TOP STORIES
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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Neurocrine will develop and commercialize seven of Takeda’s pipeline programs, including three clinical-stage assets for schizophrenia, treatment-resistant depression, and anhedonia.
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Featured Resources from BioPharm International
View our online resource center, sponsored by GE Healthcare, to explore a case study and articles on gaining and retaining skilled labor, modular bioprocessing, the good and bad of biosilimiars, and more.
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Industry News
FDA has revoked its Emergency Use Authorization hydroxychloroquine and chloroquine, citing new evidence and reanalysis of earlier data confirming that the drugs show no evidence of effectiveness against the coronavirus and raise continued concerns about cardiovascular safety risks.
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The International Coalition of Medicines Regulatory Authorities met again on June 12 to discuss policy approaches to the COVID-19 pandemic.
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Innovative Solutions for Protein Analysis and Purification: mAbs and Oligos
An online resource to discover an innovative solution for protein analysis and purification. This site includes useful webcasts, application notes, and more.
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Biopharma News
The company will invest EUR 610 million (USD$682 million) into a new vaccine production site and research center in France.
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Valneva will manufacture the Sabin vaccine strains for clinical trials in its manufacturing facility in Solna, Sweden, using Batavia’s process.
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Supplier News
Cobra Biologics has signed a supply agreement to provide GMP manufacturing for AstraZeneca’s AZD1222 COVID-19 vaccine candidate.
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Corning will use BARDA funding to expand US manufacturing capacity for pharmaceutical tubing and vials made from Valor glass.
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Regulatory News
The guidance provides recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the pandemic.
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The report highlights agency’s accomplishments in 2019, including its relocation to Amsterdam.
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FEATURED TOPICS |
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DOWNSTREAM PROCESSING
Tools such as manufacturing execution systems, artificial intelligence, and software innovations are useful for enhancing data integrity protection.
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MANUFACTURING
Automated sampling systems and integration of PAT are overcoming some of the roadblocks to increased automation of biopharmaceutical manufacturing processes.
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eBook
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The Pharmacopoeia Compliance Series features a description of ways biopharma companies can participate in monograph development, a case study of a practical approach to pharmacopoeial compliance, and a summary of this 12-part series.
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