BioSpace News Archive

Policy

GSK Submits Landmark IMPACT Data to European Medicines Agency to Support Expanded Label for Trelegy Ellipta

GSK today announced the submission of the landmark IMPACT data to the European Medicines Agency as part of a type II variation to support an expanded label for Trelegy Ellipta.

February 14, 2018

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14 min read

Business

Mazor Robotics Reports Record Fourth Quarter & Full Year 2017 Financial Results

Revenue for the three months ended December 31, 2017 increased 36% to $19.1 million compared to $14.0 million in the year-ago fourth quarter.

February 14, 2018

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26 min read

Policy

TransEnterix Announces FDA 510(k) Submission for Senhance Indication Expansion to More than Double Addressable Market in the U.S. and Provides Commercial Update

TransEnterix today announced the Company has filed a FDA 510(k) submission to expand the indication for use of its Senhance Surgical System, and provided an update about commercial results thus far for the quarter ending March 31, 2018.

February 14, 2018

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4 min read

Policy

Ortho Dermatologics Announces U.S. FDA Filing Acceptance For JEMDEL Plaque Psoriasis Treatment

If approved, JEMDEL will be the first high-potency topical steroid treatment for plaque psoriasis with dosing for as long as eight weeks.

February 14, 2018

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3 min read

Genetown

Bioverativ Release: Haemophilia Publishes a Retrospective Analysis Investigating the Use of ELOCTATE for Immune Tolerance Induction in People with Inhibitors and Severe Hemophilia A

Bioverativ today announced the publication of a retrospective analysis investigating the use of ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] for immune tolerance induction (ITI).

February 14, 2018

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7 min read

Business

IQVIA Reports Fourth-Quarter and Full-Year 2017 Results, Issues First-Quarter and Full-Year 2018 Guidance

Revenue for the fourth quarter of $2,161 million increased 10.7 percent on a reported basis, and 8.4 percent on a constant currency basis, compared to the fourth quarter of 2016.

February 14, 2018

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22 min read

Business

Owens & Minor Reports 4th Quarter & Full-Year 2017 Financial Results

Owens & Minor today reported financial results for the year ended December 31, 2017, including consolidated revenues of $9.32 billion compared to the prior year’s revenues of $9.72 billion.

February 14, 2018

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20 min read

Ramaswamy's Myovant Sciences Scores $140M

Drug Development

Tetraphase’s Lead Antibiotic Fails Another Late-Stage Study

The phase 3 IGNITE3 clinical trial enrolled 1,205 patients who were randomized 1:1 to receive IV eravacycline or ertapenem.

February 14, 2018

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7 min read

Policy

DURECT Announces Resubmission of REMOXY ER NDA by its Licensee, Pain Therapeutics

Pain Therapeutics stated that it expects a six-month review cycle by FDA, and that it expects to be notified by FDA of a PDUFA date within 60 days.

February 14, 2018

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5 min read

Business

Myomo and GRE to Conduct Screening Days in Ohio and Detroit

Myomo, Inc., a commercial stage medical robotics company, and Geauga Rehabilitation Engineering (GRE) have announced a series of free screening days to be held at the offices of GRE and its local partners near Cleveland, Detroit, Columbus and Cincinnati.

February 14, 2018

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4 min read