FDA takes a pass on pegvaliase panel; Flexion terminates an old AstraZeneca pact
⇨ BioMarin says that the FDA is indicating that it won’t be holding a panel review for pegvaliase as a new treatment for phenylketonuria (PKU). That is likely to somewhat improve its odds of success, with a priority review and a PDUFA date of February 28, 2018.
⇨ Flexion Therapeutics has sent a notice to AstraZeneca terminating their deal on FX005’s sustained-release p38 MAP, or mitogen-activated protein, kinase inhibitor development program. Flexion has dumped the drug from its pipeline.
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