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Search Results: Clinical Trials
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Destiny Pharma’s XF-73 succeeds in phase 1 skin irritation study
By PBR Staff Writer
Destiny Pharma, a UK-based clinical stage biotechnology company, has reported positive data for its synthetic antimicrobial drug XF-73 from a phase 1 skin irritation study.
Contract Research & Services > Clinical Trials > News
Evgen Pharma completes patient recruitment for breast cancer treatment trial
Evgen Pharma, a clinical stage drug development company, has concluded patient recruitment in its STEM Phase IIa trial of SFX-01 in metastatic breast cancer.
Contract Research & Services > Clinical Trials > News
Takeda’s Alunbrig improves PFS in phase 3 lung cancer trial
By PBR Staff Writer
Takeda’s lung cancer drug Alunbrig (brigatinib) has significantly improved progression-free survival (PFS) in phase 3 ALTA-1L (ALK in lung cancer trial of AP26113 in 1st line) trial.
Contract Research & Services > Clinical Trials > News
Chi-Med starts phase Ib/II trial of sulfatinib in NET and BTC patients
By PBR Staff Writer
Hutchison China MediTech (Chi-Med) has commenced a phase Ib/II proof-of-concept study in the US to evaluate its small molecule angio-immuno kinase inhibitor sulfatinib in pancreatic neuroendocrine tumors (NET) and biliary tract cancer (BTC).
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Leap Therapeutics to evaluate TRX518/avelumab combo for advanced solid tumors
By PBR Staff Writer
Leap Therapeutics has signed a deal to evaluate its immuno-oncology compound TRX518 in combination with Merck and Pfizer’s avelumab, and chemotherapy for the treatment of advanced solid tumors.
Contract Research & Services > Clinical Trials > News
Boehringer, Lilly diabetes drug Tradjenta succeeds in cardiovascular outcome trial
By PBR Staff Writer
Boehringer Ingelheim and Eli Lilly and Company reported that the CARMELINA cardiovascular outcome trial evaluating their diabetes drug Tradjenta met its primary endpoint.
Contract Research & Services > Clinical Trials > News
Takeda, Ovid plan to launch three trials of anti-epileptic drug TAK-935/OV935
Takeda Pharmaceutical and Ovid Therapeutics have revealed details of a clinical development program of their anti-epileptic drug TAK-935/OV935 in rare developmental and epileptic encephalopathies (DEE).
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Pfizer, Lilly’s osteoarthritis pain drug meets co-primary endpoints in phase 3 study
By PBR Staff Writer
Pfizer and Eli Lilly’s osteoarthritis (OA) pain drug, tanezumab, has met all three co-primary endpoints in a phase 3 study.
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Roche’s baloxavir marboxil succeeds in phase III flu study
By PBR Staff Writer
A phase III CAPSTONE-2 study has demonstrated that baloxavir marboxil reduced symptoms in people at high risk of complications from the flu.
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Ironwood Pharmaceuticals starts Phase IIIb study of linaclotide in adult patients with IBS-C
Ironwood Pharmaceuticals has started a phase IIIb clinical trial evaluating the efficacy and safety of linaclotide 290 mcg on multiple abdominal symptoms in addition to pain, including bloating and discomfort, in adult patients with irritable bowel syndrome with constipation (IBS-C).
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Pfizer begins pivotal phase 3 program for investigational hemophilia B gene therapy
Pfizer and Spark Therapeutics announced that Pfizer initiated a Phase 3 open-label, multi-center, lead-in study (NCT03587116) to evaluate the efficacy and safety of current factor IX prophylaxis replacement therapy in the usual care setting.
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AbbVie’s blood cancer drug Ibrutinib fails in phase 3 DLBCL trial
AbbVie’s Ibrutinib (IMBRUVICA) failed to meet its objective in a phase 3 trial DBL3001 in untreated diffuse large B-cell lymphoma (DLBCL) patients.
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Celgene’s anti-PD-L1 immunotherapy plus Abraxane improves PFS in breast cancer study
Celgene announced that the phase III IMpassion130 study, which was sponsored by Roche, met its co-primary endpoint of progression-free survival (PFS).
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Herantis Pharma initiates non-invasive CDNF development program
Herantis Pharma has initiated a non-invasive CDNF development program to broaden the application of CDNF in Parkinson’s disease and potentially other neurodegenerative disorders.
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Orion begins phase 3 trial of ALS drug levosimendan
Finnish pharmaceutical company Orion has recruited the first patients in a phase 3 clinical trial, dubbed REFALS, to evaluate orally administered levosimendan (ODM-109) for the treatment of symptoms of amyotrophic lateral sclerosis (ALS).
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CTL Laboratories - Contract Immune Monitoring and Research
Cellular Technology Limited (CTL), headquartered in Shaker Heights, OH, is a privately held biotechnology company that built its reputation as the global leader in the ELISPOT field over the past two decades by establishing the ELISPOT instrumentation and scientific principles that have helped to define the parameters of ELISPOT research for monitoring of Cell-Mediated Immunity.... Contract Research & Services > Clinical Trials > Suppliers
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PBR White Paper Recommendations

Cellular Technology Limited: A multicolor Natural Killer cell-mediated cytotoxicity detection By CTL Laboratories
A multicolor Natural Killer cell-mediated cytotoxicity detection using fluorescence and direct cell imaging.... Contract Research & Services > Clinical Trials > White Papers User vs. Software-Dependent Variability of ELISPOT Counts Obtained from ten Different Laboratories By CTL Laboratories
In ELISPOT assays, cytokine spots produced by antigen-specific T cells show a broad spectrum of sizes and densities over variable background. Therefore, even experienced investigators are likely to come up with different spot counts when subjectively judging the minimal spot size/density to be counted and the maximal spot size for the cut off between singlecell-derived spots vs. those created by cell clusters. This study aims to find out whether statistics-based automated gating can harmonize spot counts obtained in different laboratories.... Contract Research & Services > Clinical Trials > White Papers ELISPOT Assays Provide Reproducible Results Among Different Laboratories for T-cell Immune Monitoring - Even in Hands of ELISPOT's Inexperienced Investigators By CTL Laboratories
Measurements of antibodies in bodily fluids (e.g., by ELISA) have provided robust and reproducible results for decades and such assays have been validated for monitoring of B-cell immunity. In contrast, measuring T-cell immunity has proven to be a challenge due to the need to test live cells in functional assays ex vivo. Several previous efforts looking into the reproducibility of ex vivo T-cell assays between different laboratories, or even within the same laboratory, have provided rather discouraging results.... Contract Research & Services > Clinical Trials > White Papers How Frequently are Predicted Peptides Actually Recognised by CD8 Cells? By CTL Laboratories
Detection of antigen-specific CD8 cells relies on the use of peptides that can bind to HLA-Class I molecules. There is extensive knowledge on individual HLA-alleles’ peptide binding requirements and for many antigens immunogenic peptides have been defined. The 32 individual peptides that comprise the CEF peptide pool represent such well-defined peptide determinants for Cytomegalo, Epstein Barr, and Flu virus. We tested 42 healthy human donors on the accuracy of these peptide predictions.... Contract Research & Services > Clinical Trials > White Papers Four-Colour B Cell ELISPOT Assay for Simultaneous Detection of all Four Human IgG Subclasses By CTL Laboratories
ELISPOT assays are a key research tool for enumerating antigen-specific B cells.... Contract Research & Services > Clinical Trials > White Papers See more
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