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Top Stories
Colorcon Ventures looks to fund promising startups in drug manufacturing, delivery, and supply chain.
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EMA plans to issue new guidance, as US and European regulators respond to reports of nitrosamine contamination in H2 blockers, including Zantac, that contain rantidine.
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Subscribers can enjoy each full issue of Pharm Tech in print, or via Pharm Tech apps.
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Industry News
FDA approved the drug after a successful open-label study of children aged six to 11 years and living with the condition.
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The ABPI and BMA have issued responses to the publication of a government report into the scale and distribution of prescribed medicines in England.
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Supplier News
TrakCel and McKesson have formed a collaboration that is aimed at accelerating commercialization of cell and gene therapies by leveraging services to enable a more efficient development pathway.
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BIA has signed a memorandum of understanding with AstraZeneca and the Wuxi International Life-science Innovation Campus (I-Campus) to boost access for UK SMEs in China.
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Bio/Pharma News
The acquisition gives PPF a 19.2% stake in Autolus and provides a pipeline of cell therapy product candidates.
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The companies aim to integrate glucose sensing with insulin delivery technologies to help change the way diabetes is managed.
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Regulatory News
EC has granted marketing authorization approval to Roche for Tecentriq (atezolizumab), in combination with chemotherapy, as a first-line treatment for patients with extensive-stage small cell lung cancer
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Bora Pharmaceuticals has announced it has achieved success in the latest FDA general inspection of its Zhunan facility with zero 483 observations.
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PEER REVIEW
Research compared the properties of corticosteroids processed by wet and dry milling for use in inhalation formulations.
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MANUFACTURING
At-line NIR measurements can replace a laboratory HPLC measurement for API content in oral solid-dosage drug manufacturing.
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The inVia™ Qontor® is Renishaw's most advanced Raman microscope. With the addition of Renishaw's latest innovation, LiveTrack™ focus tracking technology, the inVia Qontor enables users to analyze samples with uneven, curved or rough surfaces. Optimum focus is maintained in real time during data collection and white light video viewing. This removes the need for time consuming manual focusing, pre-scanning or sample preparation.
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QUALITY SYSTEMS
Providing regulators with a holistic approach to addressing deficiencies is the best response to an inspection, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
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2019 PDA Rapid Microbiological Methods Workshop
October 23-24, 2019 | Rockville, MD
Opening with an exploration of the current regulatory framework for the validation, submission, and utilization of rapid microbiological methods and closing with the Ask the Experts and Regulators Panel Discussion, the
2019 PDA Rapid Microbiological Methods Workshop, October 23-24, provides you with insights from those with first-hand experience delivering solutions to common challenges. Questions are inevitable.
Get the answers you're looking for at PDA's Workshop!
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UPCOMING WEBCASTS
APIs and ADCs: A Journey Through High Potency
Friday, September 27, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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excipient engineering and design to enable continuous manufacturing
Thursday, September 26, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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How Can You Transform the Patient Experience through Digital Transformation?
Wednesday, September 25, 2019 at 9am EDT | 2pm BST | 3pm CEST
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The Evolution of Cellulose in Tableting Technology
Wednesday, September 25, 2019 at 10am EDT | 3pm BST | 4pm CEST
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The Product Development Superhighway: Leveraging End-to-End Solutions for Market Success
Tuesday, September 24, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Protecting Oxygen-Sensitive Formulations Throughout the Product Lifecycle
Tuesday, September 24, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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From Basics to Best Practices: Exploring Bioassays and Binding Assays
Thursday, September 19, 2019 10am EDT | 9am CDT | 3pm BST | 4pm CEST
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Events
October 9–10, 2019
October 16, 2019
October 21–22, 2019
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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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