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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
70 Results
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Business
West Pharma Services Announces Quarterly Dividend and Participation in Upcoming Investor Conferences
West Pharmaceutical Services today announced that the Company’s Board of Directors has approved a first-quarter 2018 dividend of $0.14 per share.
December 22, 2017
·
1 min read
FDA
Merck Release: FDA Approves SGLT2 Inhibitor STEGLATRO™ (ertugliflozin) and Fixed-Dose Combination STEGLUJAN (ertugliflozin and sitagliptin) for Adults With Type 2 Diabetes
STEGLATRO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
December 22, 2017
·
29 min read
Drug Development
Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase I/II Study of ARO-HBV
Pending approval, Arrowhead intends to proceed with AROHBV1001, a Phase 1/2 single-dose escalation study to evaluate the safety, tolerability, and pharmacokinetic effects of ARO-HBV in healthy adult volunteers
December 22, 2017
·
3 min read
Drug Development
Novartis’ Combination Therapy Tafinlar + Mekinist Granted FDA Priority Review for the Adjuvant Treatment of Stage III BRAF V600 Mutation-Positive Melanoma
Novartis announced today the FDA has accepted the Company’s supplemental sNDA for filing, and granted Priority Review designation for Tafinlar in combination with Mekinist for the adjuvant treatment of patients with stage III melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, following complete resection.
December 22, 2017
·
15 min read
Business
Lifestyle Delivery Systems’ Licensee, CSPA Group, Receives California State License Type 7 Manufacturing License for Volatile Solvent Extraction
During this time, the California Department of Public Health will review CSPA’s application and corresponding municipal permits and documentation for a permanent license.
December 22, 2017
·
3 min read
FDA
La Jolla Pharmaceutical Company Announces FDA Approval of Giapreza (angiotensin II)
La Jolla announced that the FDA has approved Giapreza to increase blood pressure in adults with septic or other distributive shock.
December 22, 2017
·
5 min read
Policy
Antares Pharma Provides XYOSTED Regulatory Update
Antares Pharma today announced that a written request for a Type A meeting, along with a comprehensive briefing document, have been submitted to the FDA, in response to the CRL received by Antares.
December 22, 2017
·
5 min read
Drug Development
Glycotope Initiates Phase Ib Trial of Combination of Proprietary Anti-Tumor Antibodies
Glycotope today announces it has enrolled the first patient in its international GATTO study which combines two of the Company’s immuno-oncology assets derived from its world-leading glycobiology expertise.
December 22, 2017
·
4 min read
BioMidwest
Local and National Organizations Benefit From AIT Bioscience CEO’s Leadership
The Vanguard Forum for Healthcare Leaders invited AIT Bioscience CEO Terri Pascarelli to serve as a faculty member at its November 2017 event in New York City, NY.
December 22, 2017
·
2 min read
FDA
Bausch & Lomb Receives FDA Approval of LUMIFY
Lumify is the only over-the-counter eye drop with low-dose brimonidine for the treatment of eye redness.
December 22, 2017
·
4 min read
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