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What is Enterovirus EV-D68, the disease causing alarm in the Midwest?

2014-09-09 11:55:21| Biotech - Topix.net

A respiratory virus that has sent hundreds of children to hospitals in Missouri is causing alarm across the Midwest and beyond. Ten states have contacted the Centers for Disease Control and Prevention for help investigating clusters of the virus that's being blamed for the illness.

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Keryx pill for kidney disease patients cleared, but with safety warnings attached, shares fall

2014-09-05 22:05:57| Biotech - Topix.net

Keryx Biopharmaceuticals shares fell Friday as the company received U.S. approval for its pill to treat kidney disease complications but the clearance required unexpected safety warnings. The Food and Drug Administration approved the company's ferric citrate drug to treat patients on dialysis with hyperphosphatemia, or elevated levels of phosphates, which can increase the risk of heart disease, bone density problems and death.

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Mercks Investigational Beta-lactamase Inhibitor Relebactam (MK-7655) Granted Qualified Infectious Disease Product (QIDP) and Fast Track Designations by FDA

2014-09-04 15:00:00| Merck.com - Corporate News

Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has designated relebactam (previously known as MK-7655), the companys investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product (QIDP) with designated Fast Track status. Language: English Contact: Media:Caroline Lappetito, 267-305-7639orRobert Consalvo, 908-423-6595orInvestors:Joseph Romanelli, 908-423-5185orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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09.05.14 -- FDA Breakthrough Therapy Designation For NUPLAZID For Parkinson's Disease Psychosis

2014-09-04 06:24:13| drugdiscoveryonline Home Page

09/05/14 Drug Discovery Online Newsletter

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ACADIA Pharmaceuticals Receives FDA Breakthrough Therapy Designation For NUPLAZID (Pimavanserin) For Parkinson's Disease Psychosis

2014-09-03 11:32:21| drugdiscoveryonline Home Page

ACADIA Pharmaceuticals Inc. a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in neurological and related central nervous system disorders, recently announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to NUPLAZID (pimavanserin) for the treatment of Parkinson’s disease psychosis

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