Xopenex reimbursement is being slashed by Medicare. The message: CMS wants proof of differentiation before it will pay more for line extensions and new formulations. That means trouble ahead for a lot of other products.
Michael McCaughan
Add Sepracor Inc
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The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.
Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.
MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.
Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.
The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.
The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.
The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.
