NASH
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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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MedCity Influencers, Devices & Diagnostics
A Liver Scan on the Drive-Thru Menu? It Probably Should Be.
Non-invasive liver tests provide an accessible means for healthcare providers to monitor the positive effects of patient lifestyle changes over time, reinforcing the positive behaviors that lead to improved liver health – halting or even reversing the progression of liver disease
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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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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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Terns raises $87M to advance trials of NASH drugs
The startup, which licensed three NASH candidates from Eli Lilly, raised $87 million from the drugmaker and Deerfield Management.
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Merck, Hanmi sign $870M deal for NASH drug
Hanmi will retain options for the drug, efinopegdutide, in Korea under the deal, in which Merck is paying the Seoul-based company $10 million upfront and up to $860 for development, regulatory and commercialization milestones.
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French biotech Genfit shifts gears after Phase III NASH failure
The company said it was formally terminating the Phase III study of the drug elafibranor in NASH and refocus its development of the drug on another disease, primary biliary cholangitis, as well as a diagnostic for NASH.
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Glympse Bio raises more than $46M in Series B round for biosensor technology
The company is developing biosensors, initially for NASH, that could be used in place of liver biopsy and have applicability in development of drugs for the disease.
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FDA turns down Intercept’s long-anticipated NASH drug
The FDA has requested additional data from the company’s clinical trial. Intercept’s CEO expressed disappointment at the decision, saying the agency had not communicated that the drug, obeticholic acid, was not approvable.
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Intercept hits regulatory snag at FDA, likely delaying NASH drug’s approval
The company said that the agency had requested additional data for obeticholic acid and thus pushed the upcoming advisory committee meeting back from June 9, thereby delaying its decision on approval, which had also been scheduled for June 26.
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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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Genfit’s drug flops in Phase III, joining graveyard of NASH failures
The French drugmaker said Monday that its Phase III study of elafibranor failed to meet its primary and key secondary endpoints. Analysts remarked that this extends the lead of the drug likely to get the first NASH approval, Intercept’s obeticholic acid.
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Genfit delays data from Phase III study of NASH drug as it awaits FDA feedback
Shares of the French company fell more than 3% Friday following news it would delay unblinding data from the Phase III study of elafibranor. This marks the second delay of data since September and means it will likely be announced in the second quarter rather than the first.
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The top biopharma companies targeting NASH
These are four companies that currently have drugs in Phase III development for nonalcoholic steatohepatitis or have them under Food and Drug Administration review.
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Genfit CEO says company emphasizes patient access as it considers price for its NASH drug
In an interview at the BIO CEO & Investor Conference in New York Monday, CEO Pascal Prigent said barriers to access rather than reimbursement represent the biggest concern for NASH drugs like elafibranor. As a ballpark estimate, a list price in the $10,000 range is possible.
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Singapore biotech could get more than $1B from Boehringer Ingelheim under partnership
The German drugmaker announced a partnership with Enleofen to develop the company’s suite of preclinical antibodies targeting IL-11 in diseases like NASH.
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Boehringer Ingelheim dumps NASH drug program amid concerns over drug interactions
BI said it would continue to develop the drug, BI 1467335, in other diseases and remain committed to NASH overall. Shares of the Australian company from which it licensed the drug, Pharmaxis, fell more than 40%.
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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.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
