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Vaxneuvance™ meets immunogenicity and safety endpoints in Phase III trial
Merck announces positive results from a Phase III study evaluating Vaxneuvance™ against a pneumococcal conjugate vaccine in infants.
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Drug Safety
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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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Improvements in skin and nail drug delivery using nano formulations
It might be easy to dismiss non-life-threatening diseases of the skin or nail as trivial, but their impact on physical and mental wellbeing can be significant. Such diseases are obvious targets for topical treatments, but the lack of effective formulations means patients are often faced with the prospect of oral…
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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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QA/QC & Environmental Monitoring In-Depth Focus 2021
In this in-depth focus, learn how to overcome interfering factors when using LAL for endotoxin testing and discover how the implementation of a new scrubs system benefited an aseptic production facility.
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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.
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Bacterial Endotoxin Test using LAL methodology: overcoming interfering factors
The Bacterial Endotoxin Test, using LAL methodology, is a key in-process and final product release test for sterile pharmaceuticals and medical devices. One of the challenges with LAL methodology is overcoming interfering substances as demonstrated by inhibition or enhancement of an endotoxin challenge. Here, Bio Products Laboratory’s Dr Tim Sandle…
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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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Antibody combination reduces symptomatic COVID-19 risk by 77 percent
AstraZeneca’s AZD7442 reduced the risk of developing symptomatic COVID-19 by 77 percent in PROVENT Phase III study.
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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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MHRA approve first monoclonal antibody treatment for COVID-19
The MHRA have approved Ronapreve as the first monoclonal antibody combination product for the treatment of COVID-19 infection in the UK.
