Royal Philips (PHGFF.PK, PHG) announced its eCareCoordinator and eCareCompanion telehealth applications have received 510(k) clearance from the U.S. FDA. A part of Philips Hospital to Home's suite of telehealth programs, eCareCoordinator and eCareCompanion are focused on patient care within the home...
Salix Pharmaceuticals, Ltd. (SLXP) and Progenics Pharmaceuticals, Inc. (PGNX) said Monday that the Food and Drug Administration has approved Relistor Subcutaneous Injection, 12 mg/0.6ml, for the treatment of opioid-induced constipation, or OIC, in patients taking opioids for chronic non-cancer pain....
Bristol-Myers Squibb Co. (BMY) said that the European Medicines Agency or EMA has validated for review the Marketing Authorization Application or MAA for nivolumab in non-small cell lung cancer or NSCLC, the first completed regulatory submission for a PD-1 immune checkpoint inhibitor in this tumor type. "Lung...
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AMAG Pharmaceuticals Inc. (AMAG) rose more than 28% to close at a 4-year high of $29.72 on Monday after the company announced that it is acquiring privately held Lumara Health Inc. in a deal valued at about $1.025 billion.
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Alimera Sciences Inc. (ALIM) has been granted FDA approval for its sustained release intravitreal implant ILUVIEN for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.
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Shares of Rexahn Pharmaceuticals Inc. (RNN) were up more than 14 percent to $0.87 in extending trading Wednesday after the company announced that its drug candidate RX-3117 has been granted Orphan Drug Designation by FDA for the treatment of patients with pancreatic cancer.
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Gel Spice Co., of Bayonne, New Jersey, is voluntarily recalling 16,443 cases of Fresh Finds Brand Ground Black Pepper due to possible contamination with the harmful Salmonella bacteria.
DateCompany NameTickerDrugEventOutcomeDetails
12/30/2014POZEN Inc.POZNPA8140/PA32540 (NDA resubmission)FDA decision on PA8140/PA32540 secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
-News
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

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
Avanir Pharmaceuticals Inc. (AVNR) has offered to sell 18.2 million shares of its common stock to the public at a price of $11 each. The underwriters have a 30-day option to purchase up to an additional 2.73 million shares in connection with the offering.
Aratana Therapeutics Inc. (PETX), a pet therapeutics company, has offered to sell 4.5 million shares of its common stock to the public at a price of $9.25 each. The company has granted the underwriters a 30-day option to purchase up to an additional 675,000 shares of its common stock.
Fish oil supplements may not help improve an irregular heartbeat, according to research conducted at the University of Montreal. The study, published in the Journal of the American College of Cardiology, compared 337 patients with atrial fibrillation - one group taking a fish oil supplement and the other taking a placebo.
High levels of vitamin D may not help prevent type 2 diabetes, according to research conducted at the University of Cambridge. The gene study, published in the journal Lancet Diabetes & Endocrinology, questioned results of previous studies that suggested a link between vitamin D deficiencies and diabetes.

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