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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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Clinical Trials
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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.
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Black participants make up just 3% in cancer clinical trials, says GlobalData
A new report indicates that black participants were severely underrepresented in global oncology clinical trial population, accounting for just three percent of patients from 2013-2022.
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Pfizer’s RSV vaccine effective in older patients
Pfizer’s bivalent Respiratory Syncytial Virus (RSV) vaccine candidate was 85.7 percent effective when administered to adults 60 years of age or older, according to top-line data from a Phase III trial.
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Oncolytic viruses: past and present
It is difficult to treat cancer effectively without causing adverse side effects. In this article, Dr Li, Clinical Assistant Professor at the State University of New York and Board Director of ExonanoRNA, describes how an old strategy that never got off the ground has finally been leveraged to deliver safe,…
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Can Hepatitis C drugs reduce symptoms of PTSD?
Direct acting antivirals used to treat hepatitis C virus infection may improve symptoms of posttraumatic stress disorder (PTSD) in patients without the disease, according to new research.
