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Latest From Seagen Inc.

ADC Competition Heats Up In China But Caution, Pressure Also Mount

After the anti-PD-1/L1 antibody and cell therapy rush, antibody-drug conjugates are quickly gaining attention in China as new technologies and deal-making activity heats up, but one first mover warns of potential over-crowding.

China Deals

Keytruda Cements Cervical Cancer Leadership With First-Line Nod

Although the label’s PD-L1 expression requirement could limit the addressable market, there is also potential for future combination with Seagen’s recently approved Tivdak.

Approvals ImmunoOncology

Orphazyme Wants More Time To Deal With Late-Stage Issues For Arimoclomol In EU

Following Orphazyme’s disappointment in the US regarding its investigational drug for an ultrarare disease, the company has said it will need more time to address outstanding issues raised by EU reviewers about the same medicine.

Europe Drug Review

Boehringer & BridgeBio Seek EU Fast-Track Status; Enfortumab Vedotin Reverts To Standard Review

Applications for the accelerated assessment of planned EU marketing applications for two drugs are being considered by the European Medicines Agency.

Europe Review Pathway
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    • Alpine Biosciences
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