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Clinical Trials

Aclaris starts phase 1 trial for ATI-50001 to treat alopecia totalis and alopecia universalis Aclaris Therapeutics' investigational new drug (IND) application for ATI-50001, an orally administered investigational Janus Kinase (JAK) inhibitor, for the potential treatment of alopecia totalis and alopecia universalis has cleared the 30-day review period by the US Food and Drug Administration, allowing the company to go ahead with its planned Phase 1 clinical trial
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Cascadian Therapeutics amends HER2CLIMB phase 2 trial of tucatinib Cascadian Therapeutics announced that after a recent meeting with the US Food and Drug Administration (FDA) and discussions with the Company's external Steering Committee, it has amended the HER2CLIMB Phase 2 clinical trial of tucatinib (also known as ONT-380) by increasing the sample size so that, if successful, the trial could serve as a single pivotal study to support registration.
Contract Research & Services > Clinical Trials > News Novartis' Zykadia beats chemotherapy in phase III lung cancer study Novartis has unveiled Zykadia first-line study results demonstrating 16.6 month progression-free survival in patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC).
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AstraZeneca's Tagrisso reduces lung cancer progression by 70% in phase III study
By PBR Staff Writer
A phase 3 clinical trial assessing AstraZeneca's Tagrisso (osimertinib) for the second-line treatment of epidermal growth factor receptor (EGFR) T790M mutation-positive metastatic non-small cell lung cancer (NSCLC) demonstrated a significant treatment benefit.
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Matinas starts dosing in phase 1 study of orally administered aminoglycoside antibiotic MAT2501
Matinas BioPharma has commenced dosing in the Phase 1 clinical study of its lead antibiotic product candidate MAT2501, under development for the treatment of nontuberculous mycobacterium infections (NTM) as an initial indication.
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Pfizer's Bosulif found superior to Gleevec in phase 3 study in type of leukemia
By PBR Staff Writer
Pfizer’s cancer drug Bosulif (bosutinib) was found superior to Novartis' Gleevec (imatinib mesylate) in a phase 3 study for first-line treatment of Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).
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Shire's VONVENDI meets primary endpoint in controlling bleeding in VWD adults in phase 3 study
A phase 3 clinical trial of Shire's VONVENDI [von Willebrand factor (Recombinant)] to treat bleeds in elective surgical settings for adults with severe von Willebrand disease (VWD) has met primary endpoint.
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Pfizer’s Glasdegib improves OS in AML and MDS patients in phase 2 trial
The new phase 2 results demonstrated that Pfizer's investigational compound Glasdegib improved overall survival (OS) in acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
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ACADIA begins phase 2 trial of Nuplazid in major depressive disorder
ACADIA Pharmaceuticals has started a Phase II study dubbed CLARITY to evaluate pimavanserin for adjunctive treatment in patients with major depressive disorder (MDD) who have an inadequate response to first-line therapies for clinical depression.
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Pfizer's Herceptin biosimilar succeeds in breast cancer study
By PBR Staff Writer
A clinical trial comparing the safety and efficacy of Pfizer's biosimilar PF-05280014 to Roche's Herceptin met the primary endpoint in a breast cancer trial.
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Recro Pharma's IV meloxicam meets primary endpoint in phase 3 trial
Recro Pharma has unveiled positive results from its second of two Phase III clinical trials assessing intravenous (IV) meloxicam for the treatment of acute postoperative pain.
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GSK starts phase III studies of daprodustat for anaemia
By PBR Staff Writer
GlaxoSmithKline (GSK) has started phase III development program with daprodustat for anaemia associated with chronic kidney disease.
Contract Research & Services > Clinical Trials > News
Bavarian completes enrollment of phase 3 non-inferiority study of IMVAMUNE smallpox vaccine
Bavarian Nordic has completed enrollment of a Phase 3 clinical study designed to demonstrate non-inferiority between its investigational, non-replicating smallpox vaccine, IMVAMUNE and ACAM2000, the current U.S. licensed, and replicating smallpox vaccine.
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