Sanofi-Aventis Will Enter U.S. OTC Market By Paying $1.9 Billion For Chattem

The deal, which is Sanofi's latest attempt to diversity in the face of a looming patent cliff, provides a platform for Rx-to-OTC switches.

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US FDA May Consolidate Support Services After Extensive Cuts

 

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
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The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.