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...
Brilanta by AstraZeneca Approved to Reduce Risk of Stroke
Brilanta was approved by the U.S. Food and Drug Administration (FDA) for its efficacy in reducing the risk of stroke in patients with acute-ischemic stroke based on the Phase 3 THALES Trial. Compared to aspirin alone, when taken with Brilanta there was a clinically...
Merck Acquires Velosbio for $2.75 Billion for Promising Cancer Therapy
Today (11/5) Merck announced their all-cash acquisition of San Diego’s VelosBio following the release of Phase 1 data of ROR1 targeting VLS-101. VLS-101 is a drug for treatment of hematologic malignancies, and exited clinical trial Phase 1 with results showing...
Biogen is Hopeful for First Alzheimer’s Drug in 20 Years to be Approved by FDA
Biogen’s aducanumab has been praised before a final approval meeting by the U.S. Food and Drug Administration (FDA) to treat the disease that is the sixth leading case of death among 65+, Alzheimer’s. Biogen is expecting “blockbuster” sales of over $1 billion from the...
First-of-its-Kind HIV Self-Test Approved by Health Canada
BioLytical Laboratories has been approved for the commercial use of their at-home HIV self-test kit that yields 99% accuracy and takes about one minute to produce results to combat the rising HIV cases in Canada. The INSTI HIV Self-Test kit is BioLytical’s newest...
FDA Approved Boston Scientific’s Ranger Balloon
The Ranger Drug-Coated Balloon was approved today (10/2) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with peripheral artery disease, a disease that affects 200 million people. The disease is characterized by a plaque build up in the...
Johnson & Johnson Informs CDC of Plans to Experiment Vaccine Candidate on 12-18-Year-olds
In late September, Johnson & Johnson commenced a clinical study for their COVID-19 vaccine candidate on 60,000 adults. A company executive declared that they would start experimenting as soon as possible, and depending on results, and other factors would continue...
Planning for Translations – Where to Start?
For life science companies, understanding their business needs for translations is critical for finding the right solution. With so many different options for translation, including employing freelance translators, full-service language service providers (LSP), and...
Moderna’s Late Stage COVID-19 Vaccine on Track to Release Data Next Month
Today, (10/29) Moderna said that will release data on its experimental COVID-19 vaccine that will give insight on its efficacy. The company says they will produce 20 million doses by the end of the year. Pfizer and BioNTech are using similar technology to create their...
World Health Organization Backed by COVAX to Deliver 200 Million COVID-19 Vaccines
The COVAX initiative, worth $18 billion, is planning to administer COVID-19 vaccines to two-thirds of the world’s population by 2021. Sanofi and GalxoSmithKline have agreed to supply 2 million doses to the World Health Organization (WHO) of a vaccine they have been...
FDA Grants Clearance to Abiomed’s Launch of their Artificial Lung
Abiomed’s cardiopulmonary bypass system was cleared by the U.S. Food and Drug Administration (FDA) today (10/27) proceeding their April acquisition of Breethe. The effects of COVID-19 have created an increased need for heart recovery in cardiogenic shock patients....
Moderna Inc. Agrees with Qatar Ministry of Public Health for COVID-19 Vaccine Candidate
Today (10/26), Moderna, a top Biopharmaceutical employer, agreed to supply Qatar with their candidate COVID-19 vaccine, which has not yet been approved by any regulatory body. Moderna is currently scaling up their global manufacturing capabilities to be able to...
Europe Runs Low on Pneumonia Vaccine as Demand Grows
With the spike in COVID-19 cases worldwide, there is an increasing amount of people who are seeking precautionary vaccines for respiratory issues in preparation for the winter. Merck’s Pneumovax 23, more specifically, has hit record high sale volumes worldwide in the...