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Revive Therapeutics Files for FDA Orphan Drug Designation for Bucillamine in the Prevention of Ischemia-Reperfusion Injury During Liver Transplantation November 23, 2021
Revive Therapeutics Ltd. recently announced it has filed an application with the US FDA to receive Orphan Drug Designation (ODD) for Bucillamine for the prevention of ischemia–reperfusion injury (IRI) during liver….
ImmunityBio Expands Vaccine Program to Accelerate Use of “Mix-and-Match” Technologies in Developing & Manufacturing Next-Generation COVID-19 Vaccines November 18, 2021
ImmunityBio, Inc. recently announced the expansion of the company’s cancer and infectious disease vaccine programs to include self-amplifying self-adjuvating RNA (SASA-RNA), recombinant protein vaccine candidates, and potent adjuvant formulations that….
Alzheimer’s Disease Preventative Nasal Vaccine to be Tested at Boston's Brigham & Women’s Hospital November 16, 2021
Boston's Brigham and Women’s Hospital recently announced it would test a nasal vaccine for Alzheimer’s disease. The move, the hospital said in a press...Moderna Announces Positive Data From Phase 2 Study of mRNA VEGF-A Therapeutic in Patients Undergoing Coronary Artery Bypass Grafting Surgery November 15, 2021
Moderna, Inc. recently announced positive data from the AstraZeneca-led Phase 2 (EPICCURE) study evaluating the use of an mRNA therapeutic...Finch Therapeutics Announces Positive Topline Data From Phase 2 PRISM-EXT Open-Label Study of Microbiome Therapy for Recurrent C. diff. November 10, 2021
Finch Therapeutics Group, Inc. recently announced positive topline results from PRISM-EXT, an open-label extension of the company’s PRISM3 Phase 2...Eyenovia Announces First Patient Enrolled in Phase 3 VISION-2 Trial of MicroLine for Presbyopia November 4, 2021
Eyenovia, Inc. recently announced the first patient has been enrolled in the company’s second Phase 3 clinical trial of MicroLine,...Allena Pharmaceuticals Receives Fast Track Designation From FDA for the Development of ALLN-346 for Chronic Treatment of Hyperuricemia in Patients With Gout & Advanced Chronic Kidney Disease November 3, 2021
Allena Pharmaceuticals, Inc. recently announced its orally administered, urate-degrading enzyme, ALLN-346, has received Fast Track designation from the US FDA....Coherus & Junshi Biosciences Announce FDA Acceptance of BLA Filing for Toripalimab for Treatment of Nasopharyngeal Carcinoma November 1, 2021
Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. recently announced the US FDA has accepted for review the Biologics License Application (BLA) for toripalimab in combination with….
Krystal Biotech Announces Completion of the GEM-3 Pivotal Phase 3 Study Evaluating B-VEC for the Treatment of Dystrophic Epidermolysis Bullosa October 26, 2021
Krystal Biotech, Inc. recently announced the last participant has completed the 26-week dosing period and 30-day safety follow up visit...Pfizer & BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine October 21, 2021
Pfizer Inc. and BioNTech SE recently announced topline results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of...TFF Pharmaceuticals & Augmenta Bioworks Publish Positive In Vivo Data Showing Dry Powder Formulation of COVID-19 Antibody Neutralizes SARS-CoV-2 Infection & Reduces Viral Load October 14, 2021
TFF Pharmaceuticals, Inc. and Augmenta Bioworks recently announced the publication of a research paper highlighting positive preclinical study results of...MannKind Announces First Patient Enrolled in INHALE-1 Study of Afrezza in Pediatric Population October 5, 2021
MannKind Corporation recently announced the enrollment of the first pediatric patient in the INHALE-1 study. The multi-center study will evaluate the efficacy and safety of….
Adaptive Biotechnologies Launches Enhanced clonoSEQ Assay Reports for Patients With Chronic Lymphocytic Leukemia, Now Featuring IGHV Mutation Status October 5, 2021
Adaptive Biotechnologies Corporation recently announced the launch of an enhanced version of its clonoSEQ B-cell Clonality (ID) report, which will...ARTIFICIAL INTELLIGENCE - Attempting to Speed Up Vaccine Development to Combat the Next Pandemic October 4, 2021
Lars Wegner, MD, in the wake of the huge impact Covid-19 has had around the world, presents a state-of-the-art mathematical modelling and algorithms approach to vaccine development to prevent the next pandemic.
DRUG DEVELOPMENT - Simplifying the Drug Development Journey October 4, 2021
Fran DeGrazio explains how experienced and focused collaborators can provide guidance, support services, manpower, and intellect to make it easier to achieve all the goals needed in delivering a drug to a patient.
Novartis Announces Collaboration on HARMONIA, a Phase 3, Head-to-Head Trial Evaluating Kisqali Versus Ibrance in Patients With HR+/HER2- Advanced Breast Cancer September 21, 2021
Novartis recently announced a collaboration with SOLTI Innovative Cancer Research (SOLTI) on HARMONIA, an international, randomized, Phase 3, multicenter, open-label study of….
Longeveron Partners With Kinesiometrics to Create & Implement Cutting-Edge Smart Phone App to Measure Physical Responses to Cell Therapy September 15, 2021
Longeveron Inc. has entered into an agreement with Kinesiometrics Inc., to provide a cutting-edge, digital data-driven solution for objective real-time measurement of functional capacity and quality….
MacroGenics Announces Final Overall Survival Results From SOPHIA Study of MARGENZA in Patients with HER2-Positive Metastatic Breast Cancer September 8, 2021
MacroGenics, Inc. recently announced the final overall survival (OS) results of the SOPHIA Phase 3 study in adult patients with metastatic HER2-positive breast cancer…..
Nature Medicine Publishes Positive Phase 3 Anakinra Study Results in Patients With COVID-19 Pneumonia September 8, 2021
Swedish Orphan Biovitrum AB (Sobi) and the Hellenic Institute for the Study of Sepsis recently announced that Nature Medicine has published positive results from the investigator-sponsored Phase 3….
Impel NeuroPharma Announces US FDA Approval of TRUDHESA Nasal Spray for the Acute Treatment of Migraine September 8, 2021
Impel NeuroPharma, Inc. recently announced the US FDA approved TRUDHESA (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura….
