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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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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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Industry News
By connecting manufacturing processes and logistics technology, GE Healthcare and World Courier look to accelerate the development of advanced therapies.
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FDA is supporting the development and marketing of OTC therapies, including CBD products, by proposing new rules and an expanded review office and promoting digital technologies.
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Biopharma News
A new facility to be built in the Philadelphia Navy Yard will support commercial production for autologous tumor-infiltrating lymphocyte cell therapy products from Iovance Biotherapeutics.
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The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected.
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Supplier News
New offering from Catalent targets integrated development and manufacturing of biologic drugs.
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MilliporeSigma awarded its Advance Biotech Grant to three US companies that are focused on traumatic brain injury, vaccine development, and chronic pain.
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Regulatory News
Prestige BioPharma has announced that the EMA has accepted its marketing authorization application for HD201 (Tuzune) for review.
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The agency has approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy to treat pediatric spinal muscular atrophy.
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FEATURED TOPICS |
VIRAL CLEARANCE
Testing demonstrates an automated semi-continuous process strategy for viral inactivation with steps that mimic batch processing.
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MANUFACTURING
More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.
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FACILITY DESIGN AND ENGINEERING
A multi-purpose biopharmaceutical manufacturing facility using a matrix of multi-functional cleanrooms can be adapted to efficiently meet the capacity challenges of both supplying clinical trials and launching products.
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Events
June 18–20, 2019
June 25–26, 2019
September 3–4, 2019
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eBook
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Experts share insight and advice for conducting CMC due diligence with contract development organizations, using multiple attributes methods to monitor quality attributes, and strategies for using specialized services for biopharmaceutical development applications.
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