Tag Archives: type-industry &amp; policy

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NeuClone Announces Positive Results from Phase I Study of Stelara^® (ustekinumab) Biosimilar Candidate

NeuClone Pharmaceuticals Ltd announced its biosimilar candidate of Stelara^®, NeuLara, has successfully met all primary and secondary endpoints in a Phase I clinical trial. NeuLara is being developed as a biosimilar of ustekinumab, an antibody targeting interleukin-12 and -23, approved under the brand name Stelara^® to treat patients with plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

[NeuClone Pharmaceuticals Ltd.]

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Orbus Therapeutics Expands Series A Financing to $71 Million to Support Ongoing STELLAR Phase III Study in Rare Brain Cancer

Orbus Therapeutics Inc. announced that it closed an expansion of its Series A financing. The expanded Series A funding will support the ongoing STELLAR study, a Phase III clinical trial studying eflornithine in patients with anaplastic astrocytoma whose cancer has recurred following radiation and adjuvant chemotherapy.

[Orbus Therapeutics Inc.(Globe Newswire, Inc)]

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Georgia State Start-Up Awarded NIH Grant To Develop Contrast Agent for Early Detection of Liver Disease

Inlighta Biosciences, LLC, a start-up company led by Jenny Yang, Regents’ Professor of Chemistry at Georgia State University, has been awarded a National Institute of Health grant to accelerate development of a magnetic resonance imaging contrast agent to detect liver fibrosis, formation of scar tissue in the liver caused by alcoholic and non-alcoholic fatty liver disease.

[Georgia State University]

Abstract

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Treadwell Announces Initiation of New Clinical Trial of CFI-400945 in Patients with Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

The Canadian Cancer Trials Group (CCTG) announced the commencement of a new sub-study evaluating CFI-400945, an oral, first-in-class inhibitor of Polo-like Kinase 4, in patients with mCRPC.

[Treadwell Therapeutics (Businesswire, Inc.)]

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MediciNova, in Collaboration with the University of Sydney and the Australasian Gastro-Intestinal Trials Group, Announces Plans for a Multi-center, Phase IIb Study to Evaluate MN-166 (ibudilast) in Chemotherapy-Induced Peripheral Neuropathy

MediciNova, Inc.announced that it plans to initiate a multi-center, placebo-controlled, randomized Phase IIb trial to evaluate MN-166 in chemotherapy-induced peripheral neuropathy.

[MediciNova, Inc]

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Catalent and BrainStorm Cell Therapeutics Announce Partnership for the Manufacture of Mesenchymal Stem Cell Platform Therapy NurOwn^®

Catalent and BrainStorm Cell Therapeutics, Inc announced an agreement for the manufacture of NurOwn^®, BrainStorm’s autologous cellular therapy being investigated for the treatment of ALS, also known as Lou Gehrig’s disease or motor neuron disease.

[Catalent]

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Keck Medicine of USC Enrolling Individuals in Phase III Clinical Trial to Treat Mild Alzheimer’s Disease Using Deep Brain Stimulation

Keck Medicine of USC enrolled individuals in an international phase III clinical trial to examine the safety and effectiveness of deep brain stimulation to treat Alzheimer’s. The study used electrical impulses to stimulate the region of the brain known as the fornix, which is associated with memory and learning.

[University of Southern California]

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Tagrisso Granted Priority Review in the US for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

AstraZeneca’s Tagrisso has received acceptance for its supplemental New Drug Application and has also been granted Priority Review in the US for the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumour resection with curative intent.

[AstraZeneca]

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Galera Therapeutics Announces Dosing of First Patient in the Phase I/II GRECO-1 Clinical Trial of GC4711 in Combination with SBRT for Non-Small Cell Lung Cancer

Galera Therapeutics, Inc. announced that the first patient has been dosed in the Phase I/II GRECO-1 clinical trial of GC4711 in combination with stereotactic body radiation therapy in patients with non-small cell lung cancer.

[Galera Therapeutics, Inc.]

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Bruker Introduces Vutara™ VXL Best-in-Class Super-Resolution Microscope and Spatial Biology Analysis Capabilities

Bruker Corporation announced the release of the Vutara VXL Super-Resolution Fluorescence Microscope for nanoscale biological imaging. Vutara VXL serves as a biological microscopy workstation for research on DNA, RNA, proteins, chromatin structure and chromosomal substructures. It also supports advanced spatial biology research in extracellular matrix structures, extracellular vesicles, virology, neuroscience, and live-cell imaging.

[Bruker]