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UK leads Europe in Phase I and Phase II trials, ABPI findings show
The ABPI has found that the UK is leading the rest of Europe in early-stage clinical trials and makes suggestions on how the country can maintain this position.
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UK Medicines and Healthcare products Regulatory Agency (MHRA)
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Safety warnings for opioid medicines in UK to be added to labels
Warnings about addiction will be added to the patient information leaflets of opioids, the MHRA has announced.
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Post-Brexit product supply: which way next for pharma?
Cecilia Avram details the requirements for pharma companies post-Brexit and provides practical pointers on minimising the disruption to cross-border product availability as new rules come into force.
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Clinical trial for AstraZeneca Oxford COVID-19 vaccine candidate to resume
After the clinical trial for AZD1222 was halted last week, the studies for AstraZeneca's COVID-19 vaccine candidate will now resume.
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British pharma industry responds to new Brexit guidance from MHRA
The ABPI has responded to new guidance, intended to prepare pharma companies for the end of the Brexit transition period, from the MHRA.
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MHRA issues positive opinion to avelumab for Early Access to Medicines Scheme
The UK MHRA has given a positive scientific opinion for Merck and Pfizer's avelumab on the Early Access to Medicines Scheme (EAMS).
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MHRA announces recall of Randox COVID-19 testing kits in UK
Randox is recalling COVID-19 testing kits in the UK as a precautionary measure as they do not meet the required safety standards, the MHRA has said.
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COVID-19 rapid antibody tests approved for use in UK
Abingdon Health's COVID-19 rapid antibody test has been registered with the UK's Medicines and Healthcare products Regulatory Agency.
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UK MHRA announces two Class 2 medicine recalls
A batch of Nitrofurantoin and all unexpired stock of Desmopressin nasal spray are being recalled in the UK, the MHRA has announced.
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Life sciences M&A activity during the global pandemic
COVID-19 has severely disrupted the lives of many people around the world. In this article, corporate partner Theo Godfrey and competition partner Russell Hoare from the life sciences team at law firm CMS Cameron McKenna Nabarro Olswang LLP consider some issues related to COVID-19 that have impacted life sciences merger…
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Torbay Pharmaceuticals recalls two batches of Epistatus (midazolam)
Due to a potentially faulty and incorrectly engaged child-resistant container closure, Torbay Pharmaceuticals has announced a recall of certain Epistatus (midazolam) batches.
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MHRA suspends patient recruitment to UK COVID-19 hydroxychloroquine trials
After evidence suggesting hydroxychloroquine has no benefit against COVID-19, the MHRA has suspended further recruitment to clinical trials investigating the drug in the UK.
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The COVID-19 pandemic and clinical trial disruptions
Research suggests almost 70 percent of global clinical trials have been disrupted by enrolment suspensions caused by the COVID-19 pandemic.
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Four MHRA ‘inspections and good practice’ guidances for the COVID-19 outbreak
Md Saddam Nawaz discusses four guidances released by the MHRA to help firms navigate the regulatory waters during the COVID-19 pandemic.
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How modern chromatography data systems are improving regulatory compliance in pharmaceutical manufacturing
Delivering confident QA and QC in pharmaceutical manufacturing is of critical importance. This article discusses how the latest chromatography data systems are ensuring compliance with modern regulatory requirements.
