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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.
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COMIRNATY®
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Vaxzevria has similar safety profile to mRNA COVID-19 vaccines, finds study
New studies show rates of blood clots were similar following vaccination with Vaxzevria and Comirnaty®, plus rates of rare blood clots are lower after the second Vaxzevria dose.
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Regulators call for clinical research to include pregnant and breastfeeding women
The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
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Has the threat of waiving COVID-19 vaccine intellectual property rights had its desired effect?
In this final article on the TRIPS waiver for COVID-19 vaccines, medicines, diagnostics and technologies, EPR’s Hannah Balfour considers whether it is the correct strategy to overcome COVID-19 treatment inequalities and explores other options.
podcast
EPR Podcast Episode 3 – Inhaled and intranasal drug formulations and delivery – Dr Bill Williams, University of Texas
Join Dr Bill Williams as he discusses formulation for inhaled and intranasal drug delivery and goes into detail about thin film freezing, a novel powder formulation technique he developed.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, July 2021
The Pharmacovigilance Risk Assessment Committee (PRAC) provided safety warnings on COVID-19 vaccines, and found no evidence linking Zynteglo to blood cancer.
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How could waiving COVID-19-related intellectual property rights affect biopharma?
In this article, EPR’s Hannah Balfour discusses the potential impact of waiving intellectual property rights for COVID-19-related medicine and technology on pharma, biopharma and biotech companies.
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What are the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines?
In response to the COVID-19 pandemic caused by the SARS-CoV-2 virus, the emergence of RNA vaccine technology has enabled rapid development of critical vaccines. Traditional vaccine production methods makerapid development challenging, requiring cell line production of viral proteins and laborious purification development, which requires extensive effort and long timelines. RNA…
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COVID-19 vaccines highly effective against hospitalisation by Delta variant
21 June 2021 | By
An analysis shows Comirnaty® and the COVID-19 Vaccine AstraZeneca are both over 90 percent effective in preventing hospitalisation from the Delta variant.
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Pharmacovigilance Risk Assessment Committee meeting highlights, June 2021
The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
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Comirnaty® COVID-19 vaccine protects against multiple viral variants
Laboratory study shows the blood sera of people vaccinated against COVID-19 with Comirnaty® can neutralise at least six viral variants including three variants of concern.
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Waiving COVID-19 vaccine intellectual property rights
South Africa and India’s request that the World Trade Organization waive intellectually property rights for COVID-19 vaccines, treatments, diagnostics and technology has garnered extensive media coverage, particularly since the US decision to support the proposal. In a three-part series, European Pharmaceutical Review’s Assistant Editor, Hannah Balfour, will discuss the IP…
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US begins testing mixed COVID-19 vaccine regimens
A Phase I/II trial will enrol 150 individuals already vaccinated against COVID-19 with one vaccine and assess the safety and immunogenicity of a booster dose of a different COVID-19 vaccine.
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EMA recommends first COVID-19 vaccine for children aged 12 to 15
The EMA is recommending that the Comirnaty® COVID-19 vaccine’s indication be extended to include children aged 12 to 15 years.
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EU secures up to 1.8 billion additional doses of Comirnaty® COVID-19 vaccine
Pfizer and BioNTech have agreed to supply Europe with 900 million additional doses of Comirnaty® with the option to request 900 million more in future.