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FDA halts COVID-19 vaccine production at Emergent facility
The FDA has requested Emergent’s Bayview plant be closed and vaccine production halted while the agency investigates potential good manufacturing practice (GMP) violations.
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US Food and Drug Administration (FDA)
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EMA confirms Janssen COVID-19 Vaccine benefits outweigh clotting risks
The EMA’s drug safety committee has concluded that the Janssen COVID-19 Vaccine is safe for continued use, so Johnson & Johnson will resume shipments to the EU.
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How to overcome barriers in the adoption of microbiome-based therapies
This article from the global consulting firm Charles River Associates (CRA) describes how manufacturers must address and overcome three key barriers hindering progress in the microbiome sector and the optimal strategies needed to demonstrate the value of microbiome-based therapies in successful commercialisation.
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FDA revokes bamlanivimab Emergency Use Authorization
The Emergency Use Authorization (EUA) was revoked after data suggested that, in the US, the prevalence of variants likely to be resistant to the monoclonal antibody bamlanivimab alone is increasing.
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NT-300 tablets show promise in Phase III COVID-19 trial
Initial results suggest NT-300 (nitazoxanide extended-release tablets, 300mg) reduces progression to severe illness in mild to moderate COVID-19 patients.
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US pauses administration of Janssen COVID-19 Vaccine
The FDA and CDC have decided to temporarily suspend use of Janssen’s single dose vaccine while reports of rare and severe blood clots are investigated.
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Global Pharmacovigilance Observatory to aid pharma’s understanding of regulatory decisions
The observatory will collate drug safety data, analyses and decisions into a single source to help pharma identify regional differences in decision-making.
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EC approves Cabometyx® and Opdivo® combination for advanced renal cell carcinoma
The combination was approved on Phase III trial results which show it doubled progression-free survival and reduced risk of death by 40 percent, compared to standard of care.
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FDA approves Abecma, the first cell-based gene therapy for adults with multiple myeloma
Abecma (idecabtagene vicleucel) was approved for adults with relapsed or refractory myeloma based on its 72 percent overall response rate in a trial.
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FDA sends warning to companies selling unapproved CBD products
The warning letters were issued to two companies illegally selling over-the-counter cannabidiol (CBD) products for pain relief.
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FDA approves emergency use of a non-diagnostic COVID-19 screening device
The Tiger Tech COVID Plus Monitor was granted Emergency Use Authorization (EUA) based on its ability to detect biomarkers indicative of COVID-19 infection in asymptomatic individuals.
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Novel blood cleansing device to enter first-in-human trial
The Garnet™ therapeutic product, which can capture more than 100 clinically relevant bacteria, fungi, parasites, toxins and viruses from the blood, will soon begin clinical testing.
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What is on the horizon for the pharmaceutical packaging equipment market?
European Pharmaceutical Review’s Hannah Balfour outlines the findings of market research reports exploring the challenges and drivers for the pharmaceutical packaging equipment market between 2020 and 2025.
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Dissecting the impact of COVID-19 on pharmaceutical regulatory practices
In this article, Dr Ronan Brown, IQVIA’s SVP and Head of Integrated Global Compliance, explores the long-term impact of COVID-19 on regulatory practices in three key areas: clinical trial study design, clinical trial study development and post-clinical trial regulatory submissions.
![Lines of vials labelled 'COVID-19 Vaccines' [Credit: Dimitris Barletis/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Covid-19-vaccines-2-1-300x278.jpg)
![Lines of vials labelled 'COVID-19 Vaccines' [Credit: Dimitris Barletis/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Covid-19-vaccines-2-1-e1614176959561.jpg)
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A single vaccine dose is sufficient for immunity in COVID-19 survivors, finds study
New research shows a second COVID-19 vaccine dose may be unnecessary in individuals previously infected with SARS-CoV-2 and needlessly exposes individuals to higher rates of adverse effects.
