Encysive Thelin Approval Could Come Days Ahead Of Gilead’s Ambrisentan

FDA’s regulatory timeline for reviewing the two pulmonary arterial hypertension medications may fall neck and neck.

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EMA To Consider Approvals For Eight Orphans, Including Vertex’s CF Drug Alyftrek

 

The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.

Kiji CEO On EU HTA Regulation, Hospital Exemption And The Future Of ATMPs

 

Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.

Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.