NDA Submitted by Antengene in South Korea
Antengene submitted yesterday (1/3) a New Drug Application (NDA) with Orphan Drug Designation (ODD) to South Korea’s regulatory body, the Ministry of Food and Drug Safety (MFDS), for ATG-010 (selinexor). The NDA is specifically for the approval of ATG-010 (selinexor)...
AstraZeneca Unlikely to Receive EUA Approval Until April
According to Operation Warp Speed Chief, Moncef Slaoui, the AstraZeneca and Oxford University vaccine may not receive the U.S. Food and Drug Administration’s Emergency Use Approval (EUA) until April, despite the UK's approval yesterday (12/30). Questions surrounding...
NeuroRx and Relief Therapeutics Approved to Commence Phase 2b/3 Trial for ZYESAMI
NeuroRx and Relief Therapeutics have completed enrollment for their phase 2b/3 clinical trial for their treatment of respiratory failure in patients with severe cases of COVID-19. The trial, who’s top-line data is expected in one month, has...
FDA Risk Evaluation and Mitigation Strategy (REMS) for Fentanyl Products
The U.S. Food and Drug Administration (FDA) has made their REMS requirements for transmucosal immediate-release fentanyl (TIRF) products more rigorous to minimize inappropriate prescriptions for the strong and highly addictive opioid. The REMS guidelines serve as a...
InnoCare Pharma of Beijing Receives China’s National Medical Products Association Approval
The Chinese company InnoCare Pharma announced today (12/28) that its BTK inhibitor orelabrutinib received approval for the treatment of cancer and autoimmune diseases, specifically relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma...
Walmart Sued for Prescription Opioid Sales
The Department of Justice sued Walmart yesterday (12/22) for inadequately screening for questionable prescriptions, ultimately fueling the nation’s opioid crisis. According to the lawsuit, Walmart’s understaffed pharmacies pressured employees to fill prescriptions...
ABOUT US
CSOFT Health Sciences has over 15 years of experience providing end-to-end translation and localization solutions for all stages of the product life cycle, from pre-clinical to post-launch. We also specialize in China market access consulting services, Asian regulatory and eCTD submissions. Our operation is compliant with ISO 17100 and certified by BSI in ISO 9001:2015 and ISO 13485:2016, providing customized solutions to meet the rigorous regulatory requirements in global submission. For more information, please visit: www.csoftintl.com