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Top Stories
The company says it will work with payers to create payment options for its recently approved gene therapy, Zolgensma (onasemnogene abeparvovec-xioi), priced at $2.125 million.
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Eli Lilly is set to acquire exclusive worldwide rights for potential non-opioid treatment CNTX-0290 from Centrexion Therapeutics in a deal potentially worth $997.5 million.
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Industry News
Researchers at the University of Sheffield, Sheffield, UK, have discovered and developed a new compound that can kill antibiotic-resistant bacteria, including Escherichia coli.
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Inspectors found a lack of control over computer systems and a failure to follow equipment cleaning and maintenance procedures.
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Supplier News
New offering from Catalent targets integrated development and manufacturing of biologic drugs.
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The expansion will increase the company's single-use capacity to meet growing demand.
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Bio/Pharma News
Cegedim, has announced that it is collaborating with Sanofi to deliver real-world data for the improvement of health within Europe.
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The companies will develop a new generation of biotherapeutics from cell-line development through to GMP manufacturing.
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Regulatory News
Violations found by FDA included a failure to test product for API identity and strength, failure to validate outsourced materials, and a lack of written cleaning procedures.
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The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.
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MANUFACTURING
A look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.
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OUTSOURCING
Temporary power, HVAC, and oil-free compressor systems provide flexibility and control for pharmaceutical manufacturing facilities.
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QUALITY SYSTEMS
FDA inspections can create uncertainty. Supervision of the contract manufacturer is crucial in ensuring compliance.
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June 3–6, 2019
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The editors explore novel technologies for the formulation, manufacture,
purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.
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