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EMA’s human medicines committee (CHMP) meeting highlights, May 2021
In its latest meeting the CHMP recommended eight medications for approval, 17 medicines for indication extension and concluded reviews of two COVID-19 treatments.
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Therapeutics
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CDMO sector are the big winner of the pandemic, state experts
In a presentation, experts revealed that contract services gained significantly through pandemic contracts but cautioned that capacity shortages could continue.
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Stelara® “a compelling option” for the treatment of Crohn’s disease
Janssen has released abstracts for four studies evaluating Stelara® (ustekinumab) in Crohn's disease (CD) and ulcerative colitis (UC).
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Curative cell and gene therapies and healthcare system disruption
In this article, experts from Charles River Associates discuss how the introduction of cell and gene therapies will impact upon various aspects of the healthcare system, from provision of care to delivery and supply, and pricing and market access.
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Imbruvica®-based regimens induce lasting remissions in leukaemia trials
Imbruvica® (ibrutinib) plus ventoclax and single-agent Imbruvica induced remissions lasting up to seven years in first-line treatment of chronic lymphocytic leukaemia.
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Ziltivekimab shows promise in atherosclerosis trial
Ziltivekimab was found to reduce inflammatory biomarkers of atherosclerosis by up to 93 percent in patients with chronic kidney disease and high cardiovascular risk.
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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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Driving biopharma innovation post COVID-19
Ahmed Bouzidi, VP of Biotech Strategic Development at ProductLife Group, discusses the opportunities – and funding and regulatory challenges – facing small and mid-sized biopharma companies as they deliver innovation to the global market.
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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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Evinacumab shows promise in severe hypertriglyceridemia trial
The investigational antibody evinacumab was able to lower triglycerides by up to 82 percent in severe hypertriglyceridemia patients with acute pancreatitis.
![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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New harmonised guidance for post-approval changes released by FDA
The FDA has published its finalised guidance for drug lifecycle management, including an improved framework for the management of post-approval changes.
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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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Six major risks facing pharmaceutical manufacturers in 2021
In this article, Shannon Flynn outlines six of the key risks threatening pharmaceutical manufacturers’ recovery from COVID-19 in 2021.
