December 22, 2011
By:
Erik Greb
ePT--the Electronic Newsletter of Pharmaceutical Technology
Last week, the US Department of Health and Human Services and Novartis Vaccines and Diagnostics dedicated a manufacturing plant that can create influenza vaccine using cultured animal cells instead of the conventional expression system of fertilized eggs.
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December 21, 2011
By:
Erik Greb
Equipment and Processing Report
Risk assessment is not a new concept to the pharmaceutical industry, but lately the phrase has become a mantra. A systemic, science-based way to manage risk is becoming essential to meeting the spirit and letter of FDA requirements.
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December 15, 2011
By:
Erik Greb
ePT--the Electronic Newsletter of Pharmaceutical Technology
In a Warning Letter, FDA cited "significant violations" of CGMP regulations, including several repeat observations, at three Novartis facilities located in Colorado, North Carolina, and Canada.
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December 15, 2011
By:
Stephanie Sutton
ePT--the Electronic Newsletter of Pharmaceutical Technology
After reviewing the "shortcomings in quality assurance" that were recently identified at Ben Venue Laboratories's Bedford, Ohio, facility, EMA issued several recommendations, including product recalls for Ecalta and Liminity.
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December 15, 2011
By:
Amy Ritter
ePT--the Electronic Newsletter of Pharmaceutical Technology
AstraZeneca entered into an agreement to acquire Guangdong BeiKang Pharmaceutical, a privately owned generic-drug manufacturing company based in China, for an undisclosed amount. Upon completion of the acquisition, AstraZeneca will be responsible for the manufacture and commercialization of these medicines.
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December 15, 2011
By:
Rich Whitworth
ePT--the Electronic Newsletter of Pharmaceutical Technology
The FDA and EMA are moving from "confidence-building to reliance upon" each other in a step-up in cooperation on GMP inspections; the latest move following successful completion of pilot projects this summer.
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December 8, 2011
By:
Amy Ritter
ePT--the Electronic Newsletter of Pharmaceutical Technology
On Dec. 6, 2011, FDA announced that a public meeting will be held on Dec. 16, 2011 to discuss recommendations for a user fee program for biosimilar biological products for fiscal years 2013–2017.
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December 7, 2011
By:
Courtenay C. Brinckerhoff
PTSM: Pharmaceutical Technology Sourcing and Management
The author discusses the major changes in US patent laws as a result of the recently signed patent-reform law and the implications for pharmaceutical companies.
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December 2, 2011
By:
Patricia Rafidison
Pharmaceutical Technology
As the excipient supply chain becomes more complex, industry must up the ante to comply with new standards and regulations.
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