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BioWorld - Saturday, August 13, 2022
Home » Topics » Clinical

Clinical
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Cyclerion reorganizes in wake of two phase II troubles forsGC stimulator praliciguat

Oct. 31, 2019
By Lee Landenberger
No Comments
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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Objective RA Dx: Almost nil Til now, Navidea wins with Lymphoseek tweak

Oct. 31, 2019
By Randy Osborne
No Comments
Navidea Biopharmaceuticals Inc. disclosed positive results from the first interim analysis of its ongoing NAV3-31 phase IIb study. Analysis shows the data support Navidea's hypothesis that Tc 99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis (RA).
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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
No Comments
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
No Comments
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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RNA testing resolves ambiguous DNA results for many cancer patients

Oct. 30, 2019
By Annette Boyle
No Comments
A JAMA Open Network study found that RNA testing determined whether 88% of variants of uncertain significance found in DNA testing for hereditary cancer genes were pathogenic or benign.
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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
No Comments
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.
Read More

Virocure's Australian branch launches operations with an oncolytic virus phase I trial

Oct. 29, 2019
By Jihyun Kim
No Comments
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
No Comments
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
No Comments
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
No Comments
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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