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 ...
zacks

OTLK Stock Falls on Failure to Meet Non-Inferiority Goal in AMD Study

Outlook Therapeutics (OTLK Quick Quote OTLK - Free Report) reported preliminary top-line results from the 90-day non-inferiority NORSE EIGHT clinical study evaluating ONS-5010 (Lytenava) to treat ...
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 ...
Nasdaq

Outlook Therapeutics Reports Positive 12-Week Results for ONS-5010 in Wet AMD Non-Inferiority Trial and Plans BLA Resubmission for 2025

ONS-5010 shows non-inferiority to Lucentis at 12 weeks; BLA resubmission planned for Q1 2025, with $20.4M in proceeds expected. ONS-5010 demonstrated non-inferiority to ranibizumab at week 12, ...

F2G and Shionogi Announce Positive Topline Results From Global Phase 3 OASIS Study Evaluating Oral Olorofim Versus AmBisome® Followed by Standard of Care in Patients With ...

The study achieved the primary endpoint of non-inferiority, with a rate of all-cause mortality (ACM) at Day 42 for olorofim of 23.8% and for ...
zacks

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

Novartis' GanLum met the primary endpoint in the phase III KALUMA malaria study. GanLum achieved a 97.4% cure rate versus 94.0% for Coartem, meeting non-inferiority criteria. The therapy remained ...
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 ...

Press Release: Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma

Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myelomaApproval based on multiple studies, including the ...
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 ...
Nature

A noninferiority trial evaluating the efficacy of bedinvetmab compared to grapiprant for osteoarthritis-pain in dogs using force plate gait analysis

A randomized, double-blind, non-inferiority study was conducted to evaluate efficacy of bedinvetmab compared to grapiprant using objective force plate gait analysis (FPGA). Thirty-two eligible dogs (> ...
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 ...