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.
AffaMed: IND Clearance for AM712 to Treat Retinal Diseases
AffaMed Therapeutics’ Investigational New Drug (IND) application for the clinical development of AM712 (ASKG712), a novel proprietary bispecific biologic molecule, has been cleared by the US Food and Drug Administration (FDA). AM712 has been designed to treat retinal...
Axcella: FDA Fast Track for AXA1125 to Treat NASH
The US Food and Drug Administration (FDA) has granted a Fast Track Designation to Axcella Therapeutics’ AXA1125 to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis. NASH is the most severe form of fatty liver disease and if left untreated, can lead to...
European Union Clinical Trials Regulation (EU-CTR 536/2014)
On 31 January 2022, the anticipated European Union (EU) Clinical Trials Regulation 536/2014 (EU-CTR) came into effect, replacing the long-standing European Union Clinical Trials Directive 2001/20/EC (EU-CTD) legislation that regulates the clinical trial landscape in...
FDA Awards QIDP Designation to Evofem Biosciences
The U.S. Food and Drug Administration (FDA) has awarded Evofem Biosciences a Qualified Infectious Disease Product (QIDP) Designation to EVO100 (Phexxi) for the prevention of chlamydia. Chlamydia has been reported to be responsible for up to half of all pelvic...
VCN Biosciences’ VCN-01 Receives FDA Designation
Synthetic Biologics has announced that VCN Biosciences has received an Orphan Drug Designation from the US Food and Drug Administration (FDA) for their therapy, VCN-01, to treat retinoblastoma. Retinoblastoma is a rare cancer of the eye that develops from immature...
Eureka Therapeutics: ODD to Treat Hepatocellular Carcinoma
Eureka Therapeutics has announced the US Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) to their therapies, ET140203 and ECT204, for the treatment of hepatocellular carcinoma (HCC). HCC is the most common form of liver cancer and...
NGM Bio’s NGM621 Receives FDA Fast Track Designation
The US Food and Drug Administration (FDA) has granted a Fast Track designation to NGM Bio’s NGM621 for the treatment of patients with geographic atrophy (GA) secondary to age-related macular degeneration. GA is an advanced form of age-related macular degeneration and...
BioCardia: CardiAMP System to Treat Heart Failure
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the BioCardia’s CardiAMP® Cell Therapy System designed for the treatment of heart failure. Heart Failure (HF) is a complex, progressive clinical syndrome that affects the...
Moderna’s COVID-19 Vaccine SPIKEVAX Snatches FDA Approval
The US Food and Drug Administration (FDA) has recently approved Moderna’s mRNA COVID-19 vaccine, SPIKEVAX, becoming the second COVID-19 vaccine to be fully approved in the US. Now marketed under the name SPIKEVAX, the vaccine’s name references the spike-like...
FDA Designation: THE-630 to Treat Gastrointestinal Tumors
Theseus Pharmaceuticals announced the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for THE-630 to treat patients with advanced gastrointestinal stromal tumors (GIST). GIST is the most common sarcoma of the gastrointestinal tract, and...
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