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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
48 Results
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FDA
Sage Therapeutics Submits New Drug Application to U.S. FDA for Intravenous Brexanolone in the Treatment of Postpartum Depression
Brexanolone IV submission is the Company’s first New Drug Application
April 23, 2018
·
6 min read
Genetown
Alnylam Receives Positive Opinion for Orphan Drug Designation in the European Union for ALN-TTRsc02, a Subcutaneously Delivered Investigational RNAi Therapeutic for the Treatment of Transthyretin-Mediated Amyloidosis
Designation for the treatment of transthyretin (TTR)-mediated (ATTR) amyloidosis.
April 23, 2018
·
7 min read
Lone Star Bio
DecisionDx-Melanoma Test Independently Improved Identification of High-Risk Patients Compared to AJCC Staging in Stage I-II Cutaneous Melanoma
Posters presented at the Real World Dermatology for Physician Assistants and Nurse Practitioners conference also include data demonstrating test’s clinical utility
April 23, 2018
·
5 min read
Genetown
New SPINRAZA® (nusinersen) Data Unveiled at AAN Annual Meeting Show Continued Improvement in Motor Function for Broad Age Range and Survival Benefit for Infants
SHINE data illustrates SPINRAZA’s longer-term benefits for infantile-onset SMA, including improvements in motor function and increased event-free survival in participants followed for nearly three years
April 23, 2018
·
11 min read
Business
ClinicalStudyDataRequest.com Announces Partnerships with Global Academic Research Funders to Expand Researchers’ Access to Patient-level Clinical Trial Data
First-in-class online resource giving researchers access to patient-level clinical trial data from 14 of the world’s leading pharmaceutical companies across multiple therapeutic areas, today announced new strategic collaborations with four major non-profit partners
April 23, 2018
·
3 min read
BioMidwest
Thermo Fisher Scientific Announces $50 Million Investment to Enhance Biologics Capabilities
Project will increase capacity to meet growing customer demand
April 23, 2018
·
3 min read
Pharm Country
SCYNEXIS Data Presentations at ECCMID 2018 Show SCY-078 Potent and Synergistic Antifungal Activity Against Aspergillus and Pneumocystis
SCYNEXIS, Inc. announced data presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), April 21-24, 2018, in Madrid, Spain.
April 23, 2018
·
6 min read
Drug Development
AOBiome Therapeutics Expands Clinical-Stage Pipeline, Initiates Phase 2 Clinical Trial for Episodic Migraine
Patient Dosing Has Begun in First-in-Class Nitric Oxide Modulating, Microbiome-based Therapy
April 23, 2018
·
4 min read
Business
Kaleido Biosciences Announces Appointment of Joshua Brumm as Chief Financial Officer
Kaleido Biosciences, a clinical-stage biotechnology company developing novel chemistries to unlock the power of the human microbiome, today announced the appointment of Joshua Brumm as chief financial officer.
April 23, 2018
·
3 min read
FDA
MeiraGTx Announces AAV-RPGR Granted Fast Track Designation by U.S. FDA for Treatment of X-Linked Retinitis Pigmentosa Due to RPGR Deficiency
MeiraGTx Limited, a vertically integrated, clinical stage gene therapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AAV-RPGR for the treatment of X-linked retinitis pigmentosa (XLRP) due to defects in the retinitis pigmentosa GTPase regulator (RPGR) gene.
April 23, 2018
·
3 min read
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