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TOP STORIES
Under the agreement, Roche will have access to Promedior's lead product candidate, PRM-15, a recombinant form of human pentraxin-2 that can possibly treat a range of systemic fibrotic diseases.
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The company has said that all three of its operating sites in China started back up on Feb. 12 and that it is closely monitoring the outbreak.
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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
ERS Genomics revealed that the European Patent Office (EPO) has rejected arguments filed in opposition to patent EP2800811, which is directed to the single-guide CRISPR/Cas9 gene editing system and covers uses in cellular and non-cellular settings
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The Native Antigen Company has commercially introduced antigens that have been specifically derived from the Wuhan strain of novel coronavirus, now named Covid-19.
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Biopharma News
If approved, this treatment will be the first therapy targeted for METex14-mutated advanced lung cancer.
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Through the agreement, Catalent will offer process optimization and drug substance manufacturing services for the drug candidate at its Madison, WI site.
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Supplier News
The companies have entered into a global licensing and collaboration agreement to commercialize ReForm excipients used in biotherapeutic formulations.
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Jim Walter will take on the role of vice-president of operations for Catalent’s Oral and Specialty Delivery business.
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Regulatory News
The report details OPQ’s accomplishments over the past five years.
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The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility.
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DEVELOPMENT
The commercialization of cell therapies is still at its infancy, but industry is facing an exciting period of development as the sector is expected to grow exponentially.
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UPSTREAM PROCESSING
The production of viral vectors for use in gene therapy benefits from being able to use similar cell-culture processes as mAbs, but it faces limitations under current cell-culture technologies.
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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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