Anthony W. Luttenberger’s Post

Excellent read highlighting the significance of safety monitoring in rare disease trials. Unlike chronic more prevalent conditions, rare diseases typically require a minimum long-term safety database of 100 patients, compared to 1000 for chronic conditions. The HEALEY ALS Platform Trial, an adaptive clinical Phase 2/3 trial, exemplifies effective safety monitoring and trial adaptability for optimal outcomes. Platform trials offer numerous benefits, and PharmAust's recent selection for the HEALEY ALS Platform Trial promises exciting progress updates in collaboration with Mass General. #PharmAust #RareDiseases #NeurodegenerativeDiseases #Biotech #HEALEYALSTrial

#Measles and #rubella present similar symptoms of acute fever and rash, posing serious health risks to children and teenagers. Early and accurate detection is crucial for effective treatment. #BioPerfectus offers the Measles and Rubella Viruses Real-Time PCR Kit to aid in accurate diagnosis.   Micron Biomedical, based in Georgia, #USA, recognized as a category leader, is building a mass production facility for needle-free pharmaceuticals. As a clinical-stage life science company committed to expanding access to vaccines and therapeutics globally.   Yasmine Gomaa, Principal Scientist at Micron Biomedical, shares her insight: "𝐁𝐢𝐨𝐏𝐞𝐫𝐟𝐞𝐜𝐭𝐮𝐬 𝐌𝐞𝐚𝐬𝐥𝐞𝐬 𝐚𝐧𝐝 𝐑𝐮𝐛𝐞𝐥𝐥𝐚 𝐕𝐢𝐫𝐮𝐬𝐞𝐬 𝐑𝐞𝐚𝐥-𝐓𝐢𝐦𝐞 𝐏𝐂𝐑 𝐊𝐢𝐭 𝐰𝐚𝐬 𝐬𝐚𝐯𝐢𝐧𝐠 𝐬𝐢𝐠𝐧𝐢𝐟𝐢𝐜𝐚𝐧𝐭 𝐭𝐢𝐦𝐞 𝐨𝐧 𝐫𝐮𝐧𝐧𝐢𝐧𝐠 𝐦𝐮𝐥𝐭𝐢𝐩𝐥𝐞𝐱 𝐏𝐂𝐑 𝐭𝐞𝐬𝐭𝐬 𝐨𝐧 𝐛𝐢𝐯𝐚𝐥𝐞𝐧𝐭 𝐬𝐚𝐦𝐩𝐥𝐞𝐬 𝐰𝐢𝐭𝐡 𝐬𝐢𝐦𝐢𝐥𝐚𝐫 𝐚𝐜𝐜𝐮𝐫𝐚𝐜𝐲 𝐭𝐨 𝐭𝐡𝐞 𝐂𝐪 𝐯𝐚𝐥𝐮𝐞𝐬 𝐟𝐨𝐫 𝐦𝐨𝐧𝐨𝐩𝐥𝐞𝐱. 𝐓𝐡𝐚𝐭'𝐬 𝐞𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐭. 𝐈 𝐰𝐢𝐥𝐥 𝐜𝐨𝐧𝐭𝐢𝐧𝐮𝐞 𝐭𝐨 𝐮𝐬𝐞 𝐨𝐭𝐡𝐞𝐫 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐬 𝐟𝐫𝐨𝐦 𝐁𝐢𝐨𝐏𝐞𝐫𝐟𝐞𝐜𝐭𝐮𝐬."   Together, we unite in the fight against measles and rubella, striving for improved health outcomes worldwide.   🔬Discover more about our products: https://lnkd.in/eT-j6q_j #BioPerfectus #IVD #Healthcare #Diagnostics #PCR #MolecularDiagnostic

MedPage Today spoke with Fatima Cody Stanford, MD, MPH, MPA, MBA, & Karl Nadolsky, DO, during an Instagram Live 2 years ago about the growing buzz around GLP-1 receptor agonists and their role in transforming diabetes and obesity care. Since then, the use of medications like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) has become even more widespread as the drugs' list of proven and potential benefits grow. However, the drugs have their limits -- such as weight-loss plateaus and weight regain after stopping treatment -- and as their popularity grows, questions remain about perioperative and long-term safety, compounded drug risks, as well as equitable access and affordability. In an upcoming Instagram Live, MedPage Today will revisit the conversation to discuss how the landscape has changed and what clinicians need to know about these revolutionary drugs. Join us on Monday, December 2 at 2 p.m. ET! To tune in, follow @medpage on IG: https://lnkd.in/d-38wcKS

Adicet is pleased to announce that the FDA has granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or IV lupus nephritis! The FDA’s decision to grant ADI-001 Fast Track Designation for lupus nephritis underscores the urgent need for new therapies for this chronic disease. Advancing #research is critical to the development of novel therapies for people living with #lupus. Learn more about Adicet’s #clinicaltrial in lupus nephritis at https://lnkd.in/esC4winc To see the full announcement, click here: https://lnkd.in/gmzbgGyj #celltherapy #gammadelta #CART #autoimmune #clinicaltrials #biotechnology #patientcare #clinicaltrialparticipation

Join me on April 23 to hear perspectives from top clinical research experts and disease area specialists on Alzheimer’s Disease (AD) and Multiple Sclerosis (MS) treatments. 🧠 Learn about development challenges in each, how they were overcome, and the shared lessons that can propel novel approaches to more effective clinical trials.   Register now to secure your spot and join in this innovative conversation! #Alzheimers #MultipleSclerosis #ClinicalTrials #Biotech

Today is #GlobalDayAgainstPain. Rapport is proud to be working toward the next frontier in pain medicine to one day give patients a better quality of life, with two different pain programs currently in development.   Our first pain program centers on peripheral neuropathic pain, a chronic condition caused by damaged or dysfunctional peripheral nerves, affecting millions of people worldwide. We’ll be evaluating our lead small molecule candidate RAP-219 in patients with this condition in an upcoming Phase 2a study. Our discovery stage pain program is more broadly focused on chronic pain indications, which may include neuropathic pain, inflammatory pain and more.    Bradley Galer, Chief Medical Officer, offers thoughts below on the enormous unmet need that exists for those living with pain conditions as well as Rapport’s mission to improve patient lives and change health outcomes through the development of novel therapeutics.   You can find more information on how Rapport is addressing pain on our website: https://bit.ly/3A5KFJp   #PainManagement #Biotech

Did you know that #glaucoma is the leading cause of irreversible blindness worldwide? Glaucoma is a disease of the optic nerve which, if left untreated, can lead to irreversible vision loss. It affects about 3.5% of the global population, yet current treatment options can still lead to disease progression in many patients. Glaucoma is also largely underdiagnosed, including in Western countries where less than 50% of people affected are actually treated, which leaves an opportunity to improve the standard of care. Currently, reducing elevated intraocular pressure (IOP) remains the only way to slow progression of the disease. But, as many as 40% of patients fail to reach target IOP with existing monotherapies, risking disease progression and permanent vision loss. There continues to be an unmet medical need for a therapy with greater IOP-lowering efficacy that is both safe and well tolerated, like Nicox’s Phase 3 investigational drug NCX 470, despite that we have established first line therapies. #blindness #eyedisease #healthcare #biotech

Join me on April 23 to hear perspectives from top clinical research experts and disease area specialists on Alzheimer’s Disease (AD) and Multiple Sclerosis (MS) treatments. 🧠 Learn about development challenges in each, how they were overcome, and the shared lessons that can propel novel approaches to more effective clinical trials.   Register now to secure your spot and join in this innovative conversation! #Alzheimers #MultipleSclerosis #ClinicalTrials #Biotech

Join us on April 23 to hear perspectives from top clinical research experts and disease area specialists on Alzheimer’s Disease (AD) and Multiple Sclerosis (MS) treatments. 🧠 Learn about development challenges in each, how they were overcome, and the shared lessons that can propel novel approaches to more effective clinical trials.   Register now to secure your spot and join in this innovative conversation! #Alzheimers #MultipleSclerosis #ClinicalTrials #Biotech

Join me on April 23 to hear perspectives from top clinical research experts and disease area specialists on Alzheimer’s Disease (AD) and Multiple Sclerosis (MS) treatments. 🧠 Learn about development challenges in each, how they were overcome, and the shared lessons that can propel novel approaches to more effective clinical trials.   Register now to secure your spot and join in this innovative conversation! #Alzheimers #MultipleSclerosis #ClinicalTrials #Biotech