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Secura Bio, Inc.

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Latest From Secura Bio, Inc.

GSK’s Blenrep: 15 Days From Confirmatory Trial Failure To Withdrawal Announcement

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.

Review Pathway Post Market Regulation & Studies

Blenrep US Withdrawal Is A Big Blow To GSK’s Blockbuster Hopes

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.

Approvals Companies

One More Message From Makena: Fighting US FDA Can Pay Off

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.

Advisory Committees Commercial

Yakult's Japan Duvelisib Decision Casts New Shadow Over Shrinking Pharma Ops

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.

Commercial Japan
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