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Top Stories
The latest continuing resolution funds the government for three weeks.
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Frustrated with chronic shortages and high costs, hospitals form their own generic drug company.
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Industry News
The company has expanded its voluntary nationwide recall to include a second lot of Nexterone injection. This recall is due to particulate matter found in the product.
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Researchers at Purdue University and industry experts have partnered up at the Advanced Lyophilization Technology Hub to optimize the 70-year-old freeze-drying process.
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Supplier News
A ceremony was held at Cambrex’s Karlskoga facility to mark the commencement of a long-term manufacturing agreement with AstraZeneca for a key intermediate.
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GE Healthcare will equip Cellular Biomedicine Group’s cell therapy manufacturing facility in Shanghai, China, with its FlexFactory single-use platform, designed to speed up cell therapy manufacturing timelines.
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Bio/Pharma News
A Takeda and Denali collaboration includes three named programs for treating Alzheimer’s disease and other neurodegenerative diseases, using Denali’s antibody transport vehicle (ATV) technology to enhance blood-brain barrier penetration.
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The company is developing a pipeline of combination therapies using its patented polymer-based matrix delivery system, known as TAOS (targeted orchestrated signalling matrix).
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Regulatory News
FDA is monitoring the IV fluid shortage occurring due to Hurricane Maria and is asking companies to submit data for the possibility of extending expiration dates.
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The two agencies have launched a program to develop safe and effective medical products to be used by American military personnel.
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Supply Chain
Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the US Drug Supply Chain Security Act serialization deadline.
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Formulation
Abuse-deterrent opioid formulations generally fall into two categories: the first is based on a physiochemical abuse-deterrent approach and the second combines the opioid with an antagonist.
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Events
February 7–8, 2018
February 11–14, 2018
February 20–22, 2018
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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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