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EMA human medicines committee (CHMP) highlights, September 2022
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
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Veklury (remdesivir)
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CHMP meeting highlights – July 2022
At its July meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 medicines for approval and extended the indication of six more, including Imvanex for the prevention of monkeypox.
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The latest on pharmaceutical counterfeiting
Here, EPR’s Hannah Balfour discusses the latest reports on pharmaceutical counterfeiting and falsification, exploring global and European crime rates, as well as recent counterfeiting incidents reported by Big Pharma.
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EMA endorses two monoclonal antibody medicines for COVID-19
The European Medicines Agency’s human medicines committee (CHMP) has recommended authorising Ronapreve™ and Regkirona for COVID-19.
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Veklury® (remdesivir) reduces COVID-19 hospitalisation risk by 87 percent
Veklury (remdesivir) significantly reduced the risk of COVID-19 related hospitalisation and death in high-risk patients in Phase III study.
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Regulators call for clinical research to include pregnant and breastfeeding women
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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How could waiving COVID-19-related intellectual property rights affect biopharma?
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.
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Real-world evidence confirms Veklury® reduces COVID-19 mortality
New real-world analyses demonstrate Veklury® (remdesivir) reduces mortality and increases likelihood of discharge in hospitalised COVID-19 patients.
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Pharmacovigilance Risk Assessment Committee meeting highlights, June 2021
The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
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EMA’s human medicines committee (CHMP) meeting highlights, May 2021
In its latest meeting the CHMP recommended eight medications for approval, 17 medicines for indication extension and concluded reviews of two COVID-19 treatments.
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ISPE announces its manufacturing Facility of the Year Awards winners
The awardees, including Takeda, Janssen and Gilead, are recognised for their state-of-the-art facility design, construction and operation projects.
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Gilead to support Indian COVID-19 crisis with donation of remdesivir
The company will donate 450,000 vials of remdesivir and support its licencing partners in expanding and accelerating the production of the drug.
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Lenzilumab™ significantly improves survival in hospitalised COVID-19 patients
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.
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EMA COVID-19 treatment evaluations update
The EMA has begun a rolling review of Celltrion’s regdanvimab (CT-P59) antibody for COVID-19 and assessing new data on Veklury (remdesivir).
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February Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights
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.
