FDA approval of Amgen’s granulocyte colony-stimulating factor for treatment of acute radiation syndrome carries seven years of orphan product exclusivity, which may keep the indication off the label of Sandoz’s biosimilar.
Orphan drug protection attached to a new claim for Amgen Inc.’s Neupogen (filgrastim) may preclude Sandoz Inc. from adding the same indication to labeling for its biosimilar Zarxio (filgrastim-sndz) in the near future.
On March 30, FDA approved Neupogen, a granulocyte colony-stimulating factor, for treatment of patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome, H-ARS).
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.
The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.
Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.
Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.
