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 PARP Inhibitor Pamiparib of BeiGene
China's regulatory body, the National Medical Products Administration (NMPA), has granted conditional approval to BeiGene's PARP inhibitor pamiparib for treatment of patients advanced ovarian cancer. The approval marks the first for pamiparib and the third for...
FDA Approves Viome’s mRNA Technology and AI Platform for Detecting Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the early detection of oral and throat cancer through their proprietary mRNA technology in combination with Viome's next-gen AI platform. The first-of-its-kind tool screens...
Pfizer & BioNTech COVID-19 Vaccine Expected Approval From FDA for Younger Teens
Pfizer & BioNTech's COVID-19 vaccine is expected to receive FDA approval for adolescents ages 12 and older sometime this week. The expected approval comes from a Phase III trial in adolescents between the ages of 12 and 15 with 2,260 participants that demonstrated...
U.S. Patent Granted to Kemin Industries for Treatment of Human Immune Function
Kemin Industries has announced that the U.S. Patent and Trademark Office has granted the US 10,912,794 patent on the beta 1, 3 glucan for treating inflammation in the intestine and modulating human immune function. The patent approval comes after the US 9,574,217...
FDA Approves Chiesi Global Rare Diseases’ Ferriprox for Sickle Cell Disease
The U.S. Food and Drug Administration (FDA) approved Chiesi Global Rare Diseases' Ferriprox for treating transfusional iron overload which is caused by sickle cell disease (SCD). The treatment is approved in patients three years old and older, and expands the drug use...
In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746: Five key questions answered for MedTech Companies
It has been almost four years since the European Commission passed the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 on May 26, 2017. With the new regulation set to be implemented in 2022, medical device manufacturers looking to market their products...
Alzheimer’s Drug Shows Language Improvement for Fragile X Syndrome
A new study published in the Nature Medicine journal has shown that Tetra Therapeutics' Alzheimer's investigational disease drug improves language and learning ability in adults diagnosed with Fragile X Syndrome. Fragile X Syndrome is a genetic condition that causes...
Moderna Working on Improving COVID-19 Vaccine
Moderna, currently one of three companies granted emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine, is continuing its efforts in improving the vaccine. Currently, the vaccine must be stored in cold temperatures;...
Parkinson’s Clinical Trial Approved by FDA
The U.S. Food and Drug Administration (FDA) announced its approval of Hope Biosciences Stem Cell Research Foundation's (HBSCRF) Phase II double blind placebo controlled Parkinson's clinical trial. The clinical trial will test the efficacy and safety of multiple...
Health Canada Grants Marketing Approval to Rockwell Medical for Triferic® AVNU™
Health Canada granted marketing approval today (April 27) to Rockwell Medical for its Triferic AVNU, a ferric pyrophosphate citrate injection designed to replace iron for hemoglobin maintenance in adults with hemodialysis-dependent chronic kidney disease. The drug is...
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