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New J&J data signals progress in ulcerative colitis treatment landscape
The biologic delivered sustained remission in adults with the inflammatory bowel disease (IBD) over the two-year study, results show.
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Clinical Trials
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FDA approves first-of-a-kind gene therapy for dystrophic epidermolysis bullosa
With clinical data showing the gene therapy can address large and challenging chronic wounds, the FDA’s decision will help improve quality of life for dystrophic epidermolysis bullosa (DEB) patients.
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New $1.7b Novartis acquisition to advance novel microRNA inhibitor
The merger deal between Novartis AG and Regulus Therapeutics is expected to push forward development of a potential first-in-class kidney disease drug.
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Eli Lilly to lead oligonucleotide therapy development in new collaboration
The partnership between Eli Lilly and Company and Creyon Bio will focus on producing safer, more effective RNA-targeted oligonucleotide therapies with the use of AI technology.
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Boehringer agrees new partnership to advance first-in-class precision cancer therapies
The collaboration between Boehringer Ingelheim and Tessellate Bio seeks to address availability of targeted medicines for a cancer type shown to be difficult to treat.
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Antibody treatment demonstrates potential in lupus kidney disease
The findings suggest that the biologic treatment could improve short-term outcomes for patients with lupus nephritis.
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FDA approves novel therapy for chronic skin condition
The US approval could improve outcomes for eligible patients with previously limited options for managing the inflammatory skin condition.
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Eli Lilly releases topline data for new oral GLP-1
Subject to regulatory approval, the small molecule drug could provide a new treatment option for diabetes and obesity, Eli Lilly’s new data suggests.
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European Commission Alzheimer’s drug approval marks advancement for EU patients
Lecanemab is the only approved Aβ monoclonal antibody that highly binds to and clears toxic protofibrils with high selectivity.
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Innovative approach could improve cancer immunotherapy
A clinical trial is currently investigating the potential of CD40L-enhanced tumour-infiltrating lymphocyte (TIL) cancer therapy in non-small cell lung cancer.
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NICE recommends new combination breast cancer drug
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.
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New analysis sets stage for improved UK clinical trials
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.
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GSK to advance antibody medicines for neurodegenerative diseases
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.
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AI in pharmaceutical development: hype or panacea?
Dave Elder reflects on the array of applications for AI to facilitate successful drug development, though proof remains elusive.
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EMA proposes streamlined approach for biosimilar development
In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
