BioSpace News Archive

FDA

Sebia Announces FDA Clearance for Its Hydrashift 2/4 Daratumumab Assay

This IVD reagent mitigates the daratumumab-mediated interference seen in Immunofixation results for patients with multiple myeloma treated with DARZALEX.

January 24, 2018
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2 min read
BioMidwest

Medtronic Launches ENCHANT Study to Evaluate ChEVAR Parallel Graft Technique With the Endurant II/IIs Stent Graft System

The first enrollment at St. Franziskus Hospital in Munster, Germany, was led by Professor Giovanni B. Torsello, M.D., chief of Vascular Surgery and principal investigator for the ENCHANT study.

January 24, 2018
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3 min read
Business

BioStem Technologies Inc. Announces New Board Member, Dr. Jennie Sandqvist

Dr. Sandqvist is a leading neurologist in Sweden, but maintains a residence in Ft Lauderdale and has been involved with the Company for more than a year as a shareholder and advisor.

January 24, 2018
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2 min read
Genetown

Partners Connected Health and Vital USA Team Up to Validate the First 5-in-1 Integrated Vital Sign Measurement Tool

Recognizing the movement of increased patient engagement in healthcare, Vital USA has teamed up with the Partners Connected Health team to validate its Vital Moto Mod health and wellness device, a 5-in-1 integrated vital sign monitoring platform.

January 24, 2018
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3 min read
BioMidwest

Riverain Technologies’ ClearRead CT Results Published in the American Journal of Roentgenology

The study documents the results of a multi-reader, multi-case, blinded reader study that shows the benefits of ClearRead CT both in terms of improved reading efficiency and reading accuracy.

January 24, 2018
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1 min read
Immuron to Receive $2.16M R&D Tax Concession Refund

This refund reflects the more than $4.6M investment the Company made in its research and development programs during the 2017.

January 24, 2018
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3 min read
Lexington Recieves Approval to Commence Clinical Study

Company prepares for volunteer enrollment.

January 24, 2018
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4 min read
Drug Development

MRI Interventions Recognizes FDA Clearance of Voyager’s Investigational New Drug Application for VY-AADC Allowing its Pivotal Program to Begin for Advanced Parkinson’s Disease

Clearance of the IND allows Voyager to formally initiate clinical trial sites and begin screening patients for its pivotal Phase 2-3 program.

January 24, 2018
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3 min read
Drug Development

Treos Bio Announces FDA Approval of IND of Its First PolyPEPI Precision Cancer Vaccine for Metastatic Colorectal Cancer

The presentation at the EBMT Conference will entail detailed correlative analyses between clinical benefit

January 24, 2018
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4 min read
Business

Sorrento Therapeutics CAR-T Manufacturing Capacity Expanded With Opening of East Coast GMP Site in Addition to Primary West Coast Facility

Sorrento estimates that the combination of its East and West Coast manufacturing capacity will allow the company to process CAR-T treatments for over 300 patients a year without the use of a third-party contract manufacturer.

January 24, 2018
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4 min read