Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
FDA Approves Amgen’s Lumakras for Lung Cancer Mutation
The U.S. Food and Drug Administration (FDA) has given Amgen’s Lumakras (sotorasib) accelerated approval as a treatment for patients diagnosed with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) - the first FDA approved treatment...
Fennec Pharmaceuticals Resubmits NDA for PEDMARK™
Fennec Pharmaceuticals has resubmitted their New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PEDMARK™, a unique sodium thiosulfate formulation. PEDMARK is designed to prevent ototoxicity caused by cisplatin chemotherapy in patients under...
FDA Places Restrictions for Obeticholic Acid (Ocaliva)
The U.S. Food and Drug Administration (FDA) has placed restrictions on the use of obeticholic acid (Ocaliva of Intercept Pharmaceuticals) in patients with primary biliary cholangitis (PBC) and advanced cirrhosis due to risk for serious liver injury. The restriction...
Belgium Suspends J&J Vaccine
The Johnson & Johnson COVID-19 vaccine has been suspended in Belgium for individuals under the age of 41 after the first reported death in the European Union linked to severe side effects associated with the shot. The European Medicines Agency (EMA) is currently...
Peace Engine Kyoto Granted cGMP Compliant by Third-Party Certification
Peace Engine Kyoto was granted U.S. cGMP (Current Good Manufacturing Practices) by a third-party certification for its manufacturing facility in Kyoto, Japan. Previously awarded a permit in 2020 by Japan's Ministry of Health, Labour, and Welfare for manufacturing...
COVID-19 Vaccine of CanSinoBIO Receives European GMP
CanSinoBIO announced today that the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI) has granted Good Manufacturing Practices (GMP) certification for its COVID-19 vaccine, Convidecia™. Dr. Xuefeng YU, Chairman and Chief Executive Officer of CanSinoBIO,...
FDA Clears Overjet’s AI Dental Assist
The U.S. Food and Drug Administration (FDA) has cleared Overjet's AI Dental Assist product, marking it the first AI technology to enter the dental industry to aid dental hygienists and dentists in real time. The SaMD (Software as a Medical Device) will support the...
Telehealth & Mental Health: COVID-19’s Impact for Global Well-being
Since the COVID-19 outbreak in 2020, there has been a significant rise in cases of mental health issues like stress, depression, and anxiety around the world. In addition to the anxiety surrounding the virus, disruptions in daily lifestyles globally have brought...
FDA Encourages Telemedicine For Gaps in Gene Therapy Trials
The U.S. Food and Drug Administration (FDA) is encouraging sponsors involved in gene therapy trials to fill data gaps with remote visits and telemedicine. The encouragement comes from Wilson Bryan, the FDA’s OTAT (Office of Tissues and Advanced Therapies) during the...
FDA Authorizes Roche for Testing COVID-19 Asymptomatic Individuals
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Roche for its cobas® SARS-CoV-2 Test. The cobas® SARS-CoV-2 Test is designed to test asymptomatic individuals suspected to have COVID-19. The Center for Disease Control (CDC)...
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