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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. Read More
Top U.S. health officials, including an FDA regulator testified on Capitol Hill this week that real-world evidence from people vaccinated against COVID-19 and data from ongoing trials will be used to decide how vaccines should be updated to handle variant strains. Read More
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. Read More
In a marked change in policy, the U.S. will send an estimated 4 million doses of AstraZeneca (AZ)/Oxford University’s COVID-19 vaccine to Canada and Mexico, according to a White House press briefing yesterday. Read More
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. Read More
A letter to vaccination sites in the UK has cautioned that supplies of COVID-19 vaccines will be tight for about four weeks starting near the end of the month, but Pfizer has offered assurance that it is on track to meet its supply commitments on time. Read More
The FDA has extended its review period for AbbVie’s supplemental New Drug Application (sNDA) for Rinvoq (upadacitinib) as a treatment for adults with psoriatic arthritis. Read More
The FDA is preparing to conduct what it’s calling the first-ever systemic study examining how pharmaceutical brand names influence perceptions about drug efficacy. Read More