In a world without the COVID-19 pandemic, the FDA’s total of more than 50 novel drugs and biologics approved in 2020 would be another notable year in a string of the most productive years in modern agency history. In light of the restrictions and competing pressures assailing the agency during the COVID-19 pandemic, the healthy class of 2020 novel approvals is nothing short of remarkable.
US FDA 2020 Novel Approval Count Rises To 53 At CDER, Plus 5 New CBER Biologics
FDA reviewers stuck to established assessment practices during the coronavirus crisis and produced one of the agency’s largest yearly novel approval counts ever.
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Top areas for potential 2025 approvals were shaped by R&D focused on increasingly tightly targeted therapies, including the eight new candidates to join the still-burgeoning kinase inhibitor class and RNA interference, as well as many varieties of antibodies.
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CBER has at least 14 and CDER another 10 novel biologics among the more than 60 candidates with a user fee goal in 2025.
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Only one-third of novel agents with 2025 goal dates come from the traditional oncology, hematology and neuroscience strongholds. Immunodermatology also is cooling, while cardiovascular drugs return to the front burner.
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South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.
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Experts say PBMs should become familiar with transparency rules and prepare to release data, although more legal wrangling could occur.