BioSpace News Archive

Business

Endo to Announce Fourth-Quarter 2017 Financial Results

Endo will announce its fourth-quarter 2017 financial results on February 27, 2018 and members of its senior management team will host a conference call and webcast before the U.S. financial markets open at 7:30 a.m. ET.

January 29, 2018
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1 min read
FDA

CutisPharma Announces FDA Approval of FIRVANQ for Treatment of Clostridium Difficile Associated Diarrhea (CDAD) and Staphylococcus Aureus Colitis

Upon its launch, which is targeted to be April 2, 2018, FIRVANQ will replace CutisPharma’s FIRST-Vancomycin Unit-of-Use Compounding Kit.

January 29, 2018
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2 min read
United Neuroscience Announces Development Plans for Vaccine to Prevent CTE

As part of the program introduction, Dr. Verma and NFL broadcaster Solomon Wilcots will discuss the medical need and opportunity for the CTE vaccine program with journalists Jan. 30-31 on Super Bowl Radio Row in Minneapolis.

January 29, 2018
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3 min read
Business

Aethlon Medical to Release Third Quarter Fiscal Year 2018 Financial Results and Host Conference Call on February 1, 2018

Aethlon Medical today announced it will issue third quarter results for the fiscal year ended March 31, 2018 at 4:15 pm eastern time on Thursday, February 1, 2018.

January 29, 2018
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2 min read
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
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
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