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Top Stories
The proposal from the Centers for Medicare and Medicaid Services (CMS) proposes to give plans more flexibility to limit coverage of certain drugs.
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AbbVie will grant Pfizer license to launch a biosimilar to AbbVie's Humira worldwide.
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Industry News
Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.
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The UK's government has revealed the details of the second Life Sciences sector deal, forming part of the Industrial Strategy.
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Biopharma News
FDA has approved Truxima (rituximab-abbs), a biosimilar to Roche's anti-cancer biologic, Rituxan (rituximab).
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The companies aim to advance research into inflammatory bowel disease.
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Supplier News
The company is investing approximately $14 million to expand biologics packaging capabilities and capacity at its biologics manufacturing facility in Bloomington, IN.
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The investment builds on a collaboration the companies entered into in 2007 for various biomanufacturing projects.
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Regulatory News
The agency is looking to leverage real-world health data to support drug development.
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Shire has announced that the European Commission has granted marketing authorisation for Takhzyro (lanadelumab) subcutaneous injection.
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FEATURE TOPICS |
QUALITY SYSTEMS
FDA's 21st Century goals can be realized by using a multi-purpose manufacturing facility with a flexible design that provides reliable production without extensive regulatory oversight.
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MANUFACTURING
Recent equipment and updated product options offer improvement to a range of biopharmaceutical manufacturing tasks.
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Events
December 10–12, 2018
January 21–23, 2019
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eBook
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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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