Top Stories
The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.
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A $800-million acquisition of MPI Research expands Charles River's offerings for early-stage contract research.
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Industry News
The awards honor innovations in drug delivery and packaging, for better patient safety and compliance.
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The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.
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Supplier News
The companies have been awarded a collaborative grant of £1.9 million (US$2.6 million) from Innovate UK.
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The company has made an equipment donation to Purdue University's continuous manufacturing research program.
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Bio/Pharma News
The acquisition strengthens an already existing collaboration between the companies to advance clinical development of therapies across multiple drug categories.
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Through its Janssen pharmaceutical companies, Johnson & Johnson, has partnered with Theravance to develop and commercialize a therapeutic for inflammatory bowel diseases.
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Regulatory News
FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.
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The agency met to discuss its new temporary and permanent premises in Amsterdam.
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Excipients
Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.
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Analytics
New technologies, such as NIR and Raman, enable online measurements of blending and content uniformity in the production of solid dosage forms.
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Manufacturing
Industry lessons from a fast-track technology transfer of a soft-gelatin capsule (softgel) are multifold. This case study reviews the success factors for effective execution of the technology transfer.
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Events
February 20–22, 2018
February 26–March 1, 2018
February 27–March 1, 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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