Latest News on Clinical Trials
BioMarin, Pioneer in Phenylketonuria, to Begin Clinical Trial with BMN 307 Gene Therapy
Health Authorities in the U.S. and U.K. Clear Path to Start of Clinical Trial, Patients Expected to be Dosed in Q1 2020 with Commercial Scale Material Potential 3rd Therapy to treat Phenylketonuria from Leader in PKU Therapies and 2nd Gene Therapy in Company's...
Cerevel Therapeutics Initiates Phase 3 Program of Tavapadon for the Treatment of Parkinson’s Disease
Studies to Enroll Approximately 1,200 Patients to Determine Effectiveness of Tavapadon Across the Full Spectrum of Early- and Late-Stage Parkinson’s BOSTON--(BUSINESS WIRE)-- Cerevel Therapeutics, a company dedicated to unraveling the mysteries of the brain to treat...
Alexion Announces Planned Initiation of Pivotal Phase 3 Study of ULTOMIRIS® (ravulizumab) in ALS
- 50-week global study to enroll ~350 patients across broad ALS population - Alexion Announces Planned Initiation of Pivotal Phase 3 Study of ULTOMIRIS® (ravulizumab) in ALS January 14, 2020 08:30 AM Eastern Standard Time BOSTON--(BUSINESS WIRE)--Alexion...
Quantum Leap Healthcare Collaborative and G1 Therapeutics Announce the Selection of Trilaciclib in the I-SPY 2 TRIAL for Breast Cancer
SAN FRANCISCO and RESEARCH TRIANGLE PARK, N.C., Jan. 14, 2020 /PRNewswire/ -- Quantum Leap Healthcare Collaborative™ and G1 Therapeutics, Inc. (Nasdaq: GTHX) announced today a collaboration to evaluate trilaciclib, an investigational therapy designed to improve...
7 of the Top 20 Pharma Companies Adopt Veeva Vault Study Startup
Leading companies are using advanced study start-up application to speed clinical trials Accelerating study start-up is a top priority among leading life sciences companies. With this shift underway, an increasing number of organizations are selecting Vault Study...
Soligenix – Advancing to Important Inflection Points With Two Pivotal Phase 3 Clinical Trials
PRINCETON, N.J., Jan. 14, 2020 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, today...
AVROBIO Announces Clinical and Regulatory Progress for Gaucher Disease Program
FDA clears IND application for AVR-RD-02 First patient consented in GAU-201, a global Phase 1/2 trial of AVR-RD-02 in Gaucher disease type 1 All global clinical sites will be supported by proprietary plato™ platform January 14, 2020 07:00 AM Eastern Standard Time...
Galapagos completes recruitment of PINTA trial in idiopathic pulmonary fibrosis
Mechelen, Belgium; 13 January 2020, 7.30 CET – Galapagos NV (Euronext & NASDAQ: GLPG) has completed recruitment for the PINTA Phase 2 clinical trial with oral GPR84 inhibitor GLPG1205. PINTA is a randomized, double-blind, placebo-controlled Phase 2 trial...
ContraFect Announces First Patient Dosed in Pivotal Phase 3 DISRUPT Study of Exebacase as a Treatment for Staph aureus Bacteremia, Including Right-Sided Endocarditis
YONKERS, N.Y., Jan. 10, 2020 (GLOBE NEWSWIRE) -- ContraFect Corporation (CFRX), a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, as new medical modalities for the...
Chi-Med Initiates a Phase II Trial of Surufatinib in Combination with Tuoyi in Patients with Advanced Solid Tumors
LONDON, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated a Phase II study in China of surufatinib in combination with Tuoyi (toripalimab) in patients with advanced solid tumors. This follows the recent...
PQ Bypass Announces 100th Patient in Clinical Study to Evaluate Percutaneous Fem-Pop Bypass for Extremely Long Blockages in Leg Arteries
MILPITAS, Calif.--(BUSINESS WIRE)-- Silicon Valley-based medical device company PQ Bypass announced today the 100th patient in the DETOUR2 Clinical Trial, which evaluates the safety and effectiveness of the minimally invasive DETOUR procedure for percutaneous...
Early-Stage Leukemia Vaccine Study Reports 80% Survival Rate
Medigene dendritic cell vaccine presents the antigens WT-1 and PRAME January 11th, 2020 – A Munich based immuno-oncology company published topline results from its completed open-label Phase I/II clinical trial of Medigene's autologous dendritic cell (DC) vaccine in...
Akcea and Ionis Announce Initiation of CARDIO-TTRansform Phase 3 Clinical Trial for AKCEA-TTR-LRx in Patients with TTR-mediated Amyloid Cardiomyopathy
Akcea Therapeutics, Inc. (NASDAQ: AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), announced today the initiation of the CARDIO-TTRansform Phase 3 cardiovascular outcomes study for AKCEA-TTR-LRx in...
Zymeworks Announces Agreement with Pfizer and Initiation of a New Phase 2 Trial Evaluating ZW25 in Combination with Ibrance® (palbociclib)
Potential for a Novel Chemotherapy-Free Treatment Option for People with Advanced HER2-positive, HR-positive Breast Cancer VANCOUVER, British Columbia--(BUSINESS WIRE)--Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional...
Positive Final 2-Year Topline Data in Completed DC Vaccine Phase I/II trial in AML Patients
MARTINSRIED, Germany and MUNICH, Germany, Jan. 10, 2020 (GLOBE NEWSWIRE) -- Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, today publishes topline results from its...
Adverum Biotechnologies Reports Continued Momentum with OPTIC Trial for ADVM-022 Intravitreal Gene Therapy in Wet AMD and Provides 2020 Outlook
-- OPTIC phase 1 trial progressing with plans to complete patient dosing in cohort three, begin enrollment in cohort four in 1Q20 -- -- IND application planned for ADVM-022 in diabetic retinopathy in 1H20; Patient enrollment targeted for 2H20 -- MENLO PARK, Calif.,...
Zai Lab and Novocure Announce First Patient Enrolled in a Phase 2 Pilot Trial of Tumor Treating Fields Together with Chemotherapy as First-Line Treatment of Gastric Cancer
Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, and Novocure (NASDAQ: NVCR), a global oncology company with a proprietary platform technology called Tumor Treating Fields, today announced that the first...
Alucent Biomedical announces FDA approval to proceed with natural vascular scaffolding clinical trial
Alucent Biomedical has received US Food and Drug Administration (FDA) approval to proceed with a phase 1 clinical trial to evaluate the safety and efficacy of its Natural Vascular Scaffolding (NVS) technology. The therapy is designed to treat peripheral arterial...
Akcea and Ionis Announce Initiation of CARDIO-TTRansform Phase 3 Clinical Trial for AKCEA-TTR-LRx in Patients with TTR-mediated Amyloid Cardiomyopathy
BOSTON and CARLSBAD, Calif., Jan. 10, 2020 (GLOBE NEWSWIRE) -- Akcea Therapeutics, Inc. (NASDAQ: AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), announced today the initiation of the CARDIO-TTRansform...
Aclaris Therapeutics Announces Positive Results From Phase 1 Single and Multiple Ascending Dose Trial of ATI-450, an Investigational Oral MK2 Inhibitor
• Oral small molecule showed marked inhibition of TNFα, IL1β, IL8, and IL6 • Preliminary data support progression to Phase 2a Proof of Concept Trials in Immuno-Inflammatory Diseases WAYNE, Pa., Jan. 09, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:...