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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…
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…
Amyotrophic lateral sclerosis (ALS) patients treated with AstroRx® had a 45 percent reduction in their disease progression rate.
The new quantitative SARS-CoV-2 IgG lab-based serology test developed by Abbott has been given the CE mark.
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)
The US has approved emergency use of Pfizer and BioNTech’s COVID-19 vaccine, BNT162b2, in people 16 years of age and older.
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.
Researchers have found that women taking metformin prior to hospitalisation had a significantly reduced risk of death from COVID-19.
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.
The first patient with bronchiectasis has been dosed in the Phase III ASPEN study of brensocatib, a reversible inhibitor of dipeptidyl peptidase 1.
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.
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.
The designation should expedite the development and review of AB201, a recombinant protein therapy being tested in hospitalised COVID-19 patients.
Researchers have shown that recipients of the Bacillus Calmette-Guérin (BCG) vaccine are less likely to contract COVID-19 in a new study.
A single-use, self-administered microneedle vaccine has been developed to provide immunisation against infectious diseases.
