NeoGenomics Laboratories’ Post

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

Are you thinking about applying for our next calls for proposals? Check out the updated drafts of the topic texts at https://europa.eu/!8d3rF8 The topics focus on treatment persistency; the use of RWD/RWE in decision-making; heart disease; the healthcare workforce; and the validation of biomarkers. #HorizonEU #HealthResearch COCIR EFPIA - European Federation of Pharmaceutical Industries and Associations EuropaBio - the European Association for Bioindustries MedTech Europe Vaccines Europe EU Science, Research and Innovation

Another important milestone for Outlook in Europe.

With compliments of the IFAPP - International Federation of Associations of Pharmaceutical Physicians & Pharmaceutical Medicine - Communication Working Group, you can read here the second edition of IFAPP TODAY of 2024! Great contributions from and about: - Introducing the New Chair of the IFAPP Young Professionals Working Group Joanne M. Ramsey - Introducing a New IFAPP Board Member: Robert Lins - The Future of Clinical Trials, the Promise of AI and Key Trends by Joanne M. Ramsey - Advancing Artificial Intelligence Regulation through the Lifecycle by Dr Varvara(Barbara) Baroutsou - Mind the Gap! by Yasmin Nagaty - AMPIF Holds “Paving the Way for Pharma Medical Organizations Evolution” Conference Alexandra Reis Stoffel - EUPATI Italy (Accademia del Paziente Esperto EUPATI): a Project for Informed Patients, Caregivers and Citizens Dominique Van Doorne - IFAPP Free Webinar on “The New Era of Cell Therapy: Innovative Approaches from Production to Commercialization”Andras Dinnyes and Takehiko Kaneko, MD #pharmaceuticalmedicine #clintrials #clinresearch #AI

Choosing predictive and clinically relevant endpoints is a key aspect of drug development in the regulatory space. By assessing orphan drug development for sickle cell disease (SCD) over the past two decades, we observed that failures in clinical development were mainly found in phase 3 due to lack of efficacy on vaso-occlusive crises as the primary study endpoint. This was likely related to variable definitions and heterogeneity of pain scoring and treatment. If you are interested in improving the debate on how fostering pharmaceutical R&D on SCD (and other rare diseases), you may wish to read our last work on this. https://lnkd.in/difgpBep #sicklecell #orphandrugs

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

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

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

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

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/gYVkAuM6