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.
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EU Decision Time For Teclistamab & Seven Other Drugs; Incyte Withdraws Parsaclisib Filing
Janssen’s bispecific antibody, teclistamab, and Eli Lilly’s potential blockbuster diabetes drug, tirzepatide, are among the products that are this week up for an opinion by the European Medicines Agency on whether they should be approved in the EU.
TG Therapeutics Pulls Ukoniq/Ublitiximab Combo Applications Due To Adverse Survival Trend
Company also withdraws Ukoniq, a P13K inhibitor, just 14 months after accelerated approval in two lymphoma indications. US oncology drugs panel will discuss safety concerns with the PI3K class on 21 April, but FDA has already staked out its position in a Lancet commentary that a new development approach is needed with survival as the ultimate safety endpoint.
Fluzone Maker Sanofi Wants Language On Failed Confirmatory Study Added To Seqirus’ Fluad Label
In new twist on debate over ‘dangling’ accelerated approvals, Sanofi wants Fluad label to reflect failure of confirmatory trial to meet primary efficacy endpoint; Seqirus says Sanofi is trying to interfere with ACIP’s possible preferential recommendation of enhanced seasonal flu vaccines in elderly.