NPS Pharmaceuticals Inc. (NPSP) announced that the U.S. Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted 8 to 5 that the available data support the approval of Natpara (rhPTH [1-84]) for the long-term treatment of Hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of parathyroid hormone, or PTH.
NxStage Medical Inc. (NXTM), a manufacturer of dialysis products, announced that its single needle technology, OneSite, has received the U.S. Food & Drug Administration or FDA clearance. The OneSite employs a unique dual lumen needle design offered in both a sharp version with MasterGuard and a buttonhole...
The United States Food and Drug Administration or FDA has approved Baxter International Inc.'s (BAX) RIXUBIS for routine prophylactic treatment, control and prevention of bleeding episodes, and perioperative management in children with hemophilia B. RIXUBIS was the first recombinant factor IX or rFIX...
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ZS Pharma Inc.'s (ZSPH) two week, pivotal phase III trial of its investigational treatment for hyperkalemia, ZS-9, has demonstrated that once-daily dosing of the compound prevented the recurrence of hyperkalemia in patients with heart failure taking a stable dose of renin angiotensin aldosterone system (RAAS) inhibitor therapy.
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Theravance Biopharma's (TBPH) ongoing phase 2b dose-ranging study of investigational long-acting muscarinic antagonist - TD-4208 - has met its primary and secondary efficacy endpoints in the treatment of chronic obstructive pulmonary disease.
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Keryx Biopharmaceuticals Inc.'s (KERX) kidney drug Ferric Citrate (formerly known as Zerenex) received FDA approval on Friday for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
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The TJX Companies Inc. is recalling "ecoato" brand Sweet Paprika Powder from store shelves due to potential contamination with Salmonella bacteria. Investigation is being carried out to identify the source of the contamination.
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The FDA is warning consumers to avoid powdered pure caffeine sold over the internet as it is potentially dangerous and can result in death. Caffeine is one of the most commonly used stimulants in the U.S.
DateCompany NameTickerDrugEventOutcomeDetails
12/05/2014Incyte CorporationINCYRuxolitinib (sNDA)FDA decision on Ruxolitinib as a potential treatment in the addnl. indication of polycythemia vera patients who have had an inadequate response to or are intolerant of hydroxyurea
-Approved in Other Countries

11/26/2014Avanir PharmaceuticalsAVNRAVP-825 (NDA)FDA decision on AVP-825 for the acute treatment of migraine.
-Drug Status

-News
11/05/2014AEterna Zentaris IncAEZ.TO, AEZSMacimorelin Acetate (NDA)FDA decision on Macimorelin Acetate in treating in Adult Growth Hormone Deficiency
10/28/2014Merck & Co Inc.MRKMK-3475 (BLA)FDA decision on MK-3475 for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab FDA approved Keytruda (formerly known as MK-3475) for the treatment of melanoma patients who have not responded to prior therapies on Sep.4, 2014
-Drug Status

10/24/2014Roche Holding AGRHHBYAvastin (sBLA)FDA decision on Avastin plus chemotherapy for the treatment of women with persistent, recurrent or metastaticcervical cancer
Submission DateCompany NameTickerDeviceCategoryOutcomeDetails
07/25/2014Guided Therapeutics, Inc.GTHP.OBLuViva Advanced Cervical Scan.PMA (Amended)
04/07/2014Myriad Genetics Inc.MYGNBRACAnalysis as a companion testPMA (First module)
04/01/2014STEREOTAXIS INCSTXSVdrive Robotic Navigation System with V-Loop Variable Loop Catheter Manipulator510(k)
02/18/2013EXACT Sciences Corp.EXASSecond module for stool DNA colorectal cancer screening test PMA
12/07/2012EXACT Sciences Corp.EXASFirst module for stool DNA colorectal cancer screening test PMA
Aastrom Biosciences Inc. (ASTM) is offering 13.72 million shares of its common stock to the public at a price of $2.55 each. The company has also granted the underwriters a 30-day option to purchase up to an additional 2.05 million shares of common stock.
Schizophrenia may actually be a collection of up to eight different diseases, not just one as previously thought, according to researchers from the Washington University School of Medicine in St. Louis. For the study the researchers analyzed DNA from over 4,000 different schizophrenia patients, taking note of any genetic modifications.
Some autoimmune diseases have been linked to the development of eating disorders, according to research conducted at the University of Helsinki. The study, published in the journal PLoS One, surveyed data on 2,000 Finnish patients suffering from anorexia nervosa, bulimia nervosa and binge eating disorders. The team found that roughly nine percent of patients suffering from eating disorders.
Mango, one of the most popular tropical fruits, is said to be an excellent source of fiber, copper as well as vitamins C, A, folate and B6. Widely known in India as the King of Fruits, mango has many health benefits associated with it.

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