RAPS

When can Non-Inferiority Trials Establish Efficacy? FDA Explains With Guidance

The US Food and Drug Administration (FDA) on Monday finalized guidance to pharmaceutical and biotech sponsors looking for more advice on when non-inferiority studies demonstrating effectiveness of an ...

Diasome Presents Phase 2b Data Demonstrating HDV™-Insulin Lispro Maintains Glycemic Control While Reducing Hypoglycemia in Adults with Type 1 Diabetes

HDV-Insulin Lispro (HDV-LIS) met A1C non-inferiority at Weeks 12 and 25, confirming comparable glycemic control to insulin ...
RAPS

Study: Most new antibiotics approved by FDA based on non-inferiority trials with surrogate outcomes

All new antibiotics approved by the US Food and Drug Administration (FDA) used surrogate outcome measures, and about half had pivotal trials with a non-inferiority design, according to recent research ...
EurekAlert!

EuroPCR 2024 – Early outcomes of a randomised non-inferiority trial comparing TAVI devices: the LANDMARK trial

Paris, France, 14-17 May 2024. The Course Directors have selected 3 major Late Breaking Trials (LBTs) that will be presented for the first time during the 2024 edition of EuroPCR. These trials were ...
Healio

Tapering csDMARDs in RA remission fails to achieve non-inferiority vs. stable dose

Please provide your email address to receive an email when new articles are posted on . Tapering regimens were linked to significantly higher flare risk among patients in RA remission. The results ...
News Medical

Study highlights non-inferiority of super-high-pressure non-compliant balloons in coronary interventions

New study findings show that utilizing super-high-pressure non-compliant balloons (NCB) is non-inferior to intravascular lithotripsy (IVL) balloon catheters for lesion preparation and stent expansion ...
Nasdaq

Novartis' Phase III Malaria Study Meets Key Non-Inferiority Endpoint

Novartis NVS reported positive top-line data from a late-stage study of its investigational new malaria treatment candidate, KLU156 (ganaplacide/lumefantrine, or ...