Pharma has come a long way in the last three years in developing tactics to respond to large, government-funded comparative clinical trials. Aggressive and well-prepared responses by the antipsychotic manufacturers to the CATIE comparison of four atypical brands to perphenazine changed what could have been a threatening study into an event for publicizing the strengths of individual brands.
By Cole Werble
The media grabbed its message quickly.
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The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.
Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
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Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
For the Trump Administration, the blockbuster GLP-1 drugs for obesity have become a poster child for the disparity between US and foreign prices.
Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.
