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Oncopeptides AB

http://www.oncopeptides.se/

Latest From Oncopeptides AB

Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.

US FDA Performance Tracker Drug Review

Status Quo: US Approvals For Pepaxto, Copiktra Remain Intact Despite Negative Panel Reviews

More than seven months after the Oncologic Drugs Advisory Committee voted that Pepaxto and Copiktra had negative benefit-risk profiles in their labeled indications, the drugs' approvals remain intact. Oncopeptides is still considering whether to heed the FDA's request to withdraw the Pepaxto NDA, even though the drug is not currently marketed. Secura Bio says Copiktra remains on the market and available for prescribing.

Post Market Regulation & Studies Review Pathway

Oncopeptides’ Melflufen: Same Data, Different Conclusions From EMA, US FDA

The two regulators were an OCEAN apart on their interpretation of the overall survival and progression-fee survival data from the Phase III confirmatory trial. European regulators saw fit to recommend Pepaxti’s approval, even after the drug was voluntarily discontinued in the US market due to FDA concerns.

Approvals Regional Comparisons

Accelerated Approval Reforms Give US FDA More Power And Flexibility – With Some Gaps

Pending legislation will give agency ability to require that confirmatory studies be underway at time of approval and expedited withdrawal process could allow FDA to skip a second advisory committee meeting, but Congress holds back on some agency requests for expanded authority.

Legislation Review Pathway
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