Tag: Clinical Trials

Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is ‘safe’ or effective, only that the trial may be conducted.

Clinical Study of Avelumab Didn’t Met Primary Endpoints

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. announced topline results of the Phase III JAVELIN Gastric 100 study evaluating avelu...

Roche Announced Positive Data from Study Evaluating Risdiplam

roche
Roche announced positive data from the pivotal Part 2 of SUNFISH, a study evaluating risdiplam in people aged 2-25 years with Type 2 or 3 spinal muscular atrophy (SMA). The study met its primary en...

Analyses of Roxadustat Showed No Increased CV Risk in CKD-Associated Anaemia

astrazeneca
AstraZeneca and partner FibroGen presented a cardiovascular (CV) safety readout at the American Society of Nephrology (ASN) conference from pooled analyses of the HIF-PH inhibitor roxadustat, also kno...

Roche’s Gazyva® Proved its Safety and Effectiveness

preclinical-research
Roche announced data from the phase II NOBILITY study, investigating the safety and efficacy of Gazyva® (obinutuzumab) for adults with proliferative lupus nephritis. The study met the primary endpo...

AstraZeneca Presented Detailed Results from Phase III Trials of Roxadustat

astrazeneca
AstraZeneca presented detailed results from the Phase III OLYMPUS and ROCKIES trials showing that roxadustat significantly increased haemoglobin (Hb) levels in non-dialysis-dependent (NDD) and dialysi...

ARM Called for Europe to Streamline Approval of Clinical Trials of Advanced Therapy Medicinal Produc...

European-Commission
The Alliance for Regenerative Medicine (ARM) has called for Europe to streamline approval of clinical trials of advanced therapy medicinal products (ATMP). ARM wants regulatory agencies to cut review ...

Takeda Presented Positive Results of Phase III Trial of NINLARO

Takeda Pharmaceutical Company Limited announced the randomized, Phase 3 TOURMALINE-MM4 study met its primary endpoint of progression free survival (PFS). The trial evaluated the effect of single-agent...

Gilead Sciences Announced Positive Results of Biktarvy® Clinical Studies

clinical-trials
Gilead Sciences, Inc. announced findings from two randomized, double-blind, active-controlled Phase 3 studies (Study 1489 and Study 1490) evaluating the safety and efficacy of Biktarvy® (bictegravir 5...

Parexel Announced Expansion of Collaboration with Society for Clinical Research Sites

Parexel announced the expansion of its collaboration with the Society for Clinical Research Sites (SCRS). The company kicked off its collaboration with SCRS with a symposium at the SCRS Global Site So...

AbbVie Announced Positive Data from RINVOQ™ Study

abbvie
AbbVie, a research-based global biopharmaceutical company, announced positive top-line data from the SELECT-PsA 2 Phase 3 study. In this study, both doses of RINVOQ™ (upadacitinib; 15 mg and 30 mg, on...

Astellas Pharma Announced Positive Results of XOSPATA® Clinical Trials

clinical-trials
The New England Journal of Medicine published detailed results from the Phase 3 ADMIRAL trial, which found that Astellas Pharma Inc.’s XOSPATA® (gilteritinib) demonstrated significantly longer Overall...

Cyclo Therapeutics Agreed with WCT to Conduct Cyclodextrin-Based Products Clinical Trials

tubes
Cyclo Therapeutics, Inc., a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of Niemann-Pick Disease Type C and Alzheimer’s Disease, announced that it h...

Mabscale Began Clinical Trials of Trastuzumab Bio-Analog

clinical trials
The joint company of the Russian pharmaceutical enterprises Ozon and PharmEco, Mabscale, began clinical trials of a phase I comparison of a bio-analog of its own trastuzumab with the original Hercepti...

Shield Therapeutics Announced Positive Results of Feraccru®/Accrufer™ Clinical Trials

clinical-trial
Shield Therapeutics plc, a commercial stage, pharmaceutical company with a focus on addressing iron deficiency with its lead product Feraccru®/Accrufer TM, announces that results from its multicentre ...

ChemRar Announced Successful Completion of Phase II Clinical Trials of AB5080

molecules pic
ChemRar, a Russian pharmaceutical research company, has announced the successful completion of the second phase of clinical trials of a new domestic drug effective against type A and B flu strains, in...

OPKO Health and Pfizer Announced Positive Phase III Trials of Investigational Hormone Somatrogon

pfizer
OPKO Health Inc. and Pfizer Inc. announced that the global Phase 3 trial evaluating somatrogon dosed once-weekly in pre-pubertal children with growth hormone deficiency (GHD) met its primary endpoint ...