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Krzysztof Nowak · dec. 15 02 21. File. Remouse Standard 3.4.1. Keygen .The federal government is allowing the importation of a drug used to treat Duchenne muscular dystrophy and other rare pediatric genetic disorders, ending a months-long battle between two American pharmacists and the US Food and Drug Administration.
On Wednesday, the FDA granted export authorization to BioMarin Pharmaceutical for the purchase of US-made laronidase, which is used to treat the MPS II (mucopolysaccharidosis type II) disease. The agency also gave permission to BioMarin to carry out the export after it had issued a formal notice of intent to require a full application for export.
BioMarin first applied for the export authorization in March 2014, but the FDA stalled it until it got a letter from the manufacturer and distributor, Cook Biotech, asking for the approval. Several other manufacturers would have had to have joined BioMarin and Cook Biotech in exporting the drug, but that was a logistical impossibility, said FDA spokesperson Erica Jefferson.
Despite the typical two-year approval delay, the drug could be delivered to Boston Children’s Hospital as early as this week, said Nicholas Mattei, a spokesperson for the hospital. “This is great news for our patients and for their families,” he said.
“We are very gratified that the FDA has authorized the export of our gene therapy product laronidase, a therapy that has already been approved for commercial sale in the European Union and Canada.
“This authorization marks another milestone in the development of this promising and effective treatment for children with MPS II disease,” said Dr. John Constantino, CEO of BioMarin Pharmaceutical, in a press release. “We expect our progress in the treatment of MPS II to accelerate in the coming months as we begin to more fully study the drug in our carefully designed clinical trials.”
The approval ends a dispute between the American pharmacists and the US government over the importation of the drug to treat MPS II, an incurable orphan disease that affects about one in 30,000 births.
In 2012, the American Pharmacists Association sued the US government over the issue, arguing that the FDA was acting against its ethical principles by barring the importation of a drug approved for sale in another country, regardless of the country�






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How to test typescript modules from the command line
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