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Top Stories
Gottlieb's tenure included record new drug approvals and steps taken to curb opioid abuse.
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The acquisition will establish a clinical pipeline for Biogen of gene-therapy candidates in ophthalmology.
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Industry News
The company is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP because of the possibility they may contain defective blister packs and incorrect tablet arrangements.
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A new report that has been published prior to CPhI Japan has stated that there will be rapid growth in the Japanese pharma market during 2019.
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Supplier News
Sartorius Stedim Biotech (SSB) and Novasep will partner to develop systems for membrane chromatography using Novasep's BioSC platform and SSB's single-use technology.
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The companies will use GeoVax's vaccine technology to develop malaria vaccine candidates.
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Bio/Pharma News
The technology uses a silica nanoparticle to deliver vaccines and cancer treatments.
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Abbott and Novo Nordisk have entered into a non-exclusive partnership aimed at providing an integrated digital solution for diabetic patients using insulin.
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Regulatory News
FDA guidance on quality considerations for continuous manufacturing should help advance implementation by providing clarity and giving companies more confidence to make investments in the new technology.
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As part of its support for novel nicotine replacement therapies, the agency published guidance on the development of these products.
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Exclusive Interview from AAPS 2018
Cutting Edge Formulations in Topic Drug Development
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MANUFACTURING
Tech transfer is key to succession advancing biopharmaceutical pipeline products from research to preclinical.
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ANALYTICS
Novel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.
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OUTSOURCING
Pharmaceutical Technology spoke with Lisa Crandall, MS, associate director CMC Project Management, and Peter Angus, PhD, director of Pharmaceutical Sciences, at Velesco Pharma, which provides a full range of stability testing of API and drug products, about best practices in stability testing.
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EU REGULATORY WATCH
Various groups and stakeholders from pharma, healthcare, and government are responding to a new draft environmental risk assessment guidance from EMA.
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March 11–13, 2019
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eBOOKS
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The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation—as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing. |
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