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Investigational malaria vaccine found safe and protective

2013-08-09 09:03:42| Biotech - Topix.net

An investigational malaria vaccine has been found to be safe, to generate an immune system response, and to offer protection against malaria infection in healthy adults, according to the results of an early-stage clinical trial published Aug. 8 in the journal Science.

Tags: found safe protective vaccine

 

Merck Announces FDA Acceptance of New Drug Application for Vorapaxar, Investigational Anti-Thrombotic Medicine

2013-07-24 14:00:00| Merck.com - Research & Development 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, today announced that the New Drug Application (NDA) for its investigational anti-thrombotic medicine, vorapaxar, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck is seeking FDA approval of vorapaxar for the secondary prevention of cardiovascular events in patients with a history of heart attack and no history of stroke or transient ischemic attack (TIA). About Merck Language:  English Contact:  MerckMedia:Pamela Eisele, (908) 423-5042orPatrick Witmer, (267) 305-4910orInvestor:Carol Ferguson, (908) 423-4465orJustin Holko, (908) 423-5088 Ticker Slug:  Ticker: MRK Exchange: NYSE read more

Tags: application medicine drug acceptance

 
 

Merck Presents Findings from Phase 1b Study of Investigational BACE Inhibitor, MK-8931, in Patients with Alzheimers Disease

2013-07-14 14:30:00| Merck.com - Research & Development News

Dateline City:  WHITEHOUSE STATION, N.J. Merck, known as MSD outside the United States and Canada, today announced the presentation of results from a Phase Ib study showing a dose-dependent decrease in amyloid levels in cerebral spinal fluid (CSF) following administration of MK-8931, Mercks investigational oral -site amyloid precursor protein cleaving enzyme (BACE1 or secretase) inhibitor, in patients with mild to moderate Alzheimers disease (AD). In the study, amyloid levels were analyzed as a measure of BACE activity. Language:  English Ticker Slug:  Ticker: MRK Exchange: NYSE read more

Tags: with study phase disease

 

Bayer Initiates Phase III Trial of an Investigational Recombinant...

2013-07-09 06:27:42| Chemicals - Topix.net

Bayer HealthCare today announced the company has started to enroll patients in an international Phase II/III trial to evaluate its investigational compound BAY94-9027 for the treatment of hemophilia A in children.

Tags: iii trial phase bayer

 

Merck Receives Complete Response Letter for Suvorexant, Mercks Investigational Medicine for Insomnia

2013-07-01 14:00:00| Merck.com - Research & Development 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 company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application for suvorexant, Mercks investigational medicine for the treatment of insomnia. In the Complete Response Letter, the FDA advised Merck that: Language:  English Contact:  MerckMedia Contacts:Steve Cragle, 415-845-1256orTracy Ogden, 267-305-2301orInvestor Contacts:Carol Ferguson, 908-423-4465orJustin Holko, 908-423-5088 Ticker Slug:  Ticker: MRK Exchange: NYSE read more

Tags: complete response letter medicine

 

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