PharmTech News

Oct 05, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Rockville, MD (Oct. 2)-The US Food and Drug Administration has issued its final Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations.
Oct 05, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
Foster City, CA (Oct. 2)-Gilead Sciences, Inc. has agreed to acquire the biopharmaceutical company Myogen, Inc. for $2.5 billion.
Oct 02, 2006
Special from Pharmaceutical Technology
More CMOs look to proprietary delivery technologies to enhance profitability.
Oct 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
GlycoFi's work could eliminate the need for mammalian cell culture and improve the performance of protein therapies.
Sep 28, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
As with pharmaceutical manufacturing as a whole, a risk-based approach is important in manufacturing highly hazardous or potent compounds. Industry groups are working with US Food and Drug Administration (Rockville, MD) to develop a baseline guide for a risk-management approach to determine containment controls required to minimize cross contamination.
Sep 28, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
FDA issued a Warning Letter from its Minneapolis District Office to Hawkins, Inc., part of a diversified chemical company and pharmaceutical repackager here.
Sep 28, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Altana AG plans to sell Altana Pharma AG and its entire pharmaceuticals business to Nycomed for EUR 4.5 billion (about $5.7 billion).
Sep 28, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Washington, DC (Sept. 26): A much-publicized Institute of Medicine report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public," though devoted to the assessment and perception of risk, focuses on premarketing clinical reviews and postmarketing pharmacovigilance. It does not address or make recommendations on drug manufacturing or quality assurance.
Sep 28, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Millennium Pharmaceuticals, Inc. entered into an agreement to acquire biopharmaceutical company AnorMED, Inc. (Langley, BC, Canada) for $515 million.
Sep 28, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
In a move that continues the consolidation trend in the generic drugs market, Hospira Inc. agreed to acquire specialty injectables company Mayne Pharma Limited (Melbourne, Australia) for $2 billion.
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