Clinical Trials - Phase IV
Found 3,421 articles
Gilead Announces Topline Data From Phase 3 STELLAR-4 Study of Selonsertib in Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
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.
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.
Mallinckrodt Provides Update on Phase 4 Data H.P. Acthar® Gel (Repository Corticotropin Injection) Clinical Trial in Patients with Rheumatoid Arthritis (RA)
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
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.
1/15/2019As 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
Company to provide first-look at preclinical and clinical portfolio
Imfinzi demonstrates clinical activity in Stage IV, 1st-line non-small cell lung cancer in Phase III MYSTIC trial
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.
At ASH, Extended Half-Life Therapies ELOCTATE® and ALPROLIX® Demonstrate Proven Efficacy and Well-Characterized Safety over Four Years
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.
GTI is proud to unveil our new website, which features a streamlined design with enhanced navigation.
Personalis, Inc. to Present New Data at the Society for Immunotherapy of Cancer’s (SITC) 33RD Annual Meeting
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.
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.
Analysis of data shows fulvestrant did not meet bioequivalence criteria
First Patient Screened in Mallinckrodt Phase 4 Trial of H.P. Acthar® Gel (Repository Corticotropin Injection) for Severe Noninfectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis
Mallinckrodt plc today confirmed screening of the first patient in the company's Phase 4, multi-center, multiple-dose, open label study to assess the effects of H.P. Acthar Gel as a therapy option in patients with Severe Noninfectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis (NIPPU).
Mallinckrodt Presents Data on H.P. Acthar® Gel (Repository Corticotropin Injection) in Rheumatoid Arthritis (RA) at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting
Phase 4 study interim analysis showed 61% of patients with persistently active RA reported in the open-label period achieved low disease activity at 12 weeks
Leica Microsystems introduces new PROVIDO multidisciplinary surgical microscope at leading otolaryngology conference in Atlanta
Acerus Announces Publication of Manuscript Reporting Early Data from Partner-Sponsored Natesto® Spermatogenesis Study
Early Data Suggests Sperm Concentration, Motility, and Total Motile Sperm Count Remain Within Normal Ranges in Hypogonadal Men Taking Natesto®
New study results provide evidence that Ofev® (nintedanib) slows progression of IPF beyond four years with consistent safety
- INPULSIS®-ON study indicates safety and efficacy of Ofev® (nintedanib) are maintained over the long term and consistent with prior findings from INPULSIS trials
DoctorLogic ranks 317 out of 5,000 fastest-growing private companies with a total growth of more than 1,500% since its launch.
New technology destroys deadly pathogens and bacteria lurking on hospital surfaces
Eisai Inc. Announces Positive Topline Results from CAMELLIA-TIMI 61, a Large-Scale Cardiovascular Outcome Trial for the Anti-Obesity Agent BELVIQ®
BELVIQ did not increase incidence of cardiovascular events in study of 12,000 obese and overweight patients