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Anavex Life Sciences Announces First Patient Dosed in Extension Study to its U.S. Phase 2 Clinical Trial of ANAVEX®2-73 in Patients for Rett Syndrome
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, Parkinson’s...
I-Mab Announces Dosing of First Patient in a Phase I Clinical Trial of TJC4, a Potentially Differentiated CD47 Antibody, for the Treatment of Cancers in the United States
I-Mab Biopharma ("I-Mab"), a clinical stage biotech company exclusively focusing on discovery and development of innovative biologics in immuno-oncology and autoimmune diseases, announces on June 24, 2019, that the first patient has been dosed in a Phase I clinical...
Navitas Life Sciences Provides Improved Clinical Trial Oversight and Actionable Insights Enabled by OneClinical™ Analytics, Powered by ThoughtSphere
ThoughtSphere, a fast growing, cloud-based clinical data hub and analytics SaaS company, today announced that Navitas Life Sciences, a full service CRO, and technology-led life sciences service provider, chose ThoughtSphere to power OneClinical Analytics, which is an...
Micro Medical Solutions Receives FDA IDE Approval for Pivotal Clinical Trial of MicroStent
Clinical investigators will study the safety and efficacy of this microvascular device designed to restore blood flow and reduce amputations resulting from below-the-knee peripheral artery disease WILMINGTON, Mass., June 24, 2019 — Micro Medical Solutions (MMS)...
NantKwest Launches First-in-class, First-in-human Phase I Clinical Trial With a Targeted PD-L1 t-haNK Cell Therapy in Patients With Solid Tumors
First engineered, GMP-grade, cryopreserved, off-the-shelf, bi-specific NK cell therapy to enter human clinical trials targeting PD-L1 and CD16 in patients with solid tumors NantKwest establishes a leading portfolio of off-the-shelf NK cells at clinical stage of...
AXIM® Biotechnologies Signs Supply Agreement to Register Cannabinoid Oral Care Products in Clinical Trials for Gingivitis and Gum Disease
Leading Cannabinoid Biotech Company Announces Use of Oral Care Product Line in Registration for Clinical Trials in Australia and New Zealand AXIM® Biotechnologies, Inc. (OTC: AXIM) (“AXIM® Biotech,” “AXIM” or “the Company”), a world leader in cannabinoid research and...
Krystal Biotech Announces Positive Results from Phase 2 Clinical Trial (“GEM-2 study”) of KB103 and Receives Regenerative Medicine Advanced Therapy (“RMAT”) Designation from FDA for KB103
Safety data from all patients show that KB103 was well tolerated with no adverse events reported Five out of six wounds treated with KB103 in the Phase 2 trial closed 100% during the trial The average time to complete 100% wound closure on KB103 treated wounds in...
ImmusanT Discontinues Phase 2 Clinical Trial for Nexvax2® in Patients With Celiac Disease
ImmusanT, Inc., a clinical stage company leveraging its Epitope-Specific Immuno-Therapy™ (ESIT™) platform to deliver first-in-class peptide-based immunomodulatory vaccine therapies to patients with autoimmune diseases, has discontinued the Phase 2 global study for its...
Dompé Announces First Patient Enrollment in Phase 2b Clinical Trial Investigating Novel Mechanism of Action in Moderate to Severe Dry Eye Disease
-- Following the successful launch of Oxervate, the first-in-class recombinant human nerve growth factor (rhNGF) for treatment of neurotrophic keratitis (NK), Dompé embarks on a new clinical trial program to further investigate the relevance of treatment with rhNGF in...
Tricida Announces Publication of Positive Long-Term Phase 3 Clinical Trial Results of Veverimer (TRC101) in The Lancet
TRCA-301E trial is the first, long-term, randomized, multicenter, blinded, placebo-controlled trial to evaluate the treatment of metabolic acidosis in patients with CKD Tricida, Inc. (TCDA), a pharmaceutical company focused on the development and commercialization of...
Immutep Completes Patient Enrolment of the AIPAC Phase IIb Clinical Trial in Metastatic Breast Cancer
226 patients with metastatic breast cancer have been enrolled in the AIPAC study Combination of eftilagimod alpha, an antigen presenting cell (APC) activator, administered in combination with chemotherapy is designed to boost the T-cell immune responses against...
Intec Pharma Announces Results from Earlier Phase 2 Clinical Trial of Accordion Pill-Carbidopa/Levodopa in Advanced Parkinson’s Disease Patients Published in Parkinsonism and Related Disorders
Accordion Pill demonstrated more stable levodopa concentrations and significantly reduced OFF time in Parkinson's disease patients Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces that results from an earlier Phase 2 clinical study of the...
Orion Transforms its Clinical Trials with Medidata
Global pharmaceutical company expands use of Medidata Rave Clinical Cloud™ to spur growth and innovation Agreement builds on long-standing relationship since 2006 Unified platform approach creates a single source of truth for greater efficiency and accelerated trials...
Dicerna™ Presents Additional Data from PHYOX™1 Study of DCR-PHXC in Patients with Primary Hyperoxaluria Type 1 (PH1) and Type 2 (PH2)
—Researchers Report Substantial Oxalate Reduction Following Single-Dose Administration of DCR-PHXC in Additional Patients with PH2— —Enrollment Underway in Pivotal PHYOX2 Trial of DCR-PHXC— CAMBRIDGE, MA, USA I June 21, 2019 I DicernaTM Pharmaceuticals, Inc. (Nasdaq:...
MEI Pharma Presents Updated Clinical Data from the ME-401 Phase 1b study in Patients with Indolent B-cell Malignancies at the 2019 International Conference on Malignant Lymphoma (ICML)
MEI Pharma, Inc. (NASDAQ:MEIP ), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, today announced that updated data presented in an oral presentation at ICML 2019 from a Phase 1b study of investigational ME-401, a selective...
New Studies Highlight Activity of XERAVA™ Against Gram-Negative and Gram-Positive Clinical Isolates, Including Multidrug-Resistant Pathogens
June 24, 2019 11:00 UTC Additional Data Points to Potential of XERAVA to Treat Carbapenem-Resistant, Multidrug-Resistant Escherichia Coli TP-6076 Demonstrates In Vivo Efficacy in Murine Lung and Thigh Infection Models with Acinetobacter Baumannii WATERTOWN,...
ADC Therapeutics Presents Clinical Data on ADCT-402 and ADCT-301 in Subtypes of Relapsed or Refractory Lymphoma at the 15th International Conference on Malignant Lymphoma
Ongoing pivotal Phase II clinical trial of ADCT-402 in patients with relapsed or refractory diffuse large B-cell lymphoma anticipated to complete enrollment in third quarter of 2019 Pivotal Phase II clinical trial of ADCT-301 in relapsed or refractory Hodgkin lymphoma...
Final Data Analysis of Phase 2 PBC Trial Shows that Genkyotex’s Anti-fibrotic Candidate GKT831 Demonstrated Statistically Significant Improvements in GGT and ALP Over Full Treatment Period
Statistically significant reductions in GGT and ALP in 400mg BID dose over 24-week treatment period (p<0.002 and p<0.001, respectively) GKT831 400mg BID significantly improved multiple quality of life metrics important to PBC patients, including fatigue...
Mallinckrodt Achieves 50 Percent Enrollment for Phase 2B Trial Investigating the Use of Acthar® Gel (Repository Corticotropin Injection) in Amyotrophic Lateral Sclerosis (ALS)
Mallinckrodt plc(NYSE: MNK), a leading global specialty biopharmaceutical company, today confirmed it has achieved 50 percent patient enrollment in the company's Phase 2B study designed to assess the efficacy and safety of Acthar® Gel (repository corticotropin...
Minerva Neurosciences Announces Achievement of Primary and Key Secondary Objectives in Phase 2b Clinical Trial of Seltorexant (MIN-202) in Insomnia
Primary endpoint, defined as Latency to Persistent Sleep (LPS) at Night 1, showed improvement with a p-value ≤0.001 after treatment with 10 and 20 mg doses of seltorexant Key secondary endpoint, defined as Wake After Sleep Onset over first 6 hours (WASO‑6) at Night 1,...