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Top Stories
Will Alex Azar's experience in the pharmaceutical industry help or hurt the initiative to keep medications affordable?
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FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve by early 2018.
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Industry News
The company announced 15 new collaborations focused on addressing unmet medical needs, including using artificial intelligence in the early detection of Alzheimer’s disease, saliva testing for throat cancers, and using the microbiome to treat sleep disorders.
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The IFPAC annual meeting on advancing the understanding and control of manufacturing processes using process analytical technology will be held Feb. 11-14, 2018.
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Supplier News
AptarGroup’s Landfill Free Certification program addresses the issue of waste production from pharmaceutical manufacturing processes by prompting its facilities to reduce and reuse operation waste.
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The companies will collaborate on the development of vaccines to expand GeoVax’s cancer immunotherapy program.
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Bio/Pharma News
The companies aim to develop a potential zinc finger protein transcription factor-based gene therapy for treating Lou Gehrig's disease.
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The companies aim to discover and develop locked nucleic acid oligonucleotides as orally available therapies for treating inflammatory bowel diseases.
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Regulatory News
The agency published draft guidance on good practices for submitting abbreviated new drug applications.
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FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.
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2018 PDA Annual Meeting
The 2018 PDA Annual Meeting will deliver the same high-quality content attendees expect in a NEW meeting format that starts on Monday afternoon. Delve into the future of bio/pharmaceutical manufacturing with the latest updates on the end user/patient perspective, innovative manufacturing strategies, and disruptive technologies. The industry's increased use of big data, artificial intelligence and robotics will also be explored.  Learn more and register today. |
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GMPs
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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Manufacturing
Optimizing water and HVAC systems can reduce resource use in all pharma facilities, and, for biopharma manufacturing, the supply chain of consumables should be evaluated.
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Drug Delivery
Modified-release lipid-based formulations in softgel capsules can address physiochemical and pharmacokinetic challenges posed by drug compounds.
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Events
February 7–8, 2018
February 11–14, 2018
February 20–22, 2018
more events |
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eBOOKS
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Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible. |
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