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Insys’ Ovarian Cancer Treatment Receives Orphan Drug Designation from the FDA

The US Food and Drug Administration (FDA) granted Orphan Drug designation for Insys Therapeutics’ ovarian cancer candidate. The agency granted the designation to Insys’ Liposomal Encapsulated Paclitaxel (LEP) candidate for the treatment of ovarian cancer. The FDA’s Office of Orphan Products Development grants novel drugs or biologics that treat rare …

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Shire Gains as FDA Approves NPS Pharma’s Endocrine Disorder Drug

On Friday, the US Food and Drug Administration (FDA) approved NPS Pharmaceuticals’ rare endocrine disorder drug Natpara (parathyroid hormone), justifying Shire’s $5.2 billion acquisition of the company. The agency approved NPS’ Natpara to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 …

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FDA and EC Approve Novartis’ Psoriasis Drug Cosentyx

The US Food and Drug Administration (FDA) and the European Commission (EC) approved Novartis’ biologic Cosentyx (secukinumab) as a treatment for psoriasis. Today, Novartis announced that it has received FDA-approval and recently received EU approval for the drug, making it the first drug in the interleukin-17A (IL-17A) inhibitor class to …

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FDA Grants Fast Track Status to Marathon’s Duchenne Muscular Dystrophy Drug

Marathon Pharmaceuticals’ investigational Duchenne Muscular Dystrophy (DMD) drug was granted Fast Track designation by US health regulators. The rare-disease focused biopharmaceutical company recently announced that the US Food and Drug Administration (FDA) granted fast track status for its deflazacort for treatment of patients with DMD, a fatal muscle disease found …

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Neurocrine Biosciences’ Rare Adrenal Disease Drug Receives Orphan Designation by the FDA

San Diego-based Neurocrine Biosciences, Inc. announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to its investigational congenital adrenal hyperplasia (CAH) drug. The agency granted orphan status to NBI-77860, a proprietary corticotropin releasing factor 1 (CRF) receptor antagonist for treatment of CAH, a disease that …

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FDA Panel Recommends Approval of Sandoz’s Biosimilar Version of Neupogen

A panel of advisors for the US Food and Drug Administration (FDA) has recommended approval of Novartis’ investigational biosimilar version of Amgen’s Neupogen (filgrastim). The agency’s independent Oncologic Drugs Advisory Committee (ODAC) voted 14-0 in favor of approving Novartis’ biosimilar version of Amgen’s cancer drug Neupogen, which boosts white blood …

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