Phase III data shows treatment with REGEN-COV™ (casirivimab and imdevimab) significantly reduces the risk of high-risk COVID-19 infected outpatients being hospitalised or dying.
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The EMA's CHMP has begun a rolling review of REGN-COV2, Regeneron's COVID-19 antibody candidate, after successful pre-clinical trials.
The EC has approved an extension of marketing authorisation for Regeneron and Sanofi's Dupixent (dupilumab) for children aged six to 11 with severe atopic dermatitis.
The Emergency Use Authorization (EUA) is based on a trial in which casirivimab and imdevimab reduced hospitalisations in mild to moderate COVID-19 patients.
The clinical trial testing the REGN-COV2 antibody cocktail should be altered, according to the Independent Data Monitoring Committee (IDMC).
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.
In combination with inhaled corticosteroids, the monoclonal antibody Dupixent improved lung function and reduced the rate of severe asthma attacks.
Two randomised Phase III clinical trials to test mAbs against COVID-19 are now enrolling healthy adults in the US, the NIH has announced.
Simultaneous Phase III trials evaluating Regeneron’s REGN-COV2 antibody as both a prophylactic and a treatment have begun in US and some South American locations.
Companies leading trial announce Kevzara failed to meet primary and secondary endpoints in critically ill COVID-19 patients, so the trial has been halted.
The UK Supreme Court has ruled that Regeneron's patent claim regarding genetically modified mice against Kymab are invalid.
A Phase II/III trial to study Kevzara (sarilumab) as a method to reduce the inflammatory response in the lungs of COVID-19 patients has begun outside of the US.
The first Pharmaceutical Invention Index, which looks at the breadth and depth of novel agents currently being developed within the most innovative pharma pipelines, has been released.
A US district court has invalidated Amgen's patent claims for antibodies targeting PCSK9.