House Ways & Means Committee clears legislation requiring manufacturers to justify 10% WAC increase in one year and 25% increase over three years, and to report number of free product samples.
Drug manufacturers would have to provide their rationale for increasing Rx drug prices by at least 10% in one year and 25% over three years under legislation that unanimously cleared the US House Ways & Means Committee April 9. They would also have to justify launch prices of at least $26,000.
The Prescription Drug Sunshine, Transparency, Accountability and Reporting Act, or the Prescription Drug STAR Act, H.R. 2113, has a good shot of being enacted given its bipartisan support and the...
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.
Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.
As South Korea gears up for a snap presidential election, its biopharma industry proposes key desired policies to candidates, most of whom have not laid out detailed plans of their own for the sector.
Joint procurement, if used by member states to respond to potential pricing and access challenges caused by a US most favored nations pricing policy, would cause more uncertainty for pharmaceutical companies, warn industry representatives.
Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
