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FDA Converts Tuberculosis Treatment to Traditional Approval FDA converted Sirturo (bedaquiline) to traditional approval following a determination that a confirmatory trial verified clinical benefit. Sirturo is indicated for pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid, also known as multi-drug resistant tuberculosis (MDR-TB), as part of a combination therapy, for adults and pediatric patients (5 years and older, weighing at least 15 kg). The National TB Surveillance System reported an increase in TB cases in the United States since 2020, including a 16% increase in overall cases in 2023 compared to 2022. MDR-TB typically makes up less than 2% of diagnosed TB cases in the U.S. Sirturo was first approved in December 2012 under FDA’s Accelerated Approval pathway. As part of the initial approval, FDA required the applicant to conduct a confirmatory clinical study and develop a patient registry to assess rates of serious adverse events. #fda #crc #cro #tuberculosis #sirturo #bedaquiline

Positive results from Phase 2A clinical trial of TBA-7371, a new drug candidate for tuberculosis Foundation for Neglected Disease Research is proud to announce that its partners, Bill & Melinda Gates Medical Research Institute and TB Alliance, have successfully completed the Phase 2A Early Bactericidal Activity clinical trial of TBA-7371, a novel DprE1 inhibitor for the treatment of tuberculosis. The results were presented at the 2023 International Union Against Tuberculosis and Lung Disease (The Union) World Conference on Lung Health in Paris. TBA-7371 was well tolerated and showed significant dose-dependent bactericidal activity with 14 days of treatment in patients with drug-susceptible pulmonary tuberculosis. TBA-7371 could have significant potential in the treatment of TB.

I am happy to share my recent review article publication with you all on host directed therapies for tuberculosis. Host directed therapies (HDT) can be one of the major tool for future of medicines. It can also help to fight new era of problems like antibiotic resistance and development of multi drug resistant bacteria/ species. HDT have the capacity to generate a better or strong immune system to fight against pathogens. This makes me very interested in this. I hope you people also like this small article. Here is the link: https://lnkd.in/g4kQtr2V

Check out this captivating article on the world of Tuberculosis treatment! Explore cutting-edge approaches for addressing drug-susceptible and drug-resistant TB, gain insights into recent trial outcomes, and get a glimpse of ongoing clinical trials.   Read more here: https://lnkd.in/ecQZkgcr   #TuberculosisTreatment #ResearchReview #MedicalAdvancements

Promising early results for a new tuberculosis compound, TBAJ-876, were presented at the Union World Conference on Lung Health. The new TB Alliance trial, NC-009, will test different doses of TBAJ-876 in combination with pretomanid and linezolid against the current standard of care for drug-sensitive TB. Another arm of the trial will also test pretomanid and linezolid in combination with bedaquiline (BPaL). The study aims to enroll 300 participants with drug-sensitive TB at 21 clinical trial sites in five countries: Georgia, Philippines, South Africa, Tanzania, and Uganda. The Aurum Institute Rustenburg has been selected as one of the clinical research sites, and screening has recently started. #EndTB #25YearsofExcellence #unionconf2023

Viral hepatitis claims 3,500 lives daily, ranking as the world's second deadliest infectious disease!   According to the latest report from the World Health Organization (WHO), 1.3 million people died globally from viral hepatitis (hepatitis B and C) in 2022, which is 200,000 more than in 2019. This translates to an average of 3,500 deaths per day, making it the second deadliest infectious disease globally, just behind tuberculosis. Patients with hepatitis must undergo regular monitoring of liver function, ultrasound scans, and fibrosis assessments to prevent progression to chronic liver disease.   GBC provides a comprehensive range of liver disease diagnostic products and reagents, covering hepatitis A to hepatitis D. Among these, Pre-S gene testing can assess the risk of hepatocellular carcinoma development. 👉 https://lnkd.in/g4dsGsB5   #GBC #GBC #ViralHepatitis #ChronicHepatitis #HepatitisScreening #Liver20 #BioFibroScore #NonInvasiveLiverFibrosisTest

Mycobacterium tuberculosis is one of the major invasive intracellular pathogens causing most deaths by a single infectious agent. The interaction between host immune cells and this pathogen is the focal point of the disease, Tuberculosis. Host immune cells not only mount the protective action against this pathogen but also serve as the primary niche for growth. Thus, recognition of this pathogen by host immune cells and following signaling cascades are key dictators of the disease state. I mmune cells, mainly belonging to myeloid cell lineage, recognize a wide variety of Mycobacterium tuberculosis ligands ranging from carbohydrate and lipids to proteins to nucleic acids by different membrane-bound and soluble pattern recognition receptors. Simultaneous interaction between different host receptors and pathogen ligands leads to immune-inflammatory response as well as contributes to virulence. This review summarizes the contribution of pattern recognition receptors of host immune cells in recognizing Mycobacterium tuberculosis and subsequent initiation of signaling pathways to provide the molecular insight of the specific Mtb ligands interacting with specific PRR, key adaptor molecules of the downstream signaling pathways and the resultant effector functions which will aid in identifying novel drug targets, and developing novel drugs and adjuvants. Learn more here👉  https://lnkd.in/gDPCnsmD #Biochem123 #science #research #data #information #immune #cell #programme #healthcare  #immunotherapy #technology #socialmedia #bigdata #drugs #development

🌎 #WorldTuberculosisDay 𝗡𝗲𝘄 𝗮𝗰𝘁𝗶𝘃𝗲 𝗮𝗴𝗲𝗻𝘁 𝗳𝗼𝗿 𝘁𝗵𝗲 𝘁𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁 𝗼𝗳 𝘁𝘂𝗯𝗲𝗿𝗰𝘂𝗹𝗼𝘀𝗶𝘀 Together with international colleagues, researchers from the DZIF Clinical Tuberculosis Unit (DZIF ClinTB) at the Research Center Borstel, Leibniz Lung Center have shown that the novel active substance ganfeborole exhibits clinical activity in patients and could be a promising candidate for the safe and effective treatment of pulmonary tuberculosis. Ganfeborol belongs to a new class of antibiotics—the so-called "leucyl-tRNA synthetase inhibitors"—which prevent the formation of new important proteins in the bacteria and thus inhibit the growth of pathogens: https://lnkd.in/e-_VZZsf #EndTB Forschungszentrum Borstel, Leibniz Lungenzentrum Maja Reimann

Baseline and acquired resistance to bedaquiline, linezolid and pretomanid, and impact on treatment outcomes in four tuberculosis clinical trials containing pretomanid