news
EMA evaluates data on Comirnaty® COVID-19 vaccine booster dose
EMA begins evaluating the application for a booster dose of Comirnaty® in adults to be given six months after the second dose.
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Regulation & Legislation
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NICE recommends bimekizumab for severe plaque psoriasis treatment
Bimzelx® (bimekizumab) becomes the first medicine to be evaluated and recommended through NICE’s new Expedited Low-Risk Fast Track Appraisal.
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Video: Automation of endotoxin assays
Want easy automation of BET assays and high throughput? Watch the video to see fast BET assay setup with centripetal microfluidic automation.
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European Pharmacopoeia publishes new chapter on balances
The new general chapter, Balances for analytical purposes (2.1.7), sets out clear requirements for equipment that is the cornerstone of every analytical procedure in the European Pharmacopoeia.
whitepaper
Application note: TOC Reference Materials – Make vs. Buy?
Explore the cost comparisons, risk reduction, and increased support that arise when using Sievers Certified Reference TOC Standards.
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FDA reaches over 100 Competitive Generic Therapy approvals
The FDA reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation.
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EC approves Ultomiris for children and adolescents with PNH
The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).
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Six major disruptors for the generics and biosimilars market
In this article, EPR's Hannah Balfour outlines six factors that could significantly challenge the generics and biosimilars market in the next decade.
news
FDA approves Invega Hayfera™ for the treatment of schizophrenia
Janssen announced US FDA approval of Invega Hayfera, the first and only twice-yearly treatment for adults with schizophrenia.
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NICE approves inclisiran for LDL cholesterol reduction
The UK approval follows a Phase III study in which Leqvio® (inclisiran) reduced low-density lipoprotein cholesterol (LDL-C) by 55 percent.
whitepaper
Application note: USP <643> TOC limit changes
This application note addresses the TOC limit changes in USP for packaged water. The new limits account for varying container volumes.
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UK life sciences sector: do you have the Vision for innovation?
Here, EPR explores some highlights of the UK’s new Life Sciences Vision for the pharma, biopharma and biotech industries, covering topics from funding to regulatory reviews and clinical trial innovation.
news
Metformin oral solution recalled due to nitrosamine impurity
A Class 2 recall notice for one batch of Rosemont Pharmaceuticals metformin hydrochloride 500mg/5ml oral solution has been issued by the MHRA.
![Researcher looking at an experiment [Credit: Unsplash].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Bell-advanced-therapies-feature-300x278.jpg)
![Researcher looking at an experiment [Credit: Unsplash].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Bell-advanced-therapies-feature.jpg)
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UK at the forefront of advanced therapies
Advanced therapies are a ground-breaking new class of medicines that use gene therapy, cell therapy or tissue engineering to treat disease and injury. Rachel Bell, Trainee Patent Attorney at Marks & Clerk, and Ceri Roberts, Scientific Training Manager – Cellular and Molecular Therapies at NHS Blood and Transplant, discuss some…
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Scrubbing up the environment
Here, colleagues from University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) share the beneficial impact of reduced cleanroom environmental contamination following an upgrade to their facilities and procedures.
