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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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US Food and Drug Administration (FDA)
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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.
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EC approves Zejula (niraparib) as a monotherapy for advanced ovarian cancer
The European Commission (EC) has approved Zejula, the first PARP-inhibitor monotherapy approved in the EU for patients with advanced ovarian cancer, regardless of their biomarker status.
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How will Trump’s ‘Buy American’ executive order impact pharmaceutical supply chains?
On 6 August 2020, US President Donald Trump signed an executive order, dubbed ‘Buy American’, with the aim of increasing the production of essential medicines in the US for domestic use. Here, Victoria Rees discusses the order and what it means for drug manufacturers in the US and rest of…
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Novel non-opioid postsurgical pain implant launched
Innocoll Holdings Limited has announced the commercial launch of the XARACOLL® (bupivacaine HCI) implant, a non-opioid treatment for acute post-surgical pain for up to 24 hours in adults following open inguinal hernia repair.
