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Top Stories
FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.
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The National Institute of Allergy and Infectious Diseases began a first-in-human trial of an experimental live, attenuated Zika virus vaccine.
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Industry News
FDA published a resource guide to promote responsible opioid prescribing in the treatment of animals.
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Pharmaceutical scientist association announces upcoming term’s board of directors.
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Biopharma News
The companies entered a multi-year R&D collaboration to develop mRNA-based flu vaccines.
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The acquisition will strengthen Astellas Pharma’s position in ophthalmology.
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Supplier News
Drug product approval from FDA follows previous approvals from European and Japanese authorities.
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The acquisition is expected to support Emergent BioSolutions’ focus on public health threats and emerging infectious disease.
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Regulatory News
FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.
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FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.
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24th Annual Validation Week
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry.
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FEATURE TOPICS |
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MANUFACTURING
The quality of the cell lines used to manufacture biopharmaceuticals are crucial for the production of high-quality, stable biopharmaceuticals.
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UPCOMING WEBCASTS
Screen Hundreds of N-Glycans per Day: More Samples – Better Decisions – Faster
Europe Broadcast: Thursday, October 4, 2018 at 2pm BST | 3pm CEST
US Broadcast: Thursday, October 4, 2018 at 11am EDT | 10am CDT | 8am PDT
Asia Pacific Broadcast: Friday, October 5, 2018 at 11am CST | 12pm JST | 1pm AEST
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The Multi-Attribute Method (MAM): Advancing Biopharmaceutical Discovery, Development, and Manufacturing
Wednesday, October 3, 2018 at 11am | 8am PDT | 4pm BST | 5pm CEST
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Hydroxyapatite Separation of Monoclonal Antibodies and Antibody Aggregates
Wednesday, September 19, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Rapid Low-level Identification and Quantitation of Host Cell Proteins
Europe: Thursday, September 6, 2018 at 2pm BST | 3pm CEST
North America: Thursday, September 6, 2018 2pm EDT | 1pm CDT | 11am PDT
Asia Pacific: Friday, September 7, 2018 at 11am CST | 12pm JST | 1pm AEST
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Characterizing Protein-Nucleic Acid Interactions by Light Scattering
Tuesday, August 21, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Events
August 21–23, 2018
September 3–5, 2018
September 26–27, 2018
more events
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eBook
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A review of new technologies and processes that are helping to drive the adoption of single-use systems for the commercial production of biologic-based drugs.
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