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Zika vaccine found safe, promising in first human trial
By PBR Staff Writer
A DNA-based Zika vaccine, dubbed GLS-5700, developed by a consortium led by Inovio Pharmaceuticals and GeneOne Life Science succeeded in a phase 1 clinical trial by producing anti-Zika response in humans.
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Motif Bio’s iclaprim meets primary endpoint in second phase 3 ABSSI trial
By PBR Staff Writer
UK-based Motif Bio reported that its skin disorder drug iclaprim has succeeded in a second phase 3 trial in patients with acute bacterial skin and skin structure infections (ABSSSI).
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10,000 to be tested in world’s first trial for universal flu vaccine
By PBR Staff Writer
NHS patients are taking part in a world-first trial for a universal flu vaccine supported by the National Institute for Health Research (NIHR) and delivered by the University of Oxford in Berkshire and Oxfordshire.
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Ablynx’s blood disease drug caplacizumab passes phase 3 aTTP trial
By PBR Staff Writer
Ablynx's blood disease drug caplacizumab succeeded in a phase 3 trial in patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare autoimmune blood clotting disorder.
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Zynerba cannabis-derived gel for Fragile X syndrome succeeds in phase 2 trial
By PBR Staff Writer
Zynerba Pharmaceuticals reported that its cannabis-derived gel to treat Fragile X syndrome (FXS) dubbed as ZYN002 has yielded positive results in a phase 2 trial.
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Tricida begins phase 3 study of TRC101 to treat metabolic acidosis associated with chronic kidney disease
Tricida announced that the first subject was enrolled in TRCA-301, a phase 3 study evaluating TRC101 in chronic kidney disease (CKD) patients with metabolic acidosis.
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MD Anderson Cancer Center, Pfizer Oncology partner to assess immuno-oncology combinations in blood cancers and solid tumors
The University of Texas MD Anderson Cancer Center and Pfizer have entered into a clinical collaboration to study novel combinations of three Pfizer investigational immuno-oncology therapies and other Pfizer agents in the treatment of various solid tumors and hematologic malignancies.
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Immune’s bertilimumab yields positive results in phase 2 bullous pemphigoid trial
By PBR Staff Writer
Immune Pharmaceuticals has reported that its ongoing phase 2 trial of bertilimumab in patients with moderate to severe bullous pemphigoid (BP) has yielded positive results.
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Bevespi Aerosphere demonstrates statistically significant improvement in lung function in patients with COPD
AstraZeneca has announced positive top-line results of the Phase III, PINNACLE 4 trial in which Bevespi Aerosphere (glycopyrronium and formoterol fumarate 14.4/9.6 µg) demonstrated a statistically significant improvement in lung function in patients with chronic obstructive pulmonary disease (COPD).
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Axovant’s Alzheimer's drug intepirdine fails in phase 3 trial
By PBR Staff Writer
Axovant Sciences has reported that intepirdine, its 5-ht6 antagonist to treat Alzheimer's disease (AD), failed to meet its co-primary efficacy endpoints in a phase 3 trial.
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NewLink Genetics announces clinical collaboration to assess IO-based combination therapies in pancreatic cancer
NewLink Genetics announced that it has entered into a clinical collaboration agreement with AstraZeneca to evaluate the combination of indoximod, NewLink Genetics’ small molecule IDO pathway inhibitor, and durvalumab, AstraZeneca’s anti-PD-L1 monoclonal antibody, along with standard of care chemotherapy for patients with metastatic pancreatic cancer.
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Pfizer spins off new company with four rare disease therapies
By PBR Staff Writer
US pharma giant Pfizer has spun off four investigational drugs into a new medicines company, dubbed SpringWorks Therapeutics.
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Eleven Biotherapeutics completes Vicinium manufacturing for ongoing clinical trials in non-muscle invasive bladder cancer
Eleven Biotherapeutics announced that it has completed the manufacturing of all Vicinium necessary for its ongoing Phase 3 registration trial in patients with non-muscle invasive bladder cancer (NMIBC), and for its cooperative research and development agreement (CRADA) with the National Cancer Institute.
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AbbVie, Bristol-Myers to evaluate ABBV-399/Opdivo regimen in advanced solid tumors
By PBR Staff Writer
AbbVie will evaluate its investigational antibody drug conjugate, ABBV-399 (telisotuzumab vedotin), in combination with Bristol-Myers Squibb’s immunotheraphy Opdivo (nivolumab) in c-Met overexpressing non-small cell lung cancer (NSCLC).
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Versartis’ phase 3 Velocity trial of somavaratan in pediatric growth hormone deficiency did not meet primary endpoint
Versartis, an endocrine-focused biopharmaceutical firm that is developing somavaratan, a novel,aong-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), announced that the Velocity Phase 3 clinical trial of somavaratan in pediatric growth hormone deficiency (GHD) did not meet its primary endpoint of non-inferiority.
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