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...
GBA-Health 2020 Annual Panel Discussion: An Interview with Co-Hosts Sam Olson and Brigid Delaney
In the face of global issues in the life sciences sector, cross-border communication and collaboration are more important than ever. To address this need, CSOFT co-organized the GBA-Health 2020 Panel Discussion on cross border opportunities and challenges in the life...
World Health Organization (WHO) Considers E-Vaccination Certificates
Today (12/3) a World Health Organization (WHO) medical expert divulged the organization’s discussions on an e-vaccination certificate for recovered COVID-19 travelers. The WHO has previously expressed concerns regarding "immunity passports" recommendations,...
Center for Disease Control (CDC) Adjusts Quarantine Guidelines
The U.S. Center for Disease Control (CDC) provided an alternative option to a 14-day quarantine standard, advising that patients with a negative test quarantine for 7 days, and those asymptomatic with no test results for 10. The adjustments were made in hopes to...
Review of Johnson & Johnson’s COVID-19 Vaccine Underway
After finding that the Johnson & Johnson vaccines triggered antibody cell formation to fight COVID-19, the European Medicines Agency (EMA) began to review the drug for emergency use authorization (EUA). Meanwhile, the company’s rivals Moderna and...
Moderna Requests FDA Emergency Use Authorization for mRNA-1273
Today (11/30) Moderna announced their plans to seek emergency use authorization from the U.S. Food and Drug Administration (FDA) for their COVID-19 vaccine candidate that reported a 94.1% efficacy rate. The study, that evaluated over 30,000 U.S participants,...
The Importance of Cross-border Cooperation at an International Event: A Reflection
In such a turbulent year, cross-border cooperation pertaining to global health has never been more important. Last week, CSOFT supported panel discussions at the Shenzhen 2020 International BioTech and Health Expo, with CSOFT CEO Shunee Yee joining speakers from key...
FDA Breakthrough Device List Includes Breast Cancer Treatment
A wide variety of medical technology devices are being more rapidly reviewed and tested for patient use through the U.S. Food and Drug Administration (FDA) Breakthrough Device List. Among the list of innovations are two breast cancer diagnostic tests along...
Essential Tremor Treatment Receives Funding from National Health Service (England)
INSIGHTEC, a global healthcare therapeutics company, has received funding from England’s public healthcare provider for their neurological disorder treatment, one that effects 41 million people globally. The treatment utilized acoustic sound energy, a...
WHO Declares Gilead’s COVID-19 Fighting Drug Ineffective
After an expert panel review of Gilead’s Remdesivir, no evidence was found that it was effective in treating COVID-19. In October, the U.S. Food and Drug Administration (FDA) granted the drug approval for usage in hospitals, and after rescinding the...
B-Cell Lymphoma Drug Receives FDA Priority Review
ADC Therapeutic’s Biologics License was approved by the U.S. Food and Drug Administration (FDA) for their relapsed/refractory diffuse large B-cell Lymphoma drug candidate. The antibody conjugate drug, that catalyzes cancer cell death is being investigated in a...
Phase 3 Trial of Johnson & Johnson COVID-19 Vaccine Underway in Spain
The Agency for Medicines and Health Products, the Spanish health regulator, has just approved the trial of the second segment of Phase 3 for Johnson & Johnson COVID-19 vaccine in 9 hospitals across the country. The New Brunswick based...
At-Home COVID-19 Test Gets FDA Emergency Use Authorization
Lucira Health, a California based company, has just received emergency use authorization (EUA) status from the U.S. Food and Drug Administration (FDA) for its fully-at-home COVID-19 diagnostic test. It will be available on a national level in Spring of 2021...
Moderna COVID-19 Vaccine Candidate Shows 95% Efficacy Rate
Based on long-term data from a late-stage trial including 30,000 participants, Moderna’s COVID-19 vaccine candidate has shown results of a 95% efficacy rate in fighting the virus. Moderna is planning to file for Emergency Use Authorization (EUA) in the coming...
Novum IQ Infusion Platform Gains Marketing Approval from Health Canada
Baxter Canada is increasing their product line in the realm of medication delivery and management with Novum IQ large volume syringe pumps, as they have just received marketing approval. The medical device uses new infusion protection...
Treatment Resistant Depression
Treatment resistant depression (TRD) describes various forms of depression that have undergone treatment and seen minimal, if any, long-term positive results. With depression affecting 6.7% of the United States’ population and over 300 million people worldwide, the...
Russia Announces Interim Results, Show Sputnik-V is 92% Effective in COVID-19 Protection
As Russian drug-makers surge to keep pace with Western pharma companies in the race for a COVID-19 vaccine, Russia has derived results from a late stage human trial on their own candidate, Sputnik-V. Their sample size of 20 participants was far smaller than...
Emergency Use Authorization Granted to Ab-Cellera Antibody
Bamlanivimab, an antibody effective in treating mild to moderate COVID-19 cases in adults and pediatric patients over 12 years of age who are at a high risk of hospitalization, was released today (11/10) by Ab-Cellera. Following their Phase 2 clinical trial,...
Pfizer Reaches Breakthrough Results with COVID-19 Vaccine Candidate
Based on initial trial results, Pfizer’s vaccine candidate for COVID-19 has proven to be 90% effective in fighting the virus. Pfizer and their German partner BioNTech expect a regulatory decision for emergency use authorization as soon as...