FDA Guidance on Oligonucleotides and the need for new analytical methodologies

The FDA paper titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics” was released in June 2022. The paper provides guidance on the development of oligonucleotide therapeutics, which are a promising new class of drugs that target genetic material. Continue reading FDA Guidance on Oligonucleotides and the need for new analytical methodologies

FDA Issues Draft Guidance on Nusinersen Sodium

The obstacle to generic oligonucleotides may be analytical methodology The U.S. Food and Drug Administration (FDA) has recently released a draft guidance on nusinersen sodium, a drug used to treat spinal muscular atrophy (SMA). The guidance was issued in February Continue reading FDA Issues Draft Guidance on Nusinersen Sodium

Nusinersen API

Nusinersen is an oligonucleotide drug approved by the FDA in 2016 for the treatment of spinal muscular atrophy (SMA). SMA is a rare genetic disease that affects the muscles used for movement, breathing, and swallowing. Nusinersen is the first and Continue reading Nusinersen API

High Potency Active Pharmaceutical Ingredients for Generic Drugs

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Rare diseases affect a small percentage of the population and often have limited treatment options. However, the availability of High Potency Active Pharmaceutical Ingredients (HPAPIs) for generic drugs has played a critical role in addressing these diseases. HPAPIs are highly Continue reading High Potency Active Pharmaceutical Ingredients for Generic Drugs