→ Just days after a damaging failure for duvalumab (Imfinzi) in a combination approach to lung cancer, the FDA has designated AstraZeneca’s checkpoint inhibitor as a “breakthrough” product deserving special treatment at the agency. Specifically, the BTD is for locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
→ Italy’s Chiesi Group is handing back its European rights to uniQure’s hemophilia B gene therapy. Chiesi CEO Ugo Di Francesco says that the decision was driven by a change in “strategic priorities.” UniQure CEO says the move leaves uniQure with unencumbered global rights to the therapy, which has demonstrated mixed results in the clinic.
→ Flex Pharma’s Christoph Westphal has selected Inotek CSO William McVicar as his replacement for the CEO job. The move comes after back-to-back failures at Inotek which decimated its stock.
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