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BioWorld - Tuesday, April 28, 2026
Breaking News: Best of BioWorld: Q1Breaking News: Best of BioWorld: Q1
Home » Topics » BioWorld, Clinical

BioWorld, Clinical
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Centering itself: Epicentrx launches a phase III in SCLC

Nov. 6, 2019
By Lee Landenberger
Corey Carter, whose company Epicentrx Inc. just dosed its first patient in a phase III trial for treating third-line and beyond small-cell lung cancer (SCLC), has made studying the disease a life goal. "With my military background, I noticed that smoking rates are higher there," Carter, the company's president and CEO, told BioWorld. "That's when it became important to me. Then, also, my dad had small-cell lung cancer."
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Amgen says it wants the Revolution for its phase Ib

Nov. 5, 2019
By Lee Landenberger
Amgen Inc. and Revolution Medicines Inc. will collaborate on a clinical trial evaluating the combination of RMC-4630, Revolution's SHP2 inhibitor, and Amgen's AMG-510, a KRAS-G12C inhibitor. Amgen will conduct the phase Ib trial to treat patients with advanced solid tumors harboring the KRAS G12C mutation and Revolution will provide Amgen with RMC-4630.
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Listen up: Otonomy effort with Otividex could mean 'turnaround' in Meniere's

Nov. 4, 2019
By Randy Osborne
San Diego-based Otonomy Inc.'s launch of the phase I/II trial for OTO-413, a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), in patients with hearing loss brought renewed investor attention to the company, consigned to the back burner after a late-stage failure.
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Cyclerion reorganizes in wake of two phase II troubles forsGC stimulator praliciguat

Oct. 31, 2019
By Lee Landenberger
Two phase II stumbles for startup Cyclerion Therapeutics Inc., an Ironwood Pharmaceuticals Inc. spinout, crushed the stock (NADAQ:CYCN), which closed down a steep 79.5% on Wednesday.
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Visen to start phase III for China's first long-acting growth hormone for children

Oct. 30, 2019
By Elise Mak
BEIJING – Shanghai-based Visen Pharmaceuticals is pushing its long-acting growth hormone therapy, which is also the first of its kind in China, one step closer to the NDA-stage after receiving clearance from Chinese regulators this week to start a phase III trial.
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Objective RA Dx: Almost nil Til now, Navidea wins with Lymphoseek tweak

Oct. 30, 2019
By Randy Osborne
An already validated approach with Navidea Biopharmaceuticals Inc.'s radioimaging agent for rheumatoid arthritis (RA) might have presaged the victory, but that didn't stop Wall Street from rewarding the shares handsomely, and the stock (NYSE:NAVB) closed Tuesday at $1.10, up 32 cents or almost 41.5%, having traded as high as $1.36.
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Virocure's Australian branch launches operations with an oncolytic virus phase I trial

Oct. 29, 2019
By Jihyun Kim
HONG KONG – South Korean biopharma Virocure Inc., based in Seoul, recently founded a local corporation in Brisbane, Australia. The new company, Virocure Australia Pty Ltd., will facilitate a phase I trial of cancer drug RC-402 in Australia.
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Molecular Targets Meeting 2019

Bispecific matchmakers can improve antibodies, CARs

Oct. 29, 2019
By Anette Breindl
BOSTON – Researchers from Memorial Sloan-Kettering Cancer Center presented encouraging, though very early, data on Merus NV's bispecific antibody MCLA-128 for the treatment of patients with NRG-1 gene fusions at the AACR-NCI-EORTC Molecular Targets meeting on Sunday.
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Pfizer tracking lung cancer resistance profile using Inivata's liquid biopsy tool

Oct. 29, 2019
By Nuala Moran
LONDON – Pfizer Inc. is taking further steps to distinguish its third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena, from the rest of the field, funding a pan-European trial that will use liquid biopsies to track the resistance profile of non-small-cell lung cancers (NSCLC).
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Takeda reports positive phase III data for eosinophilic esophagitis candidate

Oct. 29, 2019
By Michael Fitzhugh
A late-stage test of Takeda Pharmaceutical Co. Ltd.'s oral suspension of the steroid budesonide for the treatment of eosinophilic esophagitis (EoE) achieved both its co-primary endpoints, improving histologic and dysphagia symptom responses vs. placebo during the first pivotal phase III study of an EoE treatment ever to be reported in the U.S. The study, part of the largest EoE clinical program globally to date, also met secondary endpoints, including improvements from baseline to final treatment as measured by an established patient-reported outcome measurement.
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