Post de Association JULES - Jeunes Urologues du Languedoc et de Septimanie

🚀 Huge Collaboration Alert! Gossamer Bio has joined forces with Chiesi Group in a landmark $486 million deal to develop and commercialize Seralutinib, a promising new treatment for pulmonary hypertension (PH). 🔬 #Seralutinib, an innovative inhaled therapy targeting PDGFRα/β, CSF1R, and c-KIT, is currently progressing through the late-stage PROSERA study, following encouraging results from the Phase 2 TORREY trial in patients with pulmonary arterial hypertension (PAH). 🌍 This global partnership aims to initiate a worldwide Phase 3 registration trial for PH associated with interstitial lung disease (PH-ILD) by mid-2025 and explore potential applications in other areas of significant unmet medical need. 💬 “This partnership allows us to meaningfully deepen and rapidly accelerate our investment in Seralutinib,” says Faheem Hasnain, co-founder, chairman, and CEO of Gossamer Bio. 💼 Under the terms of the agreement, Gossamer will lead the global development for PAH and PH-ILD, with development costs split evenly (read more terms from the full article below). 🌟 Giuseppe Accogli, CEO of Chiesi Group, adds, “Seralutinib is a potential paradigm-shifting therapy, and we are thrilled to partner with Gossamer to bring this therapy to patients worldwide.” Read more here: https://lnkd.in/gh97XQsw For more news like this, follow World Pharmaceutical Frontiers today. #HealthcareInnovation #Biopharma #PulmonaryHypertension #worldpharmaceuticalfrontiers

Scoop ! Innovative Biologics and CMC Challenges vol.2 : les inscriptions sont ouvertes ! Après le succès de la première édition sur Toulouse l’an passé, notre Congrès européen est programmé les 11 et 12 mars 2025 au cœur de l’Europe, en Belgique, au Brussels South Charleroi BioPark, avec la complicité active de l’américain Cencora Pharmalex. L’inscription à la seconde édition est désormais officiellement ouverte ! Sur cette édition, nous aurons la chance d’être accompagnés par une entreprise internationale, experte en biothérapeutiques, pour disposer de l’appui d’un Comité Scientifique qui enrichira la valeur des Conférences et Présentations, et orientera les sujets afin qu’ils cadrent avec la thématique de l’événement. Le plus non négligeable, c’est qu’elle entretient de nombreuses relations avec des scientifiques de haut niveau et des decision-makers, ce qui peut permettre de mettre au point des sessions très intéressantes et alignées avec les apprentissages sur les normes et attentes réglementaires. Le top pour gagner en valeur ajoutée et en visibilité ! Le top pour les participants d'avoir l'opportunité de coller à la réalité de leurs préoccupations. Prenez connaissance dès maintenant des sujets de prédilection de l’événement auxquels vous pouvez associer la présentation de votre entreprise ou une Conférence et des différentes modalités de participation et prenez part au programme d’urgence ! Premier arrivés, premiers servis comme d'habitude ! Rien n’est encore définitif, tout se construit au fur et à mesure avec les participants, dans un processus interactif et sur le modèle de l’intelligence collective ! Parlez-en vite avec vos équipes ! Be part of it ! https://lnkd.in/eU2taPhG Dominique Demonte Elise Eeklaer Bruno Boulanger Pierre Lebrun Murielle RATA Sandra Villani ⭐ #biologics #biotherapeutics #CMC #biotech #pharma #pharmaceutique #biomedicament #exosome #VLP #vaccin #buzz4bio

Looking forward to speaking at the launch of the 2024 Access to Medicine Foundation Index at AllianceBernstein this week! With Loyce P. from U.S. Department of Health and Human Services (HHS), Angeli Achrekar from UNAIDS, Marshall Gordon from ClearBridge Investments, Claudia Martínez from Access to Medicine Foundation, and moderated by Bob Herr from AllianceBernstein. The big takeaway from Access to Medicine Foundation's CEO Jayasree Iyer: "The need for equitable access to medicines has never been more urgent, given the increasing burden of non-communicable diseases around the world, the rise of resistance infections and the threat of further pandemics. Innovative medical treatments can help address these challenges and radically improve global health – but they must be made available to all." Find out which pharmaceutical companies are serious about serving patient populations in low- and middle-income countries and much more here: https://lnkd.in/eQPT-fri Twinelle B. Novartis GSK Sanofi Pfizer AstraZeneca Johnson & Johnson Merck KGaA, Darmstadt, Germany Boehringer Ingelheim Takeda Bayer Roche Novo Nordisk Bristol Myers Squibb Eisai US Astellas Pharma Gilead Sciences Merck Daiichi Sankyo US Eli Lilly and Company AbbVie

Avancée de manière itérative et inventive dans la réflexion autour du Congrès Innovative Biologics and CMC Challenges vol.2 en fin de semaine dernière ! Nous avons encore franchi quelques étapes lors de notre dernière Conférence Téléphonique Cencora Pharmalex/BioPark/buzz4bio. J'aime beaucoup la manière dont nous progressons. Qu'as-tu dans ton panier cette semaine ? Ah tu vois ça comme ça ? Et si on ajoutait ça ? Et si on faisait intervenir quelques grands groupes ? As-tu des interlocuteurs ? Tu les contactes et tu vois ça avec eux ? Ah j'ai eu l'idée d'un sujet intéressant qui a émergé pendant mes explorations ! Qu'en pensez-vous ? Ah oui, intéressant ! On creuse. Je ne suis pas parvenue à convaincre l'un de mes interlocuteurs sur cette Conférence. Avez-vous d'autres personnes à contacter sur le sujet "CMC et levée de fonds" ? Oui, oui je m'en occupe. Et pour cette Conférence, nous pourrions peut-être l'enrichir en finissant par une table ronde ? Ainsi vont nos séances de travail au long cours... Il est encore temps de faire partie du programme de présentations d'entreprises et de conférences ! C'est par ici https://lnkd.in/ecUYTbmr #buzz4bio #bioproduction #biologics #CMC #CDMO #biotech #pharma #biomedicament #biotherapy #vaccine #innovativebiologics

Unveiling the Hidden Costs: The Additional Strain Costs in nAMD Clinics In the current healthcare landscape, we often overlook the true cost of diseases. Traditional cost-effectiveness assessments (CEAs) tend to focus primarily on direct drug costs, neglecting a substantial portion of non-drug costs. This narrow view can lead to an underestimation of the actual financial burden on healthcare systems and may influence the perceived value of treatments. What does this mean? • Incomplete cost observations: We only capture a portion of relevant costs, sometimes including irrelevant ones, leading to an underestimation of the true cost of diseases. • Risk of inaccurate assessments: By not accounting for the full range of benefits provided by treatments, we risk not achieving cost-effectiveness and subsequent reimbursement. Medialis Ltd has developed the nAMD Service Non-Drug Cost Instrument (nAS instrument) using Neutral theory and the Jandhyala Method, providing groundbreaking evidence for including non-drug costs in CEAs. Our comprehensive analysis revealed that a recent NICE appraisal included only three non-drug costs, while our Neutral list identified 237 non-drug costs, 36 of which differentiated between treatments. Under the traditional approach, Drug 1 was favoured over Drug 2 based on drug costs alone. However, using the nAS instrument, which includes a more extensive list of non-drug costs, Drug 2 emerged as the more cost-effective option, emphasising the importance of a comprehensive cost analysis. The durability and robustness of treatments are critical, especially under strained conditions. Incorporating non-drug costs into CEAs provides a more accurate representation of the financial burden on healthcare services. This approach is a significant step toward more comprehensive assessments in healthcare, ensuring that new treatments are appropriately valued for their full benefits. Let's work towards more inclusive and accurate evaluations of healthcare costs! For all your real-world evidence (RWE) needs, contact us at info@medialis.co.uk #nAMD #HealthcareEconomics #CostEffectiveness #HTA #HealthcareInnovation #DiseaseSpecific #nASInstrument Ascendis Pharma, AstraZeneca, Biogen, BioMarin Pharmaceutical Inc., bluebird bio, Bristol Myers Squibb, Chinook Therapeutics, Clementia Pharmaceuticals, Daiichi Sankyo US, Eli Lilly and Company, Genentech, GenSight Biologics, GSK, Roche, Immungenetics AG, ImmunityBio, Inc., Incyte, Insmed Incorporated, Ionis Pharmaceuticals, Inc., Ipsen, Janssen Inc., MediciNova, Inc., Merck, MSD Merck Sharp & Dohme A.G., Neuren Pharmaceuticals Limited, NS Pharma, Inc., Novartis, Novo Nordisk, Pfizer, QED PHARMACEUTICALS PVT LTD, Reata Pharmaceuticals, Inc., Regeneron, Rigel Pharmaceuticals Inc., RIVER RENAL SERVICES, INC., IQVIA, Sanofi, Takeda, Travere Therapeutics, Ultragenyx

Nous, les 14 laboratoires pharmaceutiques américains présents en France regroupés au sein de l’AGIPHARM nous engageons quotidiennement à faire de la France une terre d’accueil incontournable pour l’innovation thérapeutique. Notre présence importante en France, au service des patients, en témoigne pleinement. Notre engagement et nos propositions auprès des décideurs et des autorités visent à promouvoir la place de la France sur la scène internationale de la recherche scientifique et médicale tout en contribuant à renforcer l’accès des patients à l’innovation thérapeutique en France. En cette période politique particulièrement incertaine, nous souhaitons réitérer notre souhait de voir l’Etat préserver la politique d’attractivité en garantissant un cadre de régulation acceptable, stable et prévisible. AbbVie, Amgen France, #AmicusTherapeutics, Biogen, #Blueprintmedicines Bristol Myers Squibb, CSL Behring B.V., Gilead Sciences France, INCYTE BIOSCIENCES FRANCE, Johnson & Johnson Innovative Medicine France, Lilly France, MSD France Pfizer, Vertex Pharmaceuticals

Unveiling the Hidden Costs: The Additional Strain Costs in nAMD Clinics In the current healthcare landscape, we often overlook the true cost of diseases. Traditional cost-effectiveness assessments (CEAs) tend to focus primarily on direct drug costs, neglecting a substantial portion of non-drug costs. This narrow view can lead to an underestimation of the actual financial burden on healthcare systems and may influence the perceived value of treatments. What does this mean? • Incomplete cost observations: We only capture a portion of relevant costs, sometimes including irrelevant ones, leading to an underestimation of the true cost of diseases. • Risk of inaccurate assessments: By not accounting for the full range of benefits provided by treatments, we risk not achieving cost-effectiveness and subsequent reimbursement. Medialis Ltd has developed the nAMD Service Non-Drug Cost Instrument (nAS instrument) using Neutral theory and the Jandhyala Method, providing groundbreaking evidence for including non-drug costs in CEAs. Our comprehensive analysis revealed that a recent NICE appraisal included only three non-drug costs, while our Neutral list identified 237 non-drug costs, 36 of which differentiated between treatments. Under the traditional approach, Drug 1 was favoured over Drug 2 based on drug costs alone. However, using the nAS instrument, which includes a more extensive list of non-drug costs, Drug 2 emerged as the more cost-effective option, emphasising the importance of a comprehensive cost analysis. The durability and robustness of treatments are critical, especially under strained conditions. Incorporating non-drug costs into CEAs provides a more accurate representation of the financial burden on healthcare services. This approach is a significant step toward more comprehensive assessments in healthcare, ensuring that new treatments are appropriately valued for their full benefits. Let's work towards more inclusive and accurate evaluations of healthcare costs! For all your real-world evidence (RWE) needs, contact us at info@medialis.co.uk #nAMD #HealthcareEconomics #CostEffectiveness #HTA #HealthcareInnovation #DiseaseSpecific #CostInstrument #nASInstrument Ascendis Pharma, AstraZeneca, Biogen, BioMarin Pharmaceutical Inc., bluebird bio, Bristol Myers Squibb, Chinook Therapeutics, a Novartis Company, Clementia Pharmaceuticals, Daiichi Sankyo US, Eli Lilly and Company, Genentech, GenSight Biologics, GSK, Roche, Immungenetics AG, ImmunityBio, Inc., Incyte, Insmed Incorporated, Ionis Pharmaceuticals, Inc., Ipsen, Janssen Inc., MediciNova, Inc., Merck, MSD Merck Sharp & Dohme A.G., Neuren Pharmaceuticals Limited, NS Pharma, Inc., Novartis, Novo Nordisk, Pfizer, QED PHARMACEUTICALS PVT LTD, Reata Pharmaceuticals, Inc., Regeneron, Rigel Pharmaceuticals Inc., RIVER RENAL SERVICES, INC., IQVIA, Sanofi, Takeda, Travere Therapeutics, Ultragenyx

RDK, l application destinée aux généralistes, internes, etc.... outil judicieux pour contrer l errance diagnostic. #mav #avc #malformationarterioveineuse #errancediagnostic

𝐆𝐨𝐬𝐬𝐚𝐦𝐞𝐫 𝐁𝐢𝐨 𝐚𝐧𝐝 𝐂𝐡𝐢𝐞𝐬𝐢 𝐆𝐫𝐨𝐮𝐩 𝐂𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐞 𝐨𝐧 𝐒𝐞𝐫𝐚𝐥𝐮𝐭𝐢𝐧𝐢𝐛 𝐟𝐨𝐫 𝐏𝐮𝐥𝐦𝐨𝐧𝐚𝐫𝐲 𝐇𝐲𝐩𝐞𝐫𝐭𝐞𝐧𝐬𝐢𝐨𝐧 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 Gossamer Bio, Inc. (Nasdaq: GOSS) Gossamer Bio and Chiesi Farmaceutici S.p.A ("Chiesi Group") Chiesi Group have entered a global collaboration and license agreement to develop and commercialize seralutinib for pulmonary hypertension treatment. The collaboration aims to accelerate development in pulmonary hypertension associated with interstitial lung disease (PH-ILD), expanding the seralutinib franchise globally. "This partnership with Chiesi allows us to deepen our investment in seralutinib," said Faheem Hasnain Faheem Hasnain, Co-Founder, Chairman, and CEO of Gossamer. "We're thrilled to move directly into a Phase 3 trial in PH-ILD, addressing an indication with high unmet medical need." "Seralutinib is a potential paradigm-shifting therapy," said Giuseppe Accogli Giuseppe Accogli, Group CEO of Chiesi. "We're excited to bring this therapy to patients worldwide." Prevalence estimates suggest PH-ILD affects 60,000-100,000 patients in the US. Seralutinib, an inhaled inhibitor, is being evaluated for its potential in treating pulmonary hypertension. Under the agreement, Gossamer will lead global development, and both companies will evenly split development costs. In the US, commercial profits and losses will be evenly shared. Chiesi will have exclusive rights outside the US and will pay Gossamer royalties and developmental reimbursements. #PulmonaryHypertension #PHILD #Seralutinib #BiopharmaCollaboration #GlobalHealthcare #MedicalInnovation #RareDisease #ClinicalTrials #InhaledTherapy #RespiratoryHealth #LungHealth

Au #FISQ, notre collègue Nathalie Bolduc a eu le privilège d’animer ce matin le panel intitulé « Intégration des innovations en oncologie et impact sur le système de santé: défis et opportunités » présenté par The Janssen Pharmaceutical Companies of Johnson & Johnson.