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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.
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Regs & Legs
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Falsified Covishield vaccine identified in Africa and Asia
WHO urges supply chain stakeholders to be vigilant, after falsified Covishield COVID-19 vaccines were identified in Uganda, India and Myanmar.
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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.
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Minjuvi® receives EC approval to treat large B-cell lymphoma
European Commission (EC) approves Minjuvi with lenalidomide for the treatment of large B-cell lymphoma in adults.
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FDA application to be submitted for Comirnaty® booster dose
Pfizer and BioNTech will submit a supplemental biologics licence application to the FDA for booster dose of COVID-19 Vaccine Comirnaty.
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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.
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European Pharmaceutical Review Issue 4 2021
In our latest issue, features explore the use of nano formulations to improve skin and nail drug delivery, how to take cell and gene therapies from concept to commercialisation and what strategies you can use to overcome interfering factors in LAL bacterial endotoxin testing. Also in this journal, find out…
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JAK inhibitor approved in EU for atopic dermatitis treatment
The European Commission (EC) approved Rinvoq® as the first JAK inhibitor in Europe for the treatment of moderate to severe atopic dermatitis.
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Bimzelx® receives EC approval for plaque psoriasis treatment
The European Commission (EC) have approved UCB’s Bimzelx (bimekizumab) for the treatment of moderate to severe plaque psoriasis.
![Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-BioNTech-COVID-19-vaccine-300x278.jpg)
![Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-BioNTech-COVID-19-vaccine-e1629795881701.jpg)
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Pfizer-BioNTech becomes the first FDA-approved COVID-19 vaccine
Pfizer and BioNTech's vaccine is the first to be approved by the FDA for the prevention of COVID-19 in people aged 16 years and older.
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ZyCoV-D becomes world’s first plasmid DNA vaccine for COVID-19
Zydus’ ZyCoV-D received emergency use authorisation (EUA) in India, becoming the world’s first plasmid DNA vaccine for COVID-19.
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Xeljanz® receives EU marketing authorisation for juvenile arthritis
Xeljanz® (tofacitinib) received marketing authorisation in Europe for the treatment of juvenile idiopathic arthritis (JIA) and psoriatic arthritis (PsA).
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Evrenzo™ approved for CKD-related anaemia treatment in EU
The European Commission (EC) has approved Astellas’ Evrenzo™ for adult patients with symptomatic anaemia of chronic kidney disease (CKD).
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Abecma is the first treatment approved by EC for multiple myeloma
The European Commission (EC) has approved Abecma, the first anti-BCMA CAR T-cell therapy for patients with multiple myeloma.
