FDA’s newly proposed draft guidance will support IND filings of antisense oligonucleotides, a new class of drugs.
Following decades of research and study, a new class of drug, known as antisense oligonucleotides (ASO), are maturing as drug development efforts advance. In tandem with a growing ASO pipeline, FDA has recently issued a draft guidance, IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators, for dealing with ASO investigational new drug filings.
Read this article in BioPharm International's Regulatory Sourcebook March 2021 eBook.
BioPharm International
eBook: Regulatory Sourcebook, March 2021
March 2021
Pages: 6–10
When referring to this article, please cite it as F. Mirasol, “Growing Pipeline of Antisense Oligonucleotides Prompts Guidance," BioPharm International Regulatory Sourcebook eBook (March 2021).
British Patient Capital Invests £10 Million in Maxion Therapeutics, Part of Series A Financing Round
March 27th 2025The £10 million (US$13 million) investment is part of a larger £58 million (US$75 million) Series A financing round to be used for the development of Maxion Therapeutics’ preclinical lead program for treating inflammatory diseases.