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Second COVID-19 vaccine ‘Spikevax’ is approved by the FDA
The FDA has approved a second vaccine, marketed as Spikevax, shown to be 93 percent effective in preventing COVID-19.
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Regulation & Legislation
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Playbook: Critical cold chain shipments best practices
Learn how the pharma supply chain is evolving, the role of real-time data in critical cold chain shipments and how to increase & improve visibility.
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EC approves Lorviqua® (lorlatinib) as first-line lung cancer treatment
Lorviqua® monotherapy approved as first-line advanced non-small cell lung cancer therapy based on promising Phase III trial results.
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Understanding the new EU Clinical Trial Regulation: seven things sponsors should know
In this article, Sarah Bly and Aman Khera of Worldwide Clinical Trials break down the seven key differences between the EU Clinical Trial Directive and new EU Clinical Trial Regulation, discussing when and how sponsors should begin submitting their trials through the new CTIS portal system.
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CHMP meeting highlights, January 2022
The EMA’s Human Medicines Committee (CHMP) recommended approval of Paxlovid for COVID-19 and a new gene therapy for large B-cell lymphomas.
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Omicron prompts FDA to restrict use of specific antibodies
Based on the latest data, and Omicron's current dominance in the US, the FDA has announced two monoclonal antibody treatments are not authorised for use in any US states, territories and jurisdictions at this time.
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Guide: How real-time tracking supports pharma distribution
This guide explores critical concepts that supply chain professionals need to know about tracking and analysing cold chain pharmaceutical shipments.
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Whitepaper: HPLC in pharmaceutical analysis
Learn why water purity matters in this essential guide to HPLC in pharma analysis. Find out how to deal with water-related issues in drug manufacture, analysis and QC.
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International regulators call for multivalent COVID-19 vaccines
Regulators encourage the development of bivalent or multivalent variant COVID-19 vaccines to continue to combat the disease and its variants.
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New FDA medical device framework to improve women’s health
The FDA’s Center for Devices and Radiological Health releases its strategic plan to improve medical device research and regulation for women.
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mRNA COVID-19 vaccines safe for pregnant women, finds EMA review
A review of studies involving 65,000 pregnancies suggests mRNA COVID-19 vaccines do not increase the risk of pregnancy complications.
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SAHPRA and USP to increase availability of safe health products in South Africa
SAHPRA and US Pharmacopeia have signed a Memorandum of Understanding to expand access to quality-assured health products in South Africa.
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Have your say on future UK clinical trial legislation
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on far-reaching proposals to revise the clinical trial legislation in the UK.
![Gilead sign at their headquarters in Silicon Valley, California USA[Credit: Michael Vi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Gilead-2-300x278.jpg)
![Gilead sign at their headquarters in Silicon Valley, California USA[Credit: Michael Vi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Gilead-2-e1642427117214.jpg)
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Gilead joins the Association of the British Pharmaceutical Industry
With the Association of the British Pharmaceutical Industry (ABPI), Gilead Sciences will work to tackle health crises and shape international trade and regulation.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, January 2022
The EMA’s pharmacovigilance committee (PRAC) began reviewing terlipressin containing medicines and recommended updates to COVID-19 vaccine safety information.
