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Provalis PLC

Latest From Provalis PLC

FDA Lifts Hold On Blueprint’s CDK2 Inhibitor Trial, Potentially Calming Nerves

The FDA placed a partial hold in February amid ocular adverse event concerns, but soon lifted it. Other CDK2 inhibitors have had ocular toxicity issues as well.

Cancer Clinical Trials

Deal Watch: Adaptimmune, TCR2 Join Forces As Cell Therapy Company Focused On Solid Tumors

All-stock merger will create new company owned 75% by Adaptimmune’s shareholders. Grifols, Selagine to explore antibody approach to treating dry eye disease, and other recent deals.

Deal Watch Business Strategies

Blueprint Presents Positive Ayvakit Data, But Commercial Debate Could Continue

Detailed data in indolent systemic mastocytosis show improvement across primary and key secondary endpoints, but analysts pointed to lower improvement on symptoms outside of those affecting the skin.

Clinical Trials Cancer

Blueprint Still Confident In CDK2 Inhibitor Despite Partial Hold On Phase I/II Trial

The FDA placed a partial hold on the VELA study of BLU-222 due to some patients experiencing visual toxicity, but the company anticipates reporting data and said it is near identifying Phase II dose.

Clinical Trials Cancer
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