BioSpace News Archive

Policy

Theravance Biopharma and Mylan Announce FDA Acceptance of NDA for Revefenacin (TD-4208) in Adults With COPD

The FDA has assigned a PDUFA target action date of November 13, 2018, and indicated that it does not currently plan to convene an advisory committee meeting to discuss the NDA.

January 29, 2018
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13 min read
Business

Virginia Tech Carilion Research Institute Partners With INSIGHTEC on Research Program to Develop Treatments for Brain Disorders With Innovative Focused Ultrasound Technology

The research is being led by Stephen LaConte, Ph.D., Associate Professor with the VTCRI and also the Department of Biomedical Engineering and Mechanics in the College of Engineering.

January 29, 2018
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2 min read
Drug Development

SillaJen Announces First Patient Enrolled in the NCI-Sponsored Trial Evaluating Combination Therapy in Colorectal Cancer with SillaJen’s Pexa-Vec Oncolytic Immunotherapy

Under the CRADA, SillaJen will collaborate with Dr. Greten to evaluate the combination of SillaJen’s lead clinical candidate, Pexa-Vec in combination with durvaluma.

January 29, 2018
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6 min read
Business

Insulet Corporation to Announce Fourth Quarter and Full Year 2017 Financial Results on February 21, 2018

Insulet today announced plans to release its financial results for the fourth quarter and full year of 2017 on February 21, 2018 after the close of the financial markets.

January 29, 2018
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2 min read
U.S. Defense Reports Broad Travelan Reactivity to 180 Pathogenic Bacteria Including Camylobacter and Shigella

The primary goal of this program was to investigate Travelan immunological reactivity with pathogenic bacteria including Campylobacter, Enterotoxigenic Escherichia coli (ETEC) and Shigella.

January 29, 2018
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5 min read
Drug Development

China Oncology Focus Limited Receives Approval by Chinese Authorities to Begin Clinical Trials in Three Separate Cancer Indications Using Sorrento’s Anti-PD-L1 Monoclonal Antibody

The trials will be anticipated to use a 3+3 design with 5mg/kg, 10mg/kg and 15mg/kg dosing regimens. O

January 29, 2018
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7 min read
Policy

Pernix Announces Patent Litigation Settlement Agreement With Actavis Concerning Zohydro ER

The litigation has been pending in the U.S. District Court for the District of Delaware and resulted from Actavis’s submission of an ANDA to the FDA seeking approval to market a generic version of Zohydro ER.

January 29, 2018
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4 min read
Business

Prime Therapeutics and Boehringer Ingelheim Enter Into Outcomes-Based Contract for Jardiance

As a PBM owned by 18 Blue Cross and Blue Shield plans, Prime is uniquely positioned to analyze both medical and pharmacy claims data to evaluate and manage total cost of care.

January 29, 2018
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3 min read
FDA

Meso Scale Diagnostics Receives First FDA Clearance for IVD Assay

The cleared assay system includes the MESO SECTOR S 700, which is intended for the in-vitro determination of analytes in bodily fluids.

January 29, 2018
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2 min read
Drug Development

Cellectar Initiates DLBCL Cohort in Phase II Trial of CLR 131 in Refractory B-Cell Hematologic Cancers

The Company expects to enroll up to 10 patients with DLBCL into this cohort prior to conducting an interim analysis.

January 29, 2018
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8 min read