Antibiotic developers have a blunt message for Congress: the time for action is now or never. They see a targeted reimbursement change (The DISARM Act) as vital to send a signal to investors that the sector can be saved – and don’t want to delay to debate other ideas like “subscription” models.
Antibiotic drug developers and infectious disease specialists are pushing for immediate enactment of legislation to carve-out new antibiotics from inpatient payments to help preserve the pipeline of new therapies while longer term solutions are debated.
“The time to kick the can down the road has passed,” Antimicrobials Working Group representative Jeff Stein (CEO of
With the US BIOSECURE Act waiting for a Senate vote, there are signs it may be prompting some Chinese firms to look at their operations. In the meantime, two legal experts in China suggest a range of coping strategies for companies that may be deemed "of concern."
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
US lawmakers will undoubtedly continue to work on pharmacy benefit manager reform legislation in 2025, given its bipartisan support. But policies impacting rebates that could lead to higher premiums in Part D may be a tough sell in the midst of the benefit redesign.
Neither Kamala Harris nor Donald Trump mentioned drug pricing reforms in their presidential convention speeches.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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