Trump’s Big Bet On COVID-19 Vaccines May Have Shortchanged Therapeutics. Should Biden Rectify The Difference?
Incoming US President may be wise to up government investment in COVID-19 therapeutics, including both research and manufacturing, experts say. Additional government funding should target a larger variety of treatment types and prioritize better study designs.
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BARDA Funding Freeze Risks Companies Abandoning COVID Therapeutic Work
BARDA’s suspension of funding for COVID-19 therapeutics risks repeating mistakes of past pandemics as it may cause industry to pull out of the development space, experts say. Industry sources are concerned the Biden administration is focusing on funding NIH at the expense of BARDA.
Future US Purchases Of Lilly’s Bamlanivimab Will Depend On Success Of Outpatient Infusion Process
HHS reverses course on cost sharing for the antibody and says patients will not have to pay. Operation Warp Speed will watch ‘extremely carefully’ to see if the health care system is able to adapt its practices to safely administer to the drug for COVID-19, officials say at a media briefing. FDA-authorized dose of the drug is not too low, Woodcock says.
COVID-19 Should Force ‘Soul Searching’ Over Fragmented US Clinical Trials System, Woodcock Says
Among hundreds of trials underway on potential therapeutics, only about 6% of study arms are expected to yield actionable data because most are nonrandomized, underpowered or underenrolled, Operation Warp Speed’s Janet Woodcock says, renewing her pitch for adoption of master protocols and other approaches to streamline studies and improve efficiency.