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NIH spending for drugs approved 2010-2019 lower than industry spending, study finds
The first article to broadly assess the US National Institutes of Health (NIH)'s financial contribution to clinical development of new drugs has been published.
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The US Food and Drug Administration (FDA)
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Post-approval R&D key in advancing oncology treatments
The Pharmaceutical Research and Manufacturers of America (PhRMA) has highlighted in a new report five R&D mechanisms that could facilitate full clinical value of oncology treatments after initial approval from the US Food and Drug Administration (FDA).
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FDA releases analysis on drug product quality in 2022
There continues to be a correlation between low site inspection scores and potential drug recalls, states the US Office of Pharmaceutical Quality (OPQ) 2022 annual report.
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First cell therapy approved for Type 1 diabetes
US Food and Drug Administration (FDA)-approved allogeneic pancreatic islet cell therapy Lantidra could provide another treatment option for Type 1 diabetes.
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FDA publishes recommendations on psychedelic clinical trial design
New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
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Gene therapy approved for Duchenne muscular dystrophy
The first approved gene therapy for certain paediatric Duchenne muscular dystrophy (DMD) patients leads to production of the Elevidys micro-dystrophin protein.
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First adult anti-inflammatory cardiovascular drug approved
An FDA-approved anti-inflammatory drug can reduce cardiovascular disease risk by an additional 31 percent in adults, on top of standard of care, clinical data has shown.
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First redosable gene therapy approved
The “landmark approval” of a redosable gene therapy for dystrophic epidermolysis bullosa “ushers in a whole new paradigm to treat genetic diseases".
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FDA publishes paper on AI/ML in drug development
"rapid growth in the number of submissions that reference artificial intelligence and machine learning” has prompted the US Food and Drug Administration (FDA) to seek feedback on AI/ML in drug development.
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First RSV vaccine approved for older adults
The US Food and Drug Administration (FDA) has approved the first-ever vaccine for respiratory syncytial virus (RSV) in adults over 60 years old.
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FDA releases draft guidance for decentralised clinical trials
Recommendations on the conduct of remote clinical trial visits are included in new US Food and Drug Administration (FDA) draft guidance.
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FDA approves first new B-cell lymphoma treatment in 20 years
A first-line B-cell lymphoma treatment shown to reduce the risk of disease progression or relapse by 27 percent has been approved by the FDA.
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FDA approves allogeneic stem cell transplant therapy
The first allogeneic stem cell transplant therapy to be approved based on Phase III study results has been granted by the US Food and Drug Administration (FDA).
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Accelerating drug development
Here, Dave Elder explores how a ‘quick-approval, quick-withdrawal from the market’ approach is used to accelerate drug development.
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Key developments: mRNA vaccines and therapeutics
EPR summarises results from key mRNA vaccine trials, highlighting the future potential of these innovative therapeutics.
