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International Briefs: Australia’s IVD Framework; NICE Supports Two Devices

This article was originally published in The Gray Sheet

Executive Summary

Abbott weighs in on proposed amendments to Australia’s in vitro diagnostics regulatory framework. NICE gives thumbs-up to intubation and amniotic fluid leak detection devices.

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International News In Brief

Recent meeting of the International Medical Device Regulators Forum draws a big audience. Two devices receive draft support from the U.K.'s National Institute for Health and Clinical Excellence.

Finance Watch: Adlai Nortye Raises $97.5m In IPO, Brings US Total To 18

Public Company Edition: Cancer-focused Adlai Nortye launched a concurrent initial public offering and private placement, while four other drug developers announced or completed SPAC mergers. Also, Sobi grossed $540m in a rights issue and Immunovant followed early data with a $450m FOPO.

Amicus Piggybacks Off Galafold Commercial Infrastructure For Pombiliti + Opfolda Launch

The company anticipates potential sales in excess of $1bn for the late-onset Pompe disease drug by the end of the decade.

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