Could investigational drug become first-in-class bronchiectasis therapy?
The small molecule treatment is currently being reviewed by the US Food and Drug Administration (FDA), under the Prescription Drug User Fee Act (PDUFA).
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The small molecule treatment is currently being reviewed by the US Food and Drug Administration (FDA), under the Prescription Drug User Fee Act (PDUFA).
The research provides insight into effective measurement of particle adhesion, potentially enhancing pharmaceutical powder processing.
The findings suggest that the biologic treatment could improve short-term outcomes for patients with lupus nephritis.
The US approval could improve outcomes for eligible patients with previously limited options for managing the inflammatory skin condition.
Lecanemab is the only approved Aβ monoclonal antibody that highly binds to and clears toxic protofibrils with high selectivity.
A clinical trial is currently investigating the potential of CD40L-enhanced tumour-infiltrating lymphocyte (TIL) cancer therapy in non-small cell lung cancer.
The agency’s recommendation could provide eligible breast cancer patients with a treatment that analysis suggest is to likely to work as well as two medicines already recommended by NICE.
Observations from the report will help the MHRA to strengthen clinical research and lay the foundation for accelerated innovation and medicine delivery to patients in the UK.
The licensing agreement will support development of medicines for delivery across the blood-brain barrier to treat neurological disorders like Alzheimer’s and Parkinson’s.
The proposed technique holds value for real-time monitoring and surveillance of airborne bacteria with high sensitivity and rapid results, the study showed.
The research highlights that major barriers to digital innovation in life sciences include cultural attitudes on AI’s potential, governance and digital skills.
In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
The proposed approach demonstrates benefit for real-world application, establishing more robust, adaptive, and economical process systems, the research suggests.
EPR's latest Pharma Horizons report explores the latest advances in artificial intelligence (AI) for drug and clinical development, regulation and more.
The research highlights a potential approach to address cross-contamination challenges during cell-processing operations.