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Latest From Sanofi Genzyme
Orphan drugs and COVID-19 products are among the latest filings under review by the European Medicines Agency for potential pan-EU approval.
Sanofi argues that the European Medicines Agency applies a narrow interpretation of its new active substance principles which is not appropriate for biological therapies, and that the regulator fails to consider the challenges of conducting clinical research in rare diseases.
Only three planned marketing authorization applications are known to have been granted accelerated assessment status by the European Medicines Agency between July and October this year.
Marketing applications for 10 new drugs have been added to the latest list of products under review by the European Medicines Agency.
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- ILEX Oncology, Inc.
- Sangstat Medical Corporation
- Genzyme Corporation