Prevail InfoWorks’ Post

Congratulations to #DTAMember Better Therapeutics on their submission to the #FDA for Breakthrough Device Designation for its novel PDT designed to treat metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NAFLD and NASH. 🎉 📱 "This regulatory step for Better Therapeutics follows the completion of the Company’s LivVita Liver Study and the subsequent publication of its results in Gastro Hep Advances. The study successfully met its primary endpoint by reducing liver fat within 90 days, while also achieving key secondary endpoints related to improved liver health without any device related adverse events." 💡 📣 Read the full article here: https://lnkd.in/eKSECCqY #DTA #DTx #DigitalTherapeutics #DigitalHealth #MedTech

🌟Exciting News! Gilead Sciences takes a leap forward in liver disease treatment with the acquisition of CymaBay Therapeutics! 🌟 🔹 Gilead broadens its liver portfolio by welcoming Seladelpar, a potent PPARδ agonist, into its arsenal. #gilead #CymaBayTherapeutics #LiverPortfolio 🔹 Seladelpar targets Primary Biliary Cholangitis (PBC), a rare liver disease predominantly affecting women. #pbc #liverdisease 🔹 With FDA Priority Review status, Seladelpar is on track for anticipated approval in the U.S. by the third quarter of 2024. #fdaapproval #Seladelpar 🔹 Phase 3 clinical data showcases Seladelpar's exceptional efficacy, positioning it as a top contender for second-line PBC treatment. #clinicaltrials #Phase3Data 🔹 Symptoms of PBC include pruritus (itching) and fatigue, significantly impacting patients' quality of life. #liverhealth #patientcare 🔹 This strategic acquisition underscores Gilead's unwavering commitment to addressing the needs of patients with liver diseases. #healthcareinnovation #patientcentricity https://lnkd.in/g4rMWmvw

Results of a recent study “showed efruxifermin in combination with a GLP-1RA for 12 weeks reduced hepatic fat fraction by 65% vs. 10% with placebo/GLP-1RA alone, and improved noninvasive markers of liver injury and fibrosis with “significantly greater” reductions from baseline in alanine aminotransferase and aspartate aminotransferase.” “Efruxifermin with a glucagon-like peptide-1 receptor agonist was well-tolerated and reduced hepatic fat fraction and noninvasive markers of fibrosis among patients with metabolic dysfunction-associated steatohepatitis and type 2 diabetes.” “There are preliminary indications that combining these two mechanistic classes [adding efruxifermin to a background GLP-1RA] could accelerate resolution of MASH and regression of fibrosis. Stephen A. Harrison, MD, FAASLD”. Source: Harrison SA, et al. Clin Gastroenterol Hepatol. 2024;doi:10.1016/j.cgh.2024.02.022. American Association for the Study of Liver Diseases (AASLD) EASL | The Home of Hepatology Canadian Association for the Study of the Liver Barcelona Institute for Global Health (ISGlobal) Global NASH Council Global Liver Institute European Liver Patients' Association - ELPA

Roche announced today that the Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development. 👉 Approximately one in five people worldwide have elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial infarction and stroke. 👉 The Roche Diagnostics Tina-quant® Lp(a) assay measures lipoprotein (a) in a person’s bloodstream, and will be made available on Roche’s installed base of over 90,000 serum work area (SWA) systems worldwide. 👉 The test has been developed in collaboration with Amgen. Lp(a) is emerging as an important, yet under-recognised, potential risk factor for cardiovascular disease, a major public health issue. “While modern lifestyles are a major driver, as much as 30% of mortality associated with cardiovascular disease occurs in individuals without modifiable risk factors,” said Matt Sause, CEO of Roche Diagnostics. “Lp(a) is a critical marker for people at risk of cardiovascular disease, but medicine has had limited solutions to adequately address the problem. Through our collaboration with Amgen, Roche is paving the way to make elevated Lp(a) an actionable biomarker.” "Lp(a) testing rates are markedly low, and existing lab tests may not consistently and accurately measure Lp(a) levels," said Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen. "By combining Amgen’s deep legacy and expertise in cardiovascular disease with Roche’s diagnostic expertise, we can accelerate access to more standardised testing and equip more patients and healthcare providers with important information to better understand their risk for cardiovascular disease." Once approved, the new Tina-quant® test is expected to be made available to support the selection of patients who may benefit from an innovative Lp(a)-lowering therapy. #cardiovasculardisease #LpaAssay #Tinaquant #RocheDiagnostics #collaboration #Roche #Amgen

Logical from what I understand about aspirin & salicylates.

Interesting news about aspirin.

FDA Approves Monoclonal Anti-Integrin Antibody Biosimilar for Multiple Sclerosis! 👏 MS is a chronic, inflammatory, autoimmune disease of the central nervous system, where the immune system attacks healthy cells and damages the myelin sheath. It is the most common disabling neurological disease of young adults, with symptoms ranging from vision loss, pain, fatigue, and impaired coordination. Congrats to Sandoz for receiving FDA approval for Tyruko (natalizumab-sztn), the first FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS). Tyruko is a monotherapy treating all indications covered by Tysabri (natalizumab) for relapsing forms of MS, such as clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive disease, in addition to Crohn’s disease in adult patients. Tyruko works by binding to the alpha 4 subunit of integrins on endothelial cells lining blood vessels, thus preventing migration of immune cells. Integrins help the body by chemotaxis of leukocytes to sites of inflammation. Read the press release here: https://lnkd.in/d7pJbGY6 #Biointron #FDA #Immunotherapy #MultipleSclerosis #Antibodies #PharmaNews #DrugDevelopment Image from National Multiple Sclerosis Society

Exciting news from Ipsen and GENFIT! A significant milestone as elafibranor could be the first novel second-line treatment for PBC in nearly a decade. The investigational drug targets a rare cholestatic liver disease, and its potential approval could offer a new and much-needed second-line treatment choice for patients. The commitment to simultaneous filings aligns with the companies' goal to bring this crucial medicine to PBC patients as swiftly as possible. Kudos to Ipsen and GENFIT for this important step in the regulatory process! #RareDisease #IND #HealthcareAdvancements

Johnson & Johnson Innovative Medicine announced that, in the Phase 3 VIVACITY study in generalized myasthenia gravis (gMG), nipocalimab met the primary endpoint, achieving statistically significant reduction in MG-ADLa score from baseline over weeks 22 to 24 compared with placebo. Nipocalimab is an investigational, high-affinity, fully human, aglycosylated, effectorless, anti-FcRn monoclonal antibody. gMG is a chronic, life-long, rare, and highly debilitating autoantibody-driven neuromuscular disease characterized by fluctuating muscle weakness. As next steps, Johnson & Johnson plans to present full results from the Phase 3 VIVACITY study at an upcoming scientific medical congress and engage with global regulatory authorities about bringing nipocalimab to patients living with gMG. #mabs https://lnkd.in/efyrPBhp

Innovation lead by the necesecity of our patients is part of our DNA