Latest From Brenda Sandburg
President Biden announced plans to increase vaccination in the US as members of Congress and industry press the administration to take steps to expand global access to COVID-19 vaccines. BIO proposes an alternative to the TRIPS waiver that would expedite export of raw materials and manufacturing supplies.
Agency’s direct involvement in pharma product liability litigation is one of the most striking developments in the field over the past year; 16 cases in multidistrict litigation listed in chart showing status of settlements and upcoming bellwether trials.
In 5-4 vote, US FDA advisory committee recommends withdrawal of Opdivo’s accelerated approval for second-line treatment of HCC while unanimously supporting the indication in Keytruda pending outcome of ongoing studies.
Agency denies GlaxoSmithKline’s citizen petition requesting review of information about Zofran’s use in pregnancy. But GSK says agency has ‘clearly communicated its position that birth defect warnings are not warranted for Zofran.’
Agency’s direct involvement in pharma product liability litigation is one of the most striking developments in the field over the past year. Chart of 16 cases in multidistrict litigation shows status of settlements and upcoming bellwether trials.
US FDA advisory committee to consider whether new studies can take place of failed confirmatory trials to support accelerated approvals. The agency also wants the panel to consider the changing landscape of HCC following the approval of atezolizumab in combination with bevacizumab.