Richter Gedeon Nyrt. / Magyarország’s Post

Romita Das, Associate Director keeping you in the loop about #JCA. ✦ A reminder of the scope and key dates In our post (https://lnkd.in/eDF_VxiD) "What is Joint Clinical Assessment (JCA) process and how will it impact your product launch?", we shared that starting on 12th January 2025, medicinal products under Article 7(2), point (a) of Regulation (EU) 2021/2282 will undergo Joint Clinical Assessment (JCA). Initially, this includes new active substances for cancer treatment and advanced therapy medicinal products. By 13th January 2028, all orphan medicinal products and by 13th January 2030, all other medicinal products under Article 7 will be included. ✦ PICOs deadline The scope of the JCA assessment is defined through PICOs (Population, Intervention, Comparator, Outcomes) development, which consolidates diverse needs from all member states into several PICOs. Once these PICOs are communicated to pharmaceutical companies, they have only 100 days to submit the JCA dossier. This deadline is especially challenging given the need to conduct systematic literature reviews (#SLRs) on all of the PICOs. ✦ Guidance and identification The EMA’s guidance, published on 21st June 2024, instructs manufacturers who have a product indicated for the treatment of cancer or which are designated to be an ATMP on declaring their application’s scope concerning the #HTA Regulation via the EMA Letter of Intent. The Member State Co-ordination Group on Health Technology Assessment also provided a document to help identify products subject to JCA from 2025. ✦ Notification process Applicants must notify the HTACG secretariat at SANTE-HTA-JCA@ec.europa.eu, requesting access to the HTA IT Platform for uploading the EMA Letter of Intent. The email should include the health technology developer’s contact details linked to their EU Login account. Upon receipt, HTACG will provide an upload link and acknowledge the submission. Each product requires a separate upload link. Still in the dark about JCA? Connect with Romita Das, FIECON's JCA expert today to discover how to support your product launch.

⏰ 5-month countdown! ⏰ EUnetHTA's new mandatory joint clinical assessment (JCA) process goes into effect for all new oncology, hematology, and advanced therapy assets in just 5 months. This new process includes a 100-day sprint from PICOs selection to dossier submission. Are you prepared? FIECON is working with clients to de-risk this process by using #AI to predict PICOs and streamline SLRs. If you're working on the global launch of a therapy impacted by JCA and want to substantially reduce your risk of delays, then please give me a shout! #JCA #EUnetHTA #AI #HEOR #MarketAccess

𝐔𝐩𝐝𝐚𝐭𝐞 𝐨𝐧 𝐀𝐌𝐃 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭: 𝐀𝐩𝐞𝐥𝐥𝐢𝐬 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥𝐬 𝐏𝐥𝐚𝐧𝐬 𝐑𝐞-𝐞𝐱𝐚𝐦𝐢𝐧𝐚𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐆𝐞𝐨𝐠𝐫𝐚𝐩𝐡𝐢𝐜 𝐀𝐭𝐫𝐨𝐩𝐡𝐲 Apellis Pharmaceuticals Inc. (Nasdaq: APLS) Apellis Pharmaceuticals announces an update on the marketing authorization application for intravitreal pegcetacoplan. 📉 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a negative opinion, as expected. Apellis plans an immediate re-examination of the application. 💡 Jeffrey Eisele, Ph.D. Jeffrey Eisele, Chief Development Officer at Apellis, expresses disappointment but emphasizes the commitment to address CHMP questions for the benefit of millions affected by geographic atrophy (GA) secondary to age-related macular degeneration (AMD). 🔍 The MAA is based on positive results from the Phase 3 OAKS and DERBY studies at 24 months, demonstrating reduced GA lesion growth and a well-established safety profile. Over 2.5 million people in Europe are living with GA. #AMD #VisionCare #MedicalInnovation #HealthcareNews #ApellisPharma #EyeHealth #ClinicalTrials #MedicalResearch #GA #MAAUpdate

We have compiled the week's top news for you at Market Access Today! - In a groundbreaking analysis conducted by ECONiX Research, a detailed examination of the Turkish Pharmaceutical and Medical Device Agency’s (TİTCK - Türkiye İlaç ve Tıbbi Cihaz Kurumu) Detailed Drug List has shed light on the escalating costs of pharmaceuticals in Turkiye’s pharmaceutical market. (https://lnkd.in/dhZiQKGk) - The latest edition of the Schönermark Kielhorn Collegen’s (SKC Beratungsgesellschaft mbH) InnovATion NavigATor for Advanced Therapy Medicinal Products (ATMPs), offers an in-depth analysis that sheds light on the significant progress and challenges in the field of Advanced Therapy Medicinal Products, especially in their journey through the AMNOG process. (https://lnkd.in/dq-TkV-5) - The NICE - National Institute for Health and Care Excellence is pioneering a novel approach to stroke treatment with its latest proposal for genetic testing. By leveraging advances in genetic research, this groundbreaking strategy seeks to enhance the precision of post-stroke care, ensuring that patients receive the most effective stroke treatment based on their unique genetic makeup. (https://lnkd.in/dm3RbpWp) - The U.S. Food and Drug Administration (FDA) has approved Rejoyn, marking a groundbreaking achievement as it becomes the first digital therapeutic authorized for the treatment of major depressive disorder. (https://lnkd.in/d2mggRrH) - Marks a significant milestone as the U.S. Department of Health and Human Services (HHS), under the purview of the Centers for Medicare & Medicaid Services (CMS), announces the finalization of policies aimed at fortifying protections and improving access to care for individuals enrolled in Medicare Advantage and Medicare Part D prescription drug plans. (https://lnkd.in/dbpF3zF5) Stay Informed, Stay Ahead with Market Access Today: marketaccesstoday.com #marketacces #reimbursementpolicies #patientaccessschemes #healthcareindustry #pricing #healtheconomics #pharmacoeconomics #health #pharmaceuticals #medicaldevices #HEOR #HTA #RWE #insights #trends #updates 

Check out last week's top stories from Market Access Today! #marketaccess #reimbursement #pricing 

We are delighted to share with you our new paper “Maximizing the Value of Real‐World Data and Real‐World Evidence to Accelerate Healthcare Transformation in China: Summary of External Advisory Committee Meetings” just published in Pharmaceutical Medicine Journal! Thank you to everyone involved for helping to make this achievement happen. To discover how RWD sources are empowering clinical practice and patient management in China, you can read the manuscript here: https://lnkd.in/eWVFksct

We are thrilled to announce that Chief Scientific Officer, ARMELLE PINDON, PhD, and Board Member, Alexis Elder, will both be panelists at the 2024 World Orphan Drug Congress USA in Boston, MA on April 24-25. "The World Orphan Drug Congress brings together leading pharmaceutical and biotech companies, government and regulatory authorities, patient advocacy groups, payers, investors and solution providers. The conference is a place to meet and brainstorm ways to advance orphan drug development and improve access to life-saving therapies." -WODC Website We look forward to sharing more about all the wonderful discussions! #WorldOrphanDrugCongress #WODC #VCPdisease #raredisease #CureVCPDisease

Faron Pharmaceuticals Limited (AIM:FARN) CEO Dr Juho Jalkanen joined Proactive's Stephen Gunnion with details of the positive feedback from the US Food and Drug Administration (FDA) regarding its Phase III clinical trial for its lead asset, bexmarilimab (BEXMAB). Jalkanen shared that the FDA’s guidance will accelerate trials, potentially bringing new treatments to the market sooner. He explained, “We went with a humble attitude to the FDA, proposing a Phase III trial for relapsed refractory MDS. The big news is that the FDA recommended going directly into a frontline MDS study, opening up a much larger market sooner than anticipated.” This acceleration not only speeds up the process but also targets a larger patient population without significantly increasing trial costs. Jalkanen also highlighted the importance of the Frontrunner program, which promises to bring treatments to patients faster in areas of high unmet... Watch at #Proactive #ProactiveInvestors http://ow.ly/qi80105AfnJ

Gemeinsamer Bundesausschuss (G-BA) Proposes Inclusion of Tapentadol in Fixed Price Group: Public Consultation Outcomes The Gemeinsamer Bundesausschuss (G-BA), Germany's top healthcare decision-making body, has proposed an amendment to the Drug Directive to include Tapentadol in the fixed price group system. This aims to ensure cost-efficiency in the public healthcare system. After extensive public consultation, which involved stakeholders like Grünenthal Group, a producer of Tapentadol, the Gemeinsamer Bundesausschuss (G-BA) decided that Tapentadol meets the criteria for inclusion. Despite concerns about European production costs and rebate contracts, the Gemeinsamer Bundesausschuss (G-BA) emphasized that the fixed price group would ensure affordable access to Tapentadol while maintaining therapeutic effectiveness, with implementation set for September 2024. For more details please click the link! https://lnkd.in/dhrhH2DS #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

🎯 Focused on developing Greece's first biosimilar medicine. Nearly two decades after the first biosimilar medicine was approved in Europe, we are investing in the commercial-scale development of biotechnological drugs in Greece for the first time. This initiative gives the country a significant advantage: ensuring access to a broader range of pharmaceutical options. Biosimilar medicines are already providing therapeutic solutions for many serious diseases in Greece and Europe. In fact, they've become a major player in the market, with four out of ten biological medicines used in the EU by value being biosimilars. #DemoSA #AlwaysForward #Vision2027