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Will novel antibiotic become front-line for C. difficile?
Based on positive Phase II data, the first-in-class antibiotic candidate ibezapolstat for C. difficile is expected to advance to Phase III trials more quickly.
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Clinical Trials
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FDA approves first-in-class antidepressant
The first antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor has been approved for major depressive disorder (MDD) by the US Food and Drug Administration (FDA).
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Chemo-free regimen demonstrates efficacy in NSCLC
Topline results from a Phase III study in NSCLC suggest that Rybrevant® and lazertinib could advance treatment beyond tyrosine kinase inhibitor (TKI) monotherapy.
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Takeda ulcerative colitis biologic receives FDA approval
A new route of administration for a biologic to treat ulcerative colitis (UC) has been approved in the US.
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DMT-SSRI combination shows potential for depression
A Phase Ib study evaluating selective serotonin reuptake inhibitors (SSRIs) interaction with SPL026, native N, N-dimethyltryptamine (DMT) in major depressive disorder (MDD) has revealed positive data.
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ebook: Accelerate the development of your biologics
Altasciences’ Proactive Drug Development can accelerate the development of biologics by up to 40%, from lead identification to clinical POC.
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Webinar: Advantages bringing early phase trials to North America
Watch Altasciences’ on-demand webinar to learn the key advantages and differences of conducting early phase clinical trials in North America.
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Lymphoma maintenance therapy delivers promise in CTCL
One of the largest clinical trials in cutaneous T-cell lymphoma (CTCL) to date could change current clinical practice, new data shows.
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First multiple sclerosis biosimilar approved in Europe
Sandoz’s monoclonal antibody Tyruko® has been approved for all indications of reference medicine, as the first biosimilar to treat relapsing forms of multiple sclerosis (MS) in Europe.
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Radioligand therapy demonstrates novel first line benefit
Novartis’ radioligand therapy (RLT) is the first to demonstrate clinically meaningful benefit in a first line setting.
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Anti-PD-1 antibody gains EU approval for oesophageal cancer
Approval of BeiGene’s TEVIMBRA® (tislelizumab) in EU follows an agreement with Novartis to regain global rights of the antibody treatment.
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NICE recommends Eli Lilly ulcerative colitis biologic
The first IL-23p19 targeted biologic recommended by the National Institute for Health and Care Excellence (NICE) for moderately to severely active ulcerative colitis (UC) in adults in Great Britain is based on Phase III evidence of sustained clinical remission.
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New manufacturing facility could drive gold standard in cell therapy
A new manufacturing facility from the Novo Nordisk Foundation will be the first large-scale cell therapy production site in Denmark.
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Gene therapy: a radical pharmaceutical revolution
Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring provides an overview of past and present gene therapy development, plus the progress of clinical trials and key challenges in the sector.
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sa-mRNA vaccine facilitates durable COVID-19 immunisation
A novel sa-mRNA vaccine has demonstrated the ability to provide prolonged protection against COVID-19 at lower doses, Phase I/II data shows.
