nonalcoholic steatohepatitis
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Intercept hits slight delay in NASH drug approval, but analysts remain upbeat
While the FDA’s scheduling an expert panel meeting for obeticholic acid after the original action date would delay its decision, an analyst wrote it would still likely be the first to win approval in NASH.
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FDA issues draft guidance for developing drugs for NASH with cirrhosis
The agency said it would likely require such drugs to undergo the traditional approval pathway, as there is insufficient evidence to support giving drugs accelerated approval based on surrogate endpoints.
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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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Gilead NASH drug dead in the water as second Phase III trial fails
An analyst wrote that with selonsertib’s failures in fourth- and now third-stage fibrosis, the drug will have no place in NASH treatment. Gilead has entered partnerships focused on other compounds for the fatty liver disease.
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Artificial Intelligence, BioPharma
Gilead, Insitro in $250M machine learning partnership to develop NASH drugs
The deal comes days after Gilead partnered on clinical development in NASH with Denmark’s Novo Nordisk, and two months after the high-profile failure of a Phase III study in the disease.
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Intercept’s Ocaliva shows continued improvement in NASH fibrosis at European liver conference
The company’s stock was nevertheless down more than 13 percent amid investor concerns about lack of intent-to-treat analysis on two-stage fibrosis improvement and gall stone events.
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Novartis in nearly $1.6B deal to buy NASH-focused subsidiary of IFM Therapeutics
The deal includes a $310 million upfront payment plus milestones for three IFM Tre assets – one clinical drug for NASH and atherosclerosis and two preclinical molecules.
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Genfit makes $135M debut on Nasdaq
The French company, developing a drug to treat nonalcoholic steatohepatitis, or NASH, announced the pricing of its shares at $20.32 apiece.
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Genfit, developing drugs for NASH, to trade on Nasdaq
The company, one of several developing drugs for the growing fatty liver disease, said in an SEC filing that it would sell its shares at $26.33 apiece.
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Intercept could score first NASH drug approval on positive Phase III data
Shares of the New York-based company jumped nearly 20 percent Tuesday on news that the REGENERATE study of obeticholic acid showed strong improvement in NASH-related liver fibrosis.
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Gilead shares sink as NASH drug flunks Phase III study
The company said a Phase III study of selonsertib had failed, sending shares down 4 percent and feeding analyst pessimism on another Phase III study of the drug in patients with less advanced disease.
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Preclinical startup Jecure makes bee-line to exit with Genentech buyout
Venture capital firm Versant Ventures launched the company with a $20 million Series A funding round last year.
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Chinese-American startup Terns Pharmaceuticals raises $80M for NASH, cancer drugs
The company joins a growing wave of firms developing drugs for the disease, which has no approved treatments. It expects to enter two drugs into the clinic next year.
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Novartis, Pfizer partner to develop drugs for NASH
The companies will run clinical trials combining Novartis’ tropifexor with any one of several Pfizer drugs under development for the disease, which lacks approved treatments.
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OrbiMed launches 89Bio with $60M Series A round to develop Teva’s NASH drug
The new company is headquartered in San Francisco, with R&D in Israel and has launched a Phase I study of BIO89-100, formerly TEV-47948.
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Ambys Medicines garners $140 million to develop chronic liver disease treatments
The company secured $60 million in a Series A round from Third Rock and Takeda, plus a partnership with Takeda.
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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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