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UK patients with rare blood disorders receive new treatment option
NICE has recommended that Ultomiris (ravulizumab) be available on the NHS for patients with paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome.
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Drug Safety
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Dexpramipexole could be a promising treatment for eosinophilic asthma
Oral doses of dexpramipexole lowered eosinophil counts by up to 80 percent and showed signs of improving lung function in a Phase II eosinophilic asthma trial.
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mRNA COVID-19 vaccination is immunogenic in the immunocompromised
Research suggests patients who receive COVID-19 vaccines prior to a transplant and subsequent immunosuppression may be protected from the disease.
![Vials of heparin filling the screen [Credit: JLMcAnally / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Heparin2-300x278.jpg)
![Vials of heparin filling the screen [Credit: JLMcAnally / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Heparin2.jpg)
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Novel spectroscopy technique could improve safety and quality of heparin
Using time of flight secondary ion mass spectrometry (ToF-SIMS) enabled the detection of nanoscale quantities of glycosaminoglycan (GAG) contaminants in heparin.
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First UK patient enrolled in Duchenne muscular dystrophy gene therapy trial
The Phase III trial will evaluate the safety and efficacy of Pfizer’s PF-06939926 gene therapy in 99 paediatric Duchenne muscular dystrophy patients across 15 countries.
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CBD tablet significantly improves diabetic peripheral neuropathic pain
In a Phase II trial, a cannabidiol (CBD) sublingual tablet reduced pain scores in patients with diabetic peripheral neuropathy by approximately 50 percent.
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FDA outlines plan for making inspections more consistent going forward
The new report shows over 8,000 planned inspections were postponed due to COVID-19 and outlines the FDA’s plan for a more consistent future state of operations.
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European Pharmacopoeia adopts revised Raman spectroscopy chapter
The revised Raman Spectroscopy chapter (2.2.48) will be released in October, with updates focusing on enhancing the reliability of the results.
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Pakistan approves Zofin™ for compassionate use in COVID-19 patient
Organicell’s Zofin™ therapy has been approved by the Pakistani regulators to be used for a patient with severe COVID-19 on compassionate grounds.
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Gene therapy successfully treats rare immunodeficiency in paediatric patients
In three Phase I/II trials an experimental gene therapy caused all but two patients with severe combined immunodeficiency to acquire and retain robust immune function for more than two years.
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FDA allows Pfizer’s COVID-19 vaccine to be used in adolescents
The Comirnaty® vaccine’s emergency use authorisation has been extended to allow its administration to those 12 years of age and above in the US.
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Real-time bioprocess Raman analyser market to achieve significant growth
Market research shows the adoption of process analytical technologies and investment in pharma R&D and healthcare will drive growth in the real-time bioprocess Raman analyser market.
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MDMA-assisted therapy successful in PTSD patients
Three sessions of MDMA-assisted talk therapy resulted in significant symptom reductions for 88 percent of patients with severe, chronic post-traumatic stress disorder (PTSD).
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EMA begins rolling reviews for a COVID-19 therapeutic and a vaccine
The European Medicines Agency (EMA) has initiated a rolling reviews of Vero Cell, an inactivated COVID-19 vaccine, and sotrovimab, a monoclonal antibody.
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Highlights of the May 2021 Pharmacovigilance Risk Assessment Committee (PRAC) meeting
In its May meeting, the EMA’s drug safety committee (PRAC) concluded two safety signal reviews for COVID-19 vaccines and began several more.
