| | | | | | | | Recently, pharma supply chain disruption has been a major concern to the FDA and industry, amplified by the pandemic and rising geopolitical risk. Such black swan events are extremely difficult to assess until they occur. However, assessing the risk your facility has to natural disasters should be an essential part of your supply chain management process, and improved climate models and tools can help. |
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| | | | | The agency has pushed the PDUFA date by three months for Rocket's gene therapy for leukocyte adhesion deficiency-I, in order to review CMC data. |
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| The regimen is now available as a first-line treatment for metastatic pancreatic adenocarcinoma, a particularly aggressive form of cancer with limited treatment options and a poor prognosis. |
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| | | | Sponsored | | Effective viral clearance is at hand with the new, biodegradable J.T.Baker® Viral Inactivation Solution. A sustainable alternative to Triton X-100, this cGMP-ready solution supports the quality and stability of target proteins. |
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