All Clinical Development articles – Page 28
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NewsADC demonstrates meaningful survival data for HER2 cancers
Topline data from a Phase II trial signify a significant step forward for ENHERTU® (trastuzumab deruxtecan) in its potential to provide a new option in HER2 expressing cancers.
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NewsNew CKD treatment option approved in EU
The first SGLT2 inhibitor to demonstrate a statistically significant reduction in all-cause hospitalisations in chronic kidney disease (CKD) patients versus placebo has been approved in the EU.
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NewsNovel antibody therapeutic demonstrates potential in GVHD
Key data from a Phase II trial of a potentially first-in-class CSF-1R monoclonal antibody for chronic graft-versus-host disease (GVHD) has been released.
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NewsSmall molecule API market to value $284.7 billion by 2032
Key opportunities within the small molecule active pharmaceutical ingredient (API) market include adopting continuous manufacturing and delving into niche disease areas, research has indicated.
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NewsWill ESR1-mutated breast cancer treatment gain approval?
If approved by the European Commission (EC), ORSERDU® (elacestrant) would be the first treatment for ER+, HER2- advanced or metastatic breast cancer tumours with ESR1 mutations.
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NewsRoche to co-develop hypertension RNAi therapeutic
An RNAi therapeutic that has best-in-disease potential for hypertension is set to be developed under a partnership between Roche and Alnylam Pharmaceuticals.
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NewsEMA seeks public opinion on AI in drug development
Public consultation is open for the European Medicines Agency (EMA)’s draft reflection paper on using artificial intelligence (AI) when developing and regulating medicines.
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NewsGenentech to reveal new data for ocular biologic
Data shared at the 2023 American Society of Retina Specialists (ASRS) Annual Meeting will reveal new clinical and real-world evidence for the first bispecific antibody (bsAb) approved for the eye.
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ArticleThe evolution of AAVs in cell and gene therapy
AAV development for cell and gene therapy in 2023 is being impacted by manufacturing and regulation challenges, however advancing technologies offer opportunity, according to leaders in the field.
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NewsEfficacy of novel drug proven in MDD study
Significant results from a Phase II study in major depressive disorder (MDD) for a novel kappa opioid receptor (KOR) antagonist has prompted initiation of a Phase III programme.
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NewsBeyfortus approved for US infants against RSV disease
The only monoclonal antibody approved for passive immunisation to protect infants in their first RSV season has been approved by the US Food and Drug Administration (FDA).
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NewsNew data suggests novel mAb could delay progression of early Alzheimer's
Full results from the “first Phase III study of a disease-modifying therapy to replicate the positive clinical results observed in a previous study” have been published in JAMA.
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NewsNIH 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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NewsRoche agrees to develop oncology small molecule inhibitor
An agreement to obtain a global license for KSQ Therapeutics’ small molecule USP1 inhibitor, which has potential to treat a variety of cancers, has been signed by Roche.
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NewsTen-minute subcutaneous injection shows promise for MS
A Phase III trial for the only therapy approved for both relapsing and primary progressive multiple sclerosis (MS) met its clinical endpoints, Genentech has announced.
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ArticleThe future of medical cannabis development in Europe
Dr Mikael Sodergren, Chief Medical Officer at Curaleaf International, discusses the challenges of developing and researching medical cannabis products and how the European medical cannabis ecosystem is well placed to overcome them.
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NewsPost-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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NewsBispecific antibody approved in Europe for DLBCL
European approval of the bispecific antibody treatment has the potential to change the current standard of care in diffuse large B-cell lymphoma (DLBCL).
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NewsCould faecal transplants improve melanoma immunotherapy?
In the first clinical trial of its kind, faecal microbiota transplants (FMT) were shown to improve immunotherapy response in advanced melanoma.
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NewsBioNTech to support trial access for cancer immunotherapies
Signing of a major agreement between BioNTech SE and the UK government for cancer trials means more patients could access personalised immunotherapies.