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Gilead Sciences says it has no plans to relinquish the Priority Review voucher it earned from the FDA’s approval of remdesivir as a COVID-19 treatment despite urging from a consumer advocacy group that argued the company is earning more than is reasonable from the antiviral. Read More
Pfizer said it intends to handle the distribution of its COVID-19 vaccine itself after the federal government’s initial distribution to priority populations is completed. Read More
UCSF Radiopharmaceutical Facility drew a lengthy inspection report from the FDA for failing to fully investigate out-of-specification results and other quality lapses. Read More
Sanofi announced that it is acquiring a portfolio of cell immunotherapies under development to treat various cancers through the purchase of Amsterdam-based biopharma Kiadis for $358 million. Read More
The FDA plans to channel more resources to the Center for Biologics Evaluation and Research (CBER)’s Cell and Gene Therapy Program (CGTP) to deal with its rapidly growing workload, agency officials said at the first round of public meetings on the next reauthorization of the Prescription Drug User Fee Act (PDUFA). Read More
A Russian drugmaker has asked the Kremlin for a compulsory license allowing it to manufacture a generic of Gilead Sciences’ antiviral drug remdesivir. Read More
German biopharma company CureVac announced yesterday that its COVID-19 vaccine hopeful generated immune responses and was generally well-tolerated in phase 1 trial participants, lending support for a pivotal trial before year’s end. Read More