NICE Approves Etrasimod for Ulcerative Colitis: A New Hope for Patients Aged 16 and Over The National Institute for Health and Care Excellence has endorsed the use of Etrasimod for ulcerative colitis patients who have not responded well to conventional treatments. Etrasimod, sold under the name Velsipity by Pfizer, has shown promising results in clinical trials and is a cost-effective option. The guidance includes a commercial arrangement with the NHS to offer discounts on the drug. NHS England and integrated care boards are required to ensure availability of Etrasimod within a specified timeframe. For more details please click the link! https://lnkd.in/d85SBxXY #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical
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Common Drug Interactions During Chemotherapy: How Pharmacists Safeguard Your Treatment Chemotherapy patients often take multiple medications, which increases the risk of drug interactions. These interactions can reduce the effectiveness of treatment or cause harmful side effects. Here's how pharmacists help prevent these risks: 1. Comprehensive Medication Review: Pharmacists review all your medications, including over-the-counter drugs and supplements, to identify potential interactions with chemotherapy. 2. Adjusting Treatment Plans: If a risk is detected, pharmacists collaborate with your healthcare team to adjust doses or suggest alternatives, ensuring optimal treatment outcomes. 3. Patient Education: Pharmacists provide essential guidance on how to safely take medications during chemotherapy, helping you avoid interactions that could affect your health. Pharmacists are key partners in your cancer care, working to ensure that your chemotherapy regimen is both safe and effective. #Chemotherapy #PharmacistRole #DrugInteractions #CancerCare #PatientSafety #OncologyPharmacy #MedicationSafety #HealthcareProfessionals
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Empowering Managed Care & Pharmaceutical Organizations with Crucial Therapeutic Insights for Informed Formulary Decision-Making
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
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Levacetylleucine Receives FDA Approval as Stand-Alone Therapy for Niemann-Pick Disease Type C: The approval marks the only FDA-approved stand-alone therapy for the treatment of Niemann-Pick disease type C (NPC). #finance #pharmacy #lifesciences
Levacetylleucine Receives FDA Approval as Stand-Alone Therapy for Niemann-Pick Disease Type C
pharmacytimes.com
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Subcutaneous Ocrelizumab Provides New Administration Opportunities for Multiple Sclerosis: Subcutaneous ocrelizumab can be delivered in approximately 10 minutes and deliver comparable clinical benefit and safety to the IV formulation. #finance #pharmacy #lifesciences
Subcutaneous Ocrelizumab Provides New Administration Opportunities for Multiple Sclerosis
pharmacytimes.com
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In March, HCPs were excited about three FDA approvals. The first was for Madrigal Pharmacautical’s Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis. The second was for a new indication for Novo Nordisk’s Wegovy (semaglutide) injection to reduce the risk of heart attack and stroke in adults with cardiovascular disease and obesity or overweight. Lastly, Boston Scientific’s Agent paclitaxel-coated balloon, for the treatment of coronary in-stent restenosis received a positive response by HCPs. Discover what HCPs had to say about these latest product approvals via the link https://bit.ly/4aRXPH5 Better listening for better health. #pharmaceuticals #healthcare #medicine
Product Launch Tracker: eHCPs celebrated the first approved treatment for patients with NASH
https://creation.co
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FDA Approves Ascendis Pharma's Yorvipath for Hypoparathyroidism The #FDA has granted approval to Ascendis Pharma for #Yorvipath (palopegteriparatide), a groundbreaking treatment for adults with the #RareEndocrineDisorderHypoparathyroidism. This approval marks a significant milestone for patients who have long faced the limitations of conventional therapies. Yorvipath, a once-daily subcutaneous injection, is designed to restore normal #ParathyroidHormone levels, providing a crucial solution for managing both short- and long-term symptoms of the condition. #AscendisPharma is currently finalizing the manufacturing process for Yorvipath, with plans to launch the product in the U.S. by the first quarter of 2025. However, if the FDA approves the #Commercialization of existing batches, Yorvipath could reach the market as early as Q4 2024. At launch, a comprehensive #PatientSupportProgram will be introduced, offering financial assistance and guidance throughout the treatment process. Patty Keating, Executive Director of the HypoPARAthyroidism Association, described the approval as "an important milestone" for the patient community, highlighting the new treatment option as a significant advancement beyond the limits of conventional therapy. This approval follows a rigorous process, during which Ascendis addressed initial manufacturing concerns raised by the FDA. With the challenges overcome, Yorvipath now offers new hope to those affected by #Hypoparathyroidism. Stay tuned for further updates as Yorvipath approaches market availability! #FDAApproval #Yorvipath #Palopegteriparatide #Hypoparathyroidism #RareDisease #EndocrineDisorder #PharmaNews #PatientCare #HealthcareInnovation #AscendisPharma #RASLifeScienceSolutions #MarketIntelligence #MarketResearch #CompetitiveIntelligence #StrategySupport #PortfolioOptimization Detailed News: https://lnkd.in/dw5itCcv Follow our page for more industry updates: https://lnkd.in/de5zNWmK
Ascendis’ Hypoparathyrodism Drug Secures FDA Approval Following Tough Regulatory Path
biospace.com
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FDA approves imaging drug for evaluation of myocardial ischemia and infarction The U.S. Food and Drug Administration has approved Flyrcado (flurpiridaz F 18) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia (cardiac function disorder when the heart muscle doesn’t receive enough blood flow to function properly) and infarction (heart attack). Flyrcado is a cyclotron-produced radioactive diagnostic drug for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise). Flyrcado is administered by intravenous injection. CAD is the narrowing or blockage of the coronary arteries, which supply oxygen-rich blood to the heart. It is often caused by plaque buildup in these arteries. CAD is very common, impacting over 18 million adults in the U.S., and is the leading cause of death in the U.S. #fda #heart #imaging #coronary #artery https://lnkd.in/gyxhNniR
FDA approves imaging drug for evaluation of myocardial ischemia
fda.gov
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Exciting news coming from Merck. The FDA has just approved Merck's Winrevair, a groundbreaking drug designed to treat pulmonary arterial hypertension (PAH), offering hope to thousands suffering from this rare condition. Winrevair targets the root cause of PAH, a significant advancement compared to existing symptom-management medications. With an estimated annual sales projection of $5 billion by 2030, this approval marks a pivotal moment for Merck's growth strategy. Winrevair's unique administration method and promising trial results demonstrate its potential to significantly improve the quality of life for PAH patients, offering a more convenient and effective treatment option. Following this big leap in the pulmonology space, what other advancements do you foresee following suit? Winrevair offers the advantage of allowing patients or caregivers to administer it under the skin with proper training from a healthcare provider, unlike some existing PAH treatments that necessitate administration by medical professionals at an infusion center. “One of the things we heard very loud and very clear, from both patients and physicians, is that they wanted something that you could get at home,” says Merck Chief Medical Officer Eliav Barr. Read more about this in the article in the comment below. #merck #winrevair #PAH #fdaapproval #pulmonology #medicalinnovation #healthcare #treatmentoption #raredisease #patientcare #healthtech #medicalbreakthroughs
FDA approves Merck's drug for rare, deadly lung condition
cnbc.com
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New Drug Approval: Winrevair (sotatercept) is entering the market as a first-in-class activin signaling inhibitor therapy to slow down the disease progression of pulmonary arterial hypertension (PAH), which affects more than 50,000 Americans. With an annual list price of $238,000, Merck's price far exceeds where the Institute for Clinical and Economic Review (ICER) has determined this drug is priced to value, which is a range of $17,900 to $35,400 per year. Our team of experts at Aon's Pharmacy Solutions can help your organization navigate the specialty drug landscape – reach out to us today at aon.pharmacy.practice@aon.com to connect. https://shorturl.at/jALRY #ClinicalLeadership #pharmacist #thoughtleadership #newdrugapproval #FDAapproval #ICER #costeffectiveness #PAH #specialtydrugs #aonunited
FDA Approves Merck’s WINREVAIR™ (sotatercept-csrk), a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1) - Merck.com
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Plexiform Neurofibromas Targeted by Mirdametinib as FDA Grants Priority Review SpringWorks Therapeutics has received FDA Priority Review for mirdametinib, an investigational MEK inhibitor for treating plexiform neurofibromas in adults and children, with a PDUFA action date set for February 28, 2025. If approved, it could be the first treatment for adults with NF1-PN and a leading therapy for pediatric patients. The New Drug Application and the European Medicines Agency submissions are based on positive Phase 2b ReNeu trial data, showing strong response rates, pain reduction, and improved quality of life. This marks a key milestone for SpringWorks Therapeutics in addressing a significant unmet medical need. For more details please click the link! https://lnkd.in/dkJa2QhA #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical
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