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FDA approves Phase III trial of synthetic biological COVID-19 treatment
The international Phase III trial will evaluate whether a 14 day course of carrimycin can improve outcomes for COVID-19 patients with severe symptoms.
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US Food and Drug Administration (FDA)
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FDA monitoring impact of SARS-CoV-2 mutations
The FDA has alerted clinical laboratory staff and healthcare providers that it is monitoring the potential impact of SARS-CoV-2 mutations, including the UK variant.
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New process for producing synthetic insulin developed
Researchers say that their novel way to produce synthetic insulin could also be used to create at least eight other drugs.
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Trial to evaluate monoclonal antibody therapy for mild-to-moderate COVID-19
The study will determine if the combination of BRII-196 and BRII-198, two investigational antibodies for SARS-CoV-2, can prevent disease progression.
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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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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.
