Search results for " Europe" in Articles / App Notes
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Science Focus Fuels Successful Process Development for Startups
Celyad, a company developing chimeric antigen receptor (CAR)-T cell therapies, built on its previous work with a stem-cell therapy that it took from preclinical development to two Phase II trials in E…
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Drug Quality Key to Innovation and Access
…tion drug shipments, they will face multiple tracking and serialization systems under development in Europe, Asia, and South America. The lack of harmonization in these efforts reflects continued cha…
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Innovation vs. Capacity: How CMOs Compete
…ance (QA) capabilities that support dependable registration and approval of new drugs at FDA and the European Medicines Agency (EMA)
• Capabilities to support clients on a global scale, especiall…
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Aseptic Processing: Keeping it Safe
…ated processes “of the same standard as for products authorized for marketing,” according to the European Commission’s EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and V…
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Setting Standards for Biotech Therapeutics in India
Similar relationships need to be pursued with other global agencies such as National Institute of Biological Standards and Control (NIBSC), and European Directorate for the Quality of Medicines (EDQM)…
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FDA Urged to Preserve Biosimilar Naming Conventions
The practice is already established in Europe and other markets.
“These groups understand that the INN approach to biosimilar naming has proven safe and effective in Europe; it has worked in…
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Report: Branded Biopharms Most Exposed to Biosimilar Competition
"But while in Europe more than a dozen products are now commercialized, in the US no company has yet filed for approval of a biosimilar drug since the existence of the FDA's new pathway for biosimilar…
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Brazil Emerges as Global Biopharm Collaborator
According to Mussolini, citing IMS Health figures for the past five years, Brazil’s growth is considered relevant if compared with data for Europe and the US, whose growth levels were around 1%. Musso…
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Early Communication with Regulators is Essential for SMEs
SMEs on the rise
The European Union is currently calling SMEs “the powerhouse” of its Innovation Union, a concept behind its new seven-year €77 billion research program called Horizon 2020, which…
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Milestones and Moderate Progress in 2012 Drug Approvals
Twelve biopharmaceutical marketing applications were approved in the United States and/or the European Union in 2012 (see Table I). Approval numbers for the past year are in line with those recorded o…