Tag Archives: approvals

Biopharmaceuticals: Approvals Rate Best in Five Years

Overall, last year can be considered quite a successful one in terms of new product approvals. Nineteen products containing new biopharmaceutical molecular entities were approved in the United States and/or the European Union. These approval numbers are above average compared to the previous five years, which recorded a mean approval rate of 13 products. The […]
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True Pharma Innovation Lies in Quality — not Quantity — of Approvals, say FDA analysts

We’re already embroiled in the annual speculation game about whether FDA approvals this year will keep pace with last year’s near-record of 39 new molecular entities (NMEs) brought to market. The tally is closely watched as a sign of the state of biopharmaceutical innovation and the health of the pharmaceutical industry and biomedical research enterprise.
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Accelerated Approvals Could Raise Risks for Patients

By Erik Greb. FDA approved 35 innovative drugs in fiscal 2011, including treatments for hepatitis C, prostate cancer, Hodgkin’s lymphoma, and lupus. This number of approvals is among the highest in the past 10 years, and it reflects the agency’s efforts to hasten patients’ access to new drugs. In the past two years, the agency’s […]
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