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Latest From Boehringer Ingelheim International GmbH

COVID-19 Pandemic Accelerates Shift Toward Virtual Trials

As the global shut-down caused by the coronavirus pandemic continues, sponsors are rushing to adapt clinical trials that can move to partial or completely remote monitoring, allowing patients to remain in their homes but continue to participate in studies. And the outbreak may have another silver lining for the biopharma industry, a chance to rebuild its reputation. 

Coronavirus COVID-19 Clinical Trials

mRNA Vaccines – Trials Line Up Against Coronavirus

The arrival of SARS-CoV-2 has focused attention on a potential new way of making vaccines – one that promises to be quicker and cheaper than traditional methods and more reactive to novel virus outbreaks, but also one that remains to be validated.

Coronavirus COVID-19 Innovation

CDER’s Woodcock On COVID-19: Missed User Fees Unlikely, But Some Work Will Be ‘Set Aside’

In a podcast interview, Janet Woodcock talks about review deadlines, prioritizing pre-approval inspections, and how advisory committees could be held in an era of social distancing.

Coronavirus COVID-19 Leadership

Akero Heads To Top Of FGF21 Class In NASH; Genfit Says Pandemic Won’t Delay Phase III

Akero’s FGF21 analog yields 63%-72% relative hepatic fat reduction in Phase IIa study; the company awaits biopsy data hoping to see a fibrotic benefit. Also, Genfit says COVID-19 pandemic should not significantly delay its Phase III NASH readout.

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