Jazz Pharmaceuticals plc
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Latest From Jazz Pharmaceuticals plc
US FDA defers action on Spectrum’s approval application for neutropenia candidate Rolontis due to pandemic-related difficulties inspecting partner Hanmi’s plant. The action date has been put back by around four months although the companies stress no CRL has been issued.
From the rise of DTC to the shadow of Caronia, Abrams, the long-time head of the Office of Prescription Drug Promotion, monitored dramatic changes in the pharmaceutical marketplace and regulatory environment. He retired from FDA on 23 October after a tenure marked as much by careful research projects and copious guidances as it was by promotional and legal upheavals.
The company plans to file for approval in the expanded indication, for which there are currently no approved therapies.
Shanghai Henlius Biotech and Accord Healthcare have broadened their collaboration on trastuzumab, with the Chinese company licensing its Zercepac biosimilar to Accord in the US and Canada. Meanwhile, Accord has launched a Pelgraz pegfilgrastim pre-filled injector and patient app in the UK.
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