Bayer Pulls Aliqopa Combo Filings In EU, US & Other Markets – But May Resubmit
The company plans to conduct additional analyses of data from ongoing trials that are testing its PI3K inhibitor in combination with rituximab for treating types of indolent B-cell non-Hodgkin’s lymphoma.
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TG Therapeutics Ukoniq’s Future In Doubt Amidst Scrutiny Of P13K Inhibitor Accelerated Approvals
Advisory committee review of combo with ublituximab may provide forum to discuss the Phase III data showing increased risk of death that prompted US FDA safety alert.
Keeping Track Of Withdrawals: Libtayo, Parsaclisib Applications Pulled Due To Postmarketing Issues
Changing therapeutic landscape may have complicated regulatory plans for Regeneron/Sanofi’s PD-1 inhibitor in second-line cervical cancer, while accelerated approval confirmatory trial timeline appears to have been an issue for Incyte’s PI3-kinase inhibitor in lymphoma.
Hold On TG’s Program Stems From Existing – Not New – Concerns
TG expects overall survival hazard ratios to move closer to those of existing CLL drugs. Some analysts called a drop in the company’s shares overblown.