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NICE recommends first treatment for children with metachromatic leukodystrophy
The one-time gene therapy treatment for rare, neurodegenerative disease metachromatic leukodystrophy (MLD) is the most expensive drug ever evaluated by NICE.
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Regulation & Legislation
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New regulation strengthens role of EMA in EU crisis response
The regulation sees tools, structures and processes set up by EMA during the pandemic to accelerate clinical trial approval and regulatory assessments in the EU being formally recognised.
whitepaper
Whitepaper: Prioritising innovation to get ahead of the market
This whitepaper explores the conflict that exists between necessary administration tasks and innovation, demonstrating how digitalisation can help.
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Cabenuva HIV treatment approved for eight week dosing
US FDA approves Cabenuva (cabotegravir, rilpivirine) based on results from the ATLAS-2M Phase IIIb trial which showed every-two-month dosing was non-inferior to once-monthly dosing.
whitepaper
Toolkit: Water purity in pharma and healthcare
Take the quiz and journey through the interactive tool to find out about water purity in healthcare and pharma.
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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.
whitepaper
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.
article
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.
news
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.
whitepaper
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.
whitepaper
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.
news
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.
news
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.
