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Latest From Sandoz Inc.
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A Bad Fit: Dan Leonard’s Leadership Style Did Not Translate At AAM
Former employees at the Association for Accessible Medicines detail problems that emerged during Leonard’s tenure, but also say the board of directors must improve its management of the trade organization.
J.P. Morgan Day Four: Talking With Execs About BD Plans
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New Drug Exclusivity Not Impacted By Impurities In Compound, Court Finds In Loss For Sandoz
DC Circuit Court upholds FDA’s grant of new chemical entity exclusivity to Sanofi’s multiple sclerosis drug Aubagio (teriflunomide) even though the agency had previously approved teriflunomide as an impurity in Sanofi’s Arava (leflunomide). FDA reviews known impurities in drugs only to assess their impact on safety and efficacy, not to approve them, court says.
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