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Top Stories
FDA and CDC are investigating a multi-state Salmonella outbreak that appears to be caused by kratom, a plant used as an opioid substitute.
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The companies have partnered to develop and commercialize vectorized antibodies against tau for Alzheimer's and other neurodegenerative diseases.
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Industry News
The company is voluntarily recalling one lot of Acyclovir Tablet due to packaging that may contain a different product.
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Researchers at the University of Illinois developed a method to transplant pancreatic islet cells from pigs more easily to treat type I diabetes.
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Supplier News
The company has expanded its single-use manufacturing capabilities at its facility in Fermoy, Ireland.
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The companies will work together on developing regenerative medicine therapies for heart failure.
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Bio/Pharma News
Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.
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FDA approves Vertex’s cystic fibrosis drug, Symdeko (tezacaftor/ivacaftor and ivacaftor), which is made using a continuous manufacturing process.
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Regulatory News
The agency provides information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms.
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Fluarix Tetra has been approved for use in children aged six months and above.
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Drug Development
Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.
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Peer-Reviewed Research
The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.
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Quality
While more companies are embracing taggants, researchers are developing new technologies that will be extremely difficult to reproduce.
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Analytics
X-ray powder diffraction exploits the interaction between x-rays and matter to study the structural and microstructural properties of materials.
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Events
February 26–March 1, 2018
February 27–March 1, 2018
March 12–14, 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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