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obeticholic acid

This page shows the latest obeticholic acid news and features for those working in and with pharma, biotech and healthcare.

Intercept hit hard as FDA issues Ocaliva safety notice

Intercept hit hard as FDA issues Ocaliva safety notice

The US regulator issued a safety notice yesterday warning that the company's Ocaliva (obeticholic acid) for primary biliary cholangitis (PBC) had been linked to 19 deaths and 11 cases of ... the only approved PBC therapy - ursodeoxycholic acid (UDCA) or

Latest news

  • BMS claims a win in mid-stage NASH trial BMS claims a win in mid-stage NASH trial

    elafibranor and Intercept's Ocaliva (obeticholic acid), which is already on the market for another indication (primary biliary cholangitis).

  • Intercept gets EU nod for rare liver disease therapy Intercept gets EU nod for rare liver disease therapy

    The European Medicines Agency (EMA) granted a conditional approval for Ocaliva (obeticholic acid) in combination with the only approved PBC therapy - ursodeoxycholic acid (UDCA) - in adult patients who can't tolerate

  • Gilead chalks up trial success for new NASH drug Gilead chalks up trial success for new NASH drug

    Allergan has been building a pipeline of candidates through a series of bolt-on acquisitions including Akarna Therapeutics and Tobira Therapeutics, while Intercept's home-grown Ocaliva (obeticholic acid) - already approved

  • CHMP backs Intercept's rare liver disease drug CHMP backs Intercept's rare liver disease drug

    Intercept Pharmaceutical's Ocaliva (obeticholic acid) has been recommended for conditional approval by the EMA's Committee for Medicinal Products for Human Use (CHMP) - provided the US biotech company provides updates ... Ocaliva is meant to be used in

  • Biologics set to revolutionise the gastrointestinal market Biologics set to revolutionise the gastrointestinal market

    Both have been forecast by the GBI Research analysts to become blockbuster drugs by 2022, along with Intercept's Ocaliva (obeticholic acid), which received FDA approval for the treatment of primary

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