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Top Stories
Supply chain players are eligible to participate in FDA's pilot program to develop an electronic system for tracking drug products.
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The companies will jointly develop and commercialize an investigational bifunctional fusion protein immunotherapy currently in clinical development for cancer treatment.
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Industry News
Researchers used magnesium particles as tiny motors to deliver an oral vaccine against the bacterial pathogen Staphylococcus aureus.
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PDA survey and conference discussion will generate information to guidance on technology transfer.
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Biopharma News
In a deal potentially worth up to $460 million, Genentech and Xencor will develop and commercialize novel cytokine therapeutics.
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Supplier News
The company will open its first European manufacturing facility in Castlebar, Ireland.
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Andrew Alliance and Sartorius will develop a software-connected pipetting system for improved reproducibility and traceability in life-science laboratories.
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Regulatory News
New HHS proposal would remove the current safe harbor protection from the federal Anti-Kickback Statute for rebates or discounts provided to Medicare Part D drug plans and certain state Medicaid programs.
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The agency recommended six medicines for approval at its January 2019 meeting, including treatments for lung cancer, HIV-1, and autoimmune disorders.
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FEATURED TOPICS |
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QUALITY SYSTEMS
Radha Iyer, vice-president and head of Quality and Scientific Affairs, Global Developed Markets, Dr. Reddy's Laboratories, discusses new initiatives at the company.
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REGULATORY
In January 2019, a temporary measure reopened the US government until Feb. 15, 2019, allowing FDA to resume full operations. Failure to find a permanent solution could have dangerous ripple effects on patient safety and innovation, says Jim Nolan, CEO of InClinica.
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March 4–5, 2019
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This eBook covers method development, analytical techniques, and profiles of new instruments, equipment, and supplies used in the testing and analysis of raw materials, drug substances, and drug products.
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