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

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 ...
Cure Today

Patients with High-Risk Breast Cancer May Safely Skip Chemo, Trial Finds

Prosigna identified a large high-clinical-risk subgroup with minimal chemotherapy benefit, estimated to avert at most two recurrences per 100 patients treated. Enrollment broadened prior assay use by ...
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 ...
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, ...

TG Therapeutics Announces Positive Results from Phase 1 Trial Evaluating Subcutaneous BRIUMVI® (ublituximab-xiiy)

Pharmacokinetic and pharmacodynamic data support quarterly subcutaneous BRIUMVI dosing regimen currently under evaluation in fully enrolled Phase ...
TCTMD

Non-Inferiority Trials – Bridge or Barrier to Patient-Centered Progress?

Receive the the latest news, research, and presentations from major meetings right to your inbox. TCTMD ® is produced by the Cardiovascular Research Foundation ® (CRF). CRF ® is committed to igniting ...