncq, France. The company is pioneering a proprietary platform of fully biosynthetic, biomorphic, programmable, elastomeric polymers designed to address critical unmet needs in atraumatic tissue repair and tissue reconstruction. TISSIUM's diversified pipeline includes seven products across three core verticals: sutureless nerve repair, atraumatic hernia repair, and cardiovascular sealants. Each solution is designed to optimize tissue repair through controlled and consistent procedures with specialized delivery and activation devices to maximize the performance and usability of its products. Founded in 2013, TISSIUM is built on breakthrough research and intellectual property originating from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Women's Hospital). For more information, please visit and follow us on LinkedIn: TISSIUM. *** Contacts Investor relationsRomain Attard – Chief Financial Officer rattard@ Press tissium@ A Sutureless Approach to Nerve Repair: Results from a Clinical Study in Digital Nerves, Randi Bindra, Journal of Hand Surgery, submitted 2025Attachment 20250624 - TISSIUM_FDA DeNovo announcementError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store