K-Bio receives FDA Orphan Drug Designations with novel drugs
By Son, Hyung-Min | translator Kang, Shin-Kook
24.07.08 05:11:39
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Targets the U.S. market¡¦10 FDA designations in the first half of the year
Clinical trials are being conducted in various diseases, such as Fabry disease, sarcoma, and lymphomas
In the first half of the year, Korean biopharmaceutical companies succeeded in obtaining numerous Orphan Drug Designations. Few patients have rare diseases but developing innovative new drugs can create added value and an exclusive position in the market. In the United States, if a drug is designated as an orphan drug, it is provided seven years of the market exclusivity period. Additionally, the company is provided with support for development and reduced taxes. After completing a phase 2 trial, the drug can be conditionally sold. As a result, biopharmaceutical companies in Korea actively seek FDA orphan drug designation.
According to industry sources on July 8th, the U.S. Food and Drug Administration (F
Son, Hyung-Min(shm@dailypharm.com)
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