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.
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...
Acute Viral Pneumonia Treatment LungFit Approved by Beyond Air to Enter Clinical Study
In November 2020, the clinical study for treatment of acute viral pneumonia, facilitated by Beyond Air, a medical device and pharmaceutical company, is scheduled to commence. The study will consider enrollment for anyone infected with COVID-19 and pneumonia caused by...
Non-Opioid Pain Management Treatment in Phase One of Clinical Trial
Today (10/20) AmacaThera was granted approval from Health Canada to send their post-operative long-term anesthetic into phase one of clinical trial. This is the first drug they have sent through the clinical trial phase a milestone for the company. AmacaThera was...
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