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Top Stories
GW Research's Epidiolex, which treats two forms of epilepsy, receives FDA's approval; spurs FDA reminders about unapproved products.
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Strategic restructuring is designed to position GE Healthcare as a pure-play healthcare company.
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Industry News
The International Society for Pharmaceutical Engineering (ISPE) launched its philanthropic division, the ISPE Foundation, to support industry demands.
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A new oral delivery method developed by the Harvard John A. Paulson School of Engineering and Applied Sciences could change the way diabetics regulate blood sugar levels.
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Supplier News
Minakem's facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.
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The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.
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Bio/Pharma News
The approval is intended to increase patient access to treatment for opioid addiction.
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The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.
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Regulatory News
The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.
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FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.
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SUPPLY CHAIN
Demand for direct-to-patient services is exploding. Michael Sweeney, senior director of patient-centric logistics at World Courier, discusses issues that the new model presents.
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FORMULATION
Drugs in the amorphous form are loaded into porous silica particles, which provide a maintained concentration gradient for skin delivery.
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QUALITY SYSTEMS
Dissolution testing remains one of the pharmaceutical industry's most straightforward, least expensive QC tools. Research is focusing on ways to extend its reach, improve in-vitro and in-vivo correlation, and make real-time release testing a reality.
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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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