Cureline Group - Global Translational CRO’s Post

The biopharma company Cassava Sciences announced today its experimental Alzheimer’s disease drug simufilam showed no signs of working in a phase 3 clinical trial. Volunteers who took the drug performed no better in cognitive or everyday-life activities than those who received a placebo. The announcement appears to mark the end of the company’s development of simufilam for Alzheimer’s, which has been marked by scandal and controversy. https://lnkd.in/gcKucZSk

The field of complement therapeutics is rapidly advancing, offering new potential in treating autoimmune and inflammatory diseases. Our latest insight by Rohit Katoch, Senior Director, dives into the evolving landscape, spotlighting key trends and innovations driving this space forward. As biopharma continues to push boundaries, complement therapeutics is set to reshape treatment paradigms. Read more about these emerging trends here: https://lnkd.in/dmHv3B8A #PharmaStrategy #AutoimmuneDiseases #ComplementPathway #ClinicalDevelopment

EyeD Pharma is heading to Stockholm for BIO-Europe on November, 4 🇸🇪 Meet our team led by Romy Rizzo to discuss complex therapeutics for eye care and treatment of eye diseases like glaucoma or dry eye. Interested? Feel free to reach out to set up a meeting! See you in Stockholm 🇸🇪! #BIOEurope2024 #LongActingFormulations "

What a great session to start off #SABCS24 on FDA special session: new drug approvals!!💻 Specifically, the expert panel stressed the critcial importance of patient selection and predictive biomarkers in the drug development process. 🧬We need to continue conducting studies using #ctDNA #MRD to better identify those patients who really would benefit from the treatments in the adjuvant setting. 💊We need to think about that patient in front of us when sequencing treatment regimens in metastatic disease, with more and more combination regimens being approved in the first-line. As Dr. Winer said, medical oncologists have a hard time saying “No” in the presence of many exciting options in the field, but we certainly need to have really thoughtful conversations with our patients.

Groundbreaking research news: CurePSP has joined the Accelerating Medicines Partnership® in Parkinson’s Diseases and Related Disorders (AMP® PDRD). This initiative, led by the Foundation for the National Institutes of Health (FNIH), aims to better differentiate Parkinson’s disease from related neurodegenerative disorders, including progressive supranuclear palsy (PSP), multiple system atrophy (MSA) and corticobasal degeneration (CBD), to enable earlier diagnoses, more timely interventions and better outcomes. CurePSP is committed to ensuring that this focus on early and accurate diagnosis for PSP, MSA, and CBD drives meaningful progress in improving patient care. We join this effort alongside several other key partners, including Aligning Science Across Parkinson’s | ASAP, C2N Diagnostics, Denali Therapeutics, GSK, The Michael J. Fox Foundation for Parkinson's Research and Sanofi, all working together to push the boundaries of research to make a tangible impact.  #PSP #MSA #CBD #Parkinsons #Neurodegeneration #FNIH #CurePSP #EarlyDiagnosis #NIH

Rob Etherington, our CEO, discusses innovation, regulatory, and investor challenges and opportunities in the #raredisease therapeutics market with Mike Ward of Clarivate. “We’ve seen regulatory flexibility start to occur for rare diseases and it is a godsend to the patients. More needs to be done… Rare diseases are important fights that we must continue every day,” says Rob. Tune in to hear Rob’s insights on rare disease therapies as Clene Nanomedicine, Inc. works to #EndALS: https://bit.ly/3VO0HQB

Today, we announced positive data from the Phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of our CNS-penetrant TYK2 inhibitor, A-005. We expect to begin a Phase 2 clinical trial of A-005 in multiple sclerosis in 2H 2025. Learn more: https://lnkd.in/gMWBUUVh

Did you know over 7,000 #RareDiseases affect millions globally? Unlicensed medicines (ULMs) can be a game-changer for those with rare conditions. Our SVP of Managed Access Suzanne Aitken explores the potential of ULMs and the need for a more patient-centric approach to access, in her latest article in Drug Discovery World. Read it here on page six: https://lnkd.in/e-xvXETT

🚀 BioVie’s Investor Webinar Today at 4:15 PM ET! 🚀 Join us to explore BioVie’s game-changing drug therapies targeting Alzheimer’s, Parkinson’s, Long COVID, and advanced liver disease. Don’t miss this deep dive into BioVie’s upcoming clinical milestones and strategic vision! 🔗 Register here 👉 https://lnkd.in/dGkuHHTt #FDA #Biotech #BioVie #ParkinsonsDisease #Alzheimers #ClinicalTrials #FinancialNews #CapitalMarkets

Did you know that sometimes a patient group is too small for pharmaceutical companies to justify a clinical trial? And if there is a Clinical trial, this can take 10-15 years to complete while patients are waiting for a medicine to become approved in their market or to be selected for this clinical trial? Also Unlicensed medicines can be accessible to patients with rare diseases. Clinigen is making this possible with the #ManagedAccess program.