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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
Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.
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Researchers from the Department of Chemistry and Warwick Medical School developed a way to synthesize polymers to accelerate antimicrobial activity screening.
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Supplier News
The acquisition is expected to support Emergent BioSolutions’ focus on public health threats and emerging infectious disease.
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The acquisition of Juniper expands and strengthens Catalent’s offerings in formulation development, bioavailability solutions, and clinical-scale oral dose manufacturing.
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Bio/Pharma News
GSK will close the Sligo, Ireland skincare product manufacturing site by 2021.
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The companies entered a multi-year R&D collaboration to develop mRNA-based flu vaccines.
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PI18083 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.  Learn More |
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Regulatory News
Drug product approval from FDA follows previous approvals from European and Japanese authorities.
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FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.
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DOSAGE FORMS
This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.
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US REGULATORY WATCH
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
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MANUFACTURING
Modular manufacturing systems offer a less costly way to increase capacity while reducing time-to-market.
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ANALYTICS
Industry experts discuss the challenges of performing glycan analysis and how companies can gain specific expertise from outsourcing partners.
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Events
September 3–5, 2018
September 24–26, 2018
October 9–11, 2018
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eBOOKS
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This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics. |
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