Oncology drugs that have racked up a number of indications through accelerated approvals are losing some of those indications as the result of an FDA industrywide evaluation of confirmatory trials that didn’t back up the approvals.

Aveo Oncology Inc. CEO Michael Bailey said the shifting treatment paradigm in renal cell carcinoma (RCC) represents “an advantageous opportunity” for the company with Fotivda (tivozanib), approved March 10 for adults with relapsed or refractory, advanced disease who have received two or more systemic therapies.

Positive COVID-19 efficacy numbers from Vir Biotechnology Inc. and Glaxosmithkline plc (GSK) has prompted them to immediately seek an emergency use authorization (EUA) with the FDA and similar authorizations in other countries for their monoclonal antibody, VIR-7831. Meanwhile, the phase III Remdacta study of Actemra/RoActemra (tocilizumab) plus Veklury (remdesivir) vs. placebo plus Veklury, from Roche Holding AG and Gilead Sciences Inc., missed its primary endpoint in treating hospitalized patients with severe COVID-19 pneumonia receiving standard of care.

Just weeks after two unexpected cases of blood cancer landed trials of its investigational gene therapies for sickle cell disease (SCD) and beta-thalassemia on FDA-issued clinical holds, Bluebird Bio Inc. said it's talking to regulators about their resumption after what RBC analyst Luca Issi called a "partial exoneration" of the BB-305 lentiviral vector shared between the medicines.

Mouse traps. Bird excrement. Insects. Rusted equipment and peeling paint. Employees not gowning properly for a clean room or washing their hands after using the bathroom. Those are just some of the things the FDA is missing as it relies on document reviews, sampling at the border and other alternatives to onsite drug inspections during the pandemic.