Human Trials

FDA puts clinical hold on Solid Biosciences’ Duchenne gene therapy trial

The US Food and Drug Administration (FDA) has placed a clinical hold on Solid Biosciences' IGNITE DMD phase Phase I/II trial for SGT-001 microdystrophin gene transfer in Duchenne muscular dystrophy (DMD).

AbbVie’s Elagolix succeeds in second phase 3 uterine fibroid study

AbbVie, along with Neurocrine Biosciences, announced that the Phase 3 ELARIS UF-II study (M12-817) of elagolix met its primary endpoint.

Janssen’s Invokana reduces cardiovascular risk in diabetes patients

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced results of a new analysis showing that Invokana (canagliflozin) significantly reduced the risk of cardiovascular (CV) death or hospitalization for heart failure (HHF) in patients with type 2 diabetes (T2D) at high CV risk.

Regeneron’s anti-cholesterol drug Praluent reduces death risk in trial

Praluent (alirocumab), an anti-cholesterol drug being developed by Regeneron Pharmaceuticals and Sanofi, has succeeded in the Odyssey Outcomes trial by decreasing the risk of death and heart attack in high-risk patients.

Novartis to use Science 37’s technology in 10 clinical trials

Novartis said that it will use Science 37's Network Oriented Research Assistant (NORA) technology in up to 10 clinical trials over the next three years.

Boehringer Ingelheim, Lilly expand heart failure program for Jardiance with new clinical trials

Boehringer Ingelheim and Eli Lilly have unveiled plans to expand their clinical trial program for Jardiance in chronic heart failure with the EMPERIAL clinical trials.

Dermira’s acne drug fails in two phase 3 trials

Dermira said that two phase 3 clinical trials testing its acne drug, olumacostat glasaretil, failed to meet their co-primary endpoints.

Emergent, Valneva begin phase 1 trial of Zika vaccine candidate

Emergent BioSolutions and Valneva have commenced a phase 1 clinical trial in the US to evaluate the safety and immunogenicity of their vaccine candidate VLA1601, against Zika virus.

BerGenBio completes recruitment into first stage of phase II breast cancer trial

BerGenBio has completed enrolment of the planned 28 patients into the first stage of its Phase II clinical trial evaluating its investigational oral selective AXL inhibitor bemcentinib (BGB324) in combination with the Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as a potential new treatment regimen for advanced breast cancer.