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 Van Arnum
Pharmaceutical Technology
Expansion activity was limited as fine-chemical producers and CMOs of API and intermediates grapple with changing industry fundamentals.
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December 2, 2011
By:
Patricia Van Arnum
Pharmaceutical Technology
Drug shortages, supply-chain security, generic-drug incursion, and flexible manufacturing models are some of the issues shaping the bio/pharma industry.
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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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December 2, 2011
By:
Shamsuddin Sultan Khan, Mesbah Uddin Talukder
Pharmaceutical Technology
The authors developed a metronidazole-based floating drug-delivery system to investigate the effect of rate-controlling polymers on release pattern and duration of buoyancy in matrix tablets.
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December 1, 2011
By:
Erik Greb
ePT--the Electronic Newsletter of Pharmaceutical Technology
On Nov. 21, 2011, Gilead Sciences agreed to acquire Pharmasset for $137 per share in cash, or a total of approximately $11 billion. Pharmasset's board of directors unanimously approved the transaction, which is expected to close during the first quarter of 2012.
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December 1, 2011
By:
Amy Ritter
ePT--the Electronic Newsletter of Pharmaceutical Technology
The justice department announced that Merck has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx.
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November 24, 2011
By:
Stephanie Sutton
The breast cancer indication for Avastin has been revoked after FDA Commissioner Margaret A. Hamburg concluded that the drug has not been shown to be safe and effective for this use.
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