Top Stories
The proposed merger of Pfizer and Allergan will create a new top drug maker and cut Pfizer's tax bill with a headquarters move to Ireland.
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The increase in spending is said to be due to increased access to and use of medicines in emerging markets and higher prices for branded, specialty medications in developed markets.
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Industry News
UPS' 2015 “Pain in the Chain” survey suggests that pharma companies are getting better at product protection, cold chain and regulatory compliance.
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Experts at the ISPE annual meeting describe best practices, including containment and production in classified spaces.
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Supplier News
Baxter expands capacity for lyophilized cytotoxic oncology therapies at its fill/finish facility in Halle, Germany.
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Thermo Fisher Scientific announced the opening of their new GMP clinical services facility in Singapore.
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The NP-400 is an economical, heavy-duty, medium output rotary tablet press designed, engineered and manufactured in the United States. Capable of running 24/7, the NP-400 can produce up to 180,000 tablets per hour. This single footprint press continuously monitors tablet pre-compression, main compression forces and tablet ejection force. Tablet take off force, press temperature and humidity monitoring are also available. Automatic lubrication systems are standard.
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Bio/Pharma News
FDA grants accelerated approval for Darzalex (daratumumab) for the treatment of multiple myeloma.
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A landmark study by the National Institutes of Health determines that Lucentis is highly effective as a treatment for diabetic retinopathy.
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Regulatory News
Robert Califf addresses questions about drug pricing at the Senate hearing to weigh his appointment to be the next commissioner of FDA.
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FDA emphasizes the surveillance aspects of quality metrics to concerned drug manufacturers.
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FEATURED TOPICS |
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PARENTERALS
Miriam Beyer, European marketing manager, West Pharmaceutical Services, describes causes of recent parenteral drug shortages.
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MANUFACTURING
Problems in an induction-sealing process, such as untorqued or crooked caps, can be identified and corrected in real time using dynamic thermal imaging.
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OUTSOURCING
Better process development is creating industry benchmarks for bioprocessing.
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GMPs
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.
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Agilent CrossLab –From Insight to Outcome
Laboratories today face complex scientific and business challenges that require key insights into laboratory operations. Agilent CrossLab Enterprise Solutions provide these insights by leveraging laboratory operations data to help you dramatically improve scientific and business outcomes across your local, regional or global laboratory enterprise. Agilent CrossLab Enterprise Solutions -- focused on your organization’s goals.
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Webcasts
On Demand
Peptide quantitative analysis requires workflows that deliver high levels of data quality while balancing the needs of sample throughput and regulatory compliance. Learn how advances in sample preparation can enable greater speed, reproducibility, and improved data quality.
Sponsored by Thermo Fisher Scientific |
On Demand
Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment.
Sponsored by Patheon
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REFERENCE BOOKS |
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A compilation of articles Pharmaceutical Technology in a three-handbook set covering general analytical testing and stability in the manufacture, packaging, storing, and testing of formulated products.
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eBOOKS
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This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
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