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.
Study Shows AstraZeneca Vaccine Ineffective Against South African Variant
The New England Journal of Medicine published results from a study to test AstraZeneca's vaccine's efficacy for the South African variant of COVID-19. The clinical study was conducted in South Africa with 1,467 participants, of which 2.5% developed mild-to-moderate...
FDA Provides Smooth Pathway for COVID-19 Screening Tests
The U.S. Food and Drug Administration (FDA) is providing further guidance and a smoother path for COVID-19 screening tests, specifically for asymptomatic patients. Part of this process includes the release of a fact sheet for those interested in organizing screening...
EMA Offers Guidance on Labeling for COVID-19 Therapeutics
The European Medicines Agency (EMA) offered guidance on labeling requirements for COVID-19 therapeutics as a follow up on their guidance from last year that offered labeling requirement flexibilities on COVID-19 vaccinations. According to the EMA, the product's...
E-Labeling for the Life Sciences Industry
There has been a drastic increase in regulations surrounding labeling for medical devices over the past decade. As our world shifts towards a more digital landscape, e-labeling, which is an electronic version of an Instruction for Use (IFU), has become more popular...
FDA Grants Approval for Medtronic’s Labeling of Intellis™ Platform
The U.S. Food and Drug Administration (FDA) granted approval for revised commercial labeling of Medtronic's Intellis™ Platform with Differential Target Multiplexed (DTM™). The platform is meant to treat chronic and intractable leg and back pain. Charlie Covert, VP and...
Melinta Therapeutics’ Antibiotic Approved by FDA for Serious Skin Infections
The U.S. Food and Drug Administration (FDA) approved of Melinta Therapeutics' antibiotic Kimyrsa (oritavancin) for adults diagnosed with acute bacterial skin and skin structure infections (ABSSSI). Caused by susceptible isolates of designated Gram-positive...
PTC Announces Results of Real-World Study
PTC Therapeutics announced today the results of its real-world study for patients diagnosed with Becker muscular dystrophy (BMD) and Duchenne muscular dystrophy (DMD) who switched between prednisone to EMFLAZA® (deflazacort) after the U.S. Food and Drug...
FDA Clears Baxter’s AK 98 Hemodialysis Machine
Baxter International announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its Artifical Kidney 98 (AK 98) dialysis machine. The next-gen, easy-to-use, portable machine is designed to administer hemodialysis (HD) treatments. Gavin...
FDA Grants Orphan Drug Designation to Alkermes for Treatment of Mucosal Melanoma
Alkermes today (3/11) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for its nemvaleukin alfa, an investigational engineered interleukin-2 (IL-2) variant immunotherapy for treatment of mucosal melanoma, a rare type of...
FDA Grants IND Clearance for Melior Pharmaceuticals’ COVID-19 Therapy
The U.S. Food and Drug Administration (FDA) cleared Melior Pharmaceuticals' Investigational New Drug (IND) application for it's COVID-19 therapeutic candidate, tolimidone. Taken as an oral pill once a day, Tolimidone is a novel lyn kase activator designed to treat...
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