STAT+: Pharmalittle: Pfizer touts study data for hemophilia drug; former Novartis execs cleared of bribery in Greece
A report by nonpartisan congressional researchers suggests there are at least some parts of the new drug pricing law that drugmakers cannot challenge.
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Drugmakers have already hinted at suing Medicare over its new efforts to negotiate prescription drug prices, but a new report by nonpartisan congressional researchers suggests there are at least some parts of the law that cannot be challenged. At the same time, they caution it would ultimately be up to the courts to decide, STAT tells us. To speed things up, the law directs government officials to forgo the usual public rulemaking that allows for industry feedback, and it restricts the courts from reviewing aspects of that process, including the drugs chosen for negotiation and the maximum price that Medicare will pay for them.
Pfizer disclosed that late-stage study data for its experimental hemophilia therapy showed superiority to the current standard of care treatment in reducing bleeding rates in patients, Reuters writes. The therapy, marstacimab, met its main trial goal, demonstrating superiority to factor replacement therapies, with a 92% reduction in bleeding in patients with severe hemophilia A and moderately severe to severe hemophilia B. The current standard of care requires regular infusion of the missing proteins. The once-weekly Pfizer drug is an anti-tissue factor pathway inhibitor that could help initiate blood clotting.
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