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FDA puts clinical hold on Solid Biosciences' Duchenne gene therapy trial
By PBR Staff Writer
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).
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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.
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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.
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Regeneron’s anti-cholesterol drug Praluent reduces death risk in trial
By PBR Staff Writer
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.
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Summit Therapeutics extends enrolment in phase 2 PhaseOut DMD study
Summit Therapeutics has opened enrolment in a planned additional group in its phase 2 open label clinical trial dubbed PhaseOut DMD for its Duchenne muscular dystrophy (DMD) drug ezutromid.
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Novartis to use Science 37's technology in 10 clinical trials
By PBR Staff Writer
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.
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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.
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Dermira's acne drug fails in two phase 3 trials
By PBR Staff Writer
Dermira said that two phase 3 clinical trials testing its acne drug, olumacostat glasaretil, failed to meet their co-primary endpoints.
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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.
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Orano Med, RadioMedix recruit first patients in AlphaMedix phase 1 clinical trial
Orano Med and RadioMedix have recruited first three patients in the AlphaMedix phase 1 clinical trial.
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Sterna reports positive results in severe ulcerative colitis drug trial
By PBR Staff Writer
sterna biological has reported positive results from the SECURE study, a Phase 2a trial in patients with moderate to severe ulcerative colitis treated with its GATA-3 specific DNAzyme formulation SB012.
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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.
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Lilly’s Taltz yields positive results in phase 3 genital psoriasis trial
By PBR Staff Writer
Eli Lilly and Company reported that Taltz (ixekizumab) in a phase 3b trial has helped patients with moderate-to-severe genital psoriasis in significantly reducing the impact of their condition on sexual activity.
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Novartis' Cosentyx improves skin clearance in scalp psoriasis study
By PBR Staff Writer
Novartis has announced that its Cosentyx (secukinumab) improved skin clearance in patients with scalp psoriasis in the phase III Scalp study.
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Seikagaku begins phase 3 US trial for SI-6603 for lumbar disc herniation
Seikagaku has started a phase 3 clinical trial in the US for SI-6603 (Condoliase), indicated for the treatment of radicular leg pain (sciatica) due to a lumbar disc herniation.
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