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Tag: clostridium
Study finds Clostridium butyricum increases growth performance
2020-05-18 20:42:00| National Hog Farmer
University of Illinois research team sees better morphology in the pigs' intestinal tracts with the direct-fed microbial.
Tags: study
performance
growth
increases
FDA Approves Mercks ZINPLAVA (bezlotoxumab) to Reduce Recurrence of Clostridium difficile Infection (CDI) in Adult Patients Receiving Antibacterial Drug Treatment for CDI Who Are at High Risk of CDI Recurrence
2016-10-22 03:57:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved ZINPLAVA (bezlotoxumab) Injection 25 mg/mL. Merck anticipates making ZINPLAVA available in first quarter 2017. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orRobert Consalvo, 908-236-1127orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Merck Statement on FDA Advisory Committee Meeting for ZINPLAVA (bezlotoxumab), an Investigational Agent for Prevention of Clostridium difficile Infection Recurrence
2016-06-09 23:04:32| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today issued the following statement after the conclusion of a meeting of the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss ZINPLAVA (bezlotoxumab), an investigational agent for prevention of Clostridium difficile (C. difficile) infection recurrence. The Advisory Committee agreed, with a vote of 10 to 5 with one abstention, that Merck has provided substantial evidence of the safety and effectiveness of bezlotoxumab for the prevention of C. Language: English read more
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agent
meeting
committee
Merck Announces FDA Acceptance of Biologics License Application for Bezlotoxumab, an Investigational Antitoxin for Prevention of Clostridium Difficile Infection Recurrence
2016-01-27 14:30:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. FDA Grants Priority Review with Target Action Date of July 23, 2016 Marketing Authorization Application Also Filed with the European Medicines Agency KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence. The FDA granted Priority Review for bezlotoxumab, with a Prescription Drug User Fee Act (PDUFA) action date of July 23, 2016. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Robert Consalvo, 908-236-1127orInvestors:Teri Loxam, 908-740-1986Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: application
license
acceptance
prevention
Pivotal Phase 3 Studies of Bezlotoxumab, Mercks Investigational Antitoxin to Prevent Clostridium Difficile Infection Recurrence, Met Primary Endpoint
2015-09-20 18:30:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. Company Plans to Submit New Drug Applications in U.S., EU and Canada in 2015 Results Presented for the First Time at ICAAC/ICC 2015 Annual Meeting KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the two pivotal Phase 3 clinical studies for bezlotoxumab, its investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence, met their primary efficacy endpoint: the reduction in C. difficile recurrence through week 12 compared to placebo, when used in conjunction with standard of care antibiotics for the treatment of C. difficile. Language: English Contact: MerckMedia Contacts:Doris Li, 908-246-5701Ian McConnell, 973-901-5722orInvestor Contacts:Teri Loxam, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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primary
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prevent