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Top Stories
Novartis plans to acquire Endocyte, a biopharmaceutical company, to accelerate the development of innovative radioligand technology for treating cancer.
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To achieve a more dynamic marketplace, FDA is issuing guidance documents and targeted advisories to support R&D on complex generics and combination products.
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Industry News
Research from Massachusetts Institute of Technology suggests that small chips could replace standard lab-scale spectrometry equipment for many applications.
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The agency, in partnership with international regulatory and law enforcement agencies, cracked down on 465 websites marketing illegal opioids and other drugs claiming to treat conditions such as cancer and HIV.
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Biopharma News
AbbVie will assume full development and commercial responsibility for its collaboration with Galapagos to discover and develop new therapies to treat cystic fibrosis (CF).
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AstraZeneca and Innate Pharma further expand oncology collaboration with a new multi-term agreement.
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Supplier News
The company will complete an expansion of its secondary packaging capabilities at its Ravensburg, Germany site by 2020.
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The investment in the company's Mississauga, Canada, laboratory includes an expansion of existing cell/tissue culture capabilities, flow cytometry, mass spectrometry facilities, and more.
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Regulatory News
The recommended drugs include one biosimilar, two orphan medicines, and three extensions of therapeutic indications.
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Takhzyro (lanadelumab) is the first monoclonal antibody therapy approved for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
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FEATURE TOPICS |
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OUTSOURCING
Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.
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BUSINESS TRENDS
The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.
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DRUG DEVELOPMENT
Analytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics.
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QUALITY BY DESIGN
Applied throughout a product's lifecycle and across a company's portfolio, quality risk management and knowledge management will enable more agile manufacturing and better quality standards in the future.
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November 1–2, 2018
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eBook
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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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