Clinical Trials (Phase III)
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Janssen Pharmaceutical of Johnson & Johnson released new long-term data from the open-label period of its Phase III VOYAGE 1 clinical trial.
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Isofol Receives Positive Feedback From PMDA in Japan, Expanding Ongoing Global Pivotal Phase 3 AGENT Trial in First Line Metastatic Colorectal Cancer
10/18/2019
Isofol Medical AB, announced the successful completion of Japan's Pharmaceutical and Medical Devices Agency review of the Clinical Trial Notification, allowing the start of the pivotal Phase 3 AGENT clinical study in metastatic colorectal cancer at Japanese sites.
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After Cancer Drug Fails Pancreatic Cancer Trial, Lilly Plans to Continue Studies in Lung and Rena...
10/17/2019
Lilly picked up pegilodecakin, an immunotherapy that stimulates the body’s immune system and expands tumor-attacking T-cells, when it acquired ARMO BioSciences in June 2018 for $1.6 billion. -
SurgiMab recruits first US patient in pivotal Phase 3 trial evaluating SGM-101, a novel fluorescent tumor-specific antibody, for the improvement of surgical outcomes in colorectal cancer patients
10/17/2019
SGM-101 is an investigational new imaging agent for fluorescence-guided surgery designed to enable surgeons to better visualize tumor tissues in real-time
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Lysogene Appoints Mr. Stéphane Durant des Aulnois as Chief Financial Officer
10/17/2019
Lysogene (Paris:LYS) (FR0013233475 – LYS), a pioneering Phase 3 biopharmaceutical company specializing in gene therapy targeting central nervous system (CNS) diseases, today announced the appointment of Stéphane Durant des Aulnois as Chief Financial Officer
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AZTherapies Closes $26.3 Million Series C Preferred Equity FinancingProceeds to support ongoing Phase 3 Alzheimer’s clinical trial, expected to complete in 2020, and advancement of pipeline of candidates targeting neuroinflammation
10/17/2019
AZTherapies, Inc., a biopharmaceutical company developing therapeutics to extend brain health, today announced the closing of a $26.3 million Series C Preferred equity financing.
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Protalix BioTherapeutics Announces Positive 12-Month Interim Data From the BRIDGE Phase III Open Label Switch-over Study of Pegunigalsidase Alfa for the Treatment of Fabry Disease
10/17/2019
Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced positive 12-month on-treatment data from the first 16 out of the 22 adult patients enrolled in its BRIDGE Phase III study.
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Stealth BioTherapeutics Presents Data for Elamipretide on Cardiac Function in Barth Syndrome
10/17/2019
Stealth BioTherapeutics (NASDAQ: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced the presentation of new data from the open-label extension portion of the Phase 2/3 TAZPOWER study evaluating elamipretide in patients with Barth syndrome
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Bimekizumab Phase 3 Psoriasis Study Meets All Endpoints, Achieving Significantly Greater Efficacy Versus Placebo and Ustekinumab
10/17/2019
The Phase 3 BE VIVID study evaluating the efficacy and safety of bimekizumab in adults with moderate-to-severe chronic plaque psoriasis met all primary and ranked secondary endpointsi
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Verona Pharma Completes Enrollment in Phase 2b Clinical Trial with Nebulized Ensifentrine in moderate-to-severe COPDResults to Inform Development Plan and Dose Selection for Phase 3
10/17/2019
Verona Pharma plc, a biopharmaceutical company focused on respiratory diseases, announces that it has randomized the last patient in its Phase 2b dose-ranging study evaluating the effect of nebulized ensifentrine as an add-on to treatment with a long acting bronchodilator in patients with moderate-to-severe chronic obstructive pulmonary disease
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The primary endpoint of the trial was improving overall response rate at Day 28 with Jakafi compared to the best available therapy.
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Mycovia Pharmaceuticals Announces Partnership with Gedeon Richter to Commercialize and Manufacture VT-1161 for Recurrent Vulvovaginal Candidiasis
10/16/2019
Mycovia Pharmaceuticals, Inc. today announced it has entered into an exclusive license and development and technology transfer agreement with Gedeon Richter Plc., based in Budapest, Hungary, to commercialize and manufacture VT-1161 in Europe, Latin America, Australia, Russia and other CIS countries. VT-1161, an oral antifungal product candidate, is currently in Phase 3 clinical trials for the treatment of Recurrent Vulvovaginal Candidiasis (RVVC)
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Vyleesi™ Phase 3 Data To Be Presented At The 13th European Society Of Gynecology Congress
10/16/2019
Palatin Technologies, Inc. announced that data from two pivotal, double-blind placebo-controlled Phase 3 trials and the Exit Survey/Interview data on Vyleesi™ for hypoactive sexual desire disorder will be presented at the 13th European Society of Gynecology Conference in Vienna, Austria.
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Axsome Therapeutics Announces Completion of Patient Enrollment in the GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder
10/16/2019
Axsome Therapeutics, Inc. announced the completion of patient enrollment in the GEMINI study, a Phase 3, randomized, double-blind, placebo-controlled trial of AXS-05 in patients with major depressive disorder AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity.
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Lilly Announces Phase 3 Study in Patients with Metastatic Pancreatic Cancer Did Not Meet Primary Endpoint of Overall Survival
10/16/2019
Eli Lilly and Company announced top-line results from its Phase 3 SEQUOIA trial evaluating pegilodecakin plus FOLFOX compared to FOLFOX alone in patients with metastatic pancreatic cancer whose disease had progressed during or following a first-line gemcitabine-containing regimen.
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Aurinia Reports Last Patient Study Visit in Aurora Phase 3 Lupus Nephritis Study and Provides Update on ATM Facility
10/16/2019
AURORA Phase 3 results with voclosporin for the treatment of lupus nephritis remain on track to be reported by the end of the fourth quarter 2019
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New Study Reveals Superiority Of Vibativ® Over Vancomycin In Select Patients With Bacterial Pneumonia
10/15/2019
Vibativ® (telavancin) is a patented, FDA approved anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia.
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Novavax Initiates Pivotal Phase 3 Clinical Trial of NanoFlu Influenza Vaccine in Older Adults
10/15/2019
Novavax, Inc. announced the initiation of a pivotal Phase 3 clinical trial for NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate, in adults aged 65 and over.
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Staying Ahead of Biosimilar Competition, Roche's Rituxan Shows Superiority in Rare Autoimmune Ski...
10/14/2019
Roche announced results from its Phase III PEMPHIX trial evaluated MabThera/Rituxan (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris. -
The drug met all the co-primary and key secondary endpoints related to skin clearance and itch relief compared to placebo.