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Drug Development | Trials & Filings
Amgen’s Nplate Approved for ITP
Phase III study shows overall platelet response was increased with the Nplate group (71 percent) compared with placebo12.17.18
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Breaking News | cGMP Manufacture | Drug Development | Industry News
Rentschler Biopharma Buys U.S. Mfg. Site from Shire
Will leverage the development and manufacturing site for CDMO services12.17.18
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Bio News | Clinical Trials | Collaborations & Alliances | Drug Discovery | Industry News | Laboratory Testing | R&D
Alkermes, Biogen Submit NDA to FDA
For diroximel fumarate (BIIB098), a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis12.17.18
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QA/QC | Serialization | Supply Chain
Don’t Just Tick the Box, Think Outside Of It
How a quality-first approach to serialization can deliver long-term value beyond compliance.Martin Van Trieste, CEO, Civica Rx and Board Member, rfxcel 11.13.18
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Drug Development | Information Technology
IT Alliance Aims to Overcome Early Research Challenges
Accenture, Merck and Amazon Web Services launch informatics platform for pharma researchOnline Exclusives Kristin Brooks, Contract Pharma 10.08.18
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Sharp Selects Werum IT Solutions as Partner
To implement an Electronic Batch Record (EBR) infrastructure at its Netherlands facility06.18.18
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cGMP Manufacture | Collaborations & Alliances | Information Technology
Werum IT, Nymi Enter MES Partnership
To develop joint solutions for smart authentication of employees on the pharmaceutical shop floor05.31.18
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Risk Management | Supply Chain | Validation
Pharma IT Trends
The challenge of implementing MES technology with increased regulationChristian Fortunel, LZ Lifescience 05.05.16
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Inspections | Risk Management | Supply Chain
Quality Metrics: What Does it Really Mean?
Background, thoughts and the current industry dialogue on FDA’s quality metrics initiativeDr. Mike Long, ValSource 03.09.16
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Drug Discovery
Take It to the Next Level!
I always hesitate before starting out a sentence with the “There are two types of people in the world . . .” line, because in my head, I always complete it with “. . . people who divide the world into two types of people, and peopl…Derek B. Lowe, Contributing Editor 01.24.14
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Chemistry | Information Technology | Microbiology | R&D
IT & Software in Pharma R&D
A focus on Bio-Analytical TechnologiesMak Jawadekar, Contributing Editor 01.22.13
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Chemistry
