United States
US President Trump’s plan for a “25% or higher” tariff on pharmaceuticals promises to have a far-reaching impact, from higher prices and drug shortages to increased onshoring of manufacturing in the US. Is MAGA worth the chaos it might create for MAHA? The Indian industry shares its views.
The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.
The pharmaceutical industry has been quiet on Trump's early federal government overhauls that could harm the drug business, still betting he will help produce better results than Biden.
The "interwoven" nature of the offices within the agency likely means Medicare and Medicaid benefits may be disrupted by staff cuts despite assurances from the administration, Brooks-LaSure warned.
Stakeholders are waiting for the dust to settle to better understand who was laid off as part of the Trump Administration's cuts at the FDA, the reductions' impact on applications currently under review and broader drug development efforts.
The exact number of layoffs at the FDA as part of the Trump Administration’s pledge to shrink the federal government is unclear, but the most came from the agency’s Center for Devices and Radiological Health.
Jim Jones, the head of the FDA's food programs, resigned due to widespread layoffs at the agency imposed by the Trump administration’s Department of Government Efficiency.
Pink Sheet editors and special guest Michael McCaughan of Prevision Policy discuss Robert F. Kennedy Jr.’s first act as HHS Secretary, former FDA Commissioner Scott Gottlieb’s suggestion that industry extend the existing user fee agreement rather than negotiate a new one, and President Trump’s policies impacting FDA advisory committee schedules and staffing.
Congress may be empowered to change the Part D stabilization demo, but a health policy expert said CMS is more likely to repeal, adjust or replace the program.
Clinical trial draft guidance webpages are back online following a court order, but with new language disclaiming any information promoting gender ideology as "extremely inaccurate."
The US FDA is receiving more requests for regenerative medicine advanced therapy designation and granting more of them, according to recently reported agency data.
President Trump's Executive Order creating the commission names mental health and weight-loss drugs as treatments of concern. But it does not mention vaccines, which Kennedy has criticized.
President Trump imposed reciprocal tariffs on countries with duties on US exports 13 February. When asked on 7 February about the impact of US tariffs, Aurobindo said it has alternatives in place to deal with them.
Given the Trump Administration’s intense focus on cutting costs and increasing efficiency, industry and the FDA should focus on what is and is not working in PDUFA VII when negotiating the next agreement, lobbyists said at the BIO CEO and Investor Conference.
Experts worry new restrictions on remote work, plans to eliminate certain employees’ job protections and workforce cuts will make the FDA a less attractive employer and hurt pharma’s efforts to get innovative medicines to patients.
The US FDA says in a legal memo that its new guidance on scientific information on unapproved uses (SIUU) is “speech-enabling” and argues that challenges should be interpreted as attempts to roll back the approval process.
Biotech execs and lobbyists try to explain the Trump Administration's policy strategy and how to thrive in it.
Patient demand for compounded versions of FDA approved obesity drugs is unlikely to dissipate, even if semaglutide’s “shortage” status is resolved. The issue likely will continue to be a high profile concern for the brand industry.
Robert F. Kennedy Jr. will become HHS secretary while retaining his anti-vaccine positions. His first action likely will be creating a new safety commission, which industry must hope holds off more drastic action.
A federal judge granted Doctors for America’s motion for a temporary restraining order directing the FDA and CDC to restore information removed from the agencies’ websites to comply with a presidential executive order targeting “gender ideology extremism.”