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Top Stories
Pfizer has successfully completed its acquisition of Therachon, a privately held clinical-stage biotechnology company.
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GSK announced the opening of its new manufacturing facilities in Singapore after a $130-million investment.
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Industry News
New figures published by the ABPI have revealed the continuation of significant investment by the pharmaceutical industry into R&D in the United Kingdom.
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FDA sent warning letters detailing violations of current good manufacturing practices to three companies that repack APIs.
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Supplier News
Fujifilm Irvine Scientific has announced plans to open a third manufacturing facility in Tilburg, The Netherlands.
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Metabolic-disease biotech Amicus Therapeutics announced a manufacturing agreement with Catalent’s Paragon Gene Therapy unit for gene therapy manufacturing.
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Bio/Pharma News
Fresenius Kabi recalls chemotherapy drug because of possible glass particulate within the drug vials.
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The Bittium Wearable Platform with Philips EmoGraphy & CardioSense solution has been unveiled as one of five winners of GSK's "Transform the Future of Self-Care" innovation content.
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Regulatory News
FDA approved first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system.
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AstraZeneca has revealed that the CHMP of the European Medicines Agency has given a positive opinion to adding a self-administration option for Fasenra (benralizumab).
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Extractables & Leachables Symposium | September 19 | Boston, MA
Don't miss Eurofins’ full day technical seminar on Extractables & Leachables with sessions from Biogen, Bristol-Myers Squibb, Regeneron Pharmaceuticals, as well as the featured presenter, Dr. Desmond Hunt from the United States Pharmacopeia. Register for FREE and see why 72% of past attendees rated our event better than other E&L events.
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PEER-REVIEWED RESEARCH
To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.
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FILL-FINISH
Sterile filtration is often required for biologics but presents degradation and compatibility challenges.
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ANALYTICS
This article discusses current methods of endotoxin testing, its importance to the industry, sustainability issues relating to the process, and best practices.
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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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