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Top Stories
The transaction is set to be completed at the end of the first quarter of 2020.
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Under a collaboration potentially worth more than $1.5 billion, the companies aim to develop the antisense therapy to treat patients with certain cardiovascular and metabolic diseases.
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Industry News
The guidance describes an optional streamlined submission process for use of an investigational in vitro diagnostic in a clinical trial for oncology therapies.
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Following the publication of a statement from the United Kingdom’s Secretary of State for Health and Social Care, Matt Hancock, on the continuity of medicines supply in a 'no-deal' Brexit scenario, the UK BioIndustry Association (BIA) has issued a response on Oct. 9, 2019.
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Biopharma N-Glycan Analysis Resource Center
An online resource with useful tools and practical information to find out more about Biopharma N-Glycan Analysis. The site provides useful webcasts, videos, application notes, posters, and more from leading practitioners in the field of chromatography.
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Biopharma News
The collaboration focuses on baculovirus/Sf9 expression system for Prevail's pipeline of novel AAV9-based gene therapy programs neurodegenerative diseases.
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The new facility raises production capacity by an additional 19,100 m2 and creates 200 new full-time jobs.
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Supplier News
Biotechnology company, Avacta Group, and clinical-stage oncology-focused biotech, ADC Therapeutics, have entered into a collaboration and option agreement focused on the development of potent Affimer-drug conjugates.
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In an Oct. 10, 2019 press release, ChargePoint Technology announced that its smart monitoring system, Verifi, is now available for the biopharma market.
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Regulatory News
The agency announced that FDA scientists have developed candidate vaccine viruses that may be used to produce influenza vaccines.
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Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products due to a lack of assurance of sterility.
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FEATURED TOPICS |
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BUSINESS TRENDS
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying risk to reduce costs.
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OUTSOURCING
What direction is the bio/pharma industry is taking regarding the outsourcing of early development operations to contract research organizations?
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AAPS PHARMSCI 360 EXHIBITOR GUIDE
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From the establishment of cell banks through clinical studies and marketed products, Charles River supports the development of biologic therapies with a variety of stand-alone, package and insourced testing solutions.
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New Products and Services
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With sites in the US, Belgium, India, and Japan, Ajinomoto Bio-Pharma Services offers comprehensive CDMO capabilities for small and large-molecule APIs, including high potency, ADCs, and oligonucleotides.
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Bio-Rad provides a wide range of instruments, software, consumables, reagents, and content for the growing fields of cell biology, gene expression, protein purification, and protein quantitation with workflows that provide solutions for biomarker discovery and validation, immuno-oncology, biosimilars, and gene editing.
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Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies and consumer health products.
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PTI is a global leader in package testing equipment. It specializes in non-destructive package testing equipment for high-risk packaging applications.
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WuXi Biologics offers comprehensive technology platforms for the development of biologics.
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Events
October 16, 2019
October 27–November 1, 2019
November 3–6, 2019
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eBook
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The editors examine the technology, practices, and regulatory approval questions facing companies employing single-use technologies for commercial manufacturing.
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