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READ NOW: NAVLIN Last Week in Review https://ow.ly/onCg50SVLRe This week from NAVLIN by EVERSANA's “Last Week in Review,” recapping the latest regulatory changes, pricing & reimbursement updates, drug approvals and more from across the world:Policy: NHS England’s consultation on CMF and BIT threshold revisions is now open, aligning with the 2024 VPAG promises. #HealthPolicy Pricing & Reimbursement: China expands its NRDL shortlist to 440 drugs, up from last year’s 344. #DrugPricing HTA: New study in IJTAHC explores HTA and decision-making connections to inform access models in Latin America. #HealthTechAssessment Drug Approval: FDA grants accelerated approval to Novartis’ Fabhalta (iptacopan) for IgAN patients at risk of rapid progression. #DrugApproval C&G Therapy: BioMarin realigns Roctavian business to focus on the U.S., Germany, and Italy, aiming to cut annual expenses by USD 60M by 2025. #GeneTherapy Managed Entry Agreements: HAS grants early access to BMS’ Abecma for relapsed and refractory multiple myeloma patients in France. #ManagedEntry Supply Issues: FDA confirms availability of Novo Nordisk’s Wegovy and Ozempic doses in the U.S. #DrugSupply Other: Charles River Laboratories sees reduced demand due to pharma R&D budget cuts, influenced by the U.S. IRA and patent cliffs. #PharmaR&D And much more...

The complex drug reimbursement process in Canada can result in long wait times for patients to receive market access to innovative drugs and treatments. CADTH and the pCPA have introduced pathways/processes which facilitate the timely assessment, temporary public funding, and earlier market access of promising new products. We have the latest on the official launch of the pCPA's Temporary Access Process (pTAP), including eligibility requirements, information on the pTAP negotiation process, and pTAP pricing. Visit the link below for our summary blog post on this latest development. #nrfcip #pharma #drugpricing #regulatorylaw https://lnkd.in/g_8N7zSH

🔍 In 2023, the FDA's Office of Generic Drugs (OGD) made significant strides in enhancing healthcare accessibility through generic drugs. Notable achievements include: 👥 Approval of 956 generic drug applications, reflecting a commitment to efficient and robust evaluation processes. 🤝 Addressing over 100 pre-ANDA meeting requests, showcasing a collaborative approach with industry stakeholders. 📄 Publishing 12 policy documents, bringing clarity and transparency to the generic drug assessment process. 🔬 Directing $20 million to research in generic drug science, underlining the commitment to innovation. 🌟 A highlight of the year was the approval of multiple first generics of Vyvanse (lisdexamfetamine dimesylate)and Xeljanz (tofacitinib) #Healthcare #FDA #GenericDrugs #Innovation #PublicHealth See more details in Office of Generic Drugs 2023 Annual Report https://lnkd.in/d8ttJFTW

📑 We invite you to read a brand new expert article exploring pricing and reimbursement laws and regulations impacting the healthcare and pharmaceutical sectors in Poland.   Authored by three of our Life Sciences lawyers: Marcin Pieklak, Agata Cichocka and Magdalena Krupa-Polak, the publication is part of an international initiative curated by Global Legal Insights (GLI), and covers 18 jurisdictions in total.   🔑 The article provides an overview of the complexities of the pricing and reimbursement landscape in Poland, including regulatory considerations, emerging trends, and key challenges.   👉 The publication is free to access: https://lnkd.in/dF4_Yvfp   #LifeSciences #Pricing #Reimbursement #Poland #GlobalLegalInsights

📌 𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐂𝐨𝐦𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐟𝐢𝐧𝐞𝐬 𝐓𝐞𝐯𝐚 €𝟒𝟔𝟐.𝟔 𝐦𝐢𝐥𝐥𝐢𝐨𝐧 𝐟𝐨𝐫 𝐚𝐛𝐮𝐬𝐢𝐧𝐠 𝐦𝐚𝐫𝐤𝐞𝐭 𝐝𝐨𝐦𝐢𝐧𝐚𝐧𝐜𝐞 𝐢𝐧 𝐦𝐮𝐥𝐭𝐢𝐩𝐥𝐞 𝐬𝐜𝐥𝐞𝐫𝐨𝐬𝐢𝐬 𝐝𝐫𝐮𝐠 The European Commission has imposed a significant €462.6 million fine 💶on 𝐓𝐞𝐯𝐚 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥𝐬 for abusing its dominant position to 𝐝𝐞𝐥𝐚𝐲 𝐜𝐨𝐦𝐩𝐞𝐭𝐢𝐭𝐢𝐨𝐧 for Copaxone, a leading treatment for multiple sclerosis 💊. According to the Commission, Teva leveraged divisional patents to prolong exclusivity on Copaxone, 𝐜𝐫𝐞𝐚𝐭𝐢𝐧𝐠 𝐥𝐞𝐠𝐚𝐥 𝐛𝐚𝐫𝐫𝐢𝐞𝐫𝐬 that delayed the entry of more affordable generics. Additionally, Teva systematically 𝐜𝐚𝐬𝐭 𝐝𝐨𝐮𝐛𝐭𝐬 𝐨𝐧 𝐭𝐡𝐞 𝐬𝐚𝐟𝐞𝐭𝐲 𝐚𝐧𝐝 𝐞𝐟𝐟𝐢𝐜𝐚𝐜𝐲 𝐨𝐟 𝐚 𝐜𝐨𝐦𝐩𝐞𝐭𝐢𝐭𝐨𝐫'𝐬 𝐠𝐞𝐧𝐞𝐫𝐢𝐜 𝐯𝐞𝐫𝐬𝐢𝐨𝐧, further hindering its adoption across the EU. ⚖️ This case and earlier actions involving H. Lundbeck, Servier, Aspen Pharmacare, and Teva & Cephalon reflect the EU’s increasing vigilance on antitrust practices within the healthcare sector. 🔗Press release: https://lnkd.in/dvkjwyWk  #Antitrust #EUCompetition #Pharma #Teva #MultipleSclerosis #PatentAbuse #Healthcare #TrojanEconomics

This article from Valentina Geisseler-Homann, Natalia Lugli, Jo Molloy and Marco Rafael in the #December 2024 issue of #RegulatoryRapporteur outlines the experiences of Roche in transitioning from the Clinical Trials Directive (CTD) to the new Clinical Trials Regulation (CTR) (#EU) before the deadline of 31 January 2025. It shares reflections on how #CTR can increase Europe’s role in global research competition. Read #RegulatoryRapporteur online now 👉 https://lnkd.in/eRcHB6fx #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. The #December 2024 issue of #RegulatoryRapporteur is out now. In this issue, we highlight the latest updates from North America, including information on the FDA’s current pilot programmes, analysis of the draft legislation on essential drug delivery outputs (#EDDOs) and Health Canada | Santé Canada’s quality overall summary (#QoS) requirements for biological investigational medicinal products (#IMPs). Find out more about the many #benefits of #TOPRA #membership, including access to #RegulatoryRapporteur 👉 www.topra.org/join

DKT Nigeria was live at the 9th National Rally & Summit of the Nigeria Association of Patent and Proprietary Medicine Dealers (NAPPMED) held in Kano State. Kindly follow our company page DKT Nigeria for more insights and updates. #NAPPMED #NAPPMEDSummit #PPMV #dktnigeria #exploringbeyondborders

A high scientific profile and clear strategies and objectives: this is what distinguishes and characterises the success of IBSA USA. Today we fly to the United States to discover another of our youngest subsidiaries. Founded in 2018, the US subsidiary is constantly consolidating its position on the pharmaceutical market, representing a great opportunity for the entire Group. All this thanks also to the synergy with the Headquarters. In the words of Nicholas Hart, CEO of IBSA USA: “There is a keen interest, a desire to understand not only what we do, but also the reasons guiding our choices. Compared to other companies in the same sector, in IBSA we look at the Person and not just the market.”    🔹 Read the story of IBSA USA in our latest news: https://lnkd.in/dq_99MY8  #IBSA #CaringInnovation #WeAreIBSA 

In our December Rx IP Update, Smart & Biggar’s Life Sciences team summarizes recent developments: ⚖️ FCA sets aside PMPRB’s order that Galderma’s patent claiming 0.3% adapalene “pertained to” 0.1% adapalene DIFFERIN 💊PMPRB releases new Draft Guidelines for comment 💊Canada finalizes Patent Term Adjustment Rules ⚖️Federal Court finds patent ineligible for listing against SNDS 💊Agile licensing amendments registered ⚖️Federal Court updates its Guidelines for Complex Proceedings ⚖️Class actions relating to opioid use disorder continue across Canada 💊Health Canada posts 2023 to 2024 review on drug shortages 💊PMPRB releases 2023 Annual Report 💊Certificate of Supplementary Protection filing fee increase effective April 1, 2025 💊Canada’s Drug Agency seeks input on HTA methods guide and also announces new coalition to improve medication use 💊2023-2024 Pan-Canadian Pharmaceutical Alliance impact report Editors: Nancy Pei, Urszula Wojtyra Contributors: Christian Bekking, Pierre-Olivier Ferko, Adam Lakusta, Katie Lee, Chen Li, David Schwartz and Urszula Wojtyra Read more: https://lnkd.in/edc7N93 #RxIPUpdate #LifeSciences #Litigation 

It is happening! I am sure we have all heard about the seismic changes that are occurring globally not only for everyone in HEOR and market access, but for the pharmaceutical industry as a whole: the Inflation Reduction Act (IRA) in the USA and the European Regulation on Health Technology Assessment (EU HTAR) in Europe. Please join me along with my Lumanity colleagues Ron Akehurst and Jonathan Kowalski for a webinar on April 18th as we explore the practical realities and our latest insights for successfully preparing for Medicare Drug Price Negotiations (as authorized under the IRA) and the new EU Joint Clinical Assessment (JCA, as part of the EU HTAR) in Europe. I am looking forward to seeing you at the webinar! Please see the registration link in the comments. #Lumanityperspectives #EUHTA #IRA #inflationreductionact #jca