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Trial to test cancer combo in adults and children with leukaemia
The Combinations Alliance, a joint initiative between Cancer Research UK and the Experimental Cancer Medicine Centres (ECMC) Network based at University of Birmingham, has launched a clinical trial testing a new treatment combination in patients with leukaemia.
Contract Research & Services > Clinical Trials > News
Madrigal’s liver drug succeeds in phase 2 clinical trial
By PBR Staff Writer
Madrigal Pharmaceuticals has said that its MGL-3196 thyroid hormone receptor (THR) β-selective agonist achieved liver biopsy endpoints in patients with non-alcoholic steatohepatitis (NASH) at 36 weeks in phase 2 clinical trial.
Contract Research & Services > Clinical Trials > News
Janssen begins phase 1b/2 clinical trial to assess multiple myeloma treatment
Janssen has commenced a phase 1b/2 clinical development program to assess JNJ-68284528 (developed based on Legend’s LCAR-B38M), a chimeric antigen receptor T cell (CAR-T) therapy directed against B cell maturation antigen (BCMA), in patients with relapsed or refractory multiple myeloma.
Contract Research & Services > Clinical Trials > News
AstraZeneca’s Fasenra fails in second phase III COPD trial
AstraZeneca’s Fasenra (benralizumab) failed to meet its objective in TERRANOVA, the second of two pivotal phase III trials of the drug in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
Contract Research & Services > Clinical Trials > News
Pfizer’s Xeljanz gets FDA approval for ulcerative colitis
By PBR Staff Writer
Pfizer’s Janus kinase (JAK) inhibitor Xeljanz (tofacitinib) has been approved by the US Food and Drug Administration (FDA) to treat adult patients with moderately to severely active ulcerative colitis.
Regulatory Affairs > News
FDA grants priority review to Loxo's larotrectinib for several solid tumors
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Loxo Oncology’s new drug application (NDA) and granted priority review for larotrectinib to treat adult and pediatric patients with locally advanced or metastatic solid tumors harboring an neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Regulatory Affairs > News
EC authorizes Clovis Oncology’s Rubraca to treat women with recurrent ovarian cancer
The European Commission (EC) has authorized Clovis Oncology’s Rubraca (rucaparib) for the treatment of women with recurrenr ovarian cancer.
Regulatory Affairs > News
Ipsen, MD Anderson form bench-to-bedside cancer drug development partnership
Ipsen has entered into a global licensing and joint development agreement with and The University of Texas MD Anderson Cancer Center for a pre-clinical oncology drug candidate discovered by researchers in the latter’s Institute for Applied Cancer Science (IACS).
Drug Research > Drug Discovery & Development > News
Roche’s Tecentriq-chemo combo extends survival in phase 3 NSCLC trial
By PBR Staff Writer
Roche said that its cancer immunotherapy Tecentriq (atezolizumab) in combination with chemotherapy as first-line of treatment improved survival of patients with advanced non-squamous non-small cell lung cancer (NSCLC) in a phase 3 trial.
Contract Research & Services > Clinical Trials > News
OliX secures CTA in UK to start phase I study with OLX10010
OliX Pharmaceuticals has received the phase I clinical trial authorization (CTA) from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its anti-scar drug, OLX10010.
Contract Research & Services > Clinical Trials > News
AB Science plans to resubmit marketing application in Europe for ALS treatment masitinib
By PBR Staff Writer
AB Science is evaluating options to resubmit the marketing authorization application (MAA) in Europe for its amyotrophic lateral sclerosis treatment (ALS), masitinib.
Regulatory Affairs > News
Centogene, Aldeyra to advance therapeutics for SLS patients
Centogene has signed an agreement with Aldeyra Therapeutics for the advancement of novel therapeutics for patients with Sjögren-Larsson Syndrome (SLS).
Drug Research > Drug Discovery & Development > News
ImmuPharma’s further phase III Lupuzor trial analysis shows positive results in Europe cohort
By PBR Staff Writer
ImmuPharma said that additional analysis from its phase III trial of Lupuzor in patients with systemic Lupus erythematosus (SLE) has demonstrated positive results in the Europe cohort.
Contract Research & Services > Clinical Trials > News
Midatech begins US clinical trial of MTX110 to treat DIPG
Midatech Pharma has commenced dosing in its first-in-human study with MTX110 for the treatment of diffuse intrinsic pontine glioma (DIPG), an aggressive form of childhood brain cancer.
Contract Research & Services > Clinical Trials > News
Janssen to halt studies of daratumumab in combination with anti-PD-(L)1
By PBR Staff Writer
Genmab announced that Janssen will discontinue the phase Ib/II study of daratumumab in combination with atezolizumab against atezolizumab monotherapy in patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC).
Contract Research & Services > Clinical Trials > News
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