The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
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In this article, EPR’s Hannah Balfour discusses the potential impact of waiving intellectual property rights for COVID-19-related medicine and technology on pharma, biopharma and biotech companies.
New real-world analyses demonstrate Veklury® (remdesivir) reduces mortality and increases likelihood of discharge in hospitalised COVID-19 patients.
The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
In its latest meeting the CHMP recommended eight medications for approval, 17 medicines for indication extension and concluded reviews of two COVID-19 treatments.
The awardees, including Takeda, Janssen and Gilead, are recognised for their state-of-the-art facility design, construction and operation projects.
The company will donate 450,000 vials of remdesivir and support its licencing partners in expanding and accelerating the production of the drug.
In a Phase III trial, adding Lenzilumab™ to steroid and remdesivir regimens improved the likelihood of survival without need for mechanical ventilation by 54 percent.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) began two new reviews and wrote guidance for healthcare professionals on the potential side effects of Strimvelis, Venclyxto and Zolgensma.
The EMA's human medicines committee has released its results for the December meeting, suggesting which therapies should receive marketing authorisation.
The fourth iteration of the COVID-19 treatment trial will determine whether remdesivir plus baricitinib or dexamethasone is more effective at promoting recovery from COVID-19.
The European Commission (EC) has signed a joint procurement contract to ensure an uninterrupted supply of Veklury (remdesivir) for participating countries.