Concerned about chronic liver injury, FDA halts development of Geron’s telomerase inhibitor imetelstat, the only drug left standing in Geron’s pipeline, and requests data for patients who discontinued treatment in Geron-sponsored plus non-Geron studies.
Geron Corp.CEO John Scarlett says it will “certainly be challenging” to provide data proving reversibility of liver abnormalities after patients stopped taking its oncologic imetelstat in trials, but that’s what the company must provide to overcome FDA’s clinical hold.
On March 12, the company announced that per a verbal agency communication on March 12, there is a “full clinical...
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Deadlines for reviewing applications for mononational trials in Belgium will be cut by 50%.
The UK MHRA is looking to support drug sponsors in using in silico data during the drug development process – a move that will reduce the use of animal models.
A new decree in Brazil establishes a new ethics governance and operational structure in clinical research and seeks to better protect clinical trial participants.
Clinical trial sponsors could soon benefit from a streamlined clinical trial approval process in Australia, Canada, Singapore, Switzerland and the UK under a new ACCESS Consortium project.
Clinical trial sponsors could soon benefit from a streamlined clinical trial approval process in Australia, Canada, Singapore, Switzerland and the UK under a new ACCESS Consortium project.
The FDA reviewed its efforts to bring PROs into cancer drug development at its 10th annual workshop on clinical outcome assessment in cancer trials.
The World Health Organization’s Global Clinical Trials Forum brings optimism for pharma companies and other stakeholders, as it aims to strengthen the clinical trials environment and infrastructure across nations.
