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Oncopeptides AB

Latest From Oncopeptides AB

AstraZeneca/Daiichi Sankyo’s Enhertu To Get Lung Cancer Label For EU

The European Medicines Agency has recommended new uses for 11 approved medicines, including an antibody drug conjugate for treating advanced non-small cell lung cancer.

Europe Approvals

Pink Sheet Podcast: What We Learned From The First Medicare Price Negotiation List, Pepaxto Withdrawal Update

Pink Sheet reporters and editors consider lessons and next steps after the first list of drugs subject to Medicare price negotiations was released and discuss Oncopeptides’ Pepaxto facing withdrawal under the US FDA’s new and potentially faster process.

Pricing Debate Drug Review

The US FDA Committee ‘Hearing’ Is Dead! Long Live The Committee Hearing!

The US FDA is free from the need to reconsider Accelerated Approvals in a formal hearing in front of an advisory committee. But now the agency is now trying that approach to hear an appeal of a rejected application.

Advisory Committees Drug Approval Standards

To Save Pepaxto, Oncopeptides Throws Shade At IMiD Use In Elderly Myeloma Patients

Seeking to head off US FDA withdrawal of its alkylating agent, sponsor says pomalidomide comparator in OCEAN confirmatory trial rendered overall survival results difficult to interpret because immunomodulatory drugs are detrimental in elderly patients. CDER says IMiD analysis is exploratory and cannot negate adverse overall survival finding with Pepaxto.

Review Pathway Post Market Regulation & Studies
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