BioSpace News Archive

Drug Development

Amgen Release: EMA Accepts Filing for EVENITY (Romosozumab)

If approved in Europe, EVENITY will be a novel osteoporosis treatment that increases bone formation and reduces bone resorption simultaneously to increase BMD and reduce the risk of fracture.

January 8, 2018
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14 min read
BioCapital

QIAGEN Adds to Growth Momentum in Next-Generation Sequencing With 2018 Plans for Significant Portfolio Enhancements

QIAGEN has set a goal to exceed $140 million in 2018 sales from this portfolio, up from over $115 million in 2017.

January 8, 2018
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2 min read
Drug Development

TopiVert Pharma Limited: Positive Results From TOP1288 Phase I Study

TopiVert announces positive data from its Phase 1 study (TV03) with its oral formulation of TOP1288 for the treatment of ulcerative colitis (UC).

January 8, 2018
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6 min read
Drug Development

Medivir Release: Successful Completion of Pre-clinical Safety Studies With MIV-818, Enabling Start of Phase I Clinical Studies in 2018

Medivir AB today announced the successful completion of the pre-clinical safety studies for MIV-818 to enable the start of phase I clinical trials in 2018.

January 8, 2018
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2 min read
Policy

Ascentage Pharma Announces Acceptance of IND Application by China FDA for Clinical Study of Novel IAP Inhibitor to Treat Hepatitis B Infection

APG-1387 is the first IAP inhibitor to be studied in patients with HBV in China.

January 8, 2018
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4 min read
Policy

Ionis’ Inotersen NDA Accepted for Priority Review by the FDA

The FDA has set a PDUFA date of July 6, 2018.

January 8, 2018
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7 min read
Biotech Bay

Bay Area’s Intuity Medical Scores $70M

Financing will fund the commercial launch of Intuity Medical’s POGO Automatic Blood Glucose Monitoring System.

January 8, 2018
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4 min read
Business

Hologic Preliminary Revenues Increase 8% to Approximately $791M in the First Quarter of Fiscal 2018

Hologic announced today preliminary revenue results for its first fiscal quarter ended December 30, 2017.

January 8, 2018
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7 min read
Pharm Country

Regeneron Forms Consortium of Leading Life Sciences Companies to Accelerate Largest Widely-Available ‘Big Data’ Human Sequencing Resource With UK Biobank

Regeneron along with new collaborators AbbVie, Alnylam, AstraZeneca, Biogen and Pfizer, today announced the formation of a major ‘pre-competitive’ consortium to fund the generation of genetic exome sequence data from the 500,000 volunteer participants who make up the UK Biobank health resource.

January 8, 2018
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13 min read
Neovasc Reports Tiara’s Clinical Case Load Accelerating

Neovasc today provided an update on its clinical program for the Tiara valve.

January 8, 2018
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8 min read