BioSpace News Archive

Policy

TearLab Submits 510(k) for U.S. FDA Clearance of TearLab Discovery Platform

TearLab Discovery will also be capable of performing the Company’s current FDA cleared tear osmolarity test.

January 4, 2018
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4 min read
Business

ChemoCentryx: Avacopan Conditional Marketing Authorization Application Accepted for Regulatory Review by European Medicines Agency

Under the terms of its kidney health alliance with VFMCRP, ChemoCentryx will receive a milestone payment triggered by this validation of the avacopan CMA application by the EMA.

January 4, 2018
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13 min read
Drug Development

Foamix Pharma’s Acne Drug Performs in Late-Stage Study

Patients continued for up to an additional 40 weeks of open-label treatment with FMX-101.

January 4, 2018
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5 min read
Drug Development

ABIVAX to Initiate Long-Term Extension Study of ABX464 in Patients With Ulcerative Colitis

The new study will recruit patients from the ongoing ulcerative colitis proof-of-concept study who are responding to treatment with ABX464 into the 12-month open label follow-up study.

January 4, 2018
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3 min read
Celtaxsys Secures Private Financing to Advance Acebilustat Phase III Cystic Fibrosis (CF) Program Preparatory Activities

In conjunction with the financing, Khalil Barrage, Managing Director at Invus, will join Celtaxsys’ board of directors.

January 4, 2018
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4 min read
Business

Paul Stead Joins Adaptimmune as Vice President of Business Development

Paul joins Adaptimmune, most recently, from Inovio Pharmaceuticals, Inc.

January 4, 2018
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3 min read
Policy

U.K. NICE Updates Endobronchial Valve Treatment Guidance to Standard Care

Pulmonx, today announced that the UK’s NICE has updated its guidance for endobronchial valves used to treat severe emphysema, an advanced form of COPD, and now considers current evidence sufficient to support routine use.

January 4, 2018
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4 min read
Medigene AG: Expitope 2.0 Helps to Identify Safer Antigens for Immunotherapy of Cancer

MediGene AG announces that a scientific article has been published in the current issue of “BMC Cancer”.

January 4, 2018
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4 min read
Drug Development

Cidara Therapeutics: Newly Published Journal of Antimicrobial Chemotherapy Supplement Provides Insights into the Future of Echinocandin Therapy for Invasive Fungal Infections

The papers reviews evidence and provides insights into the future of echinocandin therapy, including strategies for the treatment and prevention of life-threatening invasive fungal infections.

January 4, 2018
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5 min read
Drug Development

Celsion Announces FDA Clearance of the OVATION II Study for the Evaluation of GEN-1 Immunotherapy to Treat Newly Diagnosed Stage III/IV Ovarian Cancer

The Phase I/II trial was developed with extensive input from the Company’s Medical Advisory Board.

January 4, 2018
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6 min read