PHARMAnetwork magazine is media partner 2024 PDA Advanced Therapy Medicinal Products Conference to be held on 24 - 25 June, 2024 in Amsterdam, The Netherlands The advanced therapies medicinal products (ATMPs) class of therapeutics does not only comprise cell and gene therapies, as one familiar with the topic would assume, but also medical devices comprised of animal/human-derived starting materials and other products that are notoriously challenging to produce safely. Join PDA on 24-25 June 2024, in Amsterdam, The Netherlands, for an enriching experience. Organized by the PDA and the Scientific Program Planning Committee, this conference, themed "Next Steps in AMTPs and Beyond", promises a comprehensive exploration of the latest developments in advanced therapy medicinal products. With thousands of therapies currently in development across hospitals, start-ups, and pharmaceutical manufacturing portfolios, the common goal is to successfully bring these therapies to market. However, this journey is laden with challenges, including regulatory requirements, manufacturing options, costs, and sustainability concerns. The PDA Advanced Therapy Medicinal Products Conference has been a steadfast supporter of this path for many years. PDA program will be designed to feature diverse sessions covering cutting-edge topics, discussions with authorities, and intensive exchanges during question-and-answer sessions and breaks. Explore system solutions in the Exhibition area and engage in enlightening poster sessions. PDA eagerly anticipate your participation in this gathering of industry leaders and experts. Amsterdam awaits you for a conference that promises valuable insights, networking opportunities, and a shared commitment to advancing the field of advanced therapy medicinal products. https://lnkd.in/ebVBFRX7 Caroline Lynar, Stefanie Nebelin #PDA #therapies #medicinal
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🧬 "𝐠𝐥𝐨𝐛𝐚𝐥 𝐚𝐝𝐯𝐚𝐧𝐜𝐞𝐝 𝐭𝐡𝐞𝐫𝐚𝐩𝐲 𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐚𝐥 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐬 𝐂𝐃𝐌𝐎 𝐦𝐚𝐫𝐤𝐞𝐭 𝐢𝐬 𝐞𝐱𝐩𝐞𝐜𝐭𝐞𝐝 𝐭𝐨 𝐫𝐞𝐚𝐜𝐡 𝐔𝐒𝐃 𝟏𝟖.𝟖 𝐛𝐢𝐥𝐥𝐢𝐨𝐧 𝐛𝐲 𝟐𝟎𝟑𝟎 𝐚𝐧𝐝 𝐢𝐬 𝐞𝐱𝐩𝐞𝐜𝐭𝐞𝐝 𝐭𝐨 𝐫𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐚 𝐂𝐀𝐆𝐑 𝐨𝐟 𝟏𝟖.𝟗𝟐% 𝐟𝐫𝐨𝐦 𝟐𝟎𝟐𝟒 𝐭𝐨 𝟐𝟎𝟑𝟎" 🔬 Recent report showing the expectations of the ATMP CDMO market, highlighting the increase in awareness for ATMP treatments and rise in clinical trials for ATMPs as key factors in this markets growth. Check out the full article and report below 👇 https://lnkd.in/eARAsVPE #advancedtherapies #atmp #contractmanufacturing #cdmo
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Source: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences A liquid chromatography-tandem mass spectrometry method was developed and validated for simultaneous quantification of amiodarone, desethylamiodarone, and mexiletine in human plasma and serum. The method was shown to be accurate, precise, and stable during eight months of clinical use. It is applicable for therapeutic drug monitoring and can guide drug therapy of amiodarone and mexiletine.
Development, validation and long-term evaluation of a liquid chromatography-tandem mass spectrometry method for simultaneous quantification of amiodarone, desethylamiodarone and mexiletine in human plasma and serum
pubmed.ncbi.nlm.nih.gov
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Here it is out! Our new article published in Science Translational Medicine today addresses the longstanding question in the clinic of why several phosphate ester prodrugs e.g., corticosteroid phosphate ester have itch as a side effect. Our research reveals that while linking phosphate to the active drug compound enhances solubility allowing I.V. administration, it also leads to the binding to one of the itch receptors, MRGPRX4. Various pharmaceutical companies are currently engaged in the development of MRGPRX4 antagonists, with some undergoing clinical trials. Please check our article below if interested in more details. Thanks to everyone who involved in this study!
MRGPRX4 mediates phospho-drug–associated pruritus in a humanized mouse model
science.org
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Nomeculature Series #Central_Nervous_System 🧠 Anti- Multiple Sclerosis Drugs 🧠Natalizumab #Natali: probably it’s just a prefix to make the drug name unique. #Zumab: refers to the nature of the drug which is humanized monoclonal antibody. Join me and Atheer Alrawashdeh on our enlightening adventure as we explore the world of #drugnaming #pharmacology #pharmacy #pharmacist #nomeculature
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#DPU_Pharmacy_Publication_Lookout We are at Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune happy to announce that our faculty member Mrs. Rachana Bhimanwar published a review article for their work titled "Recent advancements in the structural exploration of TGR5 agonists for diabetes treatment" in RSC Medicinal Chemistry. About the Publication- TGR5, a receptor that interacts with bile acids on cell surfaces, has become a promising therapeutic target for type II diabetes due to its ability to regulate energy expenditure and blood sugar levels. While several TGR5 agonists have been identified, only a few are currently in clinical trials. This article reviews the promising TGR5 agonists discovered in recent years, highlighting the chemical structure and pharmacological profile of the most effective compounds. With the limited number of effective drugs available for treating type II diabetes, the search for a potent TGR5 agonist with high efficacy and fewer side effects continues. The goal of this article is to provide an overview of the latest advancements in TGR5 agonists and offer insights for the future development of novel, potent TGR5 agonists for diabetes treatment. A noteworthy aspect addressed in the discussion is the common side effect associated with TGR5 agonist treatment – gallbladder filling. The review also explores potential strategies to mitigate this side effect, with the goal of improving the overall safety and tolerability of TGR5-targeted therapies. Impact Factor- 4.1 Link to the publication- https://lnkd.in/gD8hifza We wish Mrs. Rachana Bhimanwar all the best and more success.
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Celanese and Secarna Collaborate on Long-Acting Antisense Therapies US chemical group Celanese and Germany’s Secarna Pharmaceuticals, an antisense drug discovery and development company, entered a research #collaboration for the development of long-acting implants that deliver antisense oligonucleotides (ASOs). ASOs are synthetic molecules designed to target specific messenger RNA to prevent the production of proteins implicated in the progression of a wide range of diseases including cardiometabolic, central nervous system, oncological and rare diseases. Antisense therapy is an innovative #therapeutic approach, but often requires frequent administration or the delivery of large doses to achieve uptake at the intended site of action. Read more on #CMI online: https://lnkd.in/eXuXrEvc
Celanese and Secarna Collaborate on Long-Acting Antisense Therapies
chemanager-online.com
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🌟 Proud Moment for Korea's Pharmaceutical and Clinical Research Industries! 🌟 I want to share that Korea continues to lead the fight against disease with significant strides in the biosimilar market. According to the latest report by the Buyer Economics Research Center of the Korea Bio Association, the U.S. FDA has recently approved 11 biosimilars in the first half of 2024 alone, bringing the total to 56 approved biosimilars by the end of June 2024. Korea, a significant player in the biosimilar market, has secured 12 of these FDA approvals, a clear showcase of our nation's unwavering dedication to advancing pharmaceutical and clinical research. (The USA: 24, South Korea: 12, Swiss: 6, Germany: 5, India: 5, Iceland: 2, China: 1, Taiwan: 1) This commitment is a testament to the respect and value we place on the importance of research in improving healthcare outcomes. These biosimilar approvals are not just numbers. They who were involved in those difficult and lengthy journeys represent a significant step towards improving healthcare outcomes worldwide. They are a testament to the relentless efforts of our scientists, researchers, and industry professionals. These approvals are not just a sign of innovation and excellence. They also reflect our industry's unwavering resolve. We are committed to making cutting-edge treatments accessible and affordable despite the challenges. Our focus remains steadfast—pioneering new solutions to combat diseases and enhance the quality of life for people globally. Kudos to everyone involved in this incredible journey! Let's continue to support and celebrate our industry's achievements. 🚀💊🌍 #Pharmaceuticals #ClinicalResearch #Biosimilars #Korea #HealthcareInnovation #FDAGoals #ProudMoment #CRO #ClinicalTrials #CNRResearch #BiosimilarClinicalTrials #EMA #MFDS #FDA #EuropeClinicalTrials #씨엔알리서치 #임상시험 #바이오시밀러 #한국임상시험
Biosimilar Drug Information
fda.gov
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Recently, Jiangsu Hengrui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration for a "Drug Clinical Trial Approval Notice," allowing the clinical trial of Funakizumab Injection (SHR-1314) for the treatment of moderate to severe plaque psoriasis in children and adolescents aged 6 to under 18 who are eligible for systemic therapy or phototherapy. Funakizumab (SHR-1314) is a recombinant humanized monoclonal antibody independently developed by Hengrui Medicine that targets human IL-17A. It is intended for the treatment of autoimmune diseases related to the IL-17 pathway. By binding to IL-17A, it blocks its interaction with IL-17R, leading to the inhibition of downstream inflammatory signal transduction. Several clinical studies of SHR-1314 have already been completed or are ongoing, including studies on adult plaque psoriasis, ankylosing spondylitis, and psoriatic arthritis, to evaluate its efficacy in various autoimmune diseases. Among these, the New Drug Application for treating moderate to severe plaque psoriasis in adults eligible for systemic therapy or phototherapy, and for treating adult patients with active ankylosing spondylitis who have not responded well to conventional therapy, has been accepted for review. #APIs #Medical #Rawmaterials #Pharma #Medicine #Pharmaceutical
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We at the Psychedelic Therapeutics & Drug Development Conference are excited to have Ed Christian, Ph.D., Executive Director Clinical Science, Gilgamesh Pharmaceuticals presenting at our 4th annual event, which is taking place in Boston on May 23-24. Dr. Christian will present results of Phase 1 single and multiple dose studies of the Gilgamesh proprietary oral NMDA antagonist, GM-1020, in healthy volunteers. Results have identified a hypothetical clinical dose range where resting EEG and subjective pharmacodynamic scales establish increasing target engagement. Over this dose range, however, minimal dissociative and sedative adverse events were observed, which are well known to be significant and undesirable adverse effects that necessitate clinical supervision during subanesthetic ketamine / esketamine dosing to treat major depression. In this presentation, Dr. Christian will discuss details of the Phase 1 safety, PK and PD results in which they established good dose-proportional PK with high oral bioavailability, and PD effects supporting a range of target engagement across the study regimen. Learn more about this event by visiting https://lnkd.in/eM5iiPn. #psychedelics #psychedelicresearch #psychedelictherapy #boston Christian Gray Laszlo Kiss jonathan sporn
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