Merck Moves Molnupiravir as Health Canada Agrees to Rolling Submission

TrialSite just reported that Merck’s Australian unit secured a provisional determination from the drug regulatory body there called Therapeutic Goods Administration (TGA), opening the door for imminent provisional approval Down Under. Merck’s making moves to own the early antiviral treatment of COVID-19, a market TrialSite suggests could be worth several billion per annum. Over 90% of COVID-19 cases are either asymptomatic or mild-to-moderate. Front line care doctors have identified early treatment as absolutely essential to managing the pandemic, along with vaccination. They go hand-in-hand. Now Merck Canada announced the initiation of a rolling submission to Health Canada for the antiviral targeting COVID-19 called Molnupiravir. This investigational twice-daily oral antiviral agent is currently in a handful of clinical trials.

TrialSite follows up with a brief breakdown of this milestone.

Is there a great need for antiviral-like treatments targeting COVID-19, especially early on?

Yes. The U.S. government is now subsidizing a few pharmaceutical initiatives and a new repurposing study (ACTIV-6) that includes ivermectin. Ridgeback Biotherapeutics chief executive ...

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