Top Stories
The new company name, Viatris, derives from Latin and represents the company’s main goals.
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Developers of biosimilars have become dismayed with difficulties in gaining acceptance and reimbursement from the US healthcare system.
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Biopharma N-Glycan Analysis Resource Center
An online resource with useful tools and practical information to find out more about Biopharma N-Glycan Analysis. The site provides useful webcasts, videos, application notes, posters, and more.
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Industry News
A simulation-based drug discovery company, Turbine, has announced the closing of an institutional funding round worth EUR 3 million (US $3.3 million), which will be used to redesign the oncology drug discovery process.
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A clinical-stage company that was spun out of the VUB university in Belgium, eTheRNA immunotherapies, has revealed it will be participating in an EU research project aimed at developing off-the-shelf mRNA nanomedicines.
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Biopharma News
Norwegian clinical-stage immunoncology company, Lytix Biopharma, has entered into a clinical collaboration with US-based Iovance Biotherapeutics.
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The plant in Singen, Germany will be used for formulation, filling, and packaging of Takeda’s vaccine candidate.
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Supplier News
The companies will acquire Orflo’s two flagship products, the Moxi Z and the Moxi Go.
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The new center will handle the delivery of novel and high-quality therapeutics by providing expertise in critical analytical processes and specialized workflows.
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Regulatory News
FDA issued a warning letter to the company for obtaining over-the-counter drugs made by foreign manufacturers that violated federal law.
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Roche’s ADC, Kadcyla, is used for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment.
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FEATURED TOPICS |
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MANUFACTURING
Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.
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ANALYTICS
The following details some of the latest tools and systems available for biopharmaceutical laboratory operations.
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UPSTREAM PROCESSING
Modeling is being used for everything from yield improvement to facility design, but new initiatives plan to broaden its reach, both upstream and downstream.
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Events
December 4-5, 2019
December 4-6, 2019
December 9–11, 2019
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eBook
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The editors examine the technology, practices, and regulatory approval questions facing companies employing single-use technologies for commercial manufacturing.
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