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New microneedle vaccine shows promise in pre-clinical trials
A single-use, self-administered microneedle vaccine has been developed to provide immunisation against infectious diseases.
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US Food and Drug Administration (FDA)
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US pharma initiates litigation challenging HHS and FDA action
PhRMA and other organisations have challenged action by the HHS and FDA that permits the importation of drugs from Canada without drug manufacturers’ oversight.
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FDA approves first treatment for rare paediatric genetic diseases
Zokinvy (lonafarnib) capsules have been approved for the treatment of Hutchinson-Gilford progeria syndrome and certain progeroid laminopathies in patients over one year old.
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FDA grants EUA to investigational antibody treatment for COVID-19
The Emergency Use Authorization (EUA) is based on a trial in which casirivimab and imdevimab reduced hospitalisations in mild to moderate COVID-19 patients.
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UK and US could administer first approved COVID-19 vaccines next month
Both the UK and US have said that, if approved, the Pfizer and BioNTech COVID-19 vaccine could be administered to people as early as December.
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Pfizer and BioNTech submit for EUA of COVID-19 vaccine with FDA
The companies suggest if the Emergency Use Authorization (EUA) is approved, high-risk patients in the US could begin receiving the BNT162b2 vaccine by the end of December 2020.
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Novel antibiotic shows promise in Phase II C. difficile study
Ibezapolstat cured all 10 patients of their Clostridioides difficile infections and prevented recurrence for at least 30 days.
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FDA grants EUA to baricitinib with remdesivir to treat COVID-19
The FDA has issued an Emergency Use Authorization for baricitinib in combination with remdesivir to treat COVID-19 in hospitalised patients.
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Moderna’s COVID-19 vaccine is 94.5 percent effective, according to interim analysis
The analysis reveals that mRNA-1273 was generally well tolerated and prevented COVID-19 with an efficacy of 94.5 percent in a Phase III study.
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Maintaining pharmaceutical operations during a pandemic through innovation and remote technologies
G Balaji and Ravi Kalla explains how Pharma 4.0 can be implemented at a CRO to enable work to continue even during a global pandemic.
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FDA grants emergency use authorisation to COVID-19 antibody bamlanivimab
The neutralising antibody therapy bamlanivimab (LY-CoV555) is authorised for emergency use in recently diagnosed patients who are at risk of developing severe COVID-19.
![Close up view of the Merck logo on the top corner of a glass building [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Merck-aquisition-300x278.jpg)
![Close up view of the Merck logo on the top corner of a glass building [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Merck-aquisition-scaled-e1605009301887.jpg)
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Merck to acquire VelosBio for $2.75 billion
The acquisition will strengthen Merck’s oncology pipeline with VLS-101, an investigational antibody-drug conjugate in trials for haematological malignancies and solid tumours.
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Pfizer COVID-19 vaccine candidate over 90 percent effective, Phase III study shows
The COVID-19 vaccine candidate BNT162b2, made by Pfizer and BioNTech, has demonstrated over 90 percent efficacy in its first interim analysis during its Phase III trial.
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IDMC recommends modifications to Regeneron COVID-19 antibody trial
The clinical trial testing the REGN-COV2 antibody cocktail should be altered, according to the Independent Data Monitoring Committee (IDMC).
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FDA publishes list of essential medicines and medical countermeasures
The agency has compiled a list of essential medicines, medical countermeasures and critical inputs, as directed by Trump’s executive order in August.
