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Injection could help postpartum depression, says study
Data demonstrated that a one-time injection of the drug BRII-296 is safe and effective for most patients with postpartum depression (PPD).
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Clinical Trials
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Lecanemab diminishes mental deterioration in early Alzheimer’s
Phase III trial confirmed Eisai’s lecanemab significantly decreased cognitive decline in patients with mild Alzheimer’s disease.
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Large diabetic drug comparison study releases results
Two of the four diabetes drugs tested (insulin glargine and liraglutide) in combination with metformin, extended the blood glucose stability period for patients.
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mRNA vaccines protect pregnant women against severe COVID-19
Results from the first real-world clinical trial showed strong evidence that ensuring pregnant women are vaccinated and boosted with mRNA vaccines helps prevent severe COVID-19.
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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New draft guidance by the US Food and Drug Administration (FDA) evaluates the ethics of children participating in clinical studies.
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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.
