MHRA joins international regulatory consortium
By joining the Access Consortium, the MHRA will work together with agencies from Australia, Canada, Singapore and Switzerland to expedite therapeutic product approvals.
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By joining the Access Consortium, the MHRA will work together with agencies from Australia, Canada, Singapore and Switzerland to expedite therapeutic product approvals.
The adaptive ACTIV-5/BET study will test two monoclonal antibody therapies in hospitalised COVID-19 patients to establish if they warrant larger clinical trials.
The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) for the treatment of Zaire ebolavirus infection in adults and children.
A Phase I clinical trial to test VXA-CoV2-1, an oral tablet COVID-19 vaccine candidate, has been initiated with the first patient dosed.
J&J has paused its Phase III trial for its COVID-19 vaccine candidate following an unexplained illness in a study participant.
Celltrion Group's CT-P59 antibody will be tested as a COVID-19 prophylactic in a Phase III clinical trial.
In combination with inhaled corticosteroids, the monoclonal antibody Dupixent improved lung function and reduced the rate of severe asthma attacks.
The US government will develop and manufacture AstraZeneca’s investigational monoclonal antibody cocktail, AZD7442, a potential prophylactic treatment for COVID-19.
Researchers have shown that mucoadhesive buccal films containing simvastatin inclusion complex and drug mixed micelles can improve the drug's bioavailability.
NICE has launched a public consultation for suggestions on updating how it selects the topics to develop guidance on, to improve medicine evaluations.
The ABPI has found that the UK is leading the rest of Europe in early-stage clinical trials and makes suggestions on how the country can maintain this position.
J&J has agreed that it will supply the EU with 200 million doses of its COVID-19 vaccine candidate following regulatory approval.
The FDA has given small molecules APG-115 and APG-1252, two cancer treatments, Orphan Drug Designation.
The European Commission (EC) has signed a joint procurement contract to ensure an uninterrupted supply of Veklury (remdesivir) for participating countries.
The ITAC trial will establish if adding hyperimmune intravenous immunoglobulin (hIVIG) to a remdesivir regimen can improve hospitalised COVID-19 patient outcomes.