NASH

Liver cirrhosis is a chronic and progressive condition characterized by the gradual replacement of healthy liver tissue with scar tissue, known as fibrosis. This scarring disrupts the normal structure and function of the liver. It also leads to symptoms such as confusion, ascites, pruritus, weakness, fatigue, and b...

Zealand Pharma Announces the Positive Topline Results from its Phase III trial of Glepaglutide Zealand Pharma A/S, a biotech company specializing in peptide-based medicines, announced positive topline results from its phase III trial of glepaglutide. In the evenly randomized double-blind trial, 106 patients with...

AstraZeneca’s Danicopan Shows Positive Results in Phase III Trial Danicopan, an oral Factor D inhibitor developed by AstraZeneca, was expected to fail a phase II trial in rare kidney disease in 2020, but a new readout could revive the drug. Danicopan (ALXN2040) has demonstrated efficacy as an adjunct treatment f...

A New Dawn for CRISPR, Intellia Edits Cells Inside the Body Intellia Therapeutics, along with its partner Regeneron Pharmaceuticals, recently announced its successful attempt in editing the cells inside the body leveraging the CRISPR technique. The world’s first-ever trial that has their DNA edited through an in...

TLX66 Meets Study Objectives, Holding Out in AL Amyloidosis Telix Pharmaceuticals reported the results from the TRALA trial (Targeted Radiotherapy for AL Amyloidosis), a Phase I/IIa trial evaluating the safety and toxicity of TLX66 as the sole bone marrow conditioning agent prior to autologous hematopoietic stem...

Gannex received US FDA fast track designation for its NASH drug, ASC42 an FXR Agonist Gannex Pharma has received Fast Track designation approval from FDA for its drug candidate ASC42 for non-alcoholic steatohepatitis (NASH). The FTA designation will help the pharma company to advance its research and development...

Orchard licenses the gene therapy technology from GlaxoSmithKline  Orchard Therapeutics has permitted lentiviral stable cell line technology from GlaxoSmithKline for its use in hematopoietic stem cell gene therapies. GSK filed for patents on the tech before selling its rare disease gene therapy portfolio to...

Intercept Pharmaceuticals receives a clear rejection from the FDA for its NASH drug, Obeticholic acid (OCA) Intercept Pharmaceuticals announced the issuance of a Complete Response Letter (CRL) by the FDA regarding the New Drug Application (NDA) for Obeticholic acid (OCA) for the treatment of fibrosis due to ...

Algernon Pharmaceuticals has announced the submission of an Investigational New Drug (IND) application of its drug, NP-120 for COVID-19.  The company has submitted the IND with the US FDA for its planned multinational Phase 2b/3 study of its repurposed drug NP-120 (Ifenprodil) for the treatment of patients ...

Horizon Therapeutics has become the first company to receive the regulatory approval of its drug Tepezza for the cure of Thyroid Eye Tepezza (teprotumumab-trbw) is the first-ever treatment approved for thyroid eye is a progressive autoimmune disorder hampering the ability of vision. The drug was approved under P...