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Tag: biologics
US FDA Accepts for Review a Biologics License Application for Merck and Sanofi Pasteurs Investigational Pediatric Hexavalent Vaccine
2014-10-20 14:00:00| Merck.com - Research & Development News
Dateline City: WHITEHOUSE STATION, N.J. & SWIFTWATER, Pa. Phase III clinical study data presented at IDWeek in Philadelphia WHITEHOUSE STATION, N.J. & SWIFTWATER, Pa.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT:SAN and NYSE:SNY), announced today that the Biologics License Application (BLA) filed for the companies investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB1, has been accepted for review by the U.S. Food and Drug Administration (FDA). Language: English Contact: MerckMedia:Deb Wambold, (215) 652-2913orInvestors:Justin Holko, (908) 423-5088orSanofi PasteurMedia:Susan Watkins, (570) 957-2563susan.watkins@sanofipasteur.comorInvestors:George Grofik, (908) 981-5560IR@sanofi.com Ticker Slug: Ticker: MRK Exchange: NYSE Ticker: SAN Exchange: BOURSE Ticker: SNY Exchange: NYSE read more
Tags: review
application
license
accepts
BioLife Solutions Forms Biologistex CCM(SM) Joint Venture with SAVSU Technologies To Market Intelligent, Controlled Temperature Containers For Biologics
2014-10-01 13:33:08| drugdiscoveryonline Home Page
BioLife Solutions, Inc. (NASDAQ: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products for cells and tissues ("BioLife" or the "Company"), today announced the formation of a joint venture under the brand name of biologistex Cold Chain Management ("CCM"), a play on biologistics, defined as the processes, tools, and data used to monitor and manage the movement of biologic materials such as vaccines, cells, tissues, and organs across time and space
Tags: market
solutions
forms
technologies
Pfizer Announces FDA Acceptance Of And Priority Review Designation For Biologics License Application For Investigational Meningococcal B Vaccine
2014-09-03 12:22:48| drugdiscoveryonline Home Page
Pfizer Inc. recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds
Tags: review
application
license
acceptance
GSK Implements Genedata Biologics as Antibody Discovery Platform
2014-05-28 06:00:00| Industrial Newsroom - All News for Today
Genedata Biologics integrates GlaxoSmithKline's Biopharm Discovery workflows across multiple Biopharm RD groups and sites<br /> <br /> Basel, Switzerland – Genedata, a leading provider of advanced software solutions for drug discovery and life science research, today announced that Biopharm RD at GlaxoSmithKline (GSK) has selected Genedata Biologics™ as a key R&D data management and workflow-support platform. The Genedata Biologics platform will support multiple GSK Biopharm R&D ...This story is related to the following:Scientific Software |
Tags: platform
discovery
implements
antibody
Merck Announces FDA Acceptance for Review of MK-3475 Biologics License Application for Advanced Melanoma
2014-05-06 14:40:00| Merck.com - Corporate News
Dateline City: BOSTON Priority Review Designation for MK-3475 BLA for Proposed Indication of Unresectable or Metastatic Melanoma in Patients Who Have Been Previously Treated with Ipilimumab Advancing New Phase 3 Studies with MK-3475 in Adjuvant Melanoma, Previously-Untreated Non-Small Cell Lung Cancer, Advanced Head & Neck and Bladder Cancers Data from Studies in Three Different Cancer Types to be presented at 2014 ASCO Annual Meeting Initiating Phase 1 Study with Investigational Anti-GITR Antibody (MK-4166) BOSTON--(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 MK-3475, Mercks investigational anti-PD-1 antibody, for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab. Language: English Contact: MerckMedia:Ian McConnell, 973-901-5722Claire Mulhearn, 908-423-7425orInvestors:Carol Ferguson, 908-423-4465Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: advanced
review
application
license
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