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TOP STORIES
The decision was made after it was determined that many of the event’s largest stakeholders would be unable to travel to the conference due to the novel coronavirus outbreak.
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With the first announced drug shortage tied to the coronavirus outbreak, FDA emphasizes urgency for monitoring drug supply chain.
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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
The All-Party Parliamentary Group (APPG) for Life Sciences, aimed at raising awareness of the United Kingdom’s life sciences among parliamentarians and to explore the challenges and opportunities facing the sector, was relaunched on Feb. 27, 2020.
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If approved, the therapy may become the first-choice treatment for relapsing multiple sclerosis patients and will be the first B-cell therapy that can be self-administered using an autoinjector pen.
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Biopharma News
The companies are entering into a development and manufacturing collaboration for the advancement and production of human monoclonal antibodies for the potential treatment of novel coronavirus.
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The partnership will begin in the second half of 2020.
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Supplier News
Takeda announced the acquisition after the conclusion of a Phase 1 study of the investigational medicine TAK-062 (Kuma062) for the treatment of uncontrolled celiac disease.
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The company presented data on its G2 glycosylation studies at the 15th European Conference on Fungal Genetics in Rome on Feb. 19, 2020.
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Regulatory News
As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.
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Kyowa Kirin has announced that its treatment for X-linked hypophosphatemia (XLH), Crysvita (burisumab), has been approved by Swissmedic for use in adults, adolescents, and children (1 year and older).
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PEER-REVIEWED RESEARCH
The authors present a risk analysis of the impact of various business and operating risks on three facility layout strategies.
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QUALITY
Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.
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In BioPharm International’s Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, FDA Form 483s, and essentials for quality risk management.
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