Articles From: FDA Grants Breakthrough Therapy Designation to cPMP Replacement Therapy for Patients with Molybdenum Cofactor Deficiency (MoCD) Type A to Fear of Data Sharing Rose Significantly in Last Two Years


Alexion Pharma International Sàrl, a subsidiary of Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN), today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy designation to cyclic pyranopterin monophosphate (cPMP, or ALXN1101), an enzyme co-factor replacement therapy for the treatment of patients with molybdenum cofactor deficiency (MoCD) type A, a severe and life-threatening, ultra-rare, genetic metabolic disorder that causes catastrophic and irreversible neurologic damage within the first weeks of life.
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2014/2/5
-- Enrollment in Huntington's Phase 2 Trial Expected Soon --
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2013/10/23
INDIANAPOLIS , Oct.
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2013/12/18
-- Phase 2 Program Expected to Begin Next Quarter --
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-- Phase 2 Clinical Trial in Huntington's Disease Slated to Begin This Year --
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2014/1/21
Alexion Pharmaceuticals (Nasdaq:ALXN) today announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to Soliris ® (eculizumab), a first-in-class terminal complement inhibitor, for the prevention of delayed graft function (DGF) in renal transplant patients.
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TEL AVIV, Israel, Dec.
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Genzyme , a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the Food and Drug Administration (FDA) has granted a six-month Priority Review designation to its New Drug Application (NDA) for Cerdelga™ (eliglustat), an investigational oral therapy for adult patients with Gaucher disease type 1.
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2014/1/13
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2013/9/16
HAIFA, Israel, Sept.
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2014/1/16
By John Kell A U.S. Food and Drug Administration panel has voted against expanding use of the blood thinner Xarelto to treat patients with a certain heart problem, a decision that comes after reviewing the results of a related Phase 3 trial.
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2014/2/13
MONROVIA, Calif.
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Requires Premarket Approval for ECP Devices for Other Intended Uses WESTBURY, N.Y. , Jan.
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By Thomas M.
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2013/11/25
THE WOODLANDS, Texas, Nov.
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By Hester Plumridge U.S. regulators said Tuesday they are to review clinical trial data for one of AstraZeneca PLC's key diabetes drugs, following concerns expressed in a medical journal last year over increased risk of heart failure.
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U.S. regulators said Tuesday they are to review clinical trial data for one of AstraZeneca PLC's key diabetes drugs, following concerns expressed in a medical journal last year over increased risk of heart failure.
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2014/4/4
SAN DIEGO , April 4, 2014 /PRNewswire/ -- Today, Health and Human Services (HHS) Secretary Kathleen Sebelius , and U.S. Food and Drug Administration (FDA) Commissioner Dr.
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By Patrick Fitzgerald The Federal Deposit Insurance Corp.
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By Saabira Chaudhuri Already saddled with mounting regulatory scrutiny, Bank of America Corp.
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2013/10/1
For the second consecutive year, Chase led the nation in deposit growth as customers added $87 billion to their bank accounts, according to Federal Deposit Insurance Corp.
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2014/3/14
WASHINGTON (MarketWatch) -- The Federal Deposit Insurance Corp.
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2014/3/14
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2014/3/14
By Stephanie Armour WASHINGTON--The Federal Deposit Insurance Corp.
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By Drew FitzGerald Best Buy Co.
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2014/1/9
McCann's 'Truth About Privacy' Study Also Finds Concerns About Bullying Are Shifting Social Media Behavior Among Youth 'Youth migration' patterns also underscore what's cool/not cool in social media LAS VEGAS , Jan.
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Articles From: FDA Grants Breakthrough Therapy Designation to cPMP Replacement Therapy for Patients with Molybdenum Cofactor Deficiency (MoCD) Type A to Fear of Data Sharing Rose Significantly in Last Two Years
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