Gary Monk’s Post

PTSD Setback: FDA Rejects MDMA-Assisted Therapy License, but Lykos Therapeutics and Researchers Press Forward The FDA has rejected the approval of MDMA-assisted therapy for post-traumatic stress disorder, requiring another Phase 3 trial before reconsideration. This decision has significantly impacted Lykos Therapeutics, the sponsor of MDMA-AT, leading to a 75% staff reduction and leadership changes, including the resignation of Rick Doblin, PhD. Despite the setback, interest in MDMA research remains strong, with ongoing studies funded by philanthropic organizations and the VETERANS ADMINISTRATION. However, without FDA approval, MDMA remains classified as a Schedule 1 drug, complicating research efforts. Although Lykos Therapeutics faces challenges, independent researchers continue exploring MDMA’s potential, with support from the VETERANS ADMINISTRATION and other entities. For more details please click the link! https://lnkd.in/dzWKStiV #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Just days into a new EU mandate, it’s time to discuss how we can build a healthier, more competitive, and secure Europe—together. Today, we launch the 2024 EFPIA Pipeline Review, spotlighting innovations like: - New antimicrobials and vaccines against AMR - Gene therapies for rare diseases - Treatments for major depressive disorder - Vaccines to prevent neurological conditions and fight cancer “From #prevention through #care to #cure, we exist to help people live longer and feel better,” said EFPIA Director General Nathalie Moll. Our industry is in a unique position. Not only to impact on European health but our health and economic #security as well. But we can only sustain this if Europe can find a way to be more competitive. For our sector, there are 4 things we can do to help us help Europe to be THE location for discovering, developing and manufacturing the next generation of treatments and vaccines 1.     Ensure leadership, coordination and smarter regulation through a dedicated Office for Life Sciences in the Commission and dialogue with the sector in a standing European Life Sciences Council. 2.     Strengthen intellectual property across the EU, including ensuring enforcement at national level to increase predictability for innovators. 3.     Unlock Europe’s full potential for clinical trials through fully harmonised dossier reviews, well-resourced coordination mechanisms and rapid approval. 4.    Put resources behind a reformed and agile regulatory system to support faster approvals of new medicines and investment in modern manufacturing.   With 12,700 medicines and vaccines in development, we have the chance to transform the lives of patients across Europe.   With the right leadership, accountability and coherent policies we can help transform Europe’s economic health too. Watch the livestream: https://lnkd.in/dMrvTQ78 #WeWontRest

AstraZeneca’s Vision for India: Pioneering Science for Better Healthcare. I recently came across an insightful article in Business Standard, where Sanjeev Panchal, Managing Director and Country President of AstraZeneca Pharma India, shared the company's ambitious plans to accelerate healthcare innovation in India. With a global target to reach $80 billion in revenue by 2030, AstraZeneca is making significant strides to ensure that cutting-edge treatments are available to patients here. Key highlights include: ✅ Aiming to bring 15 new launches or a combination of assets to India by 2025, with 9 already approved. ✅ Leveraging AI-driven lung cancer screening technology, in collaboration with state governments, to promote early diagnosis. ✅ Strengthening India’s role through the Global Innovation and Technology Centre (GITC), which supports over 100 countries. ✅ Conducting 50+ clinical trials focused on oncology, respiratory, cardiovascular, and metabolic diseases. ✅ Emphasizing the need for favorable policy support, especially since India largely remains an out-of-pocket healthcare market. This forward-thinking approach is driving positive change and enhancing patient care across the country. It's inspiring to see such a strong focus on improving healthcare access and outcomes for millions of people. #HealthcareInnovation #CancerCare #ClinicalTrials #AstraZenecaIndia #EarlyDiagnosis #DigitalHealth #Oncology #Pharma #AI #PatientCare

Moderna is the name of a company I don't think I ever thought about before 2020 — but I think nearly everyone knows the name today for their groundbreaking work on the Covid vaccine. Interesting, that's the drugmaker's only commercial product on the market today. A second drug — a respiratory syncytial virus (RSV) shot — could earn U.S. approval next month. The company is on a journey to grow from a research-based company to potentially introducing up to 15 drugs over a five-year period to treat cancer along with rare and infectious diseases (if they hit their target). That's a big shift in thinking, in strategy, and interestingly, in technology. CIO Brad Miller weighs in on how he's helping Moderna evolve in a post-COVID world. https://lnkd.in/e2XqmFa9

𝗣𝗲𝗺𝗯𝗿𝗼𝗹𝗶𝘇𝘂𝗺𝗮𝗯 𝗠𝗮𝗿𝗸𝗲𝘁 𝟮𝟬𝟮𝟰-𝟮𝟬𝟯𝟬. 𝗚𝗹𝗼𝗯𝗮𝗹 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝗥𝗲𝗽𝗼𝗿𝘁 𝗥𝗲𝗾𝘂𝗲𝘀𝘁 𝗳𝗼𝗿 𝗦𝗮𝗺𝗽𝗹𝗲 𝗣𝗗𝗙: https://lnkd.in/dAztwNjG The report offers an in-depth exploration of the Pembrolizumab industry chain's evolution, detailing market dynamics, such as the status of Advanced Melanoma and Head and Neck Squamous Cell Carcinoma (HNSCC) variants, along with key enterprises in both developed and emerging markets. It examines cutting-edge technologies, patents, and emerging applications, while also forecasting market trends. Regionally, North America and Europe exhibit stable growth due to government initiatives and rising consumer awareness, while Asia-Pacific, notably China, dominates the global Pembrolizumab market, driven by strong domestic demand, supportive policies, and robust manufacturing capabilities. Overall, the report provides a comprehensive understanding of the Pembrolizumab market, encompassing industry-wide insights, individual component analyses, and stakeholder perspectives, while addressing market dynamics, challenges, and opportunities. 𝗧𝗼 𝗞𝗻𝗼𝘄 𝗗𝗲𝗺𝗮𝗻𝗱 𝗼𝗳 𝗣𝗲𝗺𝗯𝗿𝗼𝗹𝗶𝘇𝘂𝗺𝗮𝗯 𝗠𝗮𝗿𝗸𝗲𝘁. 𝗥𝗲𝗾𝘂𝗲𝘀𝘁 𝗳𝗼𝗿 𝗦𝗮𝗺𝗽𝗹𝗲 𝗣𝗗𝗙: https://lnkd.in/dAztwNjG *𝗕𝘆 𝗧𝘆𝗽𝗲: 50mg Injection, 100mg Injection *𝗕𝘆 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻: Advanced Melanoma, Head and Neck Squamous Cell Carcinoma (HNSCC), Unresectable or Metastatic Solid Tumor, Others *𝗕𝘆 𝗥𝗲𝗴𝗶𝗼𝗻: North America, Europe, Asia-Pacific, South America, Middle East & Africa *𝗕𝘆 𝗞𝗲𝘆 𝗣𝗹𝗮𝘆𝗲𝗿𝘀:  Merck Group #Pembrolizumab #Immunotherapy #CancerTreatment #Melanoma #HNSCC #Keytruda #ClinicalTrials #MedicalResearch #CancerAwareness #PrecisionMedicine

🔬🌟 𝐄𝐥𝐞𝐯𝐚𝐭𝐢𝐧𝐠 𝐃𝐢𝐚𝐠𝐧𝐨𝐬𝐭𝐢𝐜𝐬: 𝐃𝐢𝐚𝐠𝐧𝐨𝐬𝐭𝐢𝐜 𝐒𝐩𝐞𝐜𝐢𝐚𝐥𝐭𝐲 𝐀𝐧𝐭𝐢𝐛𝐨𝐝𝐢𝐞𝐬 𝐌𝐚𝐫𝐤𝐞𝐭 𝐈𝐧𝐬𝐢𝐠𝐡𝐭 💉💼 𝐂𝐥𝐢𝐜𝐤 𝐇𝐞𝐫𝐞, 𝐓𝐨 𝐆𝐞𝐭 𝐅𝐫𝐞𝐞 𝐒𝐚𝐦𝐩𝐥𝐞 𝐑𝐞𝐩𝐨𝐫𝐭 https://lnkd.in/g_Bx-MGt 🔍 Unraveling Disease Patterns: Diagnostic specialty antibodies play a pivotal role in medical diagnostics by targeting specific biomarkers associated with various diseases and conditions. From infectious diseases to autoimmune disorders and cancer, these antibodies enable clinicians to detect and monitor disease progression with unparalleled accuracy. 💡🩺 🚀 Key Highlights: 🌐 Targeted Precision: Diagnostic specialty antibodies offer targeted precision, recognizing and binding to specific antigens or markers present in biological samples, thereby facilitating accurate diagnosis and monitoring of diseases. 🔍 💡 Diverse Applications: With applications spanning across clinical laboratories, point-of-care testing, and research settings, diagnostic specialty antibodies are versatile tools that support a wide range of diagnostic assays and platforms. 🏥🔬 🤝 Collaborative Innovation: The Diagnostic Specialty Antibodies Market thrives on collaborative innovation, bringing together researchers, clinicians, and industry stakeholders to develop novel antibody-based diagnostics that address unmet medical needs and improve patient care. 🌟💼 #Company Sanofi Roche Abbott Bio-Rad Laboratories Boehringer Ingelheim Agilent Technologies abcam Aytu BioPharma #Type • Monoclonal Antibodies • Polyclonal Antibodies • Recombinant Polyclonal Antibodies #Application • Hospitals • Diagnostic Laboratories • Others #MedicalDiagnostics #AntibodyTechnology #HealthcareInnovation #PatientCare #MedicalAdvancements

🚀 Excited to share our latest publication "#pharmacometric #multistate model framework of #tuberculosis treatment outcomes"! In this work, we have developed a #pharmacometric multistate model to predict long-term treatment outcomes for pulmonary #tuberculosis patients. Our model identified key treatment-response predictors like early bacterial clearance and mycobacterial bacterial load on probability of conversion and recurrence, respectively. This tool enables future #biomarker evaluation and better #clinicaltrial design, pushing us closer to better TB drug development and individual care. I would like to express my deep gratitude to my incredible colleagues and supervisors Yuanxi Zou, Mats Karlsson, Elin Svensson, and the dedicated study participants who made this research possible. 🎯 Click here to read the paper: https://lnkd.in/dsNBy7gk #TBResearch #Pharmacometrics #Multistate #ClinicalTrials #PublicHealth

The polyclonal antibodies market has seen significant growth recently, reaching $1.35 billion in 2023 and projected to hit $1.43 billion in 2024, with a 6.2% CAGR. Factors driving this growth include biomedical research demand, expanded diagnostic applications, and the rise in chronic diseases, highlighting its diverse range of applications. Forecasts anticipate the market to grow to $1.83 billion by 2028, with a 6.4% CAGR. Expansion in diagnostic technologies, therapeutic advancements, and increased research funding in infectious diseases contribute to this growth. Collaborations and partnerships further shape the market landscape. Key players like Abcam PLC, Thermo Fisher Scientific Inc., and Bio-Rad Laboratories Inc. lead in this field. North America leads the market, with Asia-Pacific showing rapid growth potential in the forecast period. Read more https://lnkd.in/gfwafXSZ #polyclonalantibodies #medical #healthcare #tbrc #thebusinessresearch #marketresearch

✅ Clinical Trial Registration Complete! by Joey Bose 🖇 invest.cytonics.com 🎊 Breakthrough Milestone We are overjoyed to share a transformative milestone in our quest to redefine osteoarthritis treatment – the approval of our clinical trial registration (https://lnkd.in/eVzRA7cG) by ClinicalTrials.gov. This pivotal moment for Cytonics Corporation propels us closer to our goal of delivering innovative, effective therapies to those battling osteoarthritis. As we embark on this crucial phase, your unwavering support fuels our commitment to health innovation! 🧪 Study Design and Endpoints We are embarking on a groundbreaking journey with our Phase 1 clinical trial, aiming to revolutionize osteoarthritis treatment. This trial, registered under NCT06263270, is designed to evaluate the safety, tolerability, and preliminary efficacy of CYT-108, our novel genetically engineered A2M variant, in patients suffering from osteoarthritis. The study will involve a dosing period of three months followed by a three-month follow-up, during which safety and efficacy data will be collected along a six-month course. 🧬 Primary Endpoint: The primary endpoint is to assess the safety and tolerability of CYT-108 in participants, measured through adverse event reporting. 🧫 Secondary Endpoints: Key secondary endpoints include evaluating the impact of CYT-108 on osteoarthritis symptoms, improvements in joint function, and changes in biomarkers related to cartilage health and inflammation. This meticulously designed trial is a step towards our mission to provide a disease-modifying therapy for osteoarthritis, potentially bringing lasting relief to millions worldwide. 💰 Become a shareholder: invest.cytonics.com #biotechnology #clinicaltrials #drugdevelopment #researchanddevelopment #arthritis #regenerativemedicine