GSK’s Post

EMA's 2023 highlights: Advancements in Human Medicines 💊 We share the latest developments in the world of medicines, as highlighted by the European Medicines Agency (EMA) in their 2023 publication. The Pharmaceutical Post has compiled a comprehensive overview of the key highlights, showcasing advancements and novel treatments. 🔍 Discover more about the 77 drugs recommended for marketing authorization, including 39 with new active substances never before authorized in the EU. Notable mentions include two vaccines for respiratory syncytial virus (RSV) and the pioneering CRISPR/Cas9 gene-editing technology for rare blood disorders. 💡 EMA's positive opinions for medicines outside the EU underscore the agency's global impact, emphasizing a commitment to advancing healthcare internationally. 🔗 Read more and click below #Pharmaceuticals #HealthcareInnovation #EMA #MedicalAdvancements #genetherapy

Hope for European Medicines Agency (EMA) approval of Life Saving drug! The EMA refused to license this product at the first review, even though it showed positive results in treating the devastating symptoms caused by a rare disease cerebral adrenoleukodystrophy (CALD). So we are very pleased to hear that On the 28th of May, the Committee for Medicinal Products for Human Use (CHMP) part of the European Medicines Agency (EMA) will re-evaluate leriglitazone. This drug has been used to treat CALD in clinical trials and we are hopeful of a positive outcome of this potentially life-saving drug. @EMA_News #JournoRequest #healthjourno #CHMP #EuropeanMedicinesAgency  #adrenoleukodystrophy #raredisease

Join the conversation! The European Medicines Agency wants your input on shaping guidelines for Non-Inferiority and Equivalence Comparisons in Clinical Trials, crucial for phase 3 trials and marketing authorization applications. Submit your comments by May 31, 2024, via the EU survey form. #EMA #ClinicalTrials #HealthcareDataExchange #gmdpacademy #medicalaffairs #medicinesdevelopment

𝐄𝐌𝐀–𝐅𝐃𝐀 𝐣𝐨𝐢𝐧𝐭 𝐐&𝐀𝐬 𝐨𝐧 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐚𝐧𝐝 𝐆𝐌𝐏 𝐚𝐬𝐩𝐞𝐜𝐭𝐬 𝐨𝐟 𝐏𝐑𝐈𝐌𝐄/𝐁𝐫𝐞𝐚𝐤𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐭𝐡𝐞𝐫𝐚𝐩𝐲 𝐚𝐩𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬 On December 19, 2023, the FDA and the European Medicines Agency (EMA) jointly released a Q&A document addressing inquiries regarding the FDA’s breakthrough therapy (BT) designation and the EMA’s priority medicines (PRIME) scheme. This document aims to expedite the quality development of therapies targeting unmet medical needs, outlining the FDA’s policy on quality assessments for accelerated products as per the Center for Drug Evaluation and Research’s Manual of Policies and Procedures and FDA guidance documents. This initiative stemmed from a 2018 workshop hosted by the FDA and EMA, which delved into quality challenges and scientific strategies discussed by regulators and industry professionals to ensure the timely submission of robust quality and manufacturing data. Real-life case studies were examined during the workshop, highlighting challenges across various types of therapies. Topics of discussion included process validation, control strategy, compliance with good manufacturing practice (GMP) requirements, comparability, stability, and regulatory tools. The primary focus of these discussions was to facilitate timely patient access to medications while upholding standards of safety, efficacy, and quality, in line with current regulatory approval norms. Further dialogues between the FDA and EMA ensued, leading to the collaborative development of this document, which aims to provide insights into PRIME/BT applications. The document is structured into four sections, each addressing specific aspects related to PRIME/BT applications: Annex 1: Control strategy considerations Annex 2: Process validation approaches Annex 3: Alternatives for determining re-test periods or shelf-life Annex 4: GMP considerations It's important to note that these documents offer general information and do not serve as regulatory guidance. Applicants interested in adopting the strategies outlined should consult with the relevant regulatory authority before submitting their marketing applications."

📌 ACCESS CONSORTIUM | New Promise Pilot Pathway     ↪ The #AccessConsortium working group for new active substances has established an #AlignedProcess for priority review, which includes the decision on priority status.     ↪ In creating the #PromisePilotPathway, the #Access partners (#Australia, #Canada, #Singapore, #Switzerland and the #UK) sought #commonality in their respective criteria for #priority review. Applications for new active substances fulfilling the following criteria are eligible for the Promise Pilot Pathway:    ▶ #Diagnoses, #Treats or #Prevents a condition that is serious, life-threatening or severely debilitating and  ▶ For which no other treatment is currently #Registered and #Marketed in participating jurisdictions for the proposed indication    ↪ The scope of the Promise Pathway will be further reviewed after the pilot. At Asphalion we can help you register new prescription medicines! 📧 For further information, you can send us an email at: [email protected] https://bit.ly/41uOp04 #AccessConsortium #RegulatoryAffairs #RA #RegulatoryProcedures #OperationalProcedures #WeAreAsphalion #WeCare #KnowledgeFromExperience 

👉 The Pharmaceutical Benefits Advisory Committee (PBAC) has published its agenda for March 2024, highlighting a pivotal discussion on expanding Trikafta access to the 2–5 year age group. This significant move is set to open treatment opportunities for an additional 286 patients. This moment presents us with a shared chance to champion the extension of this transformative treatment to our youngest CF fighters. As a community coming together to provide our essential feedback, we are actively influencing the direction of CF care in Australia. We urge every one of you to contribute your unique insights and viewpoints, as they are immensely valuable in this effort. The Patient Voice Initiative (PVI) has developed the attached information to simplify and alleviate the challenges faced by consumers engaging in the PBAC process. Check it out now! Submit your feedback and be part of this pivotal moment now: https://lnkd.in/gp8dEtiD Submissions close 31st January 2024. 👉 For more details about us and this process, please follow: https://lnkd.in/g7uhji_y #PBAC #ConsumerComments #medicines #access #patientvoice #patientvoiceinitiative #cysticfibrosis #cfaustralia #cfa #CFAdvocacy #CysticFibrosisAustralia

Unlocking the Potential of Biosimilars in the EU Since 2006, the European Union has led the way in regulating biosimilars, ensuring they meet stringent standards of safety, quality, and efficacy. The European Medicines Agency (EMA) and the European Commission have released an Information Guide for healthcare professionals, detailing the science and regulations behind biosimilars. This guide covers the definition and development of biosimilars, the rigorous approval process, and key safety considerations, including comparability studies and immunogenicity. Key Highlights: The guide outlines the clinical study requirements for biosimilars, emphasizing the importance of demonstrating biosimilarity through robust scientific methods. It explains how biosimilars differ from generic medicines and provides insights into safety monitoring, post-marketing studies, and extrapolation of data. A glossary and list of abbreviations are included to clarify key terms related to biosimilars and regulatory processes. This resource is invaluable for healthcare professionals navigating the evolving landscape of biosimilar medicines in the EU.

𝗠𝗼𝗺𝗲𝗹𝗼𝘁𝗶𝗻𝗶𝗯 𝗮𝗽𝗽𝗿𝗼𝘃𝗲𝗱 𝗯𝘆 𝗠𝗛𝗥𝗔 𝗳𝗼𝗿 𝘂𝘀𝗲 𝗶𝗻 𝗺𝘆𝗲𝗹𝗼𝗳𝗶𝗯𝗿𝗼𝘀𝗶𝘀 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝘄𝗶𝘁𝗵 𝗮𝗻𝗮𝗲𝗺𝗶𝗮 📌Momelotinib (brand name Omjjara) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adult myelofibrosis patients who have anaemia. 📌The Janus kinase (JAK) inhibitor is now indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibitor naive or have been treated with ruxolitinib. 📌The MHRA approval follows the positive opinion from the European Medicines Agency‘s Committee for Medicinal Products for Human Use in November 2023 for the same indication. 📌Momelotinib is taken in tablet form, once daily, at the same time each day. #mhra #Momelotinib

The joint two-day hybrid HMA/EMA workshop on Patient Registries brought together representatives of registry holders, regulatory agencies, pharmaceutical companies, patients, healthcare professionals, academia, and Health Technology Assessment bodies (HTAs) to address the following objectives: 1) Discuss the EMA qualification procedure for patient registries and 2) Establish the value and enable the use of patient registries for regulatory decision-making by considering contexts of use for which registry data are ‘fit for purpose’, and examining tools to support data discoverability and assessment. As ALTEMS Università Cattolica researchers, we participated in the workshop as part of the More-EUROPA project. The aim of More-EUROPA is to develop, implement and establish evidentiary standards and methods to address the data and needs of regulatory authorities and HTAs towards a more efficient use of RWD for the development, registration and assessment of medicinal products in Europe. It is important to identify the key elements of a ‘feasibility assessment’ to evaluate the relevance of a registry in view of a specific study question and design. Therefore, carefully monitor the impact that the Data Qualification (DQ) Procedure & DQ framework (DQF) may have on regulatory activities and particularly those of HTA. This also in light of the implementation of the new HTA Regulation focused on clinical aspects of HTA i.e. the relative clinical effectiveness and relative clinical safety of a new health technology as compared with existing technologies: Joint Clinical Assessments (JCA) of new medicines and certain high-risk medical devices and Joint Scientific Consultations (JSC) to advise technology developers on clinical study designs that generate appropriate evidence. #medicinalproduct #registries #fitforpurpose #RWD #regulatory #dataqualityframework #EMAcatalogue #EMAqualificationprocedure #HealthTechnologyAssessment #HTAR #JCA #JSC #UCSC #ALTEMS Rossella Di Bidino https://lnkd.in/e5Xh-Dy5

📢Swissmedic is efficient, competitive and fit for purpose according to SFAO 🔎The Swiss Federal Audit Office (SFAO) conducted audits of two core processes at Swissmedic between November 2022 and July 2023. In both cases, it received very good ratings. The Agency for Therapeutic Products is well positioned for both the authorisation and vigilance of medicinal products, has a very good international network, and has efficient, properly functioning processes that are under constant development. Further details are available in the reports published by the SFAO👇 📄Prüfung des Zulassungs- und Vergütungsprozesses von Arzneimitteln 🔗 https://bit.ly/3NY6FK2 📄Prüfung des Vigilance-Systems für Arzneimittel und Impfstoffe 🔗 https://bit.ly/3NY4ki5