DENOVO BIOLABS PVT. LTD.’s Post

🚀 Great news for patients as the US FDA has given the green light to Gilead Sciences Livdelzi (seladelpar) for treating primary biliary cholangitis (PBC), a chronic autoimmune disease that mainly affects women. PBC impacts the bile ducts and, if left untreated, can lead to severe liver damage. Livdelzi's approval not only brings newfound hope for patients but also underscores the importance of continuous innovation in the medical field. In a Phase 3 study, Livdelzi made impressive strides: - ✅ Achieved a significant biochemical response in 62% of participants (compared to 20% with placebo) - ✅ Normalised alkaline phosphatase (ALP) levels in 25% of participants - ✅ Reduced pruritus (itching) significantly These achievements are particularly pivotal given that current treatment options often fall short, failing to prevent liver damage over the long term. While the long-term benefits in terms of survival and liver damage prevention remain to be seen, Livdelzi's ability to normalise ALP levels, a key marker for predicting transplant risk and mortality, positions it as a game-changer in PBC management. #GileadSciences #Livdelzi #Biotechnology #Pharmaceuticals #HealthcareInnovation #ClinialTrials #ClinicalResearch #LifeScience #ElixirAssociates #StaffingPartner

𝐆𝐞𝐧𝐞𝐧𝐭𝐞𝐜𝐡 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐏𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐏𝐡𝐚𝐬𝐞 𝐈𝐈𝐈 𝐑𝐄𝐆𝐄𝐍𝐂𝐘 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐟𝐨𝐫 𝐆𝐚𝐳𝐲𝐯𝐚 𝐢𝐧 𝐋𝐮𝐩𝐮𝐬 𝐍𝐞𝐩𝐡𝐫𝐢𝐭𝐢𝐬 Genentech Genentech, a member of the Roche Group, reported positive topline results from the Phase III REGENCY study of Gazyva® (obinutuzumab) in people with active lupus nephritis. Gazyva, when combined with standard therapy, achieved a higher complete renal response (CRR) at 76 weeks compared to standard therapy alone, with no new safety concerns identified. Key findings include: Gazyva achieved a robust CRR, potentially preserving kidney function and preventing end-stage kidney disease. Statistically significant benefits were also seen in corticosteroid reduction and proteinuric response. Data are being shared with health authorities, including the FDA and EMA, aiming to make this new treatment option available soon. Lupus nephritis is a life-threatening condition that affects around 1.7 million people worldwide, primarily women of color. Gazyva’s potential to deplete disease-causing B cells could offer hope for long-term disease control. #Genentech #LupusNephritis #ClinicalTrials #Biotech #Pharma #KidneyHealth #Gazyva #FDA #AutoimmuneDisease #HealthcareInnovation #LupusResearch #Roche

We would like to highlight important work for the treatment of post-kala-azar dermal leishmaniasis. “The study provides the first accurate measurements of miltefosine penetration into the skin, demonstrating substantial exposure and prolonged retention of miltefosine within the skin. These findings support the use of miltefosine in cutaneous manifestations of leishmaniasis.” Read full publication here: https://lnkd.in/dnvcxsMD Dermal leishmaniasis, post-kala-azar, is a disease affecting 5-10 percent of those previously affected by visceral leishmaniasis, kala-azar. The disease is mainly present in East Africa and in the Indian subcontinent. Semra Palić-Ibrović and Thomas Dorlo, with his research group, have made this publication happen, with support from Wan-Yu Chu, Shyam Sundar, Dinesh Mondal, Pradeep Das, Krishna Pandey, Sheeraz Raja, Suman Rijal, Ignace C Roseboom, Abdullah Hamadeh, Paul R V Malik, Jos H Beijnen, Alwin D R Huitema, Erik Sjögren and Fabiana Alves. Drugs for Neglected Diseases initiative - DNDi is doing work of great importance on a variety of neglected diseases. We strongly encourage international organizations, government agencies and non governmental organizations to continue to support their work, making this research happen. #infectiousdiseases #pharmaceutical #globaldevelopment #medicine

Increasing Knowledge on World Arthritis Day This World Arthritis Day 🌍, we join the millions of people affected by musculoskeletal and rheumatic diseases. These illnesses affect about one in four people, and they can lead to severe everyday challenges, reduced mobility, and chronic pain. Our goal at Kleva is to provide treatments 💊 that improve the quality of life for those who suffer from arthritis and related conditions. We are driven to develop solutions that address the complexities of these diseases by our dedication to innovation and research 🔬. Join us as we promote timely diagnosis 🕒 and effective care to enhance patient outcomes on a worldwide scale. #KlevaPharmaceuticals #PharmaIndustry #KlevaPharma #Pharmaceuticals #PharmaIndustry #WorldArthritisDay #Rheumatology #HealthcareInnovation

Gastroesophageal Reflux Disease (GERD) affects nearly 8.2% of individuals in India, with urban areas showing a higher prevalence rate of 11.1%. Amidst the current ineffective therapeutics for GERD, Torrent Pharmaceuticals brings new hope to India. Read the complete news https://lnkd.in/dsQFwj2x #pharmanow #businessmagazine #pharmabusinessmagazine #latestpharmanews #latestnewsinpharma

Asia is a large and diverse region with a complex healthcare landscape that continues to witness significant changes driven by demographic shifts, urbanisation, and rising non-communicable diseases.   Focusing on key trends in drug innovation and commercialisation, particularly in areas such as diabetes, obesity, and cardiovascular health, Executive Vice President of ZP Therapeutics, Zuellig Pharma, Rehan S., speaks with BioPharma APAC to share his insights on the challenges and opportunities within this diverse and complex region.   Read the interview to learn more about how ZP Therapeutics, Zuellig Pharma's commercialisation division, remains at the forefront of addressing these challenges through strategic partnerships, innovative approaches, and a deep understanding of the region’s unique needs: https://lnkd.in/dKnAbdEs   #ZPTherapeutics #HealthcareCommercialization #MakingHealthcareMoreAccessible

𝗕𝗿𝗲𝗮𝗸𝗶𝗻𝗴 𝗡𝗲𝘄𝘀: The U.S. Food and Drug Administration (#FDA) has granted traditional approval for #donanemab, marketed as Kisunla™, the Alzheimer’s treatment developed by Eli Lilly and Company.    This is the second-ever traditional approval to a disease-modifying therapy for the treatment of early, symptomatic #Alzheimer’s disease. First approval was #Eisai’s #Leqembi (#lacenemab) in 2023.     Here are the main points about #Lilly's #Kisunla (#donanemab):    ➡️ Kisunla is the first amyloid plaque-targeting therapy that we can stop once plaques are removed which can potentially lower treatment costs and reduce the number of infusions.    ➡️ Kisunla slows cognitive and functional decline by up to 35% compared to placebo at 18 months.    ➡️ The treatment reduced the risk of progressing to the next stage of Alzheimer's by up to 39%.    ➡️ Monthly 30-minute infusions reduced amyloid plaques by 84% on average.    ➡️ Kisunla may cause amyloid-related imaging abnormalities (#ARIA), a serious side effect.    ➡️ The cost of therapy can reach $48,696 depending on length of treatment.     The approval decision represents a significant milestone in the ongoing battle against Alzheimer’s disease and provides patients with more options and the potential for additional time. _________________________ At AIRAmed GmbH, we utilize advanced AI developed by radiologists to precisely quantify brain volume from MRI images. Our mission is to enhance early and accurate diagnosis of neurodegenerative diseases such as Alzheimer´s and other dementias. Contact us to learn more: info@airamed.de

🌟 Excited to share that I recently attended the 73rd SPSR Webinar on Prodrug Strategies for Colon-targeted Drug Delivery. The session provided insightful discussions on innovative approaches to enhance drug efficacy and safety, particularly for targeted delivery in the colon. Such advancements have the potential to revolutionize treatments for various gastrointestinal diseases. A big thank you to the organizers and speakers for their expertise and thought-provoking content! #DrugDelivery #PharmaceuticalResearch #Innovation #ColonTargeting #SPSRWebinar