Newsletter - November 12, 2020
Five Ways Pfizer’s Covid Vaccine Changes the Life for All Other Covid Vaccines
This week, Pfizer’s announcement that its Covid vaccine is 90% effective upended the path to market for all other vaccines in development. There are 10 other vaccines currently in Phase 3 clinical trials; additionally there are 14 in Phase 2, and 38 in Phase 1 clinical trials worldwide, all of which have a new world to deal with...Read More
About 90% of Clinical Data Used for FDA Approval is From Non-US Sites
While it is well known that FDA accepts clinical trial data from anywhere so long as it meets certain quality standards, the full extent of the impact of this policy comes out in a report released by FDA this week. According to the report, almost 90% of the clinical data that was used for approval of all drugs and biologics....Read More
Five Ways Pfizer’s Covid Vaccine Changes the Life for All Other Covid Vaccines
This week, Pfizer’s announcement that its Covid vaccine is 90% effective upended the path to market for all other vaccines in development. There are 10 other vaccines currently in Phase 3 clinical trials; additionally there are 14 in Phase 2, and 38 in Phase 1 clinical trials worldwide, all of which have a new world to deal with...Read More
About 90% of Clinical Data Used for FDA Approval is From Non-US Sites
While it is well known that FDA accepts clinical trial data from anywhere so long as it meets certain quality standards, the full extent of the impact of this policy comes out in a report released by FDA this week. According to the report, almost 90% of the clinical data that was used for approval of all drugs and biologics....Read More