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EMA Backs Approval For Eight New Drugs But Rejects Lagevrio For COVID-19

 
• By Neena Brizmohun

Janssen’s Akeega is among the latest drugs that the European Medicines Agency says should be approved for use in the EU. Meanwhile, MSD/Ridgeback Biotherapeutics plan to appeal the agency’s rejection of their COVID-19 treatment.

The EMA recommended approval for eight drugs but rejected another one • Source: Shutterstock

The European Medicines Agency has recommended in favor of pan-EU marketing approval for eight new medicines including Janssen’s Akeega (niraparib/abiraterone acetate), but says that MSD/Ridgeback Biotherapeutics’ COVID-19 treatment, Lagevrio (molnupiravir), should not be approved.

If authorized, niraparib in combination with abiraterone acetate (AA) will be the first dual action tablet available in the EU for first-line treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations, when given with prednisone or prednisolone, Janssen said

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Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
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