Sheila Jacobs

All articles by Sheila Jacobs

• Golexanolone shows promise in PBC in phase 2 trial

  According to interim phase 2 data, golexanolone has a favorable safety and tolerability profile in people with PBC.

• Study: Recognizing extrahepatic conditions of PBC key to diagnosis

  A recent study shows prompt identification of extrahepatic conditions (EHCs) is of key importance for the precise, timely diagnosis of PBC.

• Ascletis drops potential PBC therapy following phase 2 data

  Ascletis has decided not to pursue additional clinical trials on the farnesoid X receptor (FXR) agonist ASC42 for the treatment of PBC.

• PBC and sleep disorders: strategies for a restful night

  If you are experiencing excessive daytime sleepiness (EDS) and poor quality of sleep due to PBC, there are some things you can do to help.

• Pruritus under-documented for patients with PBC

  A study found that cholestatic pruritus is under-documented in patient medical records, compared to patient-reported responses.

• EMA accepts MAA for CymaBay’s PBC therapy

  The European Medicines Agency has accepted for review the Marketing Authorization Application (MAA) for seladelpar in PBC.

• FDA accepts sNDA for Ocaliva for the treatment of PBC

  The FDA has accepted the supplemental New Drug Application for Intercept’s Ocaliva for the treatment of PBC.

• Genetic link found between PBC and connective tissue diseases

  Using a two-sample Mendelian randomization (MR) analysis, researchers found a genetic association between PBC and CTDs.

• Tharimmune’s PBC therapeutic shows promise in Phase 1

  Phase 1 results showed TH104 had a positive safety and efficacy profile, and Tharimmune is on track to begin a phase 2 study this year.