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Top Stories
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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The acquisition will boost Bayer's cell-therapy development programs, with an initial focus on neurology, cardiology, and immunology.
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Industry News
The new position will expand the company's large-molecule and protein therapeutics services by partnering with biopharmaceutical clients who are navigating the large-molecule product development life cycle.
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The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.
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Supplier News
The acquisition will expand BioIVT's disease-state portfolio by volume and product range.
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The new facility will manufacture biopharmaceutical products under cGMP conditions.
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Renishaw's RA802 Pharmaceutical Analyser offers scientists a step change in vibrational spectroscopy-based imaging techniques. The RA802 Pharmaceutical Analyser combines Renishaw's proprietary LiveTrack™ and StreamLine™ technologies to generate chemical images up to 150 times faster than conventional methods, whilst maintaining focus – ensuring high quality pharmaceutical tablet imaging.
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Bio/Pharma News
A New Jersey court upheld the validity of patent claims for Amgen's anti-inflammatory blockbuster biologic, Enbrel (etanercept).
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Explore Innovations at PDA's Micro Conference
The 14th Annual PDA Global Conference on Pharmaceutical Microbiology will explore cell and gene therapy, endotoxin control strategies, CAR T-cell products, sterility and compliance, and barrier technologies. And, don't miss eye-opening keynotes from author Dr. Steffanie Strathdee and NASA Microbiologist Dr. Sarah Wallace.
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Regulatory News
Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling four lots of 4% lidocaine topical cream and liquid gel products due to microbiological contamination and incorrect potency.
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The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.
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Corning Valor® Glass
• Aggressive freeze-thaw testing verifies superior performance for new vial option
• New vial option 40X less likely to break during low temperature processing
• New vial technology may reduce manufacturing costs for low temperature processes
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ANALYTICAL LAB OPERATIONS
Strong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.
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FORMULATION
Formulators of parenteral drugs must be cautious of specific considerations and challenges that arise during development and manufacture.
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MANUFACTURING
Personalized medicine and direct-to-patient trial models have made the difficult even more challenging.
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Events
September 10–11, 2019
September 16–18, 2019
September 18–20, 2019
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eBOOKS
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The editors explore 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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