BioSpace News Archive

Business

Dynavax Reports Third Quarter 2017 Financial Results

Cash, cash equivalents and marketable securities were $191.7 million at September 30, 2017 compared to $81.4 million at December 31, 2016.

November 3, 2017

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10 min read

Biotech Bay

Patients and Physicians Prefer Zip Surgical Skin Closure Over Staples in First Head-to-Head Comparison of the Device versus Staples During Bilateral Knee Surgery

Results were presented today as a poster at the American Academy of Hip and Knee Surgery Annual Meeting (AAHKS) by Rodney Benner, MD, of the Shelbourne Knee Center in Indianapolis.

November 3, 2017

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2 min read

TESARO Announces U.S. FDA Approval of VARUBI IV fo

FDA

Medacta Wins FDA Nod and First Surgeries Utilizing 3DMetal Tibial Cones for Knee Revision

The 3DMetal Tibial Cones can be used for structural support in areas of bone deficiencies that may compromise revision implant fixation.

November 3, 2017

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3 min read

Biotech Beach

BIOLASE Announces Terms of Rights Offering

Upon commencement of the rights offering on November 8, 2017, the Company will distribute to its shareholders as of 5:00 p.m., Eastern Time, on November 8, 2017.

November 3, 2017

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4 min read

Business

Pulse Biosciences Announces Transition of Board of Directors, Extends Appreciation to Retiring Members and Welcomes New Board Members

Bob Duggan has been appointed Chairman of the Board; Ken Clark, Dr. Thomas Fogarty and Manmeet S. Soni have been appointed as independent directors, effective November 2, 2017.

November 3, 2017

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7 min read

Policy

Jazz Pharma Submits Vyxeos Marketing Authorization Application to EMA for Treatment of Certain Types of High-Risk AML

The CHMP granted Vyxeos accelerated assessment, which is designed to reduce the review timeline for products of major interest for public health and therapeutic innovation.

November 3, 2017

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6 min read

FDA Advisory Committee Scheduled to Review Lipocin

Policy

Ionis Announces Submission of Marketing Authorization Application for Inotersen to the EMA

The MAA will be reviewed under the EMA’s Accelerated Assessment program.

November 3, 2017

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8 min read

TearLab Tweaks Regulatory Strategy for Next-Genera

Policy

Actor Chuck Norris Sues Medical Device Manufacturers for Allegedly Poisoning His Wife

The actor claims the gadolinium contrast dye used during MRIs nearly cost Gena her life.

November 3, 2017

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2 min read

Business

Dentsply Sirona Reports Third Quarter 2017 Results

Reported net sales for the three month period ended September 30, 2017 were $1,009.2 million, an increase of 5.8% compared to $954.2 million in the third quarter of 2016.

November 3, 2017

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29 min read

Business

Digirad Corporation Reports Financial Results for the Third Quarter and Nine Months Ended September 30, 2017

Total revenues for the third quarter were $28.6 million, compared to $31.1 million in the third quarter of the prior year.

November 3, 2017

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18 min read