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Top Stories
Alkermes plans to advance its investigational new drug-enabling capabilities for lead preclinical assets in the Rodin development candidate portfolio.
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The acquisition of The Medicines Company and its investigational cholesterol-lowering therapy extends Novartis’ cardiovascular pipeline.
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Industry News
The guidance provides recommendations for the development and quality information that should be included in NDA and ANDA applications.
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The agency sent a warning letter to Torrent Pharma after an inspection found violations of current good manufacturing practices that included a failure to thoroughly investigate batch failures.
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Supplier News
Lonza and Cryoport have partnered up to strengthen Lonza’s ‘vein-to-vein’ delivery network by removing supply chain hurdles faced by developers of personalized therapeutics.
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GE Healthcare Life Sciences has announced it will be working closely with Pharmadule Morimatsu to expand its KUBio “factory in a box” so that biopharma manufacturers will be able to quickly scale up vaccines, viral vector-based therapies, and other novel modalities.
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2019 PDA Quality Week | Dec. 9-13 | Washington, DC
The Week is comprised of three individual, but contiguous events designed to educate you on all aspects of QRM. Each offering provides a different perspective, starting with a focus on the emerging regulatory landscape, framing the requirements and objectives of the regulations that govern this important but elusive concept.
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Bio/Pharma News
The companies have entered into a clinical and commercial agreement to use MaxCyte’s ExPERT platform to enable development of up to five of Vor’s engineered cell therapies.
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Luxembourg-based company, C2 Pharma (C2P), has expanded its API and botanical extracts product portfolio with digoxin micronized grade and homatropine hydrobromide, and has multiple products under tech transfer and in development.
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Regulatory News
The approval of Givlaari (givosiran) is the first for treatment of acute hepatic porphyria, which results in the buildup of toxic porphyrin molecules during the production of heme.
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The agency’s approval of Abrilada (adalimumab-afzb), a biosimilar to Humira, brings the total of approved biosimilars to 25.
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DRUG DEVELOPMENT
Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.
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QUALITY SYSTEMS
Pharma companies must comply with the pharmacopoeia requirements for each country in which they plan to distribute drugs. Often, stakeholders do not have a sufficient understanding of these requirements. In the first article in a series, learn the legal and regulatory basis for pharmacopoeia compliance and the impact of pharmacopoeias throughout a drug’s lifecycle.
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OUTSOURCING
Unforeseen challenges can be avoided in technology transfer by evaluating the variety of processes involved.
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REGULATORY/GMP COMPLIANCE
It is good industry practice to clarify the precise remit for each of the reviewers of a controlled document, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
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Events
December 4–5, 2019
December 9–11, 2019
January 15–16, 2020
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eBOOKS
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The editors explore novel technologies for the formulation, manufacture,
purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.
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