The company previously was unsuccessful securing accelerated approval based on complete response data, but event-free survival results may be more persuasive.

ANDA action rate dipped below the 90% mandate in second fiscal quarter, another illustration of the effect the pandemic and other issues have on US FDA’s generic drug assessment system.

Horning describes challenges of moving from tenured professor to industry executive in accepting the award from the Healthcare Businesswomen’s Association. She is recognized for her ‘epic tenacity’ in advancing medicines and commitment to patients. Pfizer’s Rod MacKenzie receives honorable mentor award.

Roche’s former chief medical officer has new career as board member to three companies, including COVID-19 vaccine pioneer Moderna, and is co-founder of a startup seeking to develop more affordable drugs. She helped pave the way for FDA’s breakthrough therapy designation and diversification of Genentech’s clinical trials.