Latest From Brenda Sandburg
Duke-Margolis' Mark McClellan touts the advantages networks have over individual operations, citing the dexamethasone RECOVERY trial, and notes need for real-world evidence infrastructure.
PhRMA sues to block implementation of the law, saying it could allow states to compel manufacturers to dispense other medications without compensation.
Guidance on COVID-19 vaccine development and licensure appears to set a precedent in specifying the clinical efficacy rate for a product approval; agency also takes accelerated approval off the table for now and says emergency use authorization may be granted only after safety and efficacy have been demonstrated.
Pfizer is one of 10 pharma companies that have reached settlements with the US Department of Justice over their relationships with co-pay assistance foundations. It now seeks a declaratory judgement that proposed programs for its heart drug tafamidis do not violate the anti-kickback statute.
While companies often keep clinical trial endpoints a secret, FDA's Peter Marks notes that may not be the case with COVID-19 vaccines; CDER's Patrizia Cavazzoni says agency may expand de-centralized trials.
Three host-targeted immune modulators, three anticoagulants, and three to six neutralizing antibodies are to be tested in ACTIV clinical trials, FNIH's David Wholley tells DIA meeting.