non-alcoholic steatohepatitis
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A One-Time Treatment for NASH? Kriya Strikes Deal for Liver Disease Gene Therapy
Gene therapy biotech Kriya Therapeutics has acquired Tramontane Therapeutics, a startup focused on metabolic diseases. Tramontane brings a gene therapy that’s a potential one-time treatment for the fatty liver disease NASH.
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After Second FDA Rejection, Intercept Abandons NASH Drug and Restructures
The FDA again rejected Intercept Pharmaceuticals’ application seeking accelerated approval for its NASH drug and asked for more data. Instead, the biotech will stop all work in that fatty liver disease and focus on drugs for other serious but rare liver conditions.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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NASH Drug Biotech 89bio Nails Phase 2 Goals; Next Up Is a Pivotal Clinical Trial
89bio reported its NASH drug candidate met the main endpoints of a mid-stage clinical trial. In addition to demonstrating efficacy and safety according to measures the FDA says are needed to support a regulatory submission, 89bio says the results also show its drug could offer a dosing edge over potential rivals.
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Aligos Trims Staff to Hone Focus on Early Clinical Programs in NASH, Covid-19
The Aligos Therapeutics pipeline reprioritization comes after clinical trial setbacks to two hepatitis B drug candidates led the biotech to end both programs. Still intact is a Merck research collaboration focused on developing NASH therapies.
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Metabolic disorder biotech Akero achieves key clinical trial win in liver disease NASH
Akero Therapeutics’ experimental NASH drug, efruxifermin, met the main and secondary goals of Phase 2b clinical trial. The biotech will still need to show that the drug’s efficacy can hold up in a pivotal study, but the results so far are a positive sign for the NASH field, which has been marred by clinical trial failures.
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After initial failure, Intercept Pharma feels new data can get NASH drug approval
Two years after the stinging FDA rejection of its drug for the fatty liver disease NASH, Intercept Pharmaceuticals has more safety and efficacy data from a pivotal study that could support resubmission of a new drug application. The biotech said it will meet with the FDA later this month.
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NGM Bio’s NASH drug fails in Phase 2; focus shifts to Merck-partnered programs
An NGM Biopharmaceuticals drug candidate for the fatty liver disease NASH failed a Phase 2b study less than a year after the company reported positive results from an earlier mid-stage study. The biotech will now focus on programs in eye diseases and cancer that are partnered with Merck.
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Glympse Bio raises $22 million in Series A round for disease monitoring tech
ARCH Ventures and LS Polaris Innovation Fund led the round, which the company will use to develop the tech in diseases like NASH, its lead indication.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
