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Latest From CardioMEMS, Inc.
Novavax Readying Multiple COVID-19 Vaccine Candidates To Ensure Fall Availability
CBER’s Marks said US FDA is working with Novavax on manufacturing to allow its protein-based vaccine to be ready for a fall roll-out. After some concerns about international coordination, multiple regulators seem to be settling on a monovalent approach for fall vaccinations.
J&J CEO On Stereotypes, Innovation Secret Sauce And Kenvue
J&J chairman and CEO Joaquin Duato shares striking glimpses of his own life journey at a recent summit as he underscores the value of diversity, equity and inclusion. He also discusses the company’s formulae for innovation and the Kenvue spin out.
Biomarker-Restricted Indication Urged For AstraZeneca’s Lynparza In First-Line Prostate Cancer
Eleven of 13 members of the Oncologic Drugs Advisory Committee favor limiting olaparib’s use with abiraterone in metastatic castration-resistant prostate cancer to patients with tumors that carry the BRCA mutation, a subgroup that represented only 11% of the patients in the PROpel study.
AstraZeneca’s Lynparza: US FDA Frowns Upon ‘All Comers’ Indication In First-Line Prostate Cancer
Efficacy in PROpel study was driven by the small percentage of patients with tumor BRCA mutations, agency says, raising concerns that olaparib may amount to a ‘toxic placebo’ in those without the mutation; Oncology Drugs Advisory Committee will consider whether new indication in metastatic castration-resistant prostate cancer should be restricted by mutation status.
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