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Top Stories
FDA staffers will be hard-pressed to process and review the wave of new drug application submissions in pre-established timeframes for action.
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Janssen and MeiraGTx will collaborate on the development and commercialization of gene therapies for treating inherited retinal diseases.
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Industry News
In a statement, FDA Commissioner Scott Gottlieb announced the agency's plans to publish guidance to promote the development of complex generic drugs.
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Biopharma News
Merck & Co.'s V920 (rVSV-ZEBOV) vaccine is expected to pave the way for the development of vaccines for emerging infectious disease with unpredictable disease incidence or geography, according to data and analytics company, GlobalData.
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TrakCel and WindMIL Therapeutics have formed a partnership to build a custom-configured cellular supply chain tracking and orchestration platform.
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For the past 18 years, the World Vaccine Congress Washington congress has evolved and grown into the leading vaccines congress globally, in content, speakers, attendees and networking opportunities. With 8 individual streams, including Bioprocessing and Manufacturing, Supply and Logistics and Emerging and Re-emerging Diseases. With over 145 commercial partners, the World Vaccine Congress is a central point to research, discover and network.
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Supplier News
The company added a cleanroom at its site in Birtley, UK for manufacturing single-use assemblies and sensors used in biopharmaceutical processing.
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G-CON will provide a complete cleanroom infrastructure for GE Healthcare's cell therapy and viral vector production platforms that will simplify early-stage manufacturing efforts.
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Download The Complete e-Book of Biosafety Testing to learn how Eurofins Lancaster Laboratories' team of regulatory experts and experienced scientists perform comprehensive biosafety testing, including biologics raw materials, cell bank preparation, adventitious virus testing, viral clearance studies, next-generation sequencing, genetic stability testing, and more.
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Regulatory News
The investigation into the root cause of the NDMA impurity found in API is still ongoing, but the agency believes the impurities may be caused by specific chemicals and reaction conditions in manufacturing processes.
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The guidance describes how to develop a REMS Assessment Plan, discusses the impact of REMS on patient access to drugs, and gives recommendations on reporting REMS findings to FDA.
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FEATURED TOPICS |
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MANUFACTURING
New ligands are being developed to meet the separation and purification needs of next-gen biologics.
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REGULATORY
FDA plans to support initiatives to ensure that all medicines are safe, effective, and of high quality.
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