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Pharma & Bio Ingredients
A fast-track designation allow a company to submit clinical trial data to the FDA as it becomes available, and get feedback, rather than having to wait and file it all at once.
The designation covers Nektar's Amphotericin B Inhalation Powder to help prevent fungal infections in the lungs in patients who are taking medications that suppress the immune system following organ or stem cell transplants to reduce the chances of rejection.
In February, Nektar received orphan drug status for the treatment. The status is given to drugs that treat diseases affecting less than 200,000 people in the United States. It allows seven years of market exclusivity if the drug is approved along with tax credits and help in designing a clinical trial for approval.
