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Eisai's liver cancer drug Lenvima succeeds in phase 3 trial
Eisai has announced positive topline results from the randomized, multicenter Phase 3 trial (Study 304) evaluating the company's multiple receptor tyrosine kinase inhibitor, lenvatinib (marketed as Lenvima), for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
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Onxeo completes enrollment in phase 3 hepatocellular carcinoma treatment trial
By PBR Staff Writer
Danish pharma company Onxeo has completed enrollment of patients in the phase 3 clinical trial of its advanced hepatocellular carcinoma (HCC) drug Livatag (doxorubicin transdrug).
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Actelion’s PAH drug fails to meet primary objective in Phase III study
By PBR Staff Writer
A Phase III study evaluating Actelion's macitentan in patients with pulmonary arterial hypertension (PAH) due to Eisenmenger Syndrome failed to meet its primary goal.
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FDA authorizes NantKwest’s IND application for first-in-human haNK cell therapy phase I study
The US Food and Drug Administration (FDA) has authorized NantKwest’s Investigational New Drug Application (IND) for its first-in-human, high-affinity natural killer (haNK) cell therapy phase I clinical study.
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OncoMed doses first patient in phase 1b trial of brontictuzumab
OncoMed Pharmaceuticals has dosed the first patient in a Phase 1b clinical trial of brontictuzumab (anti-Notch1, OMP-52M51) plus chemotherapy in metastatic colorectal cancer patients.
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Otonomy starts patient enrollment in phase 2 trial of OTO-104
Otonomy has started the enrollment of the first patients in a phase 2 clinical trial assessing OTO-104 for the prevention of hearing loss in cancer patients undergoing chemotherapy with platinum-based agents.
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Clinigen begins US Managed Access program for TESARO’s niraparib in ovarian cancer patients
Clinigen Group's Idis Managed Access (MA) division has partnered with TESARO to launch a Managed Access program for the investigational PARP 1/2 inhibitor, niraparib.
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Evgen Pharma doses first patient in phase II breast cancer trial
Evgen Pharma has dosed the first patient in its Phase II clinical trial of SFX-01 in breast cancer.
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AstraZeneca refines endpoints in immuno-oncology trials for NSCLC
By PBR Staff Writer
AstraZeneca has refined the endpoints of its phase III clinical trial, Mystic, evaluating durvalumab and tremelimumab for first-line treatment of patients with non-small cell lung cancer (NSCLC).
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Chi-Med starts phase II study of sulfatinib in second-line biliary tract cancer in China
Hutchison China MediTech (Chi-Med) has started a Phase II study of sulfatinib in second-line biliary tract cancer (“BTC”) patients in China.
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ObsEva completes phase 1 first-in-women study of OBE022 to treat preterm labor
ObsEva has completed a Phase 1 single and multiple ascending dose study of OBE022, a potential first-in-class, once daily, oral and selective prostaglandin F2α, or PGF2α, receptor antagonist for the treatment of preterm labor in weeks 24 to 34 of pregnancy.
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Sunovion’s dasotraline improves ADHD symptoms in children in phase 2/3 study
By PBR Staff Writer
Sunovion Pharmaceuticals’ novel drug candidate dasotraline has demonstrated significantly improved attention deficit hyperactivity disorder (ADHD) symptoms in children compared to placebo in a phase 2/3 study.
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Novartis to commence phase 2 trial with bimagrumab in obese patients with type 2 diabetes
MorphoSys said its partner Novartis will conduct a phase 2 clinical trial of the HuCAL antibody bimagrumab in obese patients having type 2 diabetes.
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Visterra doses first patient in phase 2a trial of influenza A candidate VIS410
Visterra has dosed the first patient in the VIS410 Phase 2a clinical trial to study the monoclonal antibody for the treatment of hospitalized patients with influenza A, irrespective of the viral strain.
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ValiRX’s prostate cancer drug VAL201 shows positive results in Phase l/II trial
By PBR Staff Writer
ValiRx is extending its early stage trial of a prostate cancer drug, VAL201, after demonstrating disease stabilization, with a lower dose than was predicted by its preclinical evaluations.
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