This article was originally published in The Gold Sheet
Question-based review, or QbR, could spread from generics to new drugs. And that’s the way the patent crumbles: FDA’s new tablet-scoring guidance.
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AstraZeneca will reacquire Allergan's investigational IL-23 inhibitor brazikumab, and Nestle is to buy its GI drug Zenpep, which had nine-month revenue of $208m.
The US agency is engaged with an ethylene oxide (EtO) sterilizer in Illinois that has temporarily closed to determine if there are any potential risks to the medical device supply chain. While the plant shut down about a month ago, regulators have only recently been made aware of the decision, which resulted from a law passed last year by the state legislature.