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Intravacc publishes GMP vaccine candidate manufacturing process
A new paper details the GMP manufacturing and formulation process for a semi-synthetic Shigella glycoconjugate vaccine candidate from Institut Pasteur.
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Biologics
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New preventative medicine for COVID-19 authorised in UK
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reported that Evusheld, developed by AstraZeneca, has been granted approval to help protect against the effects of COVID-19.
![Catalent logo on website through a magnifying glass [Credit: Pavel Kapysh/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Catalent-300x278.jpg)
![Catalent logo on website through a magnifying glass [Credit: Pavel Kapysh/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Catalent-e1647945626125.jpg)
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Catalent invests $30 million to modernise biopharmaceuticals site
The completed modernisation of Catalent’s facility in Limoges, France, will support the development of early phase and small-scale commercial biologic drugs.
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Is Aduhelm® of benefit to Alzheimer’s patients long-term?
New data shows that patients taking Aduhelm® (aducanumab-avwa) had significant reductions in tau and amyloid beta after nearly 2.5 years.
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mRNA vaccine candidates for HIV enter Phase I trial
Will mRNA vaccines one day protect against HIV? Three investigational mRNA vaccines, all designed to combat HIV, have entered Phase I testing.
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Could AAT be the answer to COVID-19 ARDS?
Clinical study finds alpha-1 antitryspin (AAT) reduces pro-inflammatory IL-6 and therefore may benefit COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS).
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, March 2022
EMA’s pharmacovigilance committee recommends product information updates for two COVID-19 vaccines - Janssen COVID-19 Vaccine and Moderna’s Spikevax.
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New agreement makes “Africa’s own COVID-19 vaccine” a reality
Under a new agreement with J&J, Aspen SA Operations will be able to manufacture and make available Aspen-branded COVID-19 vaccines in Africa.
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Trodelvy® improves breast cancer progression-free survival, finds study
Trodelvy® (sacituzumab govitecan-hziy) was found to significantly reduce the risk of disease progression or death in certain breast cancer patients.
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Chikungunya vaccine candidate safe and immunogenic in Phase III
Valneva’s single-shot chikungunya vaccine candidate, VLA1553, offered a very high level of seroprotection in all adults, including the elderly.
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PRIME scheme benefits drug development, finds EMA report
The report outlines the positive impact the EMA’s PRIority Medicines (PRIME) scheme has had on drug development for unmet medical need over the last five years.
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Nirsevimab first potential immunisation to protect against RSV in infants
Nirsevimab has the potential to offer RSV protection for all infants, with a single dose showing 74.5 percent efficacy in the Melody Phase III trial.
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Clostridioides difficile vaccine shows promise in Phase III trial
Pfizer’s investigational C. difficile vaccine was shown to reduce the duration and severity of disease, but not prevent primary C. difficile infection.
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FDA approves Carvykti for patients with multiple myeloma
US FDA approval based on 98 percent response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).
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USP calls for industry input in developing mRNA quality guidelines
USP is developing mRNA quality guidelines to support the development of innovative medicines and vaccines.
