Clinical Trials (Phase IV)
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Cool Science News! We Want to Know
4/17/2019
The life science industry is continually making advancements in every area! We want to know what cool science innovations are currently in progress and the professionals behind them. -
FDA Expands Real-World Evidence Partnership with Brigham and Women's Hospital and Aetion
4/10/2019
RCT DUPLICATE adds new studies to inform FDA - the first to use real-world evidence to predict treatment safety and efficacy
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AUGUSTUS Demonstrates Favorable Safety Results of Eliquis® Versus Vitamin K Antagonists in Non-Valvular Atrial Fibrillation Patients with Acute Coronary Syndrome and/or Undergoing Percutaneous Coronary Intervention
3/17/2019
AUGUSTUS is the largest trial in this high-risk patient population requiring both anticoagulant and antiplatelet therapies
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The FDA, as part of efforts to update clinical trial eligibility criteria, published four draft guidance documents on cancer clinical trial criteria and one final draft on adolescents in adult oncology trials.
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Santhera Completes Patient Enrollment in Phase IV Long-term Study with Raxone® for the Treatment of Leber’s Hereditary Optic Neuropathy
3/12/2019
Results from the 24-month active treatment study conducted in 31 study centers in Europe and the USA are expected in 2021.
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CyMedica Orthopedics® Announces Successful Clinical Trial Utilizing e-vive™
3/12/2019
Patients experience earlier returns to function following total knee replacement surgery by using new app-driven muscle strengthening device
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Luma Therapeutics Announces Positive Clinical Data for the Illuvinate System, a New In-Home Treatment for Psoriasis
3/6/2019
Results Demonstrate Significant Healing That Is Maintained Even Following Treatment
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Roche’s Flatiron Health and the U.S. Food and Drug Administration’s Information Exchange and Data Transformation (INFORMED) Program expanded a two-year-old collaboration agreement.
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Thomas Wicks, chief strategy officer of New Jersey-based TrialScope, said transparency has picked up over the past few years, particularly as large pharma companies have begun to release information about their own clinical efforts.
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Gilead Announces Topline Data From Phase 3 STELLAR-4 Study of Selonsertib in Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
2/11/2019
Gilead Sciences, Inc. announced that STELLAR-4, a Phase 3, placebo-controlled study evaluating the safety and efficacy of selonsertib, oral inhibitor of apoptosis signal-regulating kinase 1, did not meet the pre-specified week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH.
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Takeda Pharmaceutical released data from its Phase IIIb/IV clinical trial for Adynovate. On the same day, jurors in a Delaware federal court ordered Takeda’s Baxalta unit to pay $155.19 million to Bayer AG for infringing a patent for Adynovate.
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Mallinckrodt Provides Update on Phase 4 Data H.P. Acthar® Gel (Repository Corticotropin Injection) Clinical Trial in Patients with Rheumatoid Arthritis (RA)
2/5/2019
Open-label phase of study completed; primary end point results consistent¹ with prior reports (n=116) that showed 61% of patients with persistently active RA reported in the open-label period achieved low disease activity at 12 weeks
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Real-world evidence (RWE) or real-world data (RWD) relates to the collection of information about a drug’s safety and efficacy outside the structure of a clinical trial. Speaking yesterday, FDA Commissioner Scott Gottlieb laid out the FDA’s new framework for dealing with RWE and RWD.
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Your Feedback Matters! Topics in 2019
1/15/2019
As a valued member of our BioSpace community, we are eager to hear more from you and other readers in 2019. Let us know which topics you want to hear more about. -
Precigen to Debut Portfolio at Investor Event during the 37th Annual J.P. Morgan Healthcare Conference
12/31/2018
Company to provide first-look at preclinical and clinical portfolio
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Imfinzi demonstrates clinical activity in Stage IV, 1st-line non-small cell lung cancer in Phase III MYSTIC trial
12/13/2018
AstraZeneca and MedImmune, its global biologics research and development arm, have presented overall survival (OS) and progression-free survival (PFS) data from the Phase III MYSTIC trial at the European Society for Medical Oncology (ESMO) Immuno-Oncology 2018 Congress in Geneva, Switzerland.
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At ASH, Extended Half-Life Therapies ELOCTATE® and ALPROLIX® Demonstrate Proven Efficacy and Well-Characterized Safety over Four Years
12/1/2018
Bioverativ Inc., a Sanofi company, and Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) today announced the final results of ASPIRE and B-YOND, the most comprehensive long-term studies of extended half-life factor therapies in hemophilia.
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GTI launches new website at www.gti.energy
11/19/2018
GTI is proud to unveil our new website, which features a streamlined design with enhanced navigation.
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Personalis, Inc. to Present New Data at the Society for Immunotherapy of Cancer’s (SITC) 33RD Annual Meeting
11/6/2018
Personalis, Inc. will present new data at the upcoming Society for Immunotherapy of Cancer’s (SITC) 33rd Annual Meeting, taking place in Washington, D.C., November 9-11, 2018.
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The United Kingdom is calling for greater clinical trial transparency after a government committee released a report that indicates that data from about half of all clinical trials in that country are not published, raising concerns over research integrity and risks to human health.