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.
NMPA Approves Adalimumab Injection SULINNO® for Arthritis Treatment
Biopharmaceutical company Innovnet Biologics, Inc. announced today (9/3) that the National Medical Products Administration (NMPA) has approved SULINNO®, an adalimumab injection, for rheumatoid arthritis, ankylosing spondylitis and psoriasis treatment in China....
California Passes Bill to Claim Ownership of Prescription Drugs
On Monday (8/31), a bill was passed in California, with 32 in favor and 7 against, to redistribute the state’s market power to make prescription drugs more affordable and accessible. The COVID-19 pandemic has been said to act as proof that improvements must be made to...
FDA Approves Expansion of Remdesivir for Hospitalized COVID-19 Patients
Gilead, a research-based biopharmaceutical company, has reported that their new antiviral treatment for COVID-19 Remdesivir, has just been granted an expansion on emergency use authorization (EUA) by the FDA for all patients hospitalized due to COVID-19. Originally...
FDA Grants Approval to Laurent Pharmaceuticals to Start COVID-19 Phase 2 Clinical Trial in the United States
Laurent Pharmaceuticals, a Montreal based clinical stage biopharmaceutical company has come up with an oral drug candidate, LAU-7b, to potentially treat COVID-19. The U.S. Food and Drug Administration (FDA) has granted Laurent Pharmaceuticals to begin enrolling U.S....
Transcreation: Marketing Translations for Life Science Industries
Marketing translations is a vital step across all industries. With so many different cultures affecting global markets, it’s important to present branding messages in a way that is culturally sensitive as well as linguistically accurate for product’s or service’s...
RenalytixAI FDA Clearence for New Kidney Treatment Technology
RenalytixAI, an in vitro diagnostics that uses artificial intelligence, has filed a submission to the FDA to clear new kidney treatment called KidneyIntelx. KidneyIntelx is designed to optimize clinical management and patient outcomes of kidney disease research as...
EPA Grants Emergency Approval for Antiviral Coating to be Used for American Airlines
American Airlines has been given approval by the U.S. Environmental Protection Agency (EPA) to use a COVID-19 disinfectant on surfaces throughout the airplanes. The virus-killing spray is effective on surfaces for up to seven days, and the EPA is studying whether this...
Lowering Prescription Drug Prices for Affordability and Accessibility for US Citizens
One of the biggest areas of concern in the pharmaceutical industry, particularly in the United States, is the high costs of new treatments or drug therapies for patients. The recent initiatives from regulatory agencies like the Food and Drug Administration (FDA) to...
Health Canada Implements ICH Pediatric Drug Development Guidance
Health Canada has adopted a nonclinical safety testing guidance to help develop medication in pediatrics. This guidance called GuidanceS11: Nonclinical Safety Testing in Support of Development of Pediatric Medicines has been developed by the ICH and is slated to be...
FDA Rejects Gilead’s Rheumatoid Arthritis New Drug Application
Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotnib, a treatment for rheumatoid arthritis, which the FDA rejected due to safety concerns, particular in the 200mg dose. “We are disappointed in this outcome and will...
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