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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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US Food and Drug Administration (FDA)
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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.
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FDA grants COVID-19 treatment Fast Track designation
The designation should expedite the development and review of AB201, a recombinant protein therapy being tested in hospitalised COVID-19 patients.
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One of the oldest vaccines could help combat COVID-19
Researchers have shown that recipients of the Bacillus Calmette-Guérin (BCG) vaccine are less likely to contract COVID-19 in a new study.
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New microneedle vaccine shows promise in pre-clinical trials
A single-use, self-administered microneedle vaccine has been developed to provide immunisation against infectious diseases.
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US pharma initiates litigation challenging HHS and FDA action
PhRMA and other organisations have challenged action by the HHS and FDA that permits the importation of drugs from Canada without drug manufacturers’ oversight.
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FDA approves first treatment for rare paediatric genetic diseases
Zokinvy (lonafarnib) capsules have been approved for the treatment of Hutchinson-Gilford progeria syndrome and certain progeroid laminopathies in patients over one year old.
