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Updated restrictions announced for multiple sclerosis treatment
A revised indication, additional contraindications and strengthened monitoring requirements has been recommended for Lemtrada (alemtuzumab) following a review.
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In silico techniques – a JPAG event
European Pharmaceutical Review attended a JPAG event, exploring the plethora of uses for in silico techniques in the pharmaceutical industry.
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New innovation centre for biopharma technologies opens
A facility has opened in Ireland which will allow the biopharma industry to trial and simulate the latest bioprocessing and quality control technologies in a GMP environment.
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Keytruda® (pembrolizumab) with chemotherapy meets Phase III PFS endpoint
The drug’s developers reveal Keytruda increased progression-free survival (PFS) in patients with metastatic triple-negative breast cancer (mTNBC) expressing PD-L1.
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European Pharmaceutical Review Issue 1 2020
Within this issue are articles which investigate polyelectrolyte multilayers as drug carriers, discuss how developments in pharma impact logistics and examine how the industry can regulate heavy metals in medicinal cannabis. Other features include how to use the correct tablet tooling and trends for the CDMO sector this year.
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Combining crotoxin with silica enables safe administration in animals
The toxicity of crotoxin has been significantly reduced by combining it with nanostructured SBA-15 silica, used in vaccine formulations.
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FDA requests market withdrawal of weight-loss drug Belviq
After clinical trials showed an increased risk of cancer in patients taking Belviq, the FDA has recommended the withdrawal of the drug from the US market.
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The importance of labelling compliance for pharma
Bart Vansteenkiste explains why it is important to validate pharmaceutical labelling compliance to ensure good manufacturing practice.
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Whitepaper: Drug shortages – why do they happen and how can we stop them?
This whitepaper from NSF looks at the key causes of drug shortages and what we can do to stop them.
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Medicines and Medical Devices Bill introduced in UK
A new bill is now effective in the UK which aims to improve regulation for medical devices and ensure patient safety, as well as allow hospitals to develop personalised medicines.
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MHRA suspends license for Picato over concerns of skin malignancy risk
The marketing license for ingenol mebutate gel (Picato) has been suspended by the MHRA due to studies showing an increased risk of skin malignancies from the drug.
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FDA grants Priority Review to capmatinib – a targeted lung cancer therapeutic
The US Food and Drug Administration (FDA) has granted Priority Review for capmatinib, a treatment for MET exon 14 skipping mutated non-small cell lung cancer.
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Researchers find one dose of HPV vaccine as effective as other regimens
A study investigating the effectiveness of HPV vaccines has revealed that a single dose is as successful at preventing cervical cancer as multiple doses.
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NIBRT announces collaboration to improve downstream bioprocessing bottlenecks
A collaboration between the NIBRT and Avantor aims to address issues faced in downstream bioprocessing during buffer preparation for mAbs.
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MHRA issues alert for missing information on Atrolak XL tablet leaflets
Side effects revealed during post-marketing experience are not listed on Atrolak XL prolonged-release tablet patient information leaflets, announces the MHRA.
