Dyax Readies HAE Therapy Kalbitor For Launch; Awareness Precedes Approval

Despite still awaiting FDA approval, Dyax is gearing up for the launch of its hereditary angioedema agent Kalbitor (ecallantide), focusing mainly on awareness and reimbursement issues

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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.