Imminent OTC monograph reform legislation signals an agreement between industry and FDA on details of a proposal, which also includes a potential user fee program. CHPA also is hopeful for legislation restoring direct OTC drug purchases with pre-tax savings accounts.
Legislation with proposals that drug firms were hesitant to get behind – reforming FDA's OTC drug monograph program and establishing a user fee program to support the agency's work – is close to surfacing in Congress with the industry's backing.
A separate change also requiring legislation but that the industry has backed from the start, eliminating the Affordable Care Act...
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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