Monday, April 27, 2020

Gilead's COVID-19 hopeful remdesivir may get swift Japanese approval

From FierceBiotech:

"Japanese Prime Minister Shinzo Abe is set to grant Gilead Sciences' experimental COVID-19 drug remdesivir a special, speedy approval, despite it failing to show any definitive clinical signs that it works.
The report, from Japanese news site Kyodo, could make Japan the first country in the world to approve the med, which was once being tested for Ebola. A green light for the med could come as early as May, Kyodo reports.
“The pharmaceutical approval (of remdesivir) will be possible shortly,” Abe told a parliamentary session, as quoted by the news agency. Gilead will have to make an application for an approval, at which time the Japanese government is set to fast-track its way to market..."
Approved for human use before applying for a license? Wonder how much that cost.  Once the first domino is down, approval in other countries gets a lot easier.

From STAT:

"New data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients. Company still sees reason for hope"

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