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.
Jet 7 Xtra Flex Catheter for Stroke Patients Recalled by Penumbra
Following the close of the market on Tuesday, Penumbra announced the U.S. Food and Drug Administration (FDA) advised recall of their catheter device resulting from 14 reported patient deaths, among other patient hemorrhages,...
Emergency Use Authorization Given to Ellume’s At-Home COVID-19 Test
On December 15, 2020, the U.S. Food and Drug Administration (FDA) approved the first over the counter fully at-home COVID-19 Test. The test delivers results in approximately 20 minutes and diagnoses individuals as young as two years old and is expected to be delivered...
Pre-Market Review Option Rolled Out by FDA for 510k Clearance
Under its Abbreviated 510k Program, the U.S. Food and Drug Administration (FDA) outlined guidelines for the Safety and Performance Based Pathway, a fast track for medical devices in well established categories to gain market...
Pfizer and BioNTech Receive Premier COVID-19 Vaccine Authorization
Pfizer and BioNTech have made history with their COVID-19 vaccine, as it is the first to enter the U.S. market after Phase 3 clinical trial results showing 95% efficacy. The mRNA vaccine is being allocated for emergency use to hospitals nationwide,...
AstraZeneca Partners with Sputnik to Boost COVID-19 Vaccine Efficacy
Russia’s Sovereign Health Plan disclosed today (12/11) that Sputnik-V will be joining AstraZeneca in their pursuit for a COVID-19 vaccine. The joint vaccine production will enter clinical trial phases on adults 18 years and older by the...
The European Medicines Agency (EMA) Suffers Cyber Attack
BioNTech released a statement on December 9, 2020 that Pfizer and their COVID-19 vaccine documents was “unlawfully accessed” in a breach on the European Medical Agency's (EMA) system. The severity of the attack was not divulged, however the EMA disclosed that they...
FDA Breakthrough Designation Given to ReGelTec
ReGelTec, a medical device company out of Baltimore’s leading medical device HYDRAFIL, has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA). The Breakthrough Device Program was created with intentions to expedite the...
Injection for Treatment of Hereditary Angioedema Released in China
Today (12/8) Takeda announced the approval of the first modern preventative therapy for Hereditary Angioedema, TAHZYRO, for patients 12 and above from China’s National Medical Products Association (NMPA). The disease is chronic and life threatening, and it affects one...
CRISPR Therapeutics & Vertex Pharmaceuticals Present Data on Gene-Editing Therapy for Sickle Cell Disease
The New England Journal of Medicine detailed findings of a sickle cell anemia treatment that showed promising data, marking huge strides in CRISPR technology as well as gene editing. These findings were published on December 5, 2020 and were...
Analysis on Pfizer’s COVID-19 Vaccine Distribution Leaves Many Healthcare Workers Unprotected
Countrywide, hospitals are preparing for the first 3.2 million shipments of Pfizer’s COVID-19 vaccine. The first round of shipments will be distributed to five government agencies before Moderna’s vaccine hits the market. State’s will have final say on...
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