In The News
Regulatory Focus – NCI official raises concerns about FDA’s cancer drug dose optimization guidance
The head of the National Cancer Institute’s (NCI) investigational drug research branch said that recent draft guidance from the US Food and Administration (FDA) on
Pink Sheet – FDA’s Califf Calls For Return To Large, Simple Trials Without The ‘Useless Stuff’ That Slows Development
Industry should return to large, simple clinical trial designs that rely on randomization and endpoints that matter most to patients – and remove the excessive
Pink Sheet – ‘Stop Fighting Us’ On Inspections, US FDA’s Califf Tells Industry; Foods Modernization Will Bring ‘Big Change’ To Drug Quality Systems
US Food & Drug Administration Commissioner Robert Califf is touting the modernization of food safety inspections as an important initiative of his second stint at
The Cancer Letter – Ed Kim joins the board of directors at Friends of Cancer Research
City of Hope physician executive Edward S. Kim joined Friends of Cancer Research’s board of directors. Kim is physician-in-chief and senior vice president City
Politico Prescription Pulse – Domino effect: Sanofi to cut insulin prices
AND THEN THERE WERE THREE — The third major insulin manufacturer, Sanofi, said Thursday it will cut the list price of its most widely used insulin
Healio – Edward S. Kim, MD, joins Friends of Cancer Research board of directors
Friends of Cancer Research appointed Edward S. Kim, MD, MBA, FACP, FASCO, to its board of directors. Kim — an associate medical editor for Healio | HemOnc
Friends of Cancer Research Announces Election of City of Hope’s Dr. Edward S. Kim to Board of Directors
Friends of Cancer Research (Friends) is excited to announce the addition of City of Hope physician executive Edward S. Kim, M.D., M.B.A., FACP, FASCO, to
The Wall Street Journal – NIH Top Job Still Empty as Candidates Back Out
The top job at the National Institutes of Health, a prestigious role that has attracted a Nobel Prize winner and other leading scientists, is going
Pink Sheet – US FDA Open To Cell Therapy ‘Assessment Aid’ That Could Speed Development Of Next-Gen Cancer Drugs
The Center for Biologics Evaluation and Research is receptive to the idea of creating a regulatory framework on data extrapolation techniques to support the development
Precision Oncology News – Next-Gen Cell Therapies Bedeviled by Regulatory Murkiness on Product Characterization, Manufacturing
NEW YORK – Drugmakers working with the US Food and Drug Administration to bring more effective, efficient, and less toxic cancer cell therapies to market
