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SELLAS Life Sciences Announces Completion of Enrollment in Phase 2 Randomized Controlled Clinical Study November 29, 2018
SELLAS Life Sciences Group, Inc. recently announced the completion of enrollment for a Phase 2 independent investigator-sponsored clinical trial of...Cynata’s Stem Cell Therapy Meets All Safety & Efficacy Endpoints in Trial August 30, 2018
Australian stem cell and regenerative medicine company Cynata Therapeutics Limited recently announced that CYP-001, its lead Cymerus mesenchymal stem cell (MSC) product candidate, met all clinical endpoints in a Phase 1 trial for the treatment of steroid-resistant acute graft-versus-host disease (GvHD).
Eisai & Biogen Announce Positive Topline Results July 10, 2018
Eisai Co., Ltd. and Biogen Inc. recently announced positive topline results from the Phase II study with BAN2401, an anti-amyloid...Nabriva Therapeutics Announces Positive Topline Results From Pivotal Phase 3 Clinical Trial of Oral Lefamulin June 6, 2018
Nabriva Therapeutics plc recently announced positive topline results from its Lefamulin Evaluation Against Pneumonia (LEAP 2) clinical trial, the second of two global, pivotal Phase 3 clinical trials of lefamulin. LEAP 2 evaluated the safety and efficacy of 5 days of oral lefamulin compared to 7 days of oral moxifloxacin in adult patients with moderate community-acquired bacterial pneumonia (CABP).
CLINICAL TRIALS - Inconsistencies Prevalent in Study Start-Up April 2, 2018
Craig Morgan believes as stakeholders are increasingly aware that better study start-up (encompassing the activities associated with site identification, feasibility assessment, selection, and activation) processes are linked to shorter clinical timelines, the emphasis has been shifting in that direction.
Cynata Announces Encouraging Results; DSMB Recommendation Next Stage January 29, 2018
Australian stem cell and regenerative medicine company, Cynata Therapeutics, recently announced that the independent Data Safety Monitoring Board (DSMB) has...CLINICAL TRIALS - Why Are Metrics Important in Starting Clinical Trials? January 8, 2018
Craig Morgan believes metrics are indeed critical to efforts to rein in clinical trials that are either poorly initiated or have incurred unforeseen events, which place the original timelines and/or budgets at risk of overages.
DFB Pharmaceuticals Forms NanOlogy & Soria for Clinical Development of Naked Nanoparticle Platform September 14, 2017
Demand for new cancer drugs is enormous with public and private investment skyrocketing for new technologies. Immunotherapies have captured much...Selecta Biosciences Initiates Phase II Clinical Trial October 29, 2016
Selecta Biosciences, Inc. recently announced it has dosed the first patient in its Phase II clinical trial of SEL-212, the...BioPharmX Enrolls First Subject in OPAL Phase IIb Clinical Trial August 25, 2016
BioPharmX Corporation recently announced that the first subject has been enrolled in its Phase IIb clinical trial assessing the efficacy...Actinium Announces Selection of Zevacor for Clinical Production & Supply Pivotal Phase III Trial April 17, 2016
Actinium Pharmaceuticals, Inc. recently announced the company has entered into an agreement with Zevacor Pharma, Inc. (formerly IBA Molecular North...Rexahn Pharmaceuticals Announces Initiation of Phase Ib/IIa Clinical Trial of Novel Oral Anti-Cancer Therapeutic April 4, 2016
Rexahn Pharmaceuticals, Inc. recently announced that is has enrolled the first patient in its Phase Ib/IIa clinical trial of a...Chiasma Initiates Second Phase III Trial of Octreotide Capsules March 18, 2016
Chiasma, Inc. recently announced the initiation of a second Phase III clinical trial to investigate the non-inferiority of octreotide capsules...Soligenix Announces Initiation of Pivotal Phase III Clinical Trial December 15, 2015
Soligenix, Inc. recently announced that patient enrollment has been opened for its Phase III, multicenter, randomized, double-blind, placebo-controlled study evaluating...RegeneRx Announces First Patient Enrolled in Phase III Trial September 28, 2015
RegeneRx Biopharmaceuticals, Inc. recently announced the first patient has been enrolled in a Phase III clinical trial with RGN-259 (designated...Charleston Laboratories & Daiichi Sankyo Initiate Two Phase III Trials November 24, 2014
Charleston Laboratories, Inc. and their co-development and co-commercialization partner, Daiichi Sankyo, Inc., initiated two Phase III clinical trials on CL-108,...Intravacc Announces Positive Data of First in Human Intranasal OMV-Based Vaccine for SARS-CoV-2 March 26, 2024
Intravacc recently announced positive clinical data of a first in human (FIH) study of Avacc 10, an intranasal outer membrane...MoonLake Immunotherapeutics Announces Positive Feedback From FDA & EMA on Regulatory Path for Phase 3 Program February 26, 2024
MoonLake Immunotherapeutics recently announced the successful outcome of its end-of-Phase 2 interactions with the US FDA as well as positive...Ascendia Pharmaceuticals Expanding Injectable Manufacturing Capabilities in 2024 January 31, 2024
Ascendia Pharmaceuticals is all set to unveil its new injectables manufacturing opportunities with the launch of a state-of-the-art sterile cGMP production facility in March 2024…..
Anavex Initiates Regulatory Submission of Oral Blarcamesine for Alzheimer’s Disease to EMA November 20, 2023
Anavex Life Sciences Corp. recently announced representatives of Anavex met with team members of the European Medicines Agency (EMA). These...
