BioSpace News Archive

BioCapital

Xtant Medical Announces Results of Special Meeting of Stockholders

As a result of the approval of all proposals at the Special Meeting, Xtant expects that it will be able to fully execute its previously announced restructuring plan.

February 14, 2018

·

12 min read

Policy

FDA Grants Priority Review for Genentech’s Rituxan (Rituximab) for Pemphigus Vulgaris

Genentech announced today that the FDA has accepted the company’s Supplemental Biologics License Application (sBLA) and granted Priority Review for the use of Rituxan (rituximab) .

February 14, 2018

·

6 min read

Business

ImmunoQure AG and Servier Enter Into Strategic Partnership for the Development of an Interferon-Alpha Human Autoantibody

ImmunoQure and Servier will work collaboratively to advance ImmunoQure’s therapeutic human Interferon-alpha autoantibody through preclinical development and into the clinic.

February 14, 2018

·

4 min read

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

·

14 min read

Business

United Therapeutics Corporation to Report Fourth Quarter and Annual 2017 Financial Results Before the Market Opens on Wednesday, February 21, 2018

United Therapeutics will host a teleconference on Wednesday, February 21, 2018, at 9:00 a.m. Eastern Time.

February 14, 2018

·

1 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

·

26 min read

Genetown

Insulet Has Strong Presence at the International ATTD Congress; Presents Positive Study Results for Its Omnipod Horizon Hybrid Closed-Loop System

Insulet today announced promising new data for its Omnipod Horizon Automated Glucose Control System (Omnipod Horizon) hybrid closed-loop system, which will be presented at the 11th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) congress in Vienna, Austria.

February 14, 2018

·

5 min read

Ferring Announces 30M CHF Investment in New Biotech Centre in Switzerland

Ferring announced today that it is expanding its capabilities in biologics through a new biotech centre which will be installed at the company’s existing headquarters and manufacturing site in Saint-Prex, Switzerland.

February 14, 2018

·

3 min read

Drug Development

Mallinckrodt Enrolls First Patient in Phase I Study of ExpressGraft C9T1 Skin Tissue

The Phase 1 study is titled “ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers.""

February 14, 2018

·

6 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

·

4 min read