Medicine To Market News’ Post

Explore the forefront of pharmaceutical innovation with Norstella's August roundup, featuring cutting-edge insights from industry trailblazers and learn about our brands' latest news and updates. Check out the links below.👇 Puru Gaur, Senior Commercial Analyst at Norstella, shares his take on the latest Novo Nordisk earnings release in MM+M. Read the article: https://ow.ly/sJtn50ThwXc. Introducing Citeline Clinical SmartSolutions, a suite of products harnessing the power of AI to transform your clinical planning. Protocol SmartDesign recommends primary endpoints and I/E criteria, and Investigator SmartSelect generates a pool of protocol-specific investigators for your trial in minutes. Learn more: https://ow.ly/8yaL50ThwXb. Screening and valuing pharmaceutical assets can be a thorny process with many data points to consider. Evaluate Ltd's solutions provide an accurate, impartial, and timely view of pharmaceutical asset potential. Find out more: https://ow.ly/HlOq50ThwX8. MMIT (Managed Markets Insight & Technology)'s RWD data and HCP Targeting Report can help evaluate your therapy's full market potential, from the number of patients diagnosed to the high-value HCPs in the space. Learn more: https://ow.ly/IkPv50ThwX9. Treatment of anxiety and depression in pregnancy – what do the data tell us? Check out this blog from Panalgo expert Margaret (Meg) Richards, PhD, MPH, for her take: https://ow.ly/2jym50ThwXa. The lack of clarity surrounding the definition of an academic cancer center has real-world implications for manufacturers and patients. Matthew Cunningham from The Dedham Group writes about the challenges in developing a consensus definition and provides recommendations to navigate the complexity: https://ow.ly/JZuu50ThwXe. Follow our brands to stay up with the latest news, insights, and updates. #Pipeline2Patient #FollowNorstella

🚨 EU’s New Health Policies Challenge Oncology Medicine Access 🚨 The European Union is undergoing significant changes in oncology treatment availability as new health regulations are rolled out. While these reforms aim to create a unified approach across member states, they present both opportunities and challenges for patients and pharmaceutical companies. 🔍 Key Highlights: - The European Health Technology Assessment Regulation (HTAR) seeks to standardize clinical evaluations, potentially speeding up approvals in countries with less robust systems. - Proposed pharmaceutical legislation encourages simultaneous launches of new oncology drugs across the EU, yet faces hurdles from diverse national pricing and reimbursement schemes. 💡 Potential Implications: - Faster access to cancer treatments in developing assessment systems. - Increased administrative burdens may delay patient access. - Tensions between unified evaluations and national needs could arise. As the EU navigates these changes, effective policy adaptation and collaboration among stakeholders will be essential. The goal? To ensure equitable access to life-saving treatments while fostering an environment conducive to pharmaceutical innovation. 👉 Click the link for a deeper dive into how these reforms could reshape cancer care across Europe! #CancerTreatment #EUMedicine #GlobalMarketAccess #HealthTechnologyAssessment #HealthcarePolicy #HealthcarePolicyandRegulation #Oncology #Pharmaceuticals #Publications #RegulatoryAgencies #MarketAccess #MarketAccessToday

🚀 EU Takes Bold Steps to Enhance Cancer Drug Accessibility! 🎗️ The European Union is tackling the pressing issue of equitable access to oncology medicines, a challenge that significantly impacts patient outcomes across member states. Recent legislative efforts, including the new Health Technology Assessment Regulation (HTAR), aim to standardize clinical evaluations and streamline drug approval processes. Key Highlights: - Accelerated Access: HTAR could speed up drug availability in nations with developing health systems. - Navigating Complexity: Manufacturers face challenges with diverse national pricing and reimbursement landscapes. - Innovation at Risk?: Increased regulatory complexities may inadvertently hinder pharmaceutical innovation. The EU's commitment to a unified healthcare framework is commendable, but balancing standardization with national healthcare needs will be crucial. Continuous collaboration among policymakers, healthcare providers, and pharmaceutical companies will be essential for success. 🌍 Let's foster a more equitable environment for patients across Europe! 👉 Click the link for more insights! #CancerCare #EULegislation #GlobalMarketAccess #HealthTechnologyAssessment #HealthcareInnovation #HealthcarePolicyandRegulation #Oncology #PatientAccess #Pharma #PricingandReimbursement #Publications #RegulatoryAgencies #MarketAccess #MarketAccessToday

Urgent Call: Systemic Changes Needed Across Drug Supply Chain to Save Lives Systemic changes across the drug supply chain are deemed necessary to prevent further crises and save lives. Discussed at the National Comprehensive Cancer Network® (NCCN®) Annual Conference, there are pressing issues of drug shortages in oncology care. Panelists highlighted the significant impact on patient care and explored potential solutions, such as multi-sourcing and fair distribution programs, alongside legislative initiatives for transparency and manufacturing resilience. 1TCC® helps businesses navigate disruptions to the global supply chain. With 1TCC®, a fully integrated VMI platform, businesses can navigate complexities and maintain unparalleled visibility without disrupting existing trade relationships. 1TCC® streamlines every facet of your supply chain and inventory, freeing up working capital, and paving the way for long-term success through delivering capital-efficient supply chains™. 1TCC®, delivering capital-efficient supply chains™. Learn more at 1tcc.com. https://lnkd.in/g3kKYBTa #SupplyChainDisruption #CrisisManagement #SupplyChainOptimization #BusinessContinuity #SupplyChainVisibility #LogisticsSolutions #InventoryVisibility #TCC #TradeCapitalCorporation #1TCC #1TCCPlatform #BusinessResilience #LogisticsInnovation #WorkingCapitalManagement #InventoryManagement #Uncertainty #Challenges #Resiliency #CapitalEfficientSupplyChains #IndustryLeaders #TradeFinance #Leadership #BusinessSuccess #GlobalTrade #EconomicResilience #VMI #Healthcare #Pharmaceutical #PharmaceuticalShortages

Explore the forefront of pharmaceutical innovation with Norstella's August roundup, featuring cutting-edge insights from industry trailblazers and learn about our brands' latest news and updates. Check out the links below.👇 Puru Gaur, Senior Commercial Analyst at Norstella, shares his take on the latest Novo Nordisk earnings release in MM+M. Read the article: https://ow.ly/6KJn50TfSxP. Introducing Citeline Clinical SmartSolutions, a suite of products harnessing the power of AI to transform your clinical planning. Protocol SmartDesign recommends primary endpoints and I/E criteria, and Investigator SmartSelect generates a pool of protocol-specific investigators for your trial in minutes. Learn more: https://ow.ly/iAKB50TfSxN. Screening and valuing pharmaceutical assets can be a thorny process with many data points to consider. Evaluate Ltd's solutions provide an accurate, impartial, and timely view of pharmaceutical asset potential. Find out more: https://ow.ly/fCZU50TfSxL. MMIT (Managed Markets Insight & Technology)'s RWD data and HCP Targeting Report can help evaluate your therapy's full market potential, from the number of patients diagnosed to the high-value HCPs in the space. Learn more: https://ow.ly/rthc50TfSxM. Treatment of anxiety and depression in pregnancy – what do the data tell us? Check out this blog from Panalgo expert Margaret (Meg) Richards, PhD, MPH, PhD, MPH, for her take: https://ow.ly/Zw9w50TfSxK. The lack of clarity surrounding the definition of an academic cancer center has real-world implications for manufacturers and patients. Matthew Cunningham from The Dedham Group writes about the challenges in developing a consensus definition and provides recommendations to navigate the complexity: https://ow.ly/C0Xy50TfSxR. Follow our brands to stay up with the latest news, insights, and updates. #Pipeline2Patient #FollowNorstella

Economic incentives for original biologics, and an ever-changing regulatory landscape are among the many challenges facing the biosimilars market. This breakdown from the Journal of Managed Care & Specialty Pharmacy highlights key stakeholder perspectives on the market, including the policy change approaches that can improve the sustainability of the #biosimilars industry. Check it out:

📈𝘽𝙞𝙤𝙥𝙝𝙖𝙧𝙢𝙖 𝘽𝙪𝙡𝙡𝙚𝙩𝙞𝙣: 𝙎𝙩𝙖𝙮 𝘼𝙝𝙚𝙖𝙙 𝙬𝙞𝙩𝙝 𝙏𝙝𝙚𝙨𝙚 5 𝙍𝙚𝙖𝙙𝙨 📚 📌  Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, announced that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for PYRUKYND® (mitapivat) for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. The review classification for this application is Standard and the Prescription Drug User Fee Act (PDUFA) goal date is September 7, 2025. 📌 Scipher Medicine, a leader in precision medicine for autoimmune diseases, and Roivant, a global biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter, announced a strategic partnership to advance rheumatology drug discovery and development by integrating Scipher’s real-world clinical and genomic data insights into Roivant’s research and development efforts. This collaboration will leverage Scipher’s unique data and intelligence derived from its PrismRA® precision medicine diagnostic. 📌 Cellworks, a leader in Personalized Therapy Decision Support and Precision Drug Development, announced that its computational laboratory in Franklin, Tennessee, has obtained certification of compliance from the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA). This certification authorizes the lab to perform personalized therapy biosimulation for cancer patients within the U.S. 📌 Q'Apel Medical, a privately held medical device company focused on revolutionizing neurovascular interventions, announced it has received CE mark certification for its Armadillo SelectFlex™ Neurovascular Access System. The first-of-its-kind 7F system features the patented SelectFlex™ Technology and is indicated for the introduction of interventional devices into the neurovasculature. 📌 Lyndra Therapeutics, a clinical-stage biopharmaceutical company pioneering long-acting oral therapies, announced a strategic collaboration with Thermo Fisher Scientific Inc., the world leader in serving science, in which Thermo Fisher will provide global clinical research and commercial manufacturing services to Lyndra for its long-acting oral therapies.   #biotechnews #biotech #biopharma #biopharmanews

Major Announcement: LINK Medical AS acquires clinical research company CRST Oy to strengthen its position in the Nordic countries. LINK Medical was founded in Oslo in 1995. and has local presence in Norway, Sweden, Denmark, Finland, Germany and the UK. LINK Medical is a leading Nordic CRO and regulatory service provider, offering a wide range of flexible expert services and innovative technologies for the biotech, pharmaceutical and medical device industries across Northern Europe and beyond. As an international full service CRO, LINK Medical is supporting all stages of product development from pre-clinical to marketing approval. LINK Medical has built a network of trusted partners worldwide to obtain global coverage. The acquisition of CRST fully aligns with the strategy of LINK Medical to strengthen our position in the Nordic market. “CRST is a great addition to LINK Medical and our clients. By adding CRSTs extensive portfolio of Phase I/ First-in-human services we can now offer a complete range of services for our early phase clients, and we can partner with our clients from phase I all the way through phase III. The acquisition of CRST will further strengthen our position as a leading Nordic full service CRO and regulatory service provider.” says Anders Göransson, CEO of LINK Medical. “Joining forces with LINK Medical gives us good opportunities to grow and expand our international CRO business together,” says Siru Helminen, CEO of UTU Holding Ltd. UTU Holding remains a minority shareholder in LINK Medical. “I am extremely happy with the opportunities offered by the transaction. The synergies of the professional teams of both companies give us a solid platform to build our future business. Together we are able to provide bigger comprehensive projects to our customers and help them to speed up the development of new treatments,” says Anne Marjamäki, Chairman of the Board of CRST. Read full press release: https://lnkd.in/dCwhacgB

🌍💊 The ACCESS Forum: Pioneering Market and Patient Access in Pharmaceuticals 💊🌍 In a rapidly evolving pharmaceutical landscape, market and patient access strategies are more crucial than ever! The ACCESS Forum is at the forefront, providing invaluable insights, fostering collaboration, and driving innovation. With a focus on affordability, value-based care, and tackling global disparities, the Forum is committed to ensuring that every patient has access to effective therapies. Key highlights include: - Navigating complexities of gene & precision medicine - Aligning clinical outcomes with economic realities - Empowering stakeholders through actionable strategies Join the movement towards a future where groundbreaking treatments are accessible to all! 👉 Click the link for more insights on how the ACCESS Forum is shaping healthcare today! #ACCESSForum #GlobalMarketAccess #HealthcareInnovation #MarketAccess #PatientCare #Pharma #Pharmaceuticals #MarketAccess #MarketAccessToday

🌟 AbbVie Unveils Breakthrough Phase 3 Results for Parkinson’s Drug Tavapadon! 🌟 AbbVie has announced exciting top-line outcomes from its pivotal Phase 3 TEMPO-2 trial, revealing Tavapadon as a promising standalone treatment for early-stage Parkinson’s disease. Key Highlights: ✅ First D1/D5 partial agonist targeting dopaminergic pathways ✅ Significant improvements in motor function with a notable drop in MDS-UPDRS scores ✅ Consistent safety profile with mostly mild to moderate adverse events ✅ Plans to submit New Drug Application (NDA) to the FDA in 2025 Tavapadon could revolutionize the management of Parkinson's, enhancing daily living activities and quality of life for patients. The medical community eagerly awaits further data as AbbVie moves towards regulatory submission. 👉 Click the link to learn more about this groundbreaking development! #AbbVie #ClinicalResearches #Healthcare #Innovation #Neuroscience #Parkinsons #Pharma #PharmaceuticalCompanies #Pharmaceuticals #RegulatoryAgencies #MarketAccess #MarketAccessToday