AstraZeneca (AZ) has been granted a priority review by the US Food and Drug Administration (FDA) for a new four-week, fixed-dose regimen of its PD-1 inhibitor Imfinzi. AZ have stated that if the new regimen is approved, Imfinzi could be administered intravenously every four weeks at a fixed dose of 1500mg in approved indications. This includes unresectable,
Operations Regulatory CMC AssociateRegulatory ProfessionalsCheshire, UK
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Director, Regulatory AffairsRegulatory ProfessionalsLondon, UK
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Regulatory Affairs ManagerRegulatory ProfessionalsSouth East, UK
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Approval was made after an FDA inspection of the Harmans state-of-the-art, commercial-scale gene therapy manufacturing center in June 2020. Since Catalent’s partnership with AveXis, a Novartis company, was announced in July 2019, dedicated suite space has been prepared at the Harmans facility for the commercial manufacture of this adeno-associated virus (AAV) gene therapy. “This is
Janssen receives approval from the FDA for its Spravato CIII nasal spray, in combination with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behaviour. The approval is based on two phase 3 clinical trials in which Spravato, plus comprehensive standard-of-care, demonstrated a significant and rapid