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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.
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.
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.
Lorviqua® monotherapy approved as first-line advanced non-small cell lung cancer therapy based on promising Phase III trial results.
Moderna and IAVI take steps towards HIV vaccination, with initiation of a trial dosing patients with HIV immunogens delivered by mRNA.
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.
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.
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).
Regulators encourage the development of bivalent or multivalent variant COVID-19 vaccines to continue to combat the disease and its variants.
Patients treated with Imfinzi and chemotherapy experienced a 20 percent reduction in the risk of death versus chemotherapy alone.
The data adds to the body of evidence relating to the use of Keytruda® as a monotherapy in second-line HCC post sorafenib.
CME will support the delivery of automated just-in-time clinical supply, as one of the collaborators in the Medicines Manufacturing Innovation Centre Grand Challenge 2.
Study reveals riluzole is of no benefit in spinocerebellar ataxia type 2, emphasising the importance of studying homogeneous groups of patients.
Almost a third of unresectable hepatocellular carcinoma patients were alive at three years on tremelimumab and Imfinzi regimen.
The FDA’s Center for Devices and Radiological Health releases its strategic plan to improve medical device research and regulation for women.
