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Dengvaxia is the first FDA-approved vaccine for dengue disease caused by all dengue virus serotypes for individuals ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.
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The companies will work together to develop observational research analytics to assess treatment outcomes for areas of unmet need in oncology.
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Industry News
MilliporeSigma event scheduled to recognize biotech challenges and support development potential.
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FDA sent a warning letter to Dong Yuan Technology Co., Ltd. detailing CGMP violations including failure to follow laboratory and process controls.
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Supplier News
The Vaccine Development and Bioprocess Cell Culture Technology Day will take place on May 16, 2019 in Baltimore, MD.
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Bio/Pharma News
The companies have entered into a sub-licensing agreement to develop products based on Dyadic’s C1 expression platform and Alphazymes’ enzyme technology.
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A solar panel installation at Novo Nordisk's North Carolina facility was initiated in March 2019 as part of the company’s commitment to zero environmental impact globally.
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Regulatory News
The agency approved Benlysta (belimumab) intravenous infusion for treatment of children with systemic lupus erythematosus.
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The agency is updating its warning requirements for eszopiclone, zaleplon, and zolpidem after reports of complex sleep behaviors.
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UPCOMING WEBCASTs
Impact of New FDA Guidance on Bioanalytical Testing on Drug Development
Thursday, May 30, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Requirements for Fully-Integrated Service Offerings in a HPAPI and Cytotoxic Environment
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Designing Amorphous Dispersion Formulations for Poorly Soluble Drugs
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Technologies to De-Risk Biologic Candidates to Successfully Transition from Research to Clinic
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Geographic Advantage: Accelerating Clinical Supply in China and Global Trials
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Laboratory Best Practices 2018 eBook
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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