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Paediatric medicines: just a spoonful of sugar?
Here, Dave Elder discusses the ever increasing importance of child-friendly medications and the specific challenges associated with their development.
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US Food and Drug Administration (FDA)
![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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Meeting the challenge of cost-effective OTC drug manufacture with powder testing
Sharper manufacturing practice is often essential to rigorously optimise production economics and compete effectively in the over-the counter (OTC) marketplace. This article describes the application of powder testing to improve the manufacturing efficiency of OTC products detailing work by Pfizer and GlaxoSmithKline (GSK), companies with extensive OTC portfolios.
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Study shows no benefit of convalescent plasma for COVID-19 patients
An NIH trial found that COVID-19 convalescent plasma did not prevent disease progression in high-risk outpatients with early symptoms.
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FDA approves Jardiance® for heart failure with reduced ejection fraction
The FDA have approved Lilly’s Jardiance (empagliflozin) to treat adults living with heart failure with reduced ejection fraction.
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FDA approve GSK’s Jemperli for patients with dMMR solid tumours
GSK receives FDA accelerated approval for Jemperli for adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours.
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Pfizer and BioNTech submit Phase I data to FDA for COVID-19 booster
Pfizer and BioNTech have announced the submission of initial data to the US FDA to support booster dose of COVID-19 vaccine.
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FDA approves TicoVac™ tick-borne encephalitis (TBE) vaccine
The FDA has approved Ticovac, a tick-borne encephalitis (TBE) vaccine, for people aged one year and older when travelling to TBE endemic areas.
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FDA approve a new indication for Xywav to treat chronic sleep disorder
The FDA have granted a first of its kind indication for Xywav for the treatment of idiopathic hypersomnia (IH) in adults.
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Lebrikizumab displays 75 percent skin clearance in dermatitis patients
Lebrikizumab achieved at least 75 percent skin clearance in more than half of patients with atopic dermatitis (AD), shows Phase III study.
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FDA allows additional COVID-19 vaccine dose for immunocompromised
The FDA has authorised an additional dose of COVID-19 Vaccines Pfizer-BioNTech and Moderna in certain immunocompromised patients.
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Advances in technology and manufacturing to promote plant-produced therapeutics uptake
Experts suggest investing in plant-based manufacturing systems could reduce costs and help scale up therapeutic protein manufacturing.
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FDA releases guidance for near infrared (NIR) analytical procedures
New final guidance will aid drug developers in developing, validating, applying and submitting near infrared (NIR) spectroscopy-based analytical procedures.
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Ritlecitinib improves scalp hair regrowth in alopecia trial
Ritlecitinib was shown to reduce scalp hair loss to less than or equal to 20 percent after six months in Pfizer’s Phase IIb/III trial.
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FDA Fast Track designation given to mRNA RSV vaccine
Moderna’s mRNA respiratory syncytial virus (RSV) vaccine candidate, mRNA-1345, gains Fast Track designation in adults over 60 years old.
