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β-thalassemia patients achieve transfusion independence with gene therapy
Over 90 percent of β-thalassemia patients treated with Betibeglogene autotemcel (beti-cel) achieved transfusion independence lasting over a year.
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Clinical Trials
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EU pharmaceutical regulatory outlook for 2022
How will a new regulatory landscape impact the EU and UK pharma industries? Early 2022 will see major new clinical trial legislation come into effect, with proposals for an entirely new regulatory regime promised by the end of the year. Paul Ranson, Consultant at Morgan Lewis, reflects on this and…
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Application Note: Challenges and practical solutions for switching to prefilled syringes for injectables
There are several end-product formats companies can choose from when developing sterile injectable drugs. The most common ones are liquid or lyophilized vials, prefilled syringes, and cartridges. Due to an increase in self-administration of injectable drugs, the market of drug products in prefilled syringes is expected to reach $9.53 billion…
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European Pharmaceutical Review Issue 1 2022
In our latest journal, discover the innovations enabling drugs to be delivered across the blood-brain barrier, the challenges associated with downstream purification of cell and gene therapies, as well as applications of NIR spectroscopy in ingredient analysis. Also featured in this issue, explore the development and future potential of radiomolecular…
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Nexviazyme® improves respiration and mobility long-term in Pompe disease patients
Two-year data shows Pompe disease patients treated with Nexviazyme® (avalglucosidase alfa) have sustained improvements in respiratory function and mobility.
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NICE approves Wegovy™ (semaglutide) for obesity
New draft guidance means thousands of obese Brits could benefit from Novo Nordisk’s Wegovy™ (semaglutide), a drug shown to improve weight loss.
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Phase I oncology studies: rule- versus model-based design
In this article, Karen Ooms, Head of Statistics at Quanticate, compares the rule- and model-based approaches to Phase I trial design, exploring their benefits and weaknesses in defining maximum tolerated dose for oncology products.
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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.
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Clinical trial trends – what will 2022 bring?
Here, EPR’s Hannah Balfour examines the trends that look set to shape clinical research in 2022, with comment from Aman Khera, VP and Global Head of Regulatory Strategy at Worldwide Clinical Trials.
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MCAP for top bio/pharma companies reached $3.4 trillion in 2021
Market capitalisation (MCAP) for the top bio/pharma companies grew 24.9 percent in 2021, with BioNTech and Moderna entering the top 20 for the first time.
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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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First patients dosed in HIV vaccine immunogens trial
Moderna and IAVI take steps towards HIV vaccination, with initiation of a trial dosing patients with HIV immunogens delivered by mRNA.
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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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New studies look to assess immunogenicity of Omicron-based vaccines
A new clinical study by Pfizer Inc. and BioNTech SE, and Phase II study by Moderna, are seeking to evaluate the immunogenicity and safety of Omicron-based vaccines and boosters.
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Tremfya® ranks highest for skin clearance in psoriatic arthritis patients
Newly published Network Meta-Analysis (NMA) from Janssen indirectly compares all published Phase III data for approved treatments for adults with active Psoriatic Arthritis (PsA).
