Biologics
The US Biosimilar Regulatory Scheme and Comparison with the European Experience: Where Do Where Go From Here
David Rosen and Larry Lian, Foley & Lardner
The authors outline the key decision points FDA must consider in putting forth an US regulatory pathway for biosimilars.
Contract Manufacturing
A Roundup of Informex
Patricia Van Arnum, senior editor at Pharmaceutical Technology and editor of Sourcing and Management.
Contract manufacturers and fine-chemical suppliers announce capacity expansions and service enhancements of Informex.
Outsourcing
Changes Underway for Biopharmaceutical Outsourcing
Eric Langer, president of BioPlan Associates
More crucial biomanufacturing operations are expected to be outsourced.
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Reports from the Waters Bioanalysis World Tour
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CSR and Sustainability Forum
Pharmaceutical Technology’s dedicated editorial coverage on the developments in corporate social responsibility (CSR) and sustainability from the bio/pharmaceutical industry, other business sectors, and public and private organizations. This month, we feature articles on drug-development models for the developing world, a new pediatric HIV/AIDs clinic in Tanzania by Bristol-Myers Squibb, and a roundup of CSR and sustainability news.
Drug Development for Government, Nonprofit, and Developing-World Markets
Chan Harjivan and George Dougherty, PRTM
This article is Part I of a three-part series on biopharmaceutical issues in public health, government, and developing-world markets. Part I focuses on drug-development. Part II, which examines manufacturing, will be published in the April 2011 of Sourcing and Management. Part III, which analyzes distribution and the supply chain, will be published in the May 2011 issue.
Bristol-Myers Squibb Moves Forward with HIV/AIDS Project in Africa
Patricia Van Arnum, senior editor of Pharmaceutical Technology and editor of Sourcing and Management
Bristol-Myers Squibb, through a private–public partnership, opens a new pediatric HIV/AIDS clinic in Tanzania.
CSR and Sustainability Forum
A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.
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