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US legislative update: takeaways for European pharma

European Pharmaceutical Review

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars.

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Prescribing shift for Pfizer’s Paxlovid expands access but draws questions

Pharmaceutical Technology

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. They will [check] new prescriptions for appropriateness and accuracy and that doesn't really change based on who's prescribing it.”.

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Diversity and inclusion in oncology clinical trials

Clarify Health

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. Clarify launched its real-world evidence on health disparities in 2021.

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Readjusting the Life Sciences Industry’s Approach to Improving Adherence

PM360

Addressing the issue of medication adherence begins before a patient even fills their first prescription. Part of this effort must include a consideration of social determinants of health (SDoH)—food, housing, transportation, access to care, etc.”. Eli Phillips, Jr., Further confounding the issue, patient needs may change over time.