Notable third-quarter developments at major Korean pharma firms included the domestic reimbursement of Yuhan’s Leclaza, the approval of Hanmi’s Rolontis and SK Bioscience's approval filing for Novavax's COVID-19 vaccine for supply in the country, a roundup of results by Scrip shows.

Pfizer-funded systematic review of approved oncology applications that contained RWE highlights common deficiencies flagged by FDA and says strength of trial data is a key determinant of the extent to which RWE is needed and considered by the agency.

From pre-med to pharma lab rat to deputy director of operations at the FDA, Khushboo Sharma, a 2021 In Vivo Rising Leader and current VP of science and regulatory affairs at BIO, has spent her career pursuing a goal she says the FDA and biopharma industry have in common: ensuring that innovative drugs get to patients. 

Often data was not available from FDA, CDC or the sponsor to answer subgroup, safety and other questions that could have influenced the outcome of the advisory committee meeting.