Durect | MedPath

Larsucosterol Shows Promising 90-Day Mortality Reduction in Phase 2b Alcohol-Associated Hepatitis Trial

4 months ago

• Phase 2b AHFIRM trial results published in NEJM Evidence demonstrate larsucosterol reduced 90-day mortality by up to 41% in alcohol-associated hepatitis patients compared to placebo. • U.S. patient subgroup analysis revealed even more substantial mortality reductions of 57-58% with both 30mg and 90mg doses, showing strong statistical significance. • The drug demonstrated a favorable safety profile with treatment-emergent adverse events comparable to placebo, marking a potential breakthrough for a condition with no FDA-approved therapies.

Gilead's Seladelpar Receives European Commission Approval for Primary Biliary Cholangitis

5 months ago

• The European Commission has granted conditional marketing authorization for Gilead's seladelpar for primary biliary cholangitis (PBC). • Seladelpar is approved for use in combination with UDCA for those with inadequate response, or as a monotherapy for those who cannot tolerate UDCA. • The approval is based on Phase 3 RESPONSE trial data, showing significant improvements in biochemical response and pruritus reduction. • This decision provides a new treatment option for PBC patients in Europe, addressing a critical unmet need.

Novartis' Sandoz Partners with Pear Therapeutics to Combat Substance Use Disorders with Digital Solutions

7 years ago

• Sandoz, a Novartis division, has partnered with Pear Therapeutics to commercialize reSET, the first FDA-approved mobile medical application for treating substance use disorders. • The collaboration includes development of reSET-O, a specialized digital therapeutic for opioid use disorder patients undergoing buprenorphine treatment. • This strategic partnership expands upon an existing collaboration between Novartis and Pear to develop digital therapeutics for schizophrenia and multiple sclerosis patients.