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Top BioPharm International News Stories of 2018
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The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.
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Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.
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The pharma major will spin out six molecules in early stage inflammation and autoimmune programs into a new company called Viela Bio.
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The acquisition would boost Sanofi's position in hematology and specialty medicines.
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The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.
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The acquisition is expected to accelerate progress towards personalized cancer healthcare.
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Stem-cell developer TiGenix has been acquired by Takeda Pharmaceutical for approximately EUR 520 million (US$604 million).
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The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.
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President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.
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The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.
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Top BioPharm International Feature Stories of 2018
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The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).
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Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.
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Advances in TFF and single-use systems help advance UF/DF on the continuous processing path.
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Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
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More consistent and reliable production processes are critical for advancing innovative treatments.
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Early adopters are benefiting from lower costs and increased productivity.
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Advances in wearable devices have made it possible to deliver high-volume, high-viscosity biologics.
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Process understanding and careful assessment of risks are essential in developing viral clearance programs.
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Statistical methods to identify critical process parameters and critical material attributes–and approaches to control them–are needed to protect drug product and drug substances.
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Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.
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This eBook covers method development, analytical techniques, and profiles of new instruments, equipment, and supplies used in the testing and analysis of raw materials, drug substances, and drug products.
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