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Top Stories
Sandoz's new CEO will assume responsibilities no later than Aug. 1, 2019.
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Expansion at GSK's Hamilton, MT site is designed to boost vaccine production capacity.
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Industry News
Start Codon strategic initiative has been launched, aimed at providing a life-science accelerator that offers funding and support to translate innovative research into start-up companies.
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The company is voluntarily recalling the product due to difficulties with the delivery system.
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Supplier News
The investment will increase patient-centric dosage form manufacturing capabilities at Catalent's Winchester, KY, facility.
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Regis Technologies reported that no Form 483 observations were issued following a routine FDA inspection.
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Register for the free live webcast “Sustainable Sourcing and Supply Chain Engagement in Pharma.”
Various aspects of the pharma sourcing process and supplier relationships offer opportunities to advance sustainability and strategic goals. These include alternative raw materials at manufacturing facilities (e.g., biomass and recycled plastic), sourcing of renewable materials (e.g., palm oil), partnering on supplier sustainability, and more. This May 7 event is sponsored by BASF, Sustainable Brands, and Pharmaceutical Technology.
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Bio/Pharma News
The companies will join forces to use artificial intelligence (AI) and machine learning to discover and develop new treatments for two chronic diseases.
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A new facility in Frederick County, MD, will expand the company’s cell therapy manufacturing capabilities.
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Regulatory News
The agency recommended marketing authorization for two orphan drugs and treatments for opioid dependence, HIV, cancer, and more.
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The Regulatory Affairs Professional Society (RAPS) has released an updated agenda for its forthcoming conference, RAPS Regulatory Conference—Europe 2019.
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FORMULATION
Characterizing particles and understanding bulk powder behavior is critical to get the best pharma product.
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MANUFACTURING
In OSD continuous manufacturing, flexible batch sizes can optimize supply, but equipment and processing challenges are still being addressed.
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PEER-REVIEWED RESEARCH
It is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution.
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QUALITY SYSTEMS
A robust customer complaint handling system is an integral part of a quality management system, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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UPCOMING WEBCASTs
Requirements for Fully-Integrated Service Offerings in a HPAPI and Cytotoxic Environment
Two Live Events: Tuesday, May 28, 2019, at 10am JST | 9pm EDT | 6pm PDT
Tuesday, May 28, 2019, at 5pm JST | 10am CEST
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Designing Amorphous Dispersion Formulations for Poorly Soluble Drugs
Thursday, May 23, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Geographic Advantage: Accelerating Clinical Supply in China and Global Trials
Thursday, May 9 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Sustainable Sourcing & Supply Chain Engagement in Pharma
Tuesday, May 7, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Beating the Clock: Case Studies in Expediting Biologic Development
Tuesday, May 7, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Events
June 3–6, 2019
June 12–13, 2019
June 18–20, 2019
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eBOOKS
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The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation—as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing. |
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