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Top Stories
Immuno-oncology drugs are demonstrating patient benefits, but growing resistant to the high cost has implications for patients, market access, and manufacturers.
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The companies have agreed to an all-stock merger of equals transaction anticipated to close in the second half of 2016.
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ANSM lifted the suspension on Catalent's Beinheim, France facility, allowing the company to resume pharmaceutical operations.
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Supplier News
EMD Serono, the North American biopharmaceutical business of Germany’s Merck KGaA, will expand its R&D facility in Massachusetts, US.
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Almac partnered with Optel Vision to provide a line-level solution (hardware and software) integrated with Almac’s proprietary level three, site-level software.
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Natoli Engineering Company maintains a large selection of replacement parts for nearly every tablet press on the market—ready for immediate worldwide delivery. Natoli provides the highest quality parts at exceptional prices and our worldwide delivery service is the fastest in the industry. By stocking thousands of replacement parts on our premises, we’re able to save our customers up to 50% the cost of Original Equipment Manufacturers.
 Learn more Natoli. |
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Bio/Pharma News
AbbVie will acquire Stemcentrx and its lead late-stage asset rovalpituzumab tesirine (Rova-T), a novel biomarker-specific therapy derived from cancer stem cells.
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The collaborations have the goal of creating new tools that will help predict how people with Type 2 diabetes adhere to their medication.
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Regulatory News
A federal judge entered an order of permanent injunction against Paul W. Franck, the owner and operator of several compounding pharmacies in Florida.
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The agency recommends the approval of Zavicefta to treat infections caused by resistant bacteria.
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Compliance is Key Solutions to Decrease the Likelihood of Receiving a Form 483
LIVE WEBCAST: Thursday, June 23, 2016 at 11:00 am EDT
 Free registration |
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FEATURED TOPICS |
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TECH TRANSFER
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss requirements for successful product technology transfer.
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Bio/Pharma in China
New Initiatives, New Opportunities
TWO LIVE EVENTS - Part 1: Wednesday, May 18, 2016, and Part 2: Thursday, May 19, 2016 at 8:00 am PDT | 11:00 am EDT | 4:00 pm BST | 5:00 pm CEST
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OUTSOURCING
Demand is driving expansion and consolidation of formulation and clinical trial materials services.
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Employing a Lean Lab Approach to Optimize Lab Processes:
Part 1: Work Smarter Not Harder
On Demand
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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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The Top 4 Most Expensive Encapsulation Mistakes and How to Avoid Them
On Demand
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On Demand
Calibration, qualification, and the right appropriate level of routine testing for laboratory instruments are critical to ensuring high-quality results and maintaining GMP and USP compliance. Understand the relationship between these factors to optimize testing and be prepared for audit.
Sponsored by Mettler Toledo
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Ensuring Effective Drug Stability Studies
Drug Stability Testing from Development to Shipping
On Demand
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on pharmtech tv
The Impact of Biosimilars on the Innovator Market
The Future of Dosage Forms
Continuous Biopharmaceutical Manufacturing
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Events
May 18-19, 2016
June 6-8, 2016
June 6-9, 2016
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Continuous Manufacturing of Pharmaceuticals: Scale-up of a Hot Melt Extrusion Process
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REFERENCE BOOKS |
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A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
On Demand
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eBOOKS
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New materials, instruments, and processes are facilitating solid-dosage drug formulation and manufacturing. This ebook reviews methods to address quality issues for APIs, excipients, and intermediates; analysis methods for elemental impurities and continuous powder processing; modeling tools to improve workflows, and methods to improve tablet compression.
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