All posts by BTS Research

EMA’s Blood Clot Investigation Finds AstraZeneca’s COVID-19 Vaccine Still Safe and Effective

By | Drug Industry Daily | No Comments

The European Medicines Agency (EMA) has concluded its evaluation of a small number of blood-clot cases in patients vaccinated with AstraZeneca’s (AZ) COVID-19 vaccine, finding the two-shot inoculation is still safe and effective, though it could be associated with low levels of blood platelets in very rare instances.
Source: Drug Industry Daily

Report: CDER is Meeting User Fee Goals but Struggling With Biosimilar Application Targets

By | Drug Industry Daily | No Comments

The FDA approved 17 original abbreviated new drug applications (ANDAs) in the third quarter of fiscal 2020, 14 in the fourth quarter and 18 in the first quarter of fiscal 2021. It’s seen a downward trend in manufacturing supplements for new drug applications (NDAs), biologics license applications (BLAs) and ANDAs, approving 314 in the third quarter of fiscal 2020, 277 in the fourth quarter and 149 in the first quarter of this fiscal year.
Source: Drug Industry Daily

OND Managed a Slew of EUAs, a Reorg, PDUFA Goals and Regular Business During Pandemic, Says Annual Report

By | Drug Industry Daily | No Comments

Despite the unprecedented disruption and shift in priorities that COVID-19 brought to FDA’s Office of New Drugs (OND) in 2020, the office approved 53 novel drugs, published 31 new guidances and wrapped up the reorganization it had been working on since 2019, said Peter Stein, OND’s director, in the office’s annual report.
Source: Drug Industry Daily