Zent2U’s Post

FDA Approves Marstacimab for Hemophilia A, B Treatment On October 11, 2024, the FDA approved Marstacimab as routine prophylaxis for patients aged 12 years or older with hemophilia A (without factor VIII inhibitors) or hemophilia B (without factor IX inhibitors). This once-weekly subcutaneous injection marks a major advancement as the first non-factor treatment for hemophilia B in the United States. Marstacimab targets tissue factor pathway inhibitor (TFPI), an anticoagulation protein. By reducing TFPI, it increases thrombin levels, a pro-clotting enzyme, helping to prevent bleeding episodes. This approval based on results of the phase 3 BASIS trial, which included adults and adolescents with hemophilia A or B without inhibitors. After a 12-month active treatment period, marstacimab reduced the annualized bleeding rate for treated bleeds by 35% compared with routine prophylaxis and 92% compared with on-demand treatment. The most common side effects included injection-site reactions, headaches, and itching, with warnings for blood clots, hypersensitivity, and embryofetal toxicity. This approval offers new hope for hemophilia patients with its convenient once-weekly regimen, aiming to improve quality of life significantly. 🔗 Stay informed on the latest in hemophilia care! Source: FDA #FDA #Hemophilia #Marstacimab #Biopharma #HealthcareInnovation #RareDiseases #MedicalAdvances

Hair loss treatment just got easier. Convenient treatment for the second most common form of Alopecia is available now. 💊 A new treatment for Alopecia Areata, Litfulo (ritlecitinib, Pfizer), has been approved by the FDA, EMA, and NHS.     These tablets may replace the use of corticosteroids which have limitations, especially for extensive hair loss that in some cases requires local injections 💉 🔬The Janus kinase (JAK) signaling pathway plays a role in the initiation and progression of Alopecia Areata. 🩺 Current clinical trials have also focused on inhibiting this signaling 🛑 Baricitinib (NCT03570749)  Deucravacitinib (NCT05556265) EQ101(NCT05589610) 📈 According to analysts, this market size is forecasted to be worth $ 5B by 2030. #alopeciaareata Sources: https://lnkd.in/gDZ-_9ny https://lnkd.in/gp4-9Q_5 doi:10.1001/jamanetworkopen.2023.20351 https://lnkd.in/gauxmUb2 — If you like this post, please share ♻️ Follow me for more 💡 #lifesciences #healthcare — Disclaimer:  This poster represents my personal view and does not reflect those of any past, present, or future employer.

Let's talk about Wegovy (semaglutide)! On March 8th, 2024, Novo Nordisk's Wegovy received FDA approval for reducing the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease who are either obese or overweight based on results from the SELECT trial. Previously, the FDA had approved this medication solely for weight-loss purposes in non-diabetic patients. Before this recent approval, Wegovy was exclusively covered by commercial plans, but not Medicare Part D since it did not meet the definition of a Part D drug. However, with its inclusion in the Medicare Formulary Reference File (FRF) following this expanded indication, it is anticipated that Medicare Part D plans will begin adding this drug to their formularies. Considering the rising global demand for glucagon-like-peptide-1 (GLP-1) receptor agonists and nationwide shortages stemming from manufacturer's inability to meet demand, it is imperative to conduct thorough evaluations and cost-efficacy analyses to weigh the benefits of utilizing Wegovy for patients. Check out our clinical trial summary with formulary insight information! What are your thoughts on Wegovy? Want some more information or have other drug/disease inquiries? Feel free to reach out at consulting@kisrsolutions.com or send us a message! Reference: Lincoff AM, Brown-Frandsen K, et al. N Engl J Med. 2023 Dec 14;389(24):2221-2232. doi: 10.1056/NEJMoa2307563. #pharma #formulary #formularyinsight #wegovy #novonordisk #obesity #weightloss #cardiovascular #druginformation #FDA #UnitedStates #KISRSolutions #SELECTtrial

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

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

𝐃𝐫𝐲 𝐄𝐲𝐞 𝐃𝐢𝐥𝐞𝐦𝐦𝐚: 𝐔𝐊 𝐌𝐚𝐫𝐤𝐞𝐭 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬 #Dry #eye, medically known as keratoconjunctivitis sicca, is an ocular disorder caused by the lack of tear fluid to lubricate the eyes. This can be an indicator of either low production of tears or rapid evaporation of the film of tears on the surface of the eyes, which can be brought about by several conditions. 𝑩𝒚 𝑷𝒓𝒐𝒅𝒖𝒄𝒕 📌Liquid Drops 📌Gel 📌Liquid Wipes 📌Eye Ointment Dry Eye Syndrome Treatment Market size was valued at USD 5.48 Bn in 2023, registering a CAGR of 7.03 % during the forecast period (2024-2032), and the market is projected to be worth USD 10.1 Bn by 2032. 𝑲𝒆𝒚 𝑰𝒏𝒅𝒖𝒔𝒕𝒓𝒚 𝑫𝒆𝒗𝒆𝒍𝒐𝒑𝒎𝒆𝒏𝒕𝒔 𝑰𝒏 𝑻𝒉𝒆 𝑼𝑲 𝑫𝒓𝒚 𝑬𝒚𝒆 𝑻𝒓𝒆𝒂𝒕𝒎𝒆𝒏𝒕 𝑴𝒂𝒓𝒌𝒆𝒕 In January 2024, Switzerland-based Alcon's dry eye disease drug AR-15512 achieved its primary endpoints in two Phase III trials, COMET-2 and COMET-3. Following the positive data, the company planned to file for a new drug application (NDA) for AR-15512 with the US Food and Drug Administration (FDA) in mid-2024, as stated in a 9 January press release. The vehicle-controlled Phase III COMET-2 (NCT05285644) and COMET-3 (NCT05360966) trials enrolled over 930 patients, aged 30 years and older, with dry eye disease. #UKDryEyeMarket #DryEyeTreatment #Ophthalmology #EyeCare #Healthcare #HealthTech #Pharma #DryEyeSolutions #HealthcareInnovation #EyeHealth

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

What is projected to drive the global #localanesthesia market share growth in the forecast period, considering the rising cases of chronic diseases like cancer and diabetes? The increasing prevalence of chronic diseases, such as #cancer and #diabetes, leading to high #hospitalization rates globally, is expected to propel the growth of the local anesthesia market. The surge in surgeries, especially among the aging population, due to various #medical conditions, further contributes to the rising demand for local anesthesia #drugs. Explore More Insights: https://lnkd.in/d2feWUCT Key Market Players: Aspen Pharmacare, Sagent Pharmaceuticals, Fresenius Kabi, MYLAN N.V. #RDive #LocalAnesthesia #HealthcareMarket #ChronicDiseases #SurgicalInterventions #MedicalTreatments #GlobalHealth #Pharmaceuticals #PatientCare #HealthTech #MedicalResearch #AgingPopulation #DiseasePrevention #PublicHealth #MedicalInnovations #SurgeryTrends #AnestheticMedication #HealthTrends #MedicalScience #PatientWellness #GlobalHealthcare

Shareables: #Neu-REFIX Beta glucan receives rare pediatric disease and orphan drug designations from the US FDA for treatment of Duchenne Muscular Dystrophy Business Wire India Neu REFIX Beta glucan, made in Japan has received both Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (US FDA) for treatment of Duchenne muscular Dystrophy (DMD). These designations would help take the progress in pre-clinical and clinical studies conducted in Japan and India to clinical trials in the USA, for approval by FDA.   This press release features multimedia. View the full release here: https://lnkd.in/gr8hvZhZ   The parable of the lost sheep mirrors our journey to find a solution for Duchenne Muscular Dystrophy (DMD), a rare disease. […] - https://lnkd.in/gHqt-Qre 𝗖𝗹𝗶𝗰𝗸 𝘁𝗼 𝗝𝗼𝗶𝗻 𝘁𝗵𝗲 𝗙𝗮𝘀𝘁𝗲𝘀𝘁 𝗚𝗿𝗼𝘄𝗶𝗻𝗴 𝗡𝗲𝘁𝘄𝗼𝗿𝗸 - https://lnkd.in/gqWAqhyR #IndianConventions #TaleesRizvi #News #Awards #Conferences #India #HR #Marketing #Finance #StartUp #Business #B2B #B2C #C2C #D2C #leadership #Management #HumanResources #Healthcare

Case Study 44 Case Study: Domperidone-Induced Cardiac Arrhythmia Scenario: A 45-year-old patient with chronic indigestion was started on Domperidone for gastric motility. They present with palpitations and dizziness. Assessment: Domperidone can prolong the QT interval, increasing the risk of life-threatening arrhythmias such as torsades de pointes. Plan: Discontinue Domperidone immediately and conduct an ECG to evaluate the QT interval. Monitor for arrhythmias and consider alternative treatments for indigestion that do not carry the same cardiac risks. #pharmacology #medicine #pharma #pharmacy