Drug Development

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Recent M&A activity indicates a potential resurgence in the appetites of larger companies for psychiatric drug development, but experts say the space may not offer a sufficient risk-reward proposition for R&D.
Approaches and targets for depression and other mental health illnesses have remained stagnant for decades. With several readouts for novel therapies on the horizon, that could be changing.
Until compelling surface targets for lung cancer are developed, antibody-drug conjugates will fail to treat most patients with lung cancer, experts told BioSpace.
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Despite the added survival benefit for its drug, Alnylam still faces steep competition from Pfizer, whose ATTR-CM therapies have become established treatment options.
In this episode, the third and final conversation of our mini-series on diversity in clinical trials, Lori and guests discuss framing strategies designed to protect DEI initiatives from legal challenges.
The pharma continued its clinical losing streak on Thursday with the announcement that it is discontinuing late-stage studies of the anti-PD-1 therapy in non-small cell lung cancer and cutaneous squamous cell carcinoma.
Armed with new late-stage data on reducing low-density lipoprotein cholesterol, Novartis is positioning its siRNA therapy Leqvio as a preventive treatment for atherosclerotic cardiovascular disease.
Neurocrine Biosciences’ potential competitor to Bristol Myers Squibb’s KarXT improved symptoms of schizophrenia in a Phase II trial, but only at the low dose tested.
The company announced Tuesday that despite the error preventing the analysis of late-stage results, the FDA confirmed that data from other completed trials are sufficient to support an NDA submission in the first quarter of 2025.
With the FDA’s rejection of Ordspono in March, Monday’s green light from the European Commission marks the first approval worldwide and the first regulatory victory for Regeneron’s bispecific antibody platform.
In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them.
While approved by the Medicines and Healthcare products Regulatory Agency, the Alzheimer’s drug failed to win the backing of the U.K.’s National Institute for Health and Care Excellence, which said that its benefits were “too small to justify the cost.”
Patients taking Novo Nordisk’s blockbuster GLP-1 drug appear to be more likely to harbor thoughts of suicide or self-harm, especially if they are already suffering from anxiety or depressive disorders, according to a new study.