The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
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Based on new clinical results, the EMA is recommending Moderna’s Spikevax COVID-19 vaccine be approved for use in children aged 12 to 17 years.
A GlobalData report has revealed the extent to which companies will be using AI and big data in drug discovery and development processes.
Researchers have developed a novel gene therapy that could help treat children with incurable genetic and neurodegenerative diseases.
The trial will assess orally administered pritelivir for the treatment of drug resistant mucocutaneous herpes simplex virus (HSV) infections in the immunocompromised.
The Phase I/II trial will assess the safety, reactogenicity and immunogenicity of Moderna’s mRNA-1010 seasonal flu vaccine.
WHO recommends IL-6 antagonists plus corticosteroids for hospitalised COVID-19 patients based on their ability to reduce risk of death and the need for mechanical ventilation.
Under the new guidance, Development Safety Update Reports must include a description of the process used to review the worldwide safety data of the investigational drug.
The Phase II/III trial will assess the safety and immunogenicity of AstraZeneca’s novel COVID-19 variant vaccine candidate, AZD2816.
Phase I data shows VBI-2902a induced neutralisation and antibody titres up to five times that of people who had recovered from COVID-19 infection.
In UK trials where 60 percent of COVID-19 cases were caused by the Alpha SARS-CoV-2 variant, the NVX-CoV2373 COVID-19 vaccine was 89.7 percent effective.
An analysis shows a single dose of Vaxzevria induced immunity lasting at least a year and an interval of up to 45 weeks significantly increases neutralising antibody titres.
The monoclonal antibody Actemra (tocilizumab) was approved for emergency use in hospitalised paediatric and adult COVID-19 patients based on results from four clinical trials.