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Setback For Alembic-backed Rhizen After Concerns Over PI3K Inhibitors

 
• By Anju Ghangurde

Disappointment for Alembic-backed Rhizen after partner TG Therapeutics takes Ukoniq off the US market amid wider regulatory scrutiny around the PI3K inhibitor class of drugs. The Indian firm, however, remains upbeat about the US business, which saw significant growth in the fiscal fourth quarter and has15-plus launches lined up.

challenge
Challenging Phase For Rhizen • Source: Alamy

Alembic Pharmaceuticals Limited-backed Rhizen Pharmaceuticals faces a significant setback after partner TG Therapeutics, Inc. pulled its approved phosphatidylinositol 3-kinase (PI3K) inhibitor Ukoniq (umbralisib) off the US market and also paused its oncology programs, at least for now.

TG Therapeutics had recently voluntarily withdrawn Ukoniq for the approved indications of relapsed/refractory follicular lymphoma (FL) and marginal zone lymphoma (MZL) based on the retraction of a pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the “U2” combination of ublituximab and Ukoniq

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