Democrats' opposition to the length of the exclusivity allowed for some new monograph products didn't stop them from voting to send US OTC monograph overhaul legislation on for a vote by the full House. House/Senate differences and some members' questions on whether new exclusivity is needed could make it harder for reforms to pass this year.
House Energy and Commerce Committee support for legislation to overhaul FDA's OTC monograph drug process is unanimous even though the same can't be said for the bill's proposed 18-month exclusivity period for some products approved under the revised program.
Some Democratic members of the committee question the length of the proposed exclusivity period while others oppose any new exclusivity...
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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