GENFIT a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announced that the FDA has cleared the IND to proceed with the Phase II trial aimed at evaluating elafibranor in PBC.
Spark Therapeutics and Pfizer Inc announced that Lindsey A. George, M.D a hematologist and attending physician at the Children’s Hospital of Philadelphia and lead investigator in the Phase 1/2 clinical trial of SPK-9001 for treatment of hemophilia B, will present an updated dataset from the ongoing Phase 1/2 clinical trial of SPK-9001 at the 58th American Society of Hematology (ASH) Annual Meeting, to be held Dec. 3-6, 2016, in San Diego.
AbbVie a global biopharmaceutical company announced that the U.S. FDA has granted Breakthrough Therapy Designation (BTD) for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor.
SYNCONA LLP and CANCER RESEARCH TECHNOLOGY (CRT) announce the formation of Achilles Therapeutics Ltd .The new private company will bring together world-class research from UCL (University College London) and the Francis Crick Institute, funded by Cancer Research UK and the National Institute for Health Research (NIHR).
Sun Pharma has announced late-breaking data from two pivotal Phase-3 clinical trials (reSURFACE 1 and 2) achieving the primary endpoint with tildrakizumab, an investigational IL-23p19 inhibitor, in patients with moderate-to-severe plaque psoriasis at the 25th European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria.