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WHO urges countries to “step up” the fight against malaria
The WHO’s World malaria report suggests the progress in eradicating malaria has slowed due to funding shortages and that COVID-19 disruptions could result in additional deaths.
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Therapeutics
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Regulatory response to the COVID-19 pandemic
Dr Ash Ramzan, founder and principal consultant at Woodley BioReg, discusses how the COVID-19 pandemic has forced regulatory processes to adapt, focusing on the regulatory flexibilities introduced by the UK’s MHRA.
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FDA grants COVID-19 treatment Fast Track designation
The designation should expedite the development and review of AB201, a recombinant protein therapy being tested in hospitalised COVID-19 patients.
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Trial to compare dexamethasone and baricitinib in hospitalised COVID-19 patients
The fourth iteration of the COVID-19 treatment trial will determine whether remdesivir plus baricitinib or dexamethasone is more effective at promoting recovery from COVID-19.
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FDA approves first treatment for rare paediatric genetic diseases
Zokinvy (lonafarnib) capsules have been approved for the treatment of Hutchinson-Gilford progeria syndrome and certain progeroid laminopathies in patients over one year old.
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AstraZeneca starts COVID-19 prevention trial for immunocompromised patients
The trial will evaluate if the long-acting monoclonal antibody cocktail, AZD7442, can prevent COVID-19 in patients who cannot be vaccinated.
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FDA grants EUA to investigational antibody treatment for COVID-19
The Emergency Use Authorization (EUA) is based on a trial in which casirivimab and imdevimab reduced hospitalisations in mild to moderate COVID-19 patients.
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WHO expert panel advises against use of remdesivir for hospitalised COVID-19 patients
The WHO group concluded there is currently no evidence that remdesivir improves survival when reviewing data from 7000 hospitalised COVID-19 patients.
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Novel antibiotic shows promise in Phase II C. difficile study
Ibezapolstat cured all 10 patients of their Clostridioides difficile infections and prevented recurrence for at least 30 days.
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Pharma supply chain still highly vulnerable to COVID-19 pandemic, says research
Report reveals global pharma supply chain leaders are afraid of the vulnerabilities in the end-to-end supply chain as the COVID-19 pandemic continues.
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CVN058 shows promise in Phase Ib schizophrenia cognition study
A single dose of CVN058 was able to normalise brainwaves being used as a biomarker for cognitive impairment associated with schizophrenia.
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Drug Safety Research Unit says repurposed drugs for COVID-19 still require a lot of testing
The DSRU said that global collaboration would be required to successfully expedite the necessary safety and efficacy evaluations for repurposed drugs to be used in COVID-19 patients.
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COVID-19 is benefiting contract manufacturing services, suggest reports
Reports have found that the COVID-19 pandemic is providing new opportunities for contract and development manufacturing organisations (CDMOs).
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Fluvoxamine may prevent severe COVID-19 onset, suggests trial
Researchers say the promising results warrant larger trials evaluating fluvoxamine as a potential intervention to prevent COVID-19 patients developing severe symptoms.
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CHMP recommends five medicines for approval in latest meeting
The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
