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.
European Commission Provides Guidance on Codes Under IVDR
The Medical Device Coordination Group (MDCG), part of the European Commission, has provided a guidance document navigating the use of codes under the In Vitro Diagnostic Regulation (IVDR). The codes are used to describe the qualifications of both the notified body...
FDA Clears First Biodegradable Subacromial Balloon Spacer
The U.S. Food and Drug Administration (FDA) has cleared the first ever biodegradable subacromial balloon spacer developed by OrthoSpace Inc. and acquired by Stryker. The balloon, called InSpace, is the first implant for arthroscopic treatment of MIRCTs (massive...
FDA Accepts Pre-IND Request for Potential Cure for Hepatitis B
The U.S. Food and Drug Administration (FDA) has accepted Enochian BioSciences Pre-IND (Investigational New Drug) request for a potential cure of Hepatitis B (HBV). HBV is a viral infection that affects the liver. The request comes after promising results from a...
Anivive Awarded FDA Grant for Canine Cancer Research
The U.S. Food and Drug Administration (FDA) has awarded Anivive, a pet health tech company, a $500,000 USD grant to continue research on LAVERDIA™ -CA1 (verdinexor) and its effect on treating canine cancer. As one of four companies selected for the MUMS grant,...
Global Medical Affairs – The Next Generation of Innovation
On our most recent Coffee & Conversations podcast episode, podcast hosts Brigid and Shelby joined CSOFT’s President and CEO Shunee Yee and Professor Victoria Elegant, who serves as Vice-President of JAPAC Regional Medical Head of Amgen to discuss The Next...
AstraZeneca-Amgen Asthma Treatment Granted FDA Speedy Review
A drug by AstraZeneca and Amgen designed to treat asthma has been granted a speedy review by the Food and Drug Administration (FDA). The experimental drug tezepelumab aims to reduce asthma attacks for patients with severe and uncontrolled forms of asthma. Both...
UDI Guidance Finalized by FDA
The U.S. Food and Drug Administration (FDA) has finalized UDI guidance content requirements and form for unique device identifiers (UDIs), after five years from its first drafted release. The guidance covers two types of UDIs, including automatic identification and...
ANSEM Grants Cohort Temporary Authorization for Use to GenSight Biologics
ANSEM (the National Agency for Medicines and Health Products Safety), France's Competent Authority, has granted Cohort Temporary Authorization for Use (ATUc) to GenSight Biologic's LUMEVOQ®. LUMEVOQ® is a drug therapy designed to treat Leber Hereditary Optic...
Delta Variant: J&J COVID-19 Vaccine Shows Promising Results
Johnson & Johnson have announced that findings from a laboratory study have shown promising results for it its single-dose COVID-19 vaccine against the Delta variant. Blood analysis drawn from eight patients revealed that immune responses to the Delta variant were...
FDA Approves HDT Bio COVID-19 Vaccine Phase 1 Clinical Trial
The FDA (Food and Drug Administration) has evaluated HDT Bio Corp’s Investigational New Drug (IND) Application and given the company the green light for a Phase 1 clinical trial of its HDT-301 COVID-19 RNA vaccine. HDT Bio, a developer of immunotherapies for oncology...
Categories
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