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.’
Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.
Amid the wait for an action plan to apply AI tools to drug regulation at the national level in China, capital city Beijing has released its own vision of scenarios for the technology in the healthcare sector.
Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.
