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TOP STORIES
The deal is expected to close during the first half of 2021.
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PEGS: The Essential Protein Engineering and Cell Therapy Summit | May 4-8, 2020 | Boston, MA
Join world-renowned experts, visionaries, and influencers from top pharma, biotech, academic, and government institutions to hear inspiring presentations, attend in-depth training, tutorials and roundtable discussions, and to gain insights and knowledge on how the latest developments in biotherapeutics will impact and transform current research.
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The acquisition will give Gilead access to Forty Seven’s investigational lead product candidate, magrolimab, a monoclonal antibody in clinical development for the treatment of numerous cancers.
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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
Research from data and analytics company GlobalData shows that CAR-T cell therapy innovations across APAC will make the global market for these therapies more competitive.
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The conference, which was originally scheduled for March 31–April 3, 2020 at the Messe München in Germany, will be rescheduled for Oct. 19–22, 2020 at the same location.
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Biopharma News
The new center expands the company’s R&D capabilities and will help it advance its portfolio of rare disease gene therapy programs.
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The therapy works by transferring pathogen-specific antibodies from plasma gathered from recovered individuals into an infected patient, which may help the patient’s immune system respond and increase recovery.
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Supplier News
The technology enables the rapid production of large numbers of recombinant antibodies at 80-mL scale.
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The acquisition will expand Nexelis’ immunology testing expertise.
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Regulatory News
A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.
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FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.
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OUTSOURCING
Contract service organizations can offer biopharma companies early insight into dangers that may hinder a drug’s later development.
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QUALITY/REGULATIONS
While new industry guidance documents issued by FDA speak to the agency’s efforts to promote the development of new gene therapies, certain hurdles remain to challenge stakeholders.
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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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