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Novartis seeks FDA approval for second Kymriah indication
Novartis has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).
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AbbVie says Elagolix reduces pelvic pain in two phase 3 extension studies
By PBR Staff Writer
AbbVie said that its gonadotropin-releasing hormone (GnRH) antagonist elagolix demonstrated sustained reduction in average monthly menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse in two replicate Phase 3 extension studies.
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AbbVie’s psoriasis drug meets co-primary endpoints in three phase 3 trials
By PBR Staff Writer
AbbVie’s psoriasis drug risankizumab has met all co-primary and ranked secondary points in three pivotal phase 3 clinical trials.
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Novartis pediatric multiple sclerosis drug Gilenya shows significant effect in phase III trial
Novartis has announced full results from the phase III PARADIGMS study, investigating the safety and efficacy of Gilenya (fingolimod) versus interferon beta-1a, in children and adolescents (ages 10 to 17) with multiple sclerosis (MS).
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OncoQuest to collaborate with Tesaro in recurrent ovarian cancer setting
OncoQuest has entered into collaboration with Tesaro to conduct a proof-of-concept clinical trial evaluating the combination of oregovomab with ZEJULA (niraparib) in the recurrent ovarian cancer setting.
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Study uses genomics to make treatment recommendations for recurrent glioblastoma patients
A study led by the Translational Genomics Research Institute (TGen), UC San Francisco (UCSF) and the Ivy Foundation Early Phase Clinical Trials Consortium has used genomics to make treatment recommendations for recurrent glioblastoma patients.
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Gilead Sciences' GS-0976 shows positive effect in phase 2 NASH study
Gilead Sciences announced results from a Phase 2, randomized, placebo-controlled trial evaluating two doses of GS-0976, an oral, investigational inhibitor of Acetyl-CoA carboxylase (ACC), in patients with nonalcoholic steatohepatitis (NASH).
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Global Blood Therapeutics to terminate studies of idiopathic pulmonary fibrosis program
By PBR Staff Writer
Global Blood Therapeutics (GBT) has decided to terminate the GBT440 program for the treatment of idiopathic pulmonary fibrosis (IPF).
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ADC Therapeutics raises $200m to advance antibody-based cancer treatments
By PBR Staff Writer
Switzerland-based oncology drug discovery and development company ADC Therapeutics (ADCT) has closed $200m private financing to fund registrational trials of its two lead cancer programs.
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Celgene to stop clinical trials of Crohn's disease drug GED-0301
By PBR Staff Writer
Celgene has decided to stop the clinical trials of Crohn's disease drug GED-0301 (mongersen) due to lack of meaningful results.
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Exelixis’ liver cancer drug cabozantinib meets primary end point in phase 3 trial
By PBR Staff Writer
Exelixis’ liver cancer drug cabozantinib (Cabometyx) has met its primary end point in the global phase 3 Celestial trial.
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Pfizer’s lung cancer drug lorlatinib succeeds in phase 2 trial
Pfizer says that its investigational, next-generation tyrosine kinase inhibitor lorlatinib showed clinically meaningful activity against lung tumors and brain metastases in a phase 2 trial in patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer (NSCLC).
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miRagen Therapeutics reports positive clinical data of MRG-106 in patients with mycosis fungoides form of cutaneous T-cell lymphoma
miRagen Therapeutics has announced new interim results from its ongoing phase 1 clinical trial evaluating the safety, efficacy and pharmacokinetics of MRG-106 in patients with the mycosis fungoides (MF) form of cutaneous T-cell lymphoma (CTCL).
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Human clinical trial commences for first leprosy vaccine candidate
The Infectious Disease Research Institute (IDRI) and American Leprosy Missions have started a Phase 1 clinical trial in humans for leprosy vaccine candidate, the first vaccine developed specifically for leprosy.
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Ardelyx's phase 3 study of Tenapanor for IBS-C meets primary endpoint
Ardelyx has released positive results from its second Phase 3 study of tenapanor, dubbed T3MPO-2, for irritable bowel syndrome with constipation (IBS-C).
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