Amarin Corporation (AMRN) tumbled 17.7% after the company announced that the FDA’s Office of New Drugs (OND) denied the company’s appeal regarding the rescission of the Special Protocol Assessment (SPA) covering the phase III ANCHOR study on Vascepa. Vascepa has been available in the U.S. since Jan 2013 as an adjunct to diet to reduce…
Medivation, Inc (MDVN) and partner Astellas Pharma Inc (ALPMY) received a major boost with the FDA expanding the label of their prostate cancer treatment, Xtandi. Xtandi, which was earlier approved for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who had previously received docetaxel (chemotherapy), can now be used in patients with metastatic…
Orexigen Therapeutics, Inc. finally gained FDA approval for its weight loss drug, Contrave (NB32, naltrexone hydrochloride and bupropion hydrochloride extended-release tablets). We expect investors to react positively to the news. The FDA cleared Contrave as an adjunct to a healthy diet (low on calories) and physical activity for chronic weight management in obese (Body Mass…
Last week was eventful for the biotech sector with highlights including a couple of FDA approvals (Xtandi’s label expansion and Contrave) and a positive FDA panel outcome (Natpara). However, the biggest gainer was Avanir Pharmaceuticals ( AVNR ), which came out with positive phase II data for the treatment of agitation in patients with Alzheimer’s…
NPS Pharmaceuticals (NPSP) received encouraging news when the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recommended the approval of the company’s hormone replacement therapy Natpara (rhPTH [1-84]). NPS Pharma’s candidate was recommended for long-term use to treat patients suffering from hypoparathyroidism, a rare disease caused by the deficiency/absence of parathyroid hormone, by…
Shares of Avanir Pharmaceuticals (AVNR) gained a massive 85.31% to close the trading session on Sep 15 at $12.49. The jump came on the back of encouraging data from a phase II study (n=220) on Avanir‘s AVP-923, which evaluated the safety, tolerability and efficacy of the candidate for treating agitation associated with Alzheimer’s disease. Data…
