Halfway through the first year of the biosimilar user fee program, fee payments have not lived up to the expectation in President Obama’s FY 2013 budget request. Initial meetings continue to grow but at a slow pace, suggesting sponsors may remain hesitant about the pathway.
FDA’s biosimilar user fee program does not appear to be generating revenue very quickly, which may affect the pace of the emerging field.
The agency still has not received a biosimilar marketing application six months after its Oct. 1, 2012 launch, but has said a number of sponsors have submitted INDs or are...
By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.
President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.
FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.
Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.
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.
Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.
