We’re pleased to share an update within the industry: An FDA committee recently unanimously ruled that MRD is a viable endpoint for Multiple Myeloma clinical trials. Learn more about how the NeoGenomics Pharma Services team can support your Multiple Myeloma trials with our clinical-grade MRD tests: https://lnkd.in/gxtNjn-a #MultipleMyeloma #MM #MRD #MinimalResidualDisease #Flow #FlowCytometry
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Within the ever-shifting domain of pharmaceutical research and development, there is a continual need to underscore the value of preserving the precision and relevance of an Investigator Brochure. This case study takes you deep into a pivotal task: the thorough refinement of an Investigator Brochure tailored for a groundbreaking investigational product, meticulously crafted to address respiratory diseases. Here, we will explore the nuances, obstacles, and moments of success encountered by a resolute team of experts devoted to advancing healthcare through exacting scientific exploration. View more………..https://lnkd.in/dNWkBMSd
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Another important milestone for Outlook in Europe.
Outlook Therapeutics® Announces UK Submission of Marketing Authorization Application (MAA) for ONS-5010 as a Treatment for Wet AMD. https://bit.ly/4bD7IrV #OTLK #wetAMD #ophthalmology #retinadisease
Outlook Therapeutics® Announces UK Submission of Marketing Authorization Application (MAA) for ONS-5010 as a Treatment for Wet AMD | Outlook Therapeutics, Inc.
ir.outlooktherapeutics.com
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𝐂𝐞𝐥𝐥𝐭𝐫𝐢𝐨𝐧 𝐔𝐒𝐀 𝐒𝐮𝐛𝐦𝐢𝐭𝐬 𝐁𝐋𝐀 𝐟𝐨𝐫 𝐂𝐓-𝐏𝟒𝟕: 𝐀 𝐍𝐞𝐰 𝐄𝐫𝐚 𝐢𝐧 𝐑𝐡𝐞𝐮𝐦𝐚𝐭𝐨𝐢𝐝 𝐀𝐫𝐭𝐡𝐫𝐢𝐭𝐢𝐬 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 📄 Celltrion USA Celltrion USA has submitted the Biologics License Application (BLA) for CT-P47, a biosimilar candidate of ACTEMRA® (tocilizumab), to the U.S. FDA. 💊 CT-P47, containing tocilizumab, aims to provide a more accessible treatment option for rheumatoid arthritis. The submission is based on positive Phase III trial results, evaluating efficacy, safety, and more. 👥 Thomas Nusbickel Tom Nusbickel, Chief Commercial Officer at Celltrion USA, emphasizes the importance of this step in offering patients a diverse product lineup in the autoimmune disease market. 📆 Stay tuned as Celltrion actively cooperates with the FDA for a potential new treatment option for rheumatoid arthritis. #HealthcareInnovation #Biotech #FDASubmission #RheumatoidArthritis #BioPharma #MedicalAdvancements #CTP47 #ACTEMRA #CelltrionUSA #ClinicalTrials
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Within the ever-shifting domain of pharmaceutical research and development, there is a continual need to underscore the value of preserving the precision and relevance of an Investigator Brochure. This case study takes you deep into a pivotal task: the thorough refinement of an Investigator Brochure tailored for a groundbreaking investigational product, meticulously crafted to address respiratory diseases. Here, we will explore the nuances, obstacles, and moments of success encountered by a resolute team of experts devoted to advancing healthcare through exacting scientific exploration. View more………..https://lnkd.in/dNWkBMSd
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Within the ever-shifting domain of pharmaceutical research and development, there is a continual need to underscore the value of preserving the precision and relevance of an Investigator Brochure. This case study takes you deep into a pivotal task: the thorough refinement of an Investigator Brochure tailored for a groundbreaking investigational product, meticulously crafted to address respiratory diseases. Here, we will explore the nuances, obstacles, and moments of success encountered by a resolute team of experts devoted to advancing healthcare through exacting scientific exploration. View more………..https://lnkd.in/dNWkBMSd
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📢 Now Available: Sidekick’s Deep Dive on FDA’s PDURS Draft Guidance The FDA’s 2023 draft guidance on Prescription Drug Use-Related Software (PDURS) opens up new opportunities for Life Sciences to transform digital health across various therapeutic areas. In our latest whitepaper, we explore how PDURS can enhance patient engagement, improve outcomes, and give pharmaceutical companies a competitive edge. We explore use cases in the following therapeutic areas: 🎗️ Oncology 🫀 Cardiometabolic 🛡️ Immunology Explore these insights and more—download the full whitepaper here. 👉 https://lnkd.in/dN8RY3aK #DigitalHealth #LifeSciences #PharmaInnovation #PatientEngagement #PDURS #SidekickHealth
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Senior Product Manager, Life Science Solutions at Sidekick | RN | Co-Founder at Preventis | Promoting multicomponent lifestyle changes for families
There is never a dull moment in digital health! The FDA's new draft guidance on Prescription Drug Use-Related Software (PDURS) is a game-changer for pharmaceutical companies, providing a clear path to integrate digital tools that enhance patient outcomes and competitive advantage. At Sidekick Health, our Life Sciences solutions are already tailored for therapeutic areas like oncology, cardiometabolic, and immunology, and this new guidance allows us to take our partnerships to the next level. For a deep dive into how PDURS can transform patient care, check out our latest whitepaper: https://lnkd.in/eWvM2UXH
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Manager, Strategic Sourcing New Product Implementation
3moLooks great!