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.
CE Mark Approval for Medtronic Radial Artery Portfolio
Global leader in medical technology, Medtronic, has been granted CE Mark approval for its radial artery access portfolio, comprising of their Rist 079 Radial Access Guide Catheter and Rist Radial Access Selective Catheter. Characterized by its ability to access the...
GSK’s COVID-19 Antibody Treatment Approved in Japan
GSK's (GlaxoSmithKline) and Vir Biotechnology's antibody treatment for COVID-19, Sotrovimab has been approved in Japan, Health Minister Norihisa Tamura announced this week. Aiming to treat mild to moderate coronavirus cases, GSK's antibody treatment does not require...
Early Parkinson’s Disease Can be detected by Apple Watches and iPhones
Apple Devices can identify individuals with early, untreated Parkinson’s disease (PD), according to recent research. Data from the 12-month WATCH-PD study, which included 132 individuals (82 with PD and 50 controls), highlighted the differences in a finger-tapping...
Pfizer-BioNTech Booster Gains FDA Limited Authorization
Pfizer-BioNTech has been granted FDA (Food and Drug Administration) authorization for its booster shot for people aged 65 and older, as well as individuals at high risk for severe disease and those working in patient-facing healthcare, six months are their second...
Vaccines Europe Calls for Vaccine-specific HTA and Committee
Vaccines Europe has called for an EU-wide committee to implement vaccine-specific clinical health technology assessment (HTA) methodologies in a recent position paper. The paper highlights the broader need for the European Commission (EC) to employ a set of common HTA...
Cervical Cancer: Seagen & Genmab Granted FDA Accelerated Approval
The US FDA (Food and Drug Administration) has granted Seagen and Genmab accelerated approval for TIVDAK (tisotumab vedotin-tftv) to treat adult patients with recurring or metastatic cervical cancer who have previously received disease progression or chemotherapy....
Moderna Shot Higher Effectiveness than Pfizer & JJ, CDC Says
A Centers for Disease Control and Protection (CDC) US-based study has found that the Moderna vaccine is more effective than Pfizer & JJ vaccines at preventing hospitalizations due to COVID-19. The agency’s Morbidity and Mortality Weekly Report states that, the...
MS: EMA Committee Supports Diroximel Fumarate Approval
European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has announced their approval of diroximel fumarate (Vumerity, Biogen Inc) for adults diagnosed with relapsing-remitting multiple sclerosis (MS). Although Diroximel fumarate is...
Dr. Vladimir Misik Interview: What Clinical Trial Market Will Remain Competitive?
CSOFT Health Sciences sat down with Dr. Vladimir Misik, board member of leading European CRO, SanaClis, as well as Partner and Founder of LongTaal, and Partner and Co-founder of VIARES Academy, in our newest podcast episode of Coffee & Conversations to evaluate...
FDA, EMA Launch PSA Pilot for Complex, Hybrid Generic Drugs
The US FDA (Food & Drug Administration) and the EMA (European Medicines Agency) have launched a joint pilot designed to give parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines (as they’re referred to in the EU). The aim of...
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