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Top Stories
Vertex will use the acquisition to develop cell-based treatments for type 1 diabetes.
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While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.
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Industry News
A US District Court judge in Tennessee entered a consent decree of permanent injunction against Basic Reset and Biogenyx after multiple FDA inspections of the companies' facility found violations of the Federal Food, Drug, and Cosmetic Act.
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JW Pharmaceutical Corp will acquire the rights to 100% of the shares of Euvipharm along with a state-of-the-art pharmaceutical plant located in Vietnam.
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Biopharma News
Roche has extended its offering period for the purchase of Spark to provide US and UK regulatory authorities with additional time to complete their review of the acquisition.
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In a Phase III trial for advanced small-cell lung cancer, the investigational antibody drug conjugate, Rova-T (rovalpituzumab tesirine), did not demonstrate a survival benefit for patients taking it.
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Supplier News
The partnership will provide cost effective biologics for the world market.
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The joint venture, named BacThera, will operate out of headquarters in Basel, Switzerland and will serve pre-clinical to Phase II projects, with the ability to expand to Phase III and commercial manufacturing in the future.
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Regulatory News
FDA sent a warning letter to Stemell, Inc. for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice and current good manufacturing practices.
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FDA announced it is developing a series of guidance documents to promote methodological patient-focused drug development.
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UPSTREAM PROCESSING
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QUALITY SYSTEMS
Simplification is crucial to maintain data integrity, according to Siegfried Schmitt, PhD, vice-president, technical at PAREXEL Consulting.
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UPCOMING WEBCASTS
Expanded Capabilities for Bioanalysis Leveraging a Chromatography Data System
Thursday, Sept. 26, 2019, at 9am EDT | 2pm BST | 3pm CEST
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How Artificial Intelligence Can Address Analytical Challenges in Gene Therapies and Vaccines
Thursday, September 26, 2019 at 11am EDT | 8am PDT| 4pm BST | 5pm CEST
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Understanding Biotherapeutic Product Quality Attributes through a Multi-Attribute Method (MAM)
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Tuesday, September 17, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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From Small-Scale Stem Cell Production to Large-Scale hiPSC-Based Drug Development: The Flexibility of Stirred-Tank Bioreactors
Monday, September 16, 2019 at 9am EDT | 2pm BST | 3pm CEST
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Developing a Robust CQA Monitoring Method via Multi-Attribute Monitoring Principles for Therapeutic Monoclonal Antibody Development, Manufacturing, and Lifecycle Management
Tuesday, September 10, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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September 15–18, 2019
September 16–18, 2019
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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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