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Few plans submitted to FDA’s oncology review divisions in the wake of the April 2022 draft guidance were deemed acceptable, with enrollment goals being the most common topic of agency feedback. However, representatives from FDA and industry say the regulatory demand for such plans is pushing sponsors to build diversity into clinical trial programs from the start.
Restructuring Edition: OrbiMed/Foresite and Concentra responded quickly after Theseus implemented a 72% workforce reduction and began a search for strategic alternatives despite having $225.4m in cash. REGENXBIO, Novavax and Lyell also revealed job cuts despite large cash stockpiles.
Lupin’s Q2 margins jumped post launch of the first Spiriva generic in the US, encouraging launch plans for Europe and Canada. With four out of five plants clearing a regulatory overhang from earlier warning letters, the specialty engine is revving up though competition in first-to-file products launched earlier could dampen margins somewhat.
There is a greater commitment among larger, well-capitalized oncology companies to complete confirmatory trials, Oncology Center of Excellence Director Richard Pazdur says; smaller company approach of first getting accelerated approval and then using commercial proceeds to capitalize confirmatory trial is ‘unacceptable.’
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