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Sarah Karlin-Smith

Latest From Sarah Karlin-Smith

Hahn Says COVID Vaccine Review Could Take Months As Trump Floats Rejecting New EUA Guidance

Commissioner’s comments were yet another sign that US FDA won’t clear a vaccine ahead of the election, but hours later the president suggests the White House may decline to clear the agency’s new guidance on emergency use authorization standards for COVID-19 vaccines, raising new concerns about political interference in any decisions.

Coronavirus COVID-19 Vaccines

Six Pharma CEOs To Testify In House as Democrats, Trump Compete For Attention On Drug Pricing

While neither party is likely to make any big policy changes this year, the action from both sides of the aisle indicates politicians still see going after pharma as a winning issue with voters even as polls show voters are focused elsewhere. 

Pricing Debate Elections

Reimbursement Challenges Await COVID-19 Vaccines Given Emergency Use Authorization

CARES Act appears to have overlooked Medicare coverage of a vaccine not granted traditional approval by US FDA. Meanwhile, other patient and provider vaccine reimbursement issues still need to be addressed by HHS and Congress to ensure widespread, affordable access to COVID-19 vaccines cleared by FDA under any pathway.

Medicare Vaccines

Pink Sheet Podcast: COVID-19 Stresses Manufacturing, Vaccine Placebo Controls, Thorny FDA Precedents

Pink Sheet reporters and editor discuss the pandemic’s effects on non-coronavirus-related product manufacturing, US FDA efforts to ensure vaccine sponsors maintain placebo controls once a product is available, and precedents that burden the agency.

Coronavirus COVID-19 Vaccines

Novavax Push For COVID-19 Vaccine Manufacturing Capacity Delays Flu Vaccine Application

As CEO Erck touts that its COVID vaccine has the 'best data,' Novavax prepares to enter Phase III trials and inks deal with Serum Institute to boost production even as its 'almost a perfect flu vaccine' remains on hold.

Vaccines Manufacturing

Pink Sheet Podcast: COVID-19 Vaccine Trial Stopped, Sponsor Filing Pledge, Rare Voucher Extended

Pink Sheet reporters and editor discuss the ramifications of the AstraZeneca vaccine trial hold and vaccine sponsors pledging to wait until the completion of Phase III before submitting applications, as well as efforts to extend the rare pediatric disease priority review voucher program.

Coronavirus COVID-19 Vaccines
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