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BioWorld - Sunday, December 15, 2019
Home » Topics » Clinical

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ESMO Asia 2019

Panelists urge better designs, more global focus for phase I trials

November 26, 2019
By David Ho
No Comments
SINGAPORE – While a lot of focus is placed on phase III trials and the subsequent approvals, panelists during the ESMO Asia Congress pointed to the importance of designing the right kind of phase I trials, from reaching global populations to using appropriate endpoints.
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ESMO Asia 2019

Quality of life and quality of studies take stage as Takeda reports solid NSCLC findings

November 26, 2019
By David Ho
No Comments
SINGAPORE – Takeda Pharmaceutical Co. Ltd. presented new findings from its phase III ALTA-1L trial evaluating its Alunbrig (brigatinib) vs. crizotinib in adults with advanced anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer (NSCLC) who had not received a prior ALK inhibitor, showing Alunbrig reduced the risk of disease progression or death by 76% after more than two years of follow-up.
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Hua Medicine achieves primary efficacy endpoint in phase III trial for type 2 diabetes candidate

November 26, 2019
By David Ho
No Comments
HONG KONG – China-based Hua Medicine (Shanghai) Ltd.’s phase III trial of a potentially first-in-class dual-acting glucokinase activator, dorzagliatin, met its primary efficacy endpoint.
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Mixed clinical results jolt La Jolla Pharma

November 25, 2019
By Lee Landenberger
No Comments
La Jolla Pharmaceutical Co. discontinued its study LJ401-BT01 due to lack of efficacy and will reassess further development of LJPC-401 (synthetic human hepcidin) based on recent mixed clinical results.
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Cymabay’s PPAR-delta dawn darkens; seladelpar bound for NASH mansion in sky?

November 25, 2019
By Randy Osborne
No Comments
Due to the “dynamic nature of the situation,” officials of Cymabay Therapeutics Inc. declined to comment on the stoppage of work with PPAR-delta agonist seladelpar, but in a press release they pointed to “a series of investigative actions [that have begun in order] to better understand these findings.”  
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Mologic begins recruitment of COPD urine-based home test

November 25, 2019
By Nuala Moran
No Comments
LONDON – Mologic Ltd. has started recruitment in a 263-patient trial to validate its urine-based home test for anticipating exacerbations of chronic pulmonary obstructive disease (COPD). The lateral flow immunoassay self-test detects five biomarkers of the lung disease in urine that are indicative of inflammation and infection.
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Ocular-eye

Eyegate sees top-line corneal wound win as unlocking path to U.S. de novo filing

November 22, 2019
By Michael Fitzhugh
No Comments
Shares of Eyegate Pharmaceuticals Inc. (NASDAQ:EYEG) rose 54.8% to $7.09 Friday on news that its ocular bandage gel (OBG) proved superior to standard of care in healing corneal wounds following photorefractive keratectomy (PRK) surgery.
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Study supports long-term performance of Senseonics’ Eversense CGM

November 22, 2019
By Meg Bryant
No Comments
Germantown, Md.-based Senseonics Inc. said results from a recent study confirm that the sensor in its Eversense continuous glucose monitoring (CGM) system performs well over multiple, sequential 90-day and 180-day cycles. The real-world trial assessed the accuracy of the Eversense data management system by comparing sensor blood sugar values with self-monitored glucose values in 945 adults.
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Apple Heart Study delivers results as 3 new app-based trials begin

November 22, 2019
By Stacy Lawrence
No Comments
Stanford University School of Medicine and Apple Inc.have published results from the largest digital-only study. The trial has been conducted in more than 400,000 people in the U.S. over more than eight months. It was set up to screen participants via their Apple Watch for heart irregularities and then to further monitor any of those with identified issues with a wearable ECG patch.
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Primed with phase III glioblastoma data, Diffusion seeks partner for next step

November 21, 2019
By Michael Fitzhugh
No Comments
Diffusion Pharmaceuticals Inc., a company developing trans sodium crocetinate (TSC) for the treatment of cancer, has reported increased survival for inoperable glioblastoma patients enrolled in the lead-in portion of its open-label phase III study testing TSC plus standard-of-care (SOC) temozolomide and radiation therapy against SOC alone.
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