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Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drugpricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.
Overall, while the NHC appreciates CMS’ intent to streamline the data submission process and make it more accessible, we encourage ongoing dialogue and adjustments to ensure that the process remains patient-centered, efficient, and capable of capturing the full spectrum of information necessary to inform meaningful drugprice negotiations.
Rating the 1QFY25 performance of a sample of 18 leading pharma companies, the Ind-Ra report points out that normalisation of drugprices in the US and a softening in raw material prices will help companies to keep revenue growth of 9 per cent yoy and EBITDA margin of about 22 per cent during FY25.
General Comments The NHC appreciates CMS’ commitment to actively engaging with stakeholders, including patients, consumer advocates, and health experts, in implementing the Medicare DrugPrice Negotiation Program (DPNP).
From the post: The HHS Budget in Brief document describes the policy objective simply enough: “ Permit Biosimilar Substitution without Prior FDA Determination of Interchangeability” and clarifies that this means “deem all approved biosimilars to be interchangeable with their respective reference products”.
The alleged actions violated the Hatch-Waxman Act, formally known as the “DrugPrice Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications. Gilenya is an oral medication for multiple sclerosis.
We’re really having the ability now in a much more regulated framework and environment about what we can say in the pharma industry has to be on label. When you’re designing and then beginning to execute a clinical trial, you must author about 90 documents for that trial.
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