Genfit’s elafibranor was granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of Primary Biliary Cholangitis (PBC) in adults with inadequate response to ursodeoxycholic acid.
Six months after forging a hepatitis B drug development deal valued at more than $3.7 billion with Arrowhead Pharmaceuticals, Janssen Pharmaceutical presented data that showed the RNA interference (RNAi) therapeutic candidate exhibited robust effects on the liver disease that takes the lives of more than 900,000 people annually.
Cambridge, Mass.-based Alnylam Pharmaceuticals indicated that the company’s ENVISION Phase III trial of givosiran was positive for acute hepatic porphyria (AHP).
Novo Nordisk and Gilead Sciences will join forces on a clinical trial combining drugs from the two pharmaceutical firms to treat a progressive fatty liver disease known as NASH.
Regeneron Pharmaceuticals is investing $800 million in Alnylam Pharmaceuticals to develop treatments for eye and central nervous system diseases using gene-silencing RNA interference technology.
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
The U.S. Food and Drug Administration placed a clinical hold on an Investigational New Drug Application (IND) for Translate Bio’s rare liver disease treatment asset, MRT5201.
The FDA issued draft guidance for biopharma companies on developing therapies for NASH with liver fibrosis.
Swiss drugmaker Roche is buying U.S.-based Jecure Therapeutics, joining Pfizer, Gilead Sciences and Novartis in pursuit of new drugs to treat fatty liver disease.
Novartis AG and Pfizer Inc. are teaming up to develop treatments for a liver disease tied to obesity and diabetes epidemics that many drug companies believe will become a hugely lucrative market.