NAVLIN by EVERSANA’s Post

This is an important landmark! With better drugs and improved outcomes for many cancers, current requirement of overall survival as an endpoint for drug approval will mean long study follow-ups and high study cost, delay in approval and access to treatment. Having an early robust surrogate endpoint would be a great way to mitigate these issues. Kudos to Drs Brian Durie, Nikhil Munshi, Ken Anderson, Bruno Paiva and the International Myeloma Foundation for their leadership and persistence in driving this (it has taken about 8 years!) and of course the entire myeloma community for contributing data to support the case. This again highlights the power of a cohesive community of thought leaders, practiotioners and patients in moving the needle forward for myeloma treatment! #mmsm #cancertreatment

Phase 1/2 clinical trial of #SPG302 for the treatment of people with #Amyotrophic Lateral Sclerosis (#ALS). The trial will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of product candidate dosed as a once-a-day pill in ALS patients. #Spirogenix #FDA #HiRO #Innovation

New Drug Approval Afimetoran BMS-986256, WHO 11516 cas 2171019-55-7 2-[4-[2-(7,8-dimethyl-[1,2,4]triazolo[1,5-a]pyridin-6-yl)-3-propan-2-yl-1H-indol-5-yl]piperidin-1-yl]acetamide C26H32N6O,444.583, phase 1 Afimetoran is an immunomodulator and an antagonist of toll-like receptors 7 and 8.1,2 It is also is under investigation in clinical trial NCT04269356 (Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 in Healthy Male Participants). Afimetoran

Excited to present our latest research at the World Drug Safety Congress Americas conference! 🎉 Join us in Hall C to explore our study on weight reduction in PCOS patients using GLP-1 agonists and Metformin. 📊 **Presentation Times:** - October 29, 2024: 10:30 AM & 1:10 PM - October 30, 2024: 11:15 AM & 1:45 PM **Key Findings:** Patients treated with GLP-1 agonists were 1.7x more likely to achieve a normal BMI within one year and 1.9x more likely within two years compared to those on Metformin. Learn more about our findings https://lnkd.in/eTMRRev3

🔔 Exciting news: The U.S. Food and Drug Administration (FDA) has cleared our Investigational New Drug (IND) application for our Phase 1/2 clinical trial of #SPG302 for the treatment of people with Amyotrophic Lateral Sclerosis (#ALS). The trial will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of our product candidate dosed as a once-a-day pill in ALS patients. This significant milestone is crucial for us as we strive to provide a truly effective therapeutic option that can greatly enhance the lives of those fighting this devastating disease. Read more about the trial: https://lnkd.in/e3v3CZZA

We're thrilled to announce that the European Medicines Agency (EMA) has issued a positive opinion on Orphan Medicinal Product Designation (OMPD) for our lead ALS drug candidate, NUZ-001! This is a significant achievement that brings us one step closer to making a meaningful impact for ALS patients in Europe and globally.   Why this matters: OMPD offers valuable incentives, including 10 years of market exclusivity in the EU once approved, regulatory support, and reduced fees. This positions Neurizon to accelerate NUZ-001 development and bring a much-needed therapeutic option to patients battling ALS—a debilitating disease with limited treatment options. Read the full announcement and watch a video summary from Dr. Michael Thurn here: https://lnkd.in/eNibVVNG #NeurizonTherapeutics #NUZ #OMPD #ALS #NeurodegenerativeDiseases

Data presented by Palisade Chief Medical Officer, Dr. Mitchell L. Jones, at the 8th Annual Antifibrotic Drug Development (AFDD) Summit shows that PALI-2108 may offer a solution for fibrostenotic #CrohnsDisease by enhancing efficacy, safety, and therapeutic potential compared to traditional treatments. Learn more: https://bit.ly/3YZTVHx

We are following up the symposium, "NASH(MASH) market outlook: Resmetirom and Beyond". The below link will address the summary of the symposium with detailed descriptions of each speaker. https://lnkd.in/gcWb-P8y

Over the next week we are counting down the Top 3 Drug Searches on DRUGDOCS® in 2024.   Starting with #3, we have ABILIFY MAINTENA®.   In 2024, Abilify Maintena (aripiprazole) saw significant shifts in the U.S. market. The drug's market exclusivity expired in October 2024, opening the door for generic competition.  Additionally, in September the @FDA approved Cobenfy (xanomeline and trospium chloride), the first drug approved for schizophrenia that targets cholinergic receptors rather than dopamine receptors, which has long been the standard of care.   With these changes in the marketplace and the treatment landscape, patients will have more cost-effective and varied options for care going forward in 2025.   Find the clinical evidence for #Abilify Maintena at DRUGDOCS®: https://lnkd.in/eCcQWA8U

📢 The FDA has given its green light to the first interchangeable biosimilar to Soliris (eculizumab)—Bkemv (eculizumab-aeeb)—for the treatment of two rare diseases: Paroxysmal Nocturnal Hemoglobinuria (PNH) and Atypical Hemolytic Uremic Syndrome (aHUS). ✔ 💉 Bkemv can be confidently prescribed, knowing that the FDA has confirmed it to be highly similar to Soliris with no clinically meaningful differences. Subject to state pharmacy laws, it may be substituted at the pharmacy level without consulting the prescriber. Bkemv holds the same expectations for safety and efficacy as Soliris and is only available via a restricted program to ensure the benefits outweigh the risks. 👀 👉 This marks the 53rd approved biosimilar in the US, a testament to the FDA's commitment to expanding patient access to affordable treatment options and supporting a competitive biologics marketplace. Let’s celebrate this major milestone that brings hope to those battling rare diseases.🎯 👏 Congratulations to Amgen Inc. on this remarkable achievement!🚀 For more information on this update, check out the link - https://lnkd.in/g9wyXrxg #FDA #biosimilar #rarediseases #treatment #accessibility #affordability #healthcare