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MHRA approve Pfizer and AstraZeneca COVID-19 vaccine booster doses
The UK regulator confirmed that the Pfizer and AstraZeneca COVID-19 vaccines can be used as safe and effective booster doses.
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Viruses
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Roche to acquire TIB Molbiol Group to expand PCR-test portfolio
Roche signs a definitive share purchase agreement with TIB Molbiol Group to expand PCR-test portfolio against infectious diseases.
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EMA evaluates data on Comirnaty® COVID-19 vaccine booster dose
EMA begins evaluating the application for a booster dose of Comirnaty® in adults to be given six months after the second dose.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021
The EMA’s drug safety committee (PRAC) reviewed COVID-19 vaccine risks and issued a new safety signal for Imbruvica with rituximab.
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Phase III clinical trial for respiratory syncytial virus (RSV) vaccine begins
Pfizer’s RENOIR Phase III trial will evaluate the efficacy, immunogenicity and safety of their respiratory syncytial virus (RSV) vaccine.
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Fostamatinib reduces COVID-19 risks by 50 percent in Phase II study
Fostamatinib significantly reduced serious adverse effects and risk of death in hospitalised COVID-19 patients, shows Phase II study.
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HIV vaccine fails to protect women against infection
The investigational vaccine tested in sub-Saharan Africa posed no safety concerns but did not provide sufficient HIV protection.
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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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CPI launches RNA Centre of Excellence and training academy
CPI have launched an RNA Centre of Excellence in Darlington to boost development, scale-up and manufacture of RNA therapies and vaccines.
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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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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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The research-based industry response to COVID-19; collaboration and innovation
Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) gives her take on the industry response to the pandemic; highlighting the benefits of focused effort and what can be achieved through unified collaboration.
![Researcher looking at an experiment [Credit: Unsplash].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Bell-advanced-therapies-feature-300x278.jpg)
![Researcher looking at an experiment [Credit: Unsplash].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Bell-advanced-therapies-feature.jpg)
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UK at the forefront of advanced therapies
Advanced therapies are a ground-breaking new class of medicines that use gene therapy, cell therapy or tissue engineering to treat disease and injury. Rachel Bell, Trainee Patent Attorney at Marks & Clerk, and Ceri Roberts, Scientific Training Manager – Cellular and Molecular Therapies at NHS Blood and Transplant, discuss some…
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Comirnaty and Moderna COVID-19 vaccine supply to increase in the EU
The CHMP has adopted recommendations to increase manufacturing capacity and supply of COVID-19 Vaccines Comirnaty and Moderna in Europe.
![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.
