Collaborations & Alliances, Trials & Filings

Janssen-Cilag Submits HIV Combo

Combines Prezista with Gilead-developed boosting agent

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Janssen-Cilag International, a division of Johnson & Johnson, has submitted a Marketing Authorization Application (MAA) to the EMA seeking approval for a once-daily single tablet fixed-dose antiretroviral combination product containing darunavir (a protease inhibitor developed by Janssen) with cobicistat (a pharmacokinetic enhancer or boosting agent, developed by Gilead Sciences) for use in combination with other human immunodeficiency virus (HIV-1) medicines. Once-daily darunavir is market...

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