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Latest From Immunocore, Ltd.
Roche’s Vabysmo Grabs Top Growth Spot As Sales Decline
The Swiss major’s Q1 earnings show significant growth for Vabysmo, which poses a threat to competitor anti-VEGF drugs from the likes of Novartis and Bayer, even as overall group sales decreased.
The Evolution Of Drug Regulation In Post-Brexit Britain
Regulatory reliance is playing an increasingly important role in gaining marketing authorization in the UK following Brexit. Meanwhile, the country’s unique Innovative Licensing and Access Pathway is attracting growing levels of interest, not just from companies but from regulators and health technology appraisal bodies across the world.
End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes
Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year.
FDA’s Novel Approvals Again Led By Oncology And Neurology, But Dermatology Also Shone In 2022
Pink Sheet infographic breaks down the trends and surprises in 2022 approvals. Cancer therapies and non-malignant hematology exceeded the average use of expedited review programs but were weighted to orphan diseases, while dermatology saw first-in-class approvals for big markets.
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