EC approves new meningitis vaccine
MenQuadfi® has been approved for use in individuals 12 months of age and older, based on its safety and immunogenicity in 6,300 trial subjects.
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Purdue Pharma pleads guilty to criminal charges over opioids
Reports have said that Purdue Pharma has pleaded guilty to three criminal charges over issues regarding its opioid painkiller, OxyContin.
Sputnik V COVID-19 vaccine over 90 percent effective, interim data shows
Phase III trial interim data has shown that Russia's COVID-19 vaccine candidate, Sputnik V, is 91.4 percent effective.
US pharma initiates litigation challenging HHS and FDA action
PhRMA and other organisations have challenged action by the HHS and FDA that permits the importation of drugs from Canada without drug manufacturers’ oversight.
Pelareorep-based combination therapy improves glioblastoma patient survival
In a Phase Ib trial, pelareorep with GM-CSF, chemoradiotherapy and temozolomide increased progression-free survival by an average of eight months.
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.
Government funding for UK biomedical innovation insufficient, BIA says
According to the BIA, less than four percent of eligible projects received funding from a government programme for early-stage biotech companies.
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.
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.
UK and US could administer first approved COVID-19 vaccines next month
Both the UK and US have said that, if approved, the Pfizer and BioNTech COVID-19 vaccine could be administered to people as early as December.
Oxford COVID-19 vaccine 70 percent effective, interim data shows
The University of Oxford and AstraZeneca COVID-19 vaccine candidate, ChAdOx1 nCoV-2019, prevented infection from SARS-CoV-2 in two dosing regimens.
Pfizer and BioNTech submit for EUA of COVID-19 vaccine with FDA
The companies suggest if the Emergency Use Authorization (EUA) is approved, high-risk patients in the US could begin receiving the BNT162b2 vaccine by the end of December 2020.
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.
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.
FDA grants EUA to baricitinib with remdesivir to treat COVID-19
The FDA has issued an Emergency Use Authorization for baricitinib in combination with remdesivir to treat COVID-19 in hospitalised patients.
