Norman Stockbridge is appointed permanent director of the Center for Drug Evaluation & Research's Division of Cardiovascular and Renal Products. Stockbridge has been serving as acting director since Douglas Throckmorton became CDER deputy director in May 2004 (1"The Pink Sheet" April 19, 2004, p. 4). Stockbridge joined FDA in 1991 as a medical officer and was appointed Cardio-Renal division deputy director in 2002...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.
New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.
