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Results for 'product labeling'

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OVN Avatar Emmanuelle Jacqueta, Ghania Kerouani-Lafayeb, Francoise Grudeb, Sergio Goncalvesb, Annie Lorenced, Florence Turcryb, Liora Brunelb, Laetitia Belgodereb, Adrien Monardc, Gaëlle Guyaderb, Lotfi Boudalib, Nicolas Albin
Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years

Apr 7th • 12 mins read

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OVN Avatar Kushal T. Kadakia, MSc, Malke Asaad, MD, Erica Adlakha, MS, Michael J. Overman, MD, Cristina M. Checka, MD, and Anaeze C. Offodile II, MD, MPH
Virtual Clinical Trials in Oncology-Overview, Challenges, Policy Considerations, and Future Directions

Apr 8th • 4 mins read

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OVN Avatar Thakur, Sayanta & Lahiry, Sandeep
Accelerated drug approvals in oncology: Pros and cons

Sep 14th • 4 mins read

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OVN Avatar Sonoko Kawakatsu, René Bruno, Matts Kågedal, Chunze Li, Sandhya Girish, Amita Joshi, Benjamin Wu
Confounding factors in exposure–response analyses and mitigation strategies for monoclonal antibodies in oncology

Nov 20th • 12 mins read

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OVN Avatar Jorge J. García, Luis E. Raez, Daniel Rosas
A narrative review of biosimilars: a continued journey from the scientific evidence to practice implementation

Aug 3rd • 10 mins read

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OVN Avatar Shani Paluch-Shimon, Nathan I. Cherny, Elisabeth G.E. de Vries, Urania Dafni, Martine J. Piccart, Nicola Jane Latino, Fatima Cardoso
Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies

Sep 6th • 20 mins read

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OVN Avatar Peter N Morcos, Junyi Li, Iraj Hosseini, Chi‐Chung Li
Quantitative Clinical Pharmacology of T‐Cell Engaging Bispecifics: Current Perspectives and Opportunities

Nov 18th • 15 mins read

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OVN Avatar Stefanie Broes, Robbe Saesen, Denis Lacombe, Isabelle Huys
Past, Current, and Future Cancer Clinical Research Collaborations: The Case of the European Organisation for Research and Treatment of Cancer

Aug 16th • 8 mins read

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OVN Avatar Cornelius F Waller & Adriano Friganovi´c
Biosimilars in oncology: key role of nurses in patient education

Jun 15th • 10 mins read

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OVN Avatar Eric Q. Konnick
The regulatory landscape of precision oncology laboratory medicine in the United States - Perspective on the past 5 years and considerations for future regulation

May 22nd • 8 mins read

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OVN Avatar Benjamin Gregory Carlisle, Adélaïde Doussau, Jonathan Kimmelman
Patient burden and clinical advances associated with post approval monotherapy cancer drug trials: a retrospective cohort study

Feb 17th • 7 mins read

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OVN Avatar Doreen A. Ezeife MD, Francois Dionne PhD, Aline Fusco Fares MD, Ellen Laura Rose Cusano MD, Rouhi Fazelzad BSc, MISt, Wenzie Ng BSc, MPharm, RPh, Don Husereau BSc Pharm, MSc, Farzad Ali BPharm, MSc, Christina Sit MSc, Barry Stein B.Com BCL, LLB, Jennifer
Value assessment of oncology drugs using a weighted criterion-based approach

Dec 20th • 15 mins read

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OVN Avatar Idine Mousavi, BA; Timothée Olivier, MD; Vinay Prasad, MD, MPH
Cost per Event Averted in Cancer Trials in the Adjuvant Setting From 2018 to 2022

Jun 10th • 30 mins read

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OVN Avatar Roman Adam, Ariadna Tibau, Consolación Molto Valiente, Boštjan Šeruga, Alberto Ocaña, Eitan Amir, Arnoud J. Templeton
Clinical benefit of cancer drugs approved in Switzerland 2010–2019

Jun 10th • 35 mins read

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OVN Avatar Robbe Saesen, Georgios Kantidakis, Ann Marinus, Denis Lacombe, Isabelle Huys
How do cancer clinicians perceive real-world data and the evidence derived therefrom? Findings from an international survey of the European Organisation for Research and Treatment of Cancer

Aug 1st • 45 mins read

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OVN Avatar John Hair, Thomas Maryon, and Cristian Lieneck
Identification of Barriers Preventing Biosimiliar Oncology Medication Adoption

Oct 27th • 30 mins read

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OVN Avatar Deeksha Joshi, Rubiya Khursheed, Saurabh Gupta, Diksha Wadhwa, Thakur Gurjeet Singh, Sumit Sharma, Sejal Porwal, Swati Gauniyal, Sukriti Vishwas, Sanjay Goyal, Gaurav Gupta, Rajaraman D. Eri, Kylie A. Williams, Kamal Dua, Sachin Kumar Singh
Biosimilars in Oncology: Latest Trends and Regulatory Status

Dec 5th • 20 mins read

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Partner Avatar Envision Pharma Group
Patient involvement: A must-have in medicine development, but is it being overlooked in a cost-constrained environment?

May 9th • 5 mins read

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Partner Avatar Envision Pharma Group
Medical affairs: The power behind redefining commercialization

Aug 2nd • 3 mins read

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OVN Avatar E Dawn Flick, Howard R Terebelo, Susan Fish, Amani Kitali, Vrinda Mahajan, Melissa Nifenecker, Kristen Sullivan, Paul Thaler, Sarah Ussery, David L Grinblatt
The Value of Pharmaceutical Industry-Sponsored Patient Registries in Oncology Clinical Research

Jun 7th • 8 mins read