Secura Bio, Inc.
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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.
Blenrep’s withdrawal will add to GSK’s blockbuster drought, and hopes of separate trial success for the BCMA-targeting drug in earlier stage myeloma may now be harder to achieve.
The US FDA process to force the withdrawal of the pre-term labor drug Makena is in its final stages. The product seems likely to finally leave the market – but may also demonstrate that there is a business to be built in contesting FDA withdrawal proceedings.
Yakult’s decision to pull an approval application for duvelisib in Japan came shortly after a FDA advisory committee said it would re-evaluate the safety and efficacy of the PI3K inhibitor four years since its approval. The developments cast a new shadow over Yakult’s already-suffering pharmaceutical business.
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