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Lilly’s EUA Timeline For COVID-19 Combo Antibody Depends On Safety Data, Manufacturing

 
• By Joseph Haas

Single neutralizing antibody moves to US FDA with data showing reduced hospitalization, while Lilly’s EUA filing for two-antibody combo awaits safety data and more certainty about production capabilities.

Indianapolis - Circa April 2016: Eli Lilly and Company World Headquarters. Lilly makes Medicines and Pharmaceuticals IV - Image

Eli Lilly and Company’s next step in its strategy for COVID-19 monoclonal antibodies is about doubles: The timing of when it will seek an emergency use authorization for its two-antibody combo regimen depends on two factors – safety data and manufacturing confidence.

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US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
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More from Compliance

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Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.

UK Promises To ‘Turbocharge’ Clinical Trials As US Tariff Threat Remains

 
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Trump’s Tariffs Will Lead To ‘Instability’ And ‘Less Investment’ In UK

 
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While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.