Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.
FDA’s Anti-Infective Drugs Advisory Committee wants tighter subject recruiting standards and additional subgroup data to emerge from a planned confirmatory trial of Janssen Pharmaceutical Cos.’ tuberculosis drug Sirturo (bedaquiline), to which the panel recommended FDA grant accelerated approval.
If approved, Sirturo will be the first drug with a new mechanism of action to treat tuberculosis in more than 40 years, and the first of a new crop of...
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.
