news
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.
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Biologics
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On-demand webinar: The art of changing QC testing methods
Learn how you can go about changing QC test methods and how this can go a long way to helping your lab achieve data integrity compliance.
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AstraZeneca reveals $15.54 billion in revenues in H1 2021
H1 financial results show AstraZeneca’s revenues grew by 23 percent in 2021, with $14.37 billion attributed to activities aside from COVID-19 vaccine sales.
webinar
Improve efficiency and return on investment by adopting molecular spectroscopy techniques in pharma manufacturing
3 August 2021 | By Thermo Fisher Scientific
In this on-demand webinar, discover the differences between FTIR, NIR and Raman spectroscopy, learn how spectroscopy is applied in quality control labs and hear how implementation of these techniques increased efficiency and minimised costs.
news
NICE approves cost-comparison fast-track appraisal pilot
A new approach to the cost-comparison fast-track appraisal process is being piloted this summer for the review of low-risk appraisals.
news
FDA approves emergency use of REGEN-COVTM for COVID-19 prevention
The FDA have authorised REGEN-COV monoclonal antibody therapy for emergency use as prevention for COVID-19 in certain patients.
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FDARA implementation guidance for paediatric studies of molecularly targeted oncology drugs
This article addresses early planning for paediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original New Drug Application (NDAs) and Biological License Application (BLAs) are expected to be submitted to FDA, in accordance with The FDA Reauthorization Act (FDARA).
news
LBPs may offer hope to IBS patients in the near future, says report
Live biotherapeutic products (LBPs) are expected to help patients with IBS who currently have no US- or EMA-approved treatments.
![Pfizer logo on a sign in New York city, US [Credit: Molly Woodward / Shutterstock.com]](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-4-300x278.jpg)
![Pfizer logo on a sign in New York city, US [Credit: Molly Woodward / Shutterstock.com]](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-4-e1627904909506.jpg)
news
Pfizer reports 92 percent increase in revenues for Q2
The company’s second quarter (Q2) results reveal a $9.1 billion increase in revenues from Q2 2020 and significant operational growth.
whitepaper
Case study: RMM to reduce plate counts
See how a pharma company maintained product quality and reduced risk by using an RMM analyser, while also meeting their goal of reducing plate counts by 25 percent.
news
Project worth £3.1mn to develop advanced controls for biopharma manufacturing
A collaborative project will develop automated manufacturing controls for biologics such as antibodies, viral vectors and vaccines.
news
FDA approves first interchangeable biosimilar insulin product
The first interchangeable biosimilar insulin product will help increase access and affordability of insulin for diabetics.
news
BioNTech to develop and supply mRNA malaria vaccine
Collaborating with global partners BioNTech will work to develop a safe and effective malaria vaccine and set up its sustainable supply for the African continent.
news
EMA recommends approving Spikevax COVID-19 vaccine for adolescents
Based on new clinical results, the EMA is recommending Moderna’s Spikevax COVID-19 vaccine be approved for use in children aged 12 to 17 years.
whitepaper
Case study: RMM for identifying contamination sources
See how a leading biopharma company used an RMM analyser in parallel to plate counts to find the root cause of periodic bioburden excursions in its water system.
