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Tag: biologics
Merck Announces FDA Acceptance of Biologics License Application for Investigational House Dust Mite Sublingual Allergy Immunotherapy Tablet
2016-04-12 23:00:22| 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 announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MK-8237, Mercks house dust mite sublingual allergy immunotherapy (SLIT) tablet. Language: English read more
Tags: house
application
license
acceptance
FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab) in Advanced Non-Small Cell Lung Cancer
2016-03-07 14:00:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. Application Based on Data from KEYNOTE-010, Which Showed Superior Overall Survival for Patients Taking KEYTRUDA Compared to Chemotherapy in Patients with PD-L1 Expression on One Percent or More of the Cancer Cells 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 a new supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, to include data from KEYNOTE-010. Language: English Contact: MerckMedia:Pamela Eisele, (267) 305-3558orKim Hamilton, (908) 740-1863orInvestor:Teri Loxam, (908) 740-1986orJustin Holko, (908) 740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: advanced
application
license
cell
Green Biologics Named in the Global Cleantech 100 for Second Consecutive Year
2016-02-08 06:00:00| Coatings World Breaking News
Catalent Biologics And Cerenis Therapeutics Announce Phase III Trial Of CER-001 In Europe And North America Leveraging GPEx Cell Line Technology
2016-02-03 03:16:56| drugdiscoveryonline Home Page
Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, consumer health and animal health products, today announced that Cerenis Therapeutics has advanced its leading clinical candidate, CER-001, into Phase III clinical studies across Europe and North America
Tags: line
technology
north
iii
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
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