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Redx Pharma temporarily stops RXC004 cancer trial
By PBR Staff Writer
UK-based Redx Pharma is temporarily stopping the phase 1/2a clinical study of a cancer candidate, RXC004, to rectify the dose-escalation procedure and restart at a lower dose levels.
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Protagonist Therapeutics stops ulcerative colitis trial of PTG-100
Protagonist Therapeutics said it is discontinuing the Phase 2b PROPEL study of PTG-100, its investigational oral GI-restricted alpha-4-beta-7 integrin antagonist peptide, in patients with moderate to severe ulcerative colitis (UC).
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Ablynx’s vobarilizumab fails to meet primary endpoint in phase II lupus study
By PBR Staff Writer
Ablynx’s lupus erythematosus treatment vobarilizumab has failed to meet primary endpoint in the phase II dose-ranging study.
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Mitsubishi Tanabe, Hitachi to use AI for improving efficiency of clinical trials
Mitsubishi Tanabe Pharma has partnered with Hitachi to improve the efficiency of clinical trials for the development of new drugs through the latter's artificial intelligence (AI) technology.
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Roche's lung cancer combination drug shows significant survival benefit
By PBR Staff Writer
Roche has announced that its Tecentriq (atezolizumab) combined with Avastin (bevacizumab) plus carboplatin and paclitaxel (chemotherapy) showed a clinically significant survival benefit in a phase III lung cancer study.
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Pfizer's smoking cessation drug fails to meet primary endpoint in phase 4 study
By PBR Staff Writer
Pfizer said its smoking cessation drug Chantix/Champix (varenicline) has failed to achieve its primary endpoint in a phase 4 study.
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AbbVie not to seek accelerated approval for Rova-T after weak phase 2 SCLC trial data
By PBR Staff Writer
AbbVie has dropped plans to seek accelerated approval for Rova-T (rovalpituzumab tesirine) in the US in third-line relapsed/refractory (R/R) small cell lung cancer (SCLC) following disappointing results in a phase 2 trial.
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GSK begins phase III trial of Benlysta, rituximab combo in systemic lupus erythematosus
GSK has commenced a phase III trial to evaluate Benlysta (belimumab) in combination with rituximab in adult patients with systemic lupus erythematosus (SLE).
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Arena’s etrasimod meets primary and secondary endpoints in ulcerative colitis trial
Arena Pharmaceuticals has reported positive topline phase 2 results from the OASIS trial for etrasimod, an investigational, once-daily, orally administered, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of ulcerative colitis (UC).
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Heron’s pain drug succeeds in phase 3 bunionectomy and hernia repair trials
By PBR Staff Writer
Heron Therapeutics’ pain drug HTX-011 has succeeded in two phase 3 trials in patients undergoing bunionectomy and hernia repair by meeting all their primary and key secondary points.
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Alexion’s rare blood disorder treatment ALXN121 succeeds in phase 3 study
By PBR Staff Writer
Alexion Pharmaceuticals' investigational long-acting C5 complement inhibitor, ALXN1210, has succeeded in the pivotal phase 3 study of patients with rare blood disorder, paroxysmal nocturnal hemoglobinuria (PNH).
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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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