Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Aclaris, Ampio, Arch, Ascentage, Beigene, Bio-Thera, Curevac, Cynata, Edesa, Kyowa Kirin, Innovent, Kamada, Merck, Pear, PTC, Sanofi, Regeneron, Ultragenyx.
The latest global regulatory news, changes and updates affecting biopharma, including: Department of Defense, FDA, Minister of Health, National Center for Advancing Translational Sciences, NIH.
HONG KONG – Astellas Pharma Inc. reported positive results from phase III of its DOLOMITES study comparing the efficacy and safety of roxadustat to that of darbepoetin alfa in treating anemia in nondialysis-dependent, stage 3 to 5 chronic kidney disease (CKD) patients.
HONG KONG – India’s Ministry of Health and Family Welfare (MOHFW) has drafted rules for the manufacturing, import and the compassionate use of unapproved drugs in the treatment of patients.
BEIJING – Rare disease specialist Canbridge Pharmaceuticals Inc., of Beijing, said it is collaborating with the Horae Gene Therapy Center at the University of Massachusetts (UMass) Medical School to conduct gene therapy research with a focus on neuromuscular conditions.