John Guanjing Zhang’s Post

FDA Approves Lecanemab-Irmb Maintenance Dosing for Early Alzheimer Disease Treatment: Administered every 4 weeks, the approval could serve as a breakthrough for easier and more effective care for patients with early Alzheimer disease. #finance #pharmacy #lifesciences

🧠 Big news in the fight against Alzheimer's! 💊 Today, the FDA’s eleven-person advisory committee unanimously voted that Eli Lilly and Company’s anti-amyloid Alzheimer's #drug #donanemab was effective, and that the benefits of the drug outweigh the risks for people with the earliest stages of #Alzheimers disease. The agency is expected to make their final decision on approving the drug in the next few weeks. Read the full article from Being Patient's Simon Spichak👇 #AlzheimersDrugs #AlzheimersDisease #AlzheimersAwareness #BrainHealth

A new Alzheimer's drug may hit the market soon. Here's what you need to know: I spent yesterday watching the FDA #AdComm for Eli Lilly and Company's anti-amyloid drug #donanemab. While the eleven-person committee unanimously recommended the drug for approval there were still some lingering questions. The FDA will make their final decision in the coming weeks. Donanemab doesn't stop Alzheimer's disease, the evidence from the Phase 3 clinical trial suggests that it might slow its progression a bit. The trial enrolled patients based on tau levels, and excluded those with no or very low levels of tau in the brain. People with medium levels of tau seemed to benefit most from the treatment. Advisory committee members argued it wouldn't be practical or useful to require people to take a tau PET scan before being prescribed the drug. Unlike Leqembi, patients who are on the drug stop receiving it once the #amyloid plaques in the brain are cleared. In practice, this means doctors need to figure out when to time an amyloid PET scan to measure if these plaques have been cleared. Some of the members on the committee where uncertain over how much patients with two copies of the #APOE4 gene might benefit from the drug. There's also still uncertainty over why people taking the drug seemed to experience more brain shrinkage than those on placebo, even if they experienced a statistically significant reduction in symptoms and amyloid. Read more Being Patient

ALS, or Lou Gehrig’s Disease, is a disease that causes progressive degeneration of nerve cells in the spinal cord and brain. It affects 30,000 people in the US every year and treatment for it focuses primarily on reducing discomfort and slowing disease progression. US-based company Spinogenix, Inc. is developing a novel drug therapy for ALS that focuses on restoring synapses for patients affected with this disease. The treatment developed is a once-a-day pill that targets synapse loss, which is central to ALS. The company has just received FDA clearance for Investigational New Drug Application for its clinical trials in Australia. Studies so far in healthy volunteers have shown excellent tolerability and plasma levels aligned with efficacy in animal models. Read more about this drug here: https://lnkd.in/g3XiHc6d . . . #research #SimplerScience #als #healthcare #treatment #futureofhealthcare

🚨 URGENT CALL TO ACTION 🚨Attention everyone in the Prader-Willi syndrome (PWS) community and beyond! We need your support NOW! Find more information and sign the petition by May 23rd here: https://lnkd.in/gq2tMaFn We are rallying behind a critical petition urging the FDA to take action on DCCR (diazoxide choline) for individuals living with PWS. Soleno Therapeutics' investigational drug has shown remarkable promise in improving hyperphagia, reducing fat mass, and addressing challenging PWS-associated behaviors in clinical trials. Why is this so urgent? Because PWS patients, families, and clinicians are facing a staggering lack of treatment options. Without FDA-approved therapies, individuals with PWS struggle with everyday tasks and face life-threatening risks. But DCCR could change that. Sign the petition and spread the word to make a difference today!

Davelyn Eaves Hood, MD, MBA, BCMAS, and I share a common goal: to make a meaningful impact on patients in need, one at a time, and to enhance access to innovative medicine. This article encapsulates our experiences in this field—her expertise in the rare diseases therapies, and my background in expanded access. Our goal is to provide guidance for all the life science professionals considering the establishment of compassionate use programs for rare disease drugs, but struggeling with numerous questions. Thank you to Clinical Leader for the opportunity to publish this article and share our knowledge! WEP Clinical #witheverypatient #expandedaccess

The FDA has granted Boehringer Ingelheim Breakthrough Therapy designation to #survodutide for non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis, and the company has launched two Phase 3 trials (LIVERAGE & LIVERAGE-Cirrhosis) to evaluate this promising therapy. The Breakthrough Therapy designation expedites the development and review of medicines for serious or life-threatening diseases that have shown preliminary clinical evidence indicating substantial improvement over available treatments. In March, the FDA approved the first-ever MASH therapy, Madrigal Pharmaceuticals’ #Rezdiffra (resmetirom). https://lnkd.in/gNAxr94k With increased focus on MASH therapies, this could be a game-changer in liver disease treatment. Read more here: https://lnkd.in/g3rXJUvQ #MASH #LiverHealth #LiverDisease #Cirrhosis #BreakthroughTherapy

The latest study, "Real-world biologics response and super-response in the International Severe Asthma Registry cohort (LUMINANT)" has revealed a spectrum of responsiveness among real-world patients with severe asthma who initiated biologic asthma therapies, most of whom were ineligible to participate in randomized controlled trials. Read the full press release: https://lnkd.in/dqnN5pBV Read the full article here: https://lnkd.in/dSVCZe4G #ResearchInRealLife #SevereAsthma #Asthma #Research