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FDA approves Ebanga (Ansuvimab-zykl) for the treatment of Ebola
Ebanga was approved based on its ability to reduce 28-day mortality in patients with confirmed Ebolavirus infection.
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US Food and Drug Administration (FDA)
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The rise of biosimilars – navigating regulatory complexity in Europe
Gabriela Marton sets out some of the EU-associated regulatory challenges life sciences companies will need to navigate if they want to take advantage of the rise of biosimilars.
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Why cold chain requirements are not holding COVID-19 vaccines back
Despite the stringent storage conditions required for Pfizer and BioNTech’s COVID-19 vaccine, the need for a return to normal life has levelled the playing field for all candidate prophylactics against SARS-CoV-2.
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Pioneering a full-ecosystem microbiota approach to improve survival outcomes in life-threatening diseases
The human gut contains the largest ecosystem of microbial species having complex host-microbiome interactive networks that contribute to our physiology and regulate our immune system. An imbalance in this host-microbiome interaction is associated with disease and the ability to restore or stabilise the network by introducing a rich and diverse…
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Current innovations in the vaccine pipeline
As the global COVID-19 response continues, so does the rapidly expanding pipeline for a novel COVID-19 vaccine. Here, experts from Avalere Health outline ongoing US and global vaccine development efforts, including the role of public-private partnerships in accelerating vaccine development. They will also focus on the broader context of respiratory…
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AstroRx® shows promise in early phase amyotrophic lateral sclerosis trial
Amyotrophic lateral sclerosis (ALS) patients treated with AstroRx® had a 45 percent reduction in their disease progression rate.
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Abbott receives CE mark for COVID-19 IgG quantitative antibody blood test
The new quantitative SARS-CoV-2 IgG lab-based serology test developed by Abbott has been given the CE mark.
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Improved in vitro renal tubular drug transport modelling to meet regulatory and development cost challenges
Due to the high costs associated with drug discovery and the clinical demand for effective drugs, in vitro human cell-based kidney models using renal proximal tubule epithelia are becoming popular tools for early-stage testing. It is increasingly more important that in vitro models of renal drug transport are physiologically representative…
![Vials labelled 'COVID-19 Vaccine Pfizer' [Giovanni Cancemi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-covid-19-vaccine-300x278.jpg)
![Vials labelled 'COVID-19 Vaccine Pfizer' [Giovanni Cancemi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-covid-19-vaccine-scaled-e1607955047519.jpg)
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FDA grants Emergency Use Authorization for Pfizer’s COVID-19 vaccine BNT162b2
The US has approved emergency use of Pfizer and BioNTech’s COVID-19 vaccine, BNT162b2, in people 16 years of age and older.
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The future of RIM is cross-functional integration
By digitalising manual workflows and leveraging machine-learning algorithms to monitor events and offer data-driven insights, automation and AI can make regulatory information management (RIM) more effective and less time-consuming.
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Metformin associated with reduced COVID-19 death risk in women, study shows
Researchers have found that women taking metformin prior to hospitalisation had a significantly reduced risk of death from COVID-19.
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FDA grants Fast Track designation to COVID-19 ARDS treatment
The designation should expedite the review of remestemcel-L, a cellular therapy that has shown promise in treating acute respiratory distress syndrome (ARDS) in COVID-19 patients.
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First bronchiectasis patient dosed in Phase III trial to study brensocatib
The first patient with bronchiectasis has been dosed in the Phase III ASPEN study of brensocatib, a reversible inhibitor of dipeptidyl peptidase 1.
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Moderna applies for regulatory authorisation for COVID-19 vaccine
The company has submitted for Emergency Use Authorization in the US and Conditional Marketing Authorization in Europe for its mRNA-1273 vaccine against COVID-19.
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Regulatory response to the COVID-19 pandemic
Dr Ash Ramzan, founder and principal consultant at Woodley BioReg, discusses how the COVID-19 pandemic has forced regulatory processes to adapt, focusing on the regulatory flexibilities introduced by the UK’s MHRA.
