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New ethical guidance for paediatric clinical trials
New draft guidance by the US Food and Drug Administration (FDA) evaluates the ethics of children participating in clinical studies.
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Clinical Trials
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GM herpes virus fights advanced cancers
A Phase I trial showed early potential in using a genetically engineered herpes virus to combat advanced cancers that exhibited no response to immunotherapies.
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Pfizer 20vPnC vaccine as safe as Prevenar 13®
The paediatric pneumococcal conjugate vaccine (20vPnC) can help protect against all 20 pneumococcal disease-causing serotypes, says Pfizer.
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Ultomiris for generalised myasthenia gravis
The first and only long-acting C5 inhibitor, Ultomiris (ravulizumab), has been permitted in Europe for adults with generalised myasthenia gravis.
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First patient dosed with HIV gene therapy
According to researchers, the CRISPR-based gene therapy, EBT-101, has the potential to change the future of HIV therapeutics.
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Using RWE in rare disease drug development: effective innovations with historical controls
With a growing number of therapies under development for rare diseases, ICON’s Dr William Maier discusses how real-world evidence (RWE) can be effectively used as a historical control (HC), overcoming challenges presented in clinical development.
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First bispecific antibody approved in EU to combat leading causes of vision loss
Roche’s Vabysmo® (faricimab) has been approved in Europe as a four-monthly treatment for wet age-related macular degeneration and diabetic macular oedema.
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Zuranolone shows promise as episodic treatment for depression
Phase III data shows most major depressive disorder patients treated with zuranolone had minimal or mild depressive symptoms after a year.
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AbbVie’s Skyrizi® shows long-term efficacy in psoriatic arthritis
Similar rates of skin improvement at week 100 indicate Skyrizi® (risankizumab) has consistent long-term efficacy in psoriatic arthritis patients.
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Novartis’ Kisqali® provides “unparalleled survival benefit” in breast cancer
A pooled exploratory analysis shows Kisqali® plus endocrine therapy adds a year to overall survival of patients with aggressive form of breast cancer.
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Checkpoint inhibitor combination shows promise in Merkel cell carcinoma
Dual checkpoint inhibitor blockade could be a promising first-line and salvage therapeutic option for advanced Merkel cell carcinoma, say researchers.
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US begins monkeypox vaccine and therapeutic trials
US National Institutes of Health initiates trials to evaluate antiviral tecovirimat (TPOXX) and possibility of delivering Jynneos vaccine intradermally.
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Epilepsy rescue therapy significantly increases time between seizure clusters
Newly published data indicates a significant increase in time between seizure clusters (SEIVAL) treated with Neurelis’s Valtoco® CIV.
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Dolutegravir shows promise in pregnancy
Study comparing commonly used antiretroviral regimens in pregnancy reports viral suppression at delivery in considerably more participants taking dolutegravir.
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EU regulators release new workplan for accelerating clinical research
The latest workplan outlines how innovation in clinical research will be facilitated over the next four years, including modernising good clinical practice and issuing guidance on decentralised trials.
