Lack of crossover in Novartis’ pivotal BOLERO-2 trial could lead to a clean picture of the mTOR inhibitor’s ability to prolong survival, the ultimate gold standard in cancer drug approvals. An interim analysis showed a survival advantage that fell short of reaching statistical significance.
FDA approved a breast cancer claim for Novartis AG’s mTOR inhibitor Afinitor (everolimus) on the strength of a doubling in median progression-free survival in the BOLERO-2 trial, but the agency surely has its eye on a forthcoming final survival analysis, which, thanks to the study’s design, should provide a clear picture of whether the drug makes patients live longer.
On July 20, the agency approved Afinitor for use in combination with Pfizer Inc
At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.
With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.
At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.
Policy experts and pharma executives react to President Trump’s executive order on “equalizing” drug prices between the US and comparable nations at the ISPOR 2025 conference.
New draft guidance on the third cycle of Medicare drug price negotiations goes against Merck and BMS expectations for their cancer drugs. The guidance also tackles Part B and renegotiated prices for the first time.
A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.
Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.
