Secura Bio, Inc.
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Latest From Secura Bio, Inc.
US FDA Center Directors Should Not Influence Adcomm Votes Or Overrule Scientific Staff, Coalition Says
In a letter to Commissioner Robert Califf, the Patient, Consumer and Public Health Coalition says medical product center directors and other senior staff should refrain from trying to sway advisory committee votes and be reminded that overruling decisions of their own scientific staff undermines the public trust.
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.
With cash preservation in mind, Rubius will dissolve, while EQRx, Impel, Cybin and Graphite cut jobs. Meanwhile, Jounce is restructuring and it plans to merge with Redx, yet the dually troubled firms MEI Pharma and Infinity will combine, while VBL will disappear in a reverse merger with Notable Labs.
The first BCMA-targeting agent to gain approval in myeloma never became the blockbuster for which GSK had hoped, but Blenrep appears to have set a new standard for speed of voluntary withdrawal of an accelerated approval drug after a confirmatory trial failure.
- Generic Drugs
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