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Delays Ahead for Galvus? (Pharmalot)
In his blog, Ed Silverman writes about an analyst's speculation that Novartis'
application for Galvus will be further delayed. "As he sees it, the issue
of skin toxicity seen in monkeys will prompt the FDA to wait another few months
to approve the diabetes pill, and speed past the [Prescription Drug User Fee
Act] date later this month."
"That would be swell news for Merck, which a few months ago launched its own Januvia pill," he writes. "Both drugs are in a new class of Type 2 diabetes meds, and while the Novartis drug is seen to have an edge, ongoing delays will make it harder to grab market share, at least for awhile."
The analyst believes that "Galvus will ultimately emerge from the regulatory process with a competitive label."
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