Arthur Lodge Kellermann’s Post

Paediatric Patients Benefit from FDA Approval of NexoBrid for Severe Burns Treatment The FDA has approved NexoBrid by MediWound and Vericel® Corporation for pediatric burn patients, expanding its previous use for adults. The approval was based on positive results from the Phase III Children Innovative Debridement Study, which demonstrated NexoBrid's effectiveness in treating 145 pediatric patients. This breakthrough represents a significant advancement in burn care, offering a safer and less invasive treatment option for young patients. It also highlights the potential of proteolytic enzyme therapies in wound care, with MediWound continuing to innovate with products like EscharEx for chronic wounds. NexoBrid's approval not only transforms pediatric burn care but also solidifies MediWound's role in the evolving wound care industry, which is expected to grow to $38.8 billion by 2030. For more details please click the link! https://lnkd.in/dFUaps5g #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

The IDE approval launches the groundbreaking Remain-1 study, set to begin in the second half of 2024. Remain-1 is a randomized, double-blind trial of Revita versus sham in patients who have lost at least 15% total body weight on tirzepatide therapy. It is designed to be a pivotal study to potentially enable registrational filing for Revita for weight maintenance after GLP-1RA discontinuation. In parallel with the randomized portion of the Remain-1 study, Fractyl Health also announces Reveal-1, an open-label cohort that will follow a similar patient population and management protocol with anticipated open-label data updates as the study progresses. The rationale for the Remain-1 pivotal study is based on a new need for therapeutic solutions that can offer durable weight maintenance without ongoing medical therapy. Highly potent drugs in the GLP-1RA class, including semaglutide (Wegovy®) and tirzepatide (Zepbound®), are now approved for the management of obesity and have dramatically altered the treatment landscape. However, real world studies report high discontinuation rates and clinical trials have indicated the risk of substantial weight rebound after discontinuation in many participants. Strategies to maintain weight loss independent of ongoing medical therapy could provide substantial clinical and economic benefits by extending the value of GLP-1RA drugs. #obesity #obesitymanagement #clinicaltrial #clinicaloperations #innovation #medicalneed #semaglutide #glucosemanagement #drugdevelopment #regulatoryaffairs

Zent2U announces registration completion for Apixaban tablets Zent2U is pleased to announce the successful finalization of the harmonized part of the registration procedure with European authorities for Apixaban 2,5mg and 5mg tablets. At the moment, national parts of the procedure have been pending in order to obtain Marketing Authorization across European countries. 🌍 Apixaban primary indication includes the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors, such as prior stroke or transient ischemic attack (TIA), age 75 years or older, hypertension, heart failure, or diabetes mellitus. Additionally, Apixaban is prescribed for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults. 💊 Apixaban Zent2U is a generic alternative to the medication Eliquis® by Bristol Myers Squibb / Pfizer®. We are pleased to provide our partners with this new generic product, enhancing their cardiovascular portfolio. 🤝 Partner up now and connect with our team today! 📧   thomas.koene@zentiva.com - Thomas Koene - Head of Zent2U tomas.pilarcik@zentiva.com – Tomas Pilarcik – Head of B2B Europe rahul.padhye@zentiva.com – Rahul Padhye – Head of B2B International nina.fuentes@zentiva.com ­– Nina Fuentes de Tienda – Key Account Manager B2B Europe Disclaimer: Apixaban which is subject to patent protection is currently not offered or made available in countries where patents are in force.   #zent2u #innovation #HealthcareAdvancements #embolism #stroke #thrombosis

Here's another article on #diabetic #drugs and weight loss. Source: Forbes - Jul 23, 2024 From the article: "There are seven approved GLP-1 drugs in the U.S. There’s also a similar class of medications called dual GLP-1 and GIP receptor agonists, and #tirzepatide (the generic name for #Mounjaro and #Zepbound) is the only drug available in the U.S. from this group. However, only #semaglutide, #liraglutide—the generic name for #Saxenda and #Victoza—and #tirzepatide have been approved by the Food and Drug Administration for weight management. Saxenda was the first to be approved in 2014, followed by #Wegovy in 2020 and Zepbound in 2023." #Diabites #Ozempic #Trulicity #Dulaglutide #WeightLoss https://lnkd.in/gJVHbz_k

Umbereen S. Nehal, MD, MPH: "...The topic of deprescribing is relevant to adults of any age who have been refilling the same prescription for years. 'This should be a question we ask with virtually every chronic condition we take care of,' University of Colorado neurologist John Corboy, MD, MA, noted in an interview." https://lnkd.in/gTAv6Vrx #medicine #pharmaceuticals #healthcarefuture

FDA Approves Ocrevus Zunovo for 2 Forms of Multiple Sclerosis: The approval marks the first and only twice yearly, health care professional-administrated injection for both forms of multiple sclerosis (MS). #finance #pharmacy #lifesciences

Today, we announced $900,000 in new grants to the University of Rhode Island and the University of Southern California who are working to identify and address gaps in availability and dispensing of #buprenorphine at retail pharmacies. FORE funding for addressing #pharmacy-level barriers now totals $2.2 million. Led by Jef Bratberg, University of Rhode Island - College of Pharmacy is receiving $455,797 to train #pharmacists in Connecticut and Ohio to prescribe and dispense medications for #opioid use disorder, conduct a state-by-state review of pharmacy regulations, and develop toolkits for pharmacies in other states. Led by Dima Qato, USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences is receiving $437,920 to assess barriers to the availability of #buprenorphine at neighborhood pharmacies across the country, and identify trends and disparities at national, state, and local levels to inform policy discussions.

Based on recent statistics, up to 14% of women experience chronic pelvic pain, which can be disabling and associated with other chronic health conditions. Only a third of those women seek medical care. We need progress in this area, pain does not need to be normal. NICHD is grateful for partnership with FDA in this area. Join this upcoming workshop to learn more! #NICHDImpact #Womenshealth #pelvicpain #endometriosis #adenomyosis #painresearch

Pharmaceutical Industry Faces Challenges as Biden Administration Implements Bold Medicare Drug Price Cuts The Biden Administration has announced significant price reductions for ten Medicare-covered drugs under the Medicare price negotiation program established by the Inflation Reduction Act of 2022, with expected savings of $6 billion by 2026 and a projected $100 billion over ten years. Despite the potential financial relief for Medicare beneficiaries, the pharmaceutical industry has strongly opposed the initiative, citing concerns over its impact on innovation and drug development, and has filed numerous lawsuits, all of which have been dismissed by federal judges. The program's future, including potential expansions, will likely be influenced by the upcoming 2024 elections and the evolving political landscape. For more details please click the link! https://lnkd.in/dUNnBHD8 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

🧠 Amid a shortage of mental health providers, millions of adult patients are suffering from major depressive disorder (MDD), yet few evidence-based solutions without side effects exist. 💊 Click Therapeutics, Inc. is charting a new course by setting standards for bringing innovative software products to market as prescription medical treatments. 💡 Recognizing the urgent need for evidence-based solutions to address the shortage of mental health providers and the prevalence of MDD, Click Therapeutics developed Rejoyn, a groundbreaking digital therapeutic for the treatment of MDD symptoms. 🔬 But Click didn't just settle for a traditional approach. They took a bold step by engaging with the FDA to understand the rigorous evidence requirements necessary for demonstrating Rejoyn's safety and clinical performance – similar to the standards set for pharmaceutical drugs. ⚒️ Using this non-traditional approach, Click identified the specific requirements and specifications tailored to Rejoyn's unique capabilities in MDD for the 510(k) regulatory pathway. This case study showcases the FDA's nimbleness in regulating innovative treatments and Click's dedication to evidence rigor and market innovation! 🔗 Explore the full case study and discover how Click Therapeutics is changing lives through targeted digital interventions: https://bit.ly/3Kp3NUl