April 5, 2012
By:
Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology
On Mar. 29, 2012, the Generic Pharmaceutical Association reiterated its call for Congress to move forward with user-fee proposals for generic drugs and biosimilar products.
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April 5, 2012
By:
Rose Price
ePT--the Electronic Newsletter of Pharmaceutical Technology
The management board of the European Medicines Agency has introduced a range of new measures to strengthen and extend its conflicts of interest policy for scientific-committee members and experts, as well as for members of the management board.
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April 4, 2012
By:
Patricia Van Arnum
PTSM: Pharmaceutical Technology Sourcing and Management
The manufacturing capacity-sharing model in biologics between Merck & Co. and MedImmune LLC ushers in a new paradigm of co-opetition.
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April 2, 2012
By:
Kashyap R. Wadekar, Ponnaiah Ravi, Mitali Bhalme, S. Srinivasa Rao, K. Vigneshwar Reddy, L. Sampath Kumar, E. Balasubrahmanyam
Pharmaceutical Technology
In Part III of a three-part article, the authors examine various degradation routes of APIs, impurities arising from interactions in formulations, metabolite impurities, various analytical methods to measure impuritie, and ways to control impurities.
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April 2, 2012
By:
Hans Smallenbroek, Boon Meow Hoe
Pharmaceutical Technology
Comparison of the top GMP deficiencies cited by the PIC/S Participating Authorities.
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April 1, 2012
By:
Nathan Jessop
Pharmaceutical Technology Europe
Greece’s economic crisis has battered the country’s healthcare system, resulting in medicine shortages, market withdrawals and falling profits for the pharma industry.
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March 29, 2012
By:
Stephanie Sutton
ePT--the Electronic Newsletter of Pharmaceutical Technology
A US court has denied AstraZeneca's request for a preliminary injunction against the FDA.
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March 29, 2012
By:
Amy Ritter
ePT--the Electronic Newsletter of Pharmaceutical Technology
On Mar. 13, 2012, FDA issued a Warning Letter to Steven Victor, CEO of IntelliCell Biosciences for a violation of the Food, Drug, and Cosmetic Act, and for violations of cGMP and Good Tissue Practice in the manufacture of its adipose tissue-derived stem-cell product.
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March 28, 2012
By:
Stephanie Sutton
ePT--the Electronic Newsletter of Pharmaceutical Technology
The European Medicines Agency has released guidance that outlines a European-wide approach for dealing with transparency and access to information included in marketing authorization applications.
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