Top Stories
The researchers examine the top 20 cancer drugs dosed by body size in the US, and estimate that drug companies will earn $1.8 billion in 2016 in revenue from leftover cancer drugs.
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The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.
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Industry News
The US DEA will allow Kannalife access to pharmaceutical-grade cannabidiol to conduct feasibility studies for a potential treatment for neurodegenerative diseases.
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A new four-year, $29-million program plans to improve modeling and process optimization and to change industry mindsets and workflows.
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Supplier News
The inspection confirmed that the facility was compliant with GMP guidelines.
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The new group is made up of over 15 scientists who formerly worked in GSK's computational biology and genetics departments.
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Bio/Pharma News
This marks the first time a biologic manufactured in China has been released for use in a clinical trial in Europe.
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TxCell’s new facilities are based in Sophia Antipolis, France, on the premises of GenBiotech.
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Regulatory News
Sagent Pharmaceuticals issues a nationwide recall of Fluconazole injection, USP, due to out of specification impurity results.
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The EU is striving to reduce the costs and administrative burden facing pharmaceutical manufacturers when complying with variations regulations for keeping authorization dossiers up to date.
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ANALYTICS
Researchers describe a new method to compare the higher-order structure of a reference biologic with its proposed biosimilar product candidates.
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OUTSOURCING
Keith Moore, vice-president of analytical services, Metrics Contract Services discusses gains use in dissolution testing.
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The Role of Risk Management in Compliance Systems
In order to remain competitive and be compliant, organizations are adopting more Risk Management methodologies to categorize and prioritize compliance events by risk. Join EtQ and Forrester Research's Chris McClean, as we conduct a deep dive into the role of Risk Management in quality and compliance, and provide analysis and research on best practices for managing risk and compliance. Learn more |
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Webcasts
On Demand
Considerations for preparing for the process transfer, ensuring equipment and materials consistency, and post-transfer activities will be discussed.
Sponsored by Rottendorf Pharma
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Natoli Engineering Company, Inc., maintains a large selection of replacement parts for nearly every tablet press on the market ready for immediate delivery worldwide. By stocking replacement parts, up to 50% less cost than the original equipment manufacturers, Natoli is able to provide the highest quality parts at exceptional prices, faster than anyone else in the industry with next-day service! Learn more |
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On Demand
Join Tosoh Bioscience and Semba Biosciences for a discussion on the use of high capacity protein A and hydroxyapatite resins for mAb purification using a multi-column continuous chromatography process.
Sponsored by Tosoh Bioscience
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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?” LIVE WEBCAST: Wednesday, March 23, 2016 at 8 am PDT / 10 am CDT / 11 am EDT
Join this informative webinar to learn how to foster relationships with contract partners to develop a quality surveillance program that will meet FDA scrutiny. Register now |
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on pharmtech tv
Biologics Development and Manufacturing Trends
Tablet Coating
Building Biopharmaceutical Manufacturing Processes
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Events
March 14-16, 2016
April 26-28, 2016
June 6-8, 2016
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Engineering the Mechanical properties of Amorphous Spray-Dried dispersions On Demand
Capsugel Dosage Form Solutions will present a webinar discussing the aspect of engineering spray-dried dispersion properties, with a particular emphasis on the impact of atomization and drying rate on powder mechanical properties.
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REFERENCE BOOKS |
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A compilation of articles 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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Best Practices for Effective Product Transfer
On Demand Understanding all aspects of the product transfer process is critical to a successful transfer and delivery of a quality product. During this one-hour webinar, regulatory and pharma experts will discuss the critical elements and processes needed for an effective, compliant product transfer process and successful end results. Learn more |
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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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