BioSpace News Archive

FDA

Medrobotics Wins FDA Nod for World’s First and Only Flexible Transabdominal and Transthoracic Robotic Scope

This clearance reaffirms the Company’s progress to develop transformative products for single-port general, gynecological, thoracic and urological surgeries.

January 22, 2018
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2 min read
New Study Investigates the Clinical Utility of ORi™, Masimo Oxygen Reserve Index™, in Obese Patients

The researchers concluded that the study “demonstrates the ability of ORi to provide advanced warning of arterial desaturation as an adjunct to SpO2 in this high risk patient population.

January 22, 2018
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7 min read
Drug Development

Astellas, Vical’s Lead CMV Vaccine Flunks Key Phase III Study

The drug did not meet its primary or secondary endpoints in the Phase 3 HELIOS clinical trial.

January 22, 2018
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5 min read
Octapharma: Low Inhibitor Rate With Octanate® In Previously Untreated Patients (Pups) With Severe Haemophilia A

The study assessed the immunogenicity, efficacy, safety and tolerability of octanate® in PUPs with severe haemophilia A.

January 22, 2018
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4 min read
Business

David Harding to Join TransMed7, LLC Business Advisory Board

Mr. David Harding is currently the Senior Vice-President (SVP) of Corporate Strategy and Business Development at Exact Sciences, a diagnostics company focused on colorectal cancer screening.

January 22, 2018
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4 min read
Business

IONTAS to Generate Antibodies using Mammalian Display Technology for a Global Biopharma

IONTAS Limited, a leader in the discovery and optimisation of fully human antibodies, announced today that it has signed an agreement with Sanofi to discover antibodies using IONTAS’ proprietary Mammalian Display Technology.

January 22, 2018
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2 min read
MOLOGEN Presented Lefitolimod TME Data at ASCO GI 2018

The data showed that lefitolimod can significantly improve the anti-tumor effect of checkpoint inhibitors, particularly anti-PD-1 and anti-PD-L1 antibodies, and thus prolong survival in murine tumor models.

January 22, 2018
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5 min read
FDA

Bay Area’s Abaxis Snags USDA Approval of New VetScan FLEX4 Rapid Test

The FLEX4 Rapid Test is the newest addition to the VetScan Rapid Test product family.

January 22, 2018
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5 min read
Genetown

Agenus Closes $230M Royalty Monetization With HealthCare Royalty Partners

The transaction is comprised of approximately $190M of cash proceeds at closing plus up to approximately $40M in milestone payments.

January 22, 2018
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2 min read
Policy

Regeneron Announces Approval of DUPIXENT (dupilumab) in Japan for the Treatment of Atopic Dermatitis

Regeneron today announced that the MHLW in Japan has granted marketing and manufacturing authorization for DUPIXENT for the treatment of atopic dermatitis in adults not adequately controlled with existing therapies.

January 22, 2018
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9 min read