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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 Food and Drug Administration (FDA)
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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.
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First patients receive Moderna’s modified COVID-19 vaccine candidates
Moderna has begun testing two new mRNA COVID-19 vaccines, one specifically targeting the B.1.351 variant and the other a multivalent candidate.
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Bamlanivimab and etesevimab prevent COVID-19 related deaths
In a high-risk patient cohort, treatment with the combination of bamlanivimab and etesevimab reduces COVID-19 related hospitalisation and death by 87 percent.
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FDA grants Emergency Use Authorisation to Abott’s SARS-CoV-2, influenza and RSV test
The PCR based Alinity™ m Resp-4-Plex molecular assay can detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV).
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COVID-19 T cell test submitted for emergency use authorisation
In clinical testing, the T-SPOT.COVID test was found to agree with PCR test results in over 96 percent of samples taken within first 60 days of infection.
