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Amgen, Inc. (AMGN) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a positive opinion for the marketing authorization of Repatha, or evolocumab, recommending approval for use in certain patients with high cholesterol. Repatha is an...
Pernix Therapeutics Holdings Inc. (PTX) announced that the U.S. Food and Drug Administration or FDA has approved TREXIMET or sumatriptan and naproxen sodium for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura. TREXIMET is the first approved...
Vertex Pharmaceuticals Inc. (VRTX) said Tuesday that the U.S. Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee has voted 12 to 1 to recommend the approval of Orkambi for use in people with cystic fibrosis ages 12 and older who have two copies of the F508del mutation in the CFTR...
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PharmaReport-052215.jpg Shares of Otonomy Inc. (OTIC) were down more than 18% in extended trading on Thursday after the company announced that its phase IIb trial of OTO-104 in patients with unilateral Ménière's disease narrowly missed achieving statistical significance.
Pharma-052115.jpg Shares of IsoRay Inc. (ISR) skyrocketed more than 90% on Wednesday, following an on-line publication of the first major peer reviewed study, which revealed improved results of the company's Cesium-131 seeds in the treatment of lung cancer.
Sarepta-052015.jpg Shares of Sarepta Therapeutics Inc. (SRPT) are up in pre-market trading on Wednesday as investors welcome the news of the company's progress made in the NDA submission for Eteplirsen.
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Good Seed Inc. of Springfield, Virginia is recalling all packages of soybean sprouts and mung bean sprouts due to potential contamination with the deadly bacterium Listeria monocytogenes.

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Blue Bell Creameries, which shut down its production plants last month on listeria contamination, may not resume production soon at it is going to take longer than initially anticipated to clean and sanitizie its facilities as well as train employees and implement new programs and procedures.

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Jeni's Splendid Ice Creams revealed a voluntary recall of all its products and closing its scoop shops, citing the possible presence of Listeria monocytogenes. The Columbus, Ohio-based company said the ice creams, frozen yogurts, sorbets, and ice cream sandwiches being recalled were distributed in...

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Consumers are warned not to consume La Clarita Queseria Queso Fresco "Fresh Cheese" made by Queseria La Poblanita Inc. due to possible contamination with Staphylococcus aureus bacteria.

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Date Company Name Ticker Drug Event Outcome Details
08/22/2015 Alkermes plc ALKS Aripiprazole Lauroxil (NDA) FDA decision on Aripiprazole Lauroxil for the treatment of schizophrenia
08/22/2015 Alkermes plc ALKS Aripiprazole lauroxil (NDA) FDA decision on Aripiprazole lauroxil for the treatment of schizophrenia
08/11/2015 EXELIXIS INC EXEL Cobimetinib (NDA) FDA decision on Cobimetinib for treatment of patients with BRAF V600 mutation-positive advanced melanoma
07/26/2015 Amgen Inc. AMGN Kyprolis (sNDA) FDA decision on Kyprolis for the treatment of relapsed multiple myeloma
07/24/2015 Regeneron Pharmaceuticals REGN Praluent (BLA) FDA decision on Praluent for the treatment of patients with hypercholesterolemia
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Submission Date Company Name Ticker Device Category Outcome Details
07/25/2014 Guided Therapeutics, Inc. GTHP.OB LuViva Advanced Cervical Scan. PMA (Amended)
04/07/2014 Myriad Genetics Inc. MYGN BRACAnalysis as a companion test PMA (First module)
04/01/2014 STEREOTAXIS INC STXS Vdrive Robotic Navigation System with V-Loop Variable Loop Catheter Manipulator 510(k)
02/18/2013 EXACT Sciences Corp. EXAS Second module for stool DNA colorectal cancer screening test PMA
12/07/2012 EXACT Sciences Corp. EXAS First module for stool DNA colorectal cancer screening test PMA
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Momenta Pharmaceuticals Inc. (MNTA) has offered to sell 7.25 million shares of its common stock to the public at a price of $19.00 each. The underwriters have an option to purchase up to an additional 1.08 million shares of the company's common stock, exercisable for 30 days.
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Many freshman female students have experienced at least some type of rape, according to a new study. The study, published in the Journal of Adolescent Health, looked at 483 women who were a representative sample of the freshman class and who volunteered to partake in the study. The women filled out questionnaires when they arrived on campus and at the end of their fall semester.
Habitual marijuana use may cause early puberty and stunt growth amongst teenage boys, according to a new study from researchers at the Agriculture University Rawalpindi in Pakistan. For the study the researchers collected health data from 220 non-smoking and 217 cannabis-addicted boys. They found elevated levels of puberty hormones like testosterone and luteinising hormone among the smokers.
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