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Top Stories
A New Jersey court upheld the validity of patent claims for Amgen's anti-inflammatory blockbuster biologic, Enbrel (etanercept).
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Jack Bailey, president, US Pharmaceuticals, GlaxoSmithKline, will step down from his position at the end of 2019 and will be succeeded by a Merck KGaA executive.
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Industry News
The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.
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Industry has responded favorably to the recent announcement from the UK's PM that immigration rules should be developed to ensure scientific talent is attracted to the country.
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Biopharma News
GNA Biosolutions has completed its latest round of Series C financing in which it raised US$13.5 million.
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Using Alternating Tangential Flow in a 3000-L perfusion bioreactor, the company expects to reduce production time by up to 30%
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Supplier News
The companies have entered into a manufacturing agreement for the production of Phase III clinical trial material.
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The acquisition expands Eurofins Genomics' gene portfolio while bolstering Blue Heron's production capabilities.
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Regulatory News
Spectrum Laboratory Products received an FDA warning letter after violations were found at its New Brunswick, NJ facility.
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The agency is planning to clean out its drug listing records and urges companies to update any inaccurate active drug listing submission.
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FEATURED TOPICS |
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ANALYTICS
Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.
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OUTSOURCING
Using advanced HDX-MS and native MS techniques can improve the identification of potentially successful biologic drugs and de-risk CMC and clinical designs.
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UPCOMING WEBCASTS
Understanding Biotherapeutic Product Quality Attributes through a Multi-Attribute Method (MAM)
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Tuesday, September 17, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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From Small-Scale Stem Cell Production to Large-Scale hiPSC-Based Drug Development: The Flexibility of Stirred-Tank Bioreactors
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Native MS for Aggregate and Charge Variant Analysis of Biotherapeutics
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The Versatility of High Throughput Dynamic Light Scattering in Protein Characterization and Formulation Development
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