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Tag: biologics
Merck Provides Regulatory Update on Biologics Licensing Application for Investigational Agent Bezlotoxumab
2016-07-21 22:30:00| 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 said that the U.S. Food and Drug Administration (FDA) has requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials previously submitted to the pending Biologics Licensing Application (BLA) for bezlotoxumab, an investigational agent for prevention of Clostridium difficile (C. difficile) infection recurrence. 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
update
agent
regulatory
Merck Announces FDA Accepts Samsung Bioepis Biologics License Application (BLA) for SB2 (Infliximab), an Investigational Biosimilar of Remicade
2016-05-24 01:50:08| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. First BLA Filed by Samsung Bioepis as Part of Its Partnership with Merck 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 a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade. Language: English read more
Tags: of
application
license
samsung
FDA Announces Updates to Standards for Biologics
2016-05-04 10:00:00| Expeditors Newsflash - Americas Edition
Expeditors Newsflash - Americas Edition
Tags: standards
updates
announces
fda
Green Biologics Signs Second US Distributor for Its High Value Chemicals
2016-04-18 17:59:00| Coatings World Breaking News
FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab) in Recurrent or Metastatic Head and Neck Cancer, and Grants Priority Review
2016-04-13 13:00:00| Merck.com - Product 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 accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558An Phan, 908-255-6325orInvestors:Teri Loxam, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: review
application
head
license
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