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The U.S. Food and Drug Administration has issued the draft guidance “Nonclinical Testing of Individualized Antisense Oligonucleotide (ASO) Drug Products for Severely Debilitating or Life-Threatening Diseases - Guidance for Sponsor-Investigators.”
Aro Biotherapeutics, a biotech firm engaged in the development of protein biologics called Centyrins, has signed a licencing deal that can potentially generate up to $1.4bn for the company.