EMA concludes review of Lilly’s COVID-19 antibody therapies
The human medicines committee decided that there was significant evidence to endorse the use of a combination of bamlanivimab and etesevimab in outpatients at high risk of severe COVID-19.
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The human medicines committee decided that there was significant evidence to endorse the use of a combination of bamlanivimab and etesevimab in outpatients at high risk of severe COVID-19.
In a trial of over 400 adult patients with mild COVID-19, ivermectin did not significantly improve the time to symptom resolution compared to placebo.
Starting with the publication of clinical data used to support the authorisations of the Moderna COVID-19 vaccine, EMA and Health Canada said they will continue the open access approach for all COVID-19 vaccines.
The sub-studies evaluating VIR-7831 and BRII-196 with BRII-198 have stopped enrolment based on recommendations from the Data and Safety Monitoring Board.
The EU regulator has begun reviewing preclinical and early trial data for Sputnik V, the COVID-19 vaccine developed by Russia.
The trial evaluating COVID-19 convalescent plasma as a treatment for COVID-19 patients with mild to moderate symptoms was stopped due to ineffectiveness.
Merck has entered into multiple agreements to support the expansion of the supply of COVID-19 medicines and vaccines.
Find out what the WHO has to say about the use of hydroxychloroquine in COVID-19 prevention and the results of a severe COVID-19 pneumonia trial with tocilizumab.
The Phase I/IIa trial of BT-001 will assess the safety and efficacy of the virus’ dual mode of action in solid tumours.
The FDA has issued an Emergency Use Authorization for the single-dose Janssen COVID-19 Vaccine, making it the third COVID-19 vaccine available for use in the US.
The EMA’s committee adopted positive opinions of six medications, including two orphan drugs, and concluded its review of the use of REGN-COV2 – an investigational antibody therapy for COVID-19.
The European Medicines Agency has set out its guidelines for vaccine manufacturers adapting their approved COVID-19 vaccines to combat viral variants.
In the trial Leukine® (sargramostim, rhuGM-CSF) improved oxygenation in COVID-19 patients with acute respiratory failure by at least a third in over half of those treated.
The EMA has begun a rolling review of Celltrion’s regdanvimab (CT-P59) antibody for COVID-19 and assessing new data on Veklury (remdesivir).
Based on new stability data, the US regulator will allow COMIRNATY® to be transported and stored at standard pharmaceutical freezer temperatures for up to two weeks.