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Keeping Track: Orladeyo, Danyelza, Imcivree Bring CDER 2020 Novel Approval Count Even With Full-Year 2019

Executive Summary

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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Rhythm Leans On Imcivree Rare Disease Commercialization For New Indication

The company got FDA approval for the drug in Bardet-Biedl syndrome, on top of the existing approval from November 2020 in obesity due to POMC, PCSK1 and LEPR deficiency.

Hereditary Angioedema Market Snapshot: Room For Pills And Injections As Prophylaxis Makes Gains

While many HAE patients converted from injectable prophylaxis to BioCryst’s oral Orladeyo last year, physicians said a promising injectable candidate from Ionis could benefit from varied patient preference.

Deal Watch: Lilly Teams With Regor On Metabolic Disorders

Chinese firm RareStone licenses Rhythm’s Imcivree in greater China and will help enroll label-expansion studies for the drug. Omeros sells ophthalmic surgery drug Omidria and its commercial team to Rayner Surgical Group.

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