BioSpace News Archive

Drug Development

ORYX Announces Positive Phase I/IIa Data for Oncolytic Virus ParvOryx Demonstrating Safety, Anti-tumor Effects, Partial Responses and Prolonged Overall Survival in Metastatic, Inoperable Pancreatic Cancer

ORYX, a translational medicine company focused on oncolytic virotherapy and cancer vaccines, today published positive clinical trial results from a dose-escalating Phase I/IIa trial with oncolytic virus ParvOryx in metastatic, inoperable pancreatic cancer.

October 30, 2019
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4 min read
Business

SeraNovo Enters into License Agreement with Carna Biosciences for Development of Oral Formulation of Carna’s Kinase Inhibitor

SeraNovo B.V. announced that it has signed a License Agreement with Carna Biosciences, Inc., a company engaged in drug development specializing in the development of kinase inhibitors.

October 30, 2019
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2 min read
Pharm Country

8th Annual eCOA Forum Hosted by Signant Health to Convene Clinical Operations and Outcomes Research Leaders Guiding the Future of Patient-Centric Technology

Lilly, Otsuka, AbbVie, Sanofi, Sage Therapeutics to join keynote speakers, clinical research sites and patient advocates to discuss essential topics in eCOA, eConsent, patient engagement, virtual trials, sensors and wearables, AI and machine learning

October 30, 2019
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4 min read
Policy

FDA Places Partial Clinical Hold on Zolgensma Trial Over Safety Concerns

Novartis said it will work diligently with the FDA to resolve the partial clinical hold and resume the study.

October 30, 2019
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2 min read
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Alex Keown
FDA

FDA Approval of Vumerity for MS Triggers $150 Million Milestone Payment from Biogen to Alkermes

The approval was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway.

October 30, 2019
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2 min read
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Mark Terry
Policy

Based on Failed Confirmatory Trial, FDA Adcom Recommends Pulling AMAG’s Makena From the Market

Makena has been approved to decrease preterm birth in pregnant women with a previous spontaneous preterm birth.

October 30, 2019
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3 min read
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Mark Terry
Biotech Bay

Epidemic of deaths due to heart failure underway in U.S.

Kaiser Permanente research identifies national trend linked to aging of baby boomers and upturn in heart disease mortality

October 30, 2019
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3 min read
Business

Arranta Bio announces $82M in new funding, and a strategic partnership with Thermo Fisher Scientific

Arranta Bio announced the completion of an $82 million funding round and a strategic partnership with Thermo Fisher Scientific.

October 30, 2019
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4 min read
Policy

FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder

Satralizumab represents a potential new approach to treating neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating disease often misdiagnosed as multiple sclerosis (MS)

October 30, 2019
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8 min read
Medivir Presents MIV-818 Data at AACR-NCI-EORTC in Boston

Medivir AB announces that a poster entitled “MIV-818 stimulates an anti-tumor immune response in vitro and enhances the effects of pembrolizumab” was presented at the AACR-NCI-EORTC conference in Boston.

October 30, 2019
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2 min read