Amgen Expects At-Risk CERA Launch, But Says Swiss Gamble Won’t Pay Off

After failing to block the importation of pegylated erythropoietin, Amgen anticipates Roche will launch its continuous EPO receptor activator Mircera at risk

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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.

Argentina Speeds Up Market Access Process

 

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.