Citeline, a Norstella company

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

The new US FDA vaccine guidelines introduced on 20 May might cause financial woes for Moderna, but overall vaccine makers should not be as impacted as feared.

The Oncologic Drugs Advisory Committee voted 5-4 that the overall benefit-risk of UGN-102 is not favorable in patients with recurrent low grade, intermediate-risk, non-muscle invasive bladder cancer and also divided on whether randomized trials should be required for future development programs.

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

The brunt of the tariff exposure stems from Singapore and Costa Rica, which together account for an estimated 70% to 80% of the tariff-related cost burden. Less than 10% of the exposure is tied to China.

Cipla's CEO underlines that US generic prices are already “very significantly comparable” with the rest of the world and expects President Donald Trump's executive order on drug pricing to primarily impact branded pharmaceuticals. The company also shared updates on its US pipeline.

Lupin CEO Vinita Gupta speaks on Trump’s most favored nation policy, the Inflation Reduction Act’s “pill penalty” and other developments in the US, a major market for the company. The company also outlines a five-year plan focused on complex generics and technology platforms.

As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.