Sanofi-Synthelabo extends its offer for Aventis U.S. shareholders to exchange their shares for Sanofi stock until June 30, Sanofi announces. The original deadline of May 28 was extended pending a decision by the French stock market regulator Autrite des Marches Financiers to set an expiration date. Sanofi has articulated a desire to close the $65 bil. merger in the second quarter. The firm also is awaiting final clearance from the Federal Trade Commission. Aventis accepted Sanofi's offer April 25 (1"The Tan Sheet" May 3, 2004, p. 8)...
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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.’
Although the UK Health Research Authority’s initial proposal for simplified informed consent was rejected by stakeholders, it has yielded valuable insights into reducing trial burden and widening access
Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.
Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.
