Analysts believe that pan-EU authorization for Intercept Pharmaceuticals’ obeticholic acid for advanced fibrosis due to nonalcoholic steatohepatitis may come in the first quarter of 2021.
Intercept Pharmaceuticals, which recently submitted a marketing application to the European Medicines Agency for obeticholic acid, believes the product has the potential to become an essential treatment for people living with advanced fibrosis due to nonalcoholic steatohepatitis (NASH), the most severe form of non-alcoholic fatty liver disease.
Intercept is among several companies in the race to market a drug for NASH in the industrialized world; the company...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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