Nearly 18% of clinical data reported in August were focused on the COVID-19 pandemic, representing the highest percentage for any single month this year. During the month, as the Delta variant took hold throughout the U.S., news of COVID-19 efforts spiked, doubling the amounts seen in both June and July, in which about 9% of the news was pandemic-related, and up significantly from 10% in May.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amivas, Biocryst, Calliditas, Camurus, Cour, GSK, Golden, NFL, Pfizer, Stada, Takeda.
As members of the White House COVID-19 Response Team talk about COVID-19 boosters as if they are a fait accompli for Americans even before the FDA completes its evaluation of the data, the controversy continues to roil around the need for another vaccine dose.
Continuing an upward trajectory, BioWorld’s Drug Developers Index (BDDI) has climbed more than 10% since the start of this year, following sharp drops at the end of March and May. Shares began to rebound in June and the index has shown a steady incline, similar with the Nasdaq Biotechnology Index, which is currently up 12%.
The Biden administration’s haste to roll out an eight-month COVID-19 vaccine booster program next week is bumping up against the reality of the data and the regulatory process.
With the U.S. logging more than 4 million new COVID-19 cases in the past few weeks, federal purchasing of antibody cocktails from Regeneron Pharmaceuticals Inc. and Eli Lilly and Co. is continuing to grow. The government has placed orders for $2.94 billion worth of Regeneron's REGEN-COV (casirivimab and imdevimab) and about $330 million of Lilly's etesevimab to complement doses of bamlanivimab it previously purchased. Both antibody combinations, approved under FDA emergency use authorizations (EUAs), have been shown to reduce risk of hospitalization or death from COVID-19.