Latest News on Clinical Trials
Myoscience Announces Data Demonstrating iovera Therapy is an Effective Alternative to Opioids for Pain Relief Following Knee Replacement Surgery
Myoscience, Inc., a medical device company dedicated to relieving pain through targeted therapies, today announced clinical trial results demonstrating that iovera° therapy significantly reduced the use of opioids following total knee arthroplasty (TKA) surgery...
GENFIT announces FDA Protocol Clearance for Phase 2 Clinical Trial of Elafibranor in Pediatric NASH
FDA accepts study protocol, providing green light for GENFIT to initiate Phase 2 clinical trial in pediatric NASH Elafibranor, the first molecule with positive results on registrational endpoint in Phase 2b clinical trial in adult NASH to be evaluated in...
LogicBio Plans First Clinical Trial for Gene Editing in Children
Following last year’s stellar initial public offering in October, where it raised $80.5 million, about $10 million over initial expectations, LogicBio Therapeutics is planning a gene-editing clinical trial in children. Based in Cambridge, Mass., LogicBio focuses on...
CytoDyn Reports Significant Reduction in Breast Cancer Tumor Metastasis in Preclinical Study and Requests FDA Fast Track Designation for Leronlimab (PRO 140) in Metastatic-Triple Negative Breast Cancer (mTNBC)
CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”) a late stage biotechnology company developing a novel humanized CCR5 monoclonal antibody for multiple therapeutic indications, today announced that leronlimab (PRO 140), its lead investigational CCR5 inhibitor,...
Marshall University joins clinical trial for late-stage fatty liver disease
A clinical trial evaluating the safety and efficacy of an investigational drug for late-stage liver disease is now available at the Marshall University Joan C. Edwards School of Medicine. "The most serious liver complication of obesity is Non-Alcoholic...
Viveve Completes Enrollment in VIVEVE II Trial
Resultscould support a marketing application for an expanded U.S. indication forimprovement of sexual function in women ENGLEWOOD, CO / ACCESSWIRE / March 11, 2019 / Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women’s intimate health,...
Cynata Receives Favourable Advice from UK MHRA on CLI Clinical Trial
Cynata Therapeutics Limited (ASX: CYP), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce that it has received favourable advice from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom,...
CORRECTING and REPLACING – Yuhan Corp and Sorrento Therapeutics Announce Completion of Phase 1 Clinical Study of Anti-PD-L1 Antibody IMC-001
In a release issued under the same headline earlier today by Sorrento Therapeutics, Inc. (Nasdaq: SRNE), please note that in the subheadline the year the Phase 2 study will start should be 2019, not 2020 as previously stated. The corrected release follows: Yuhan...
Rocket Pharmaceuticals Sponsors Clinical Trial at University of California, Los Angeles (UCLA)
- Donald B. Kohn, M.D., of UCLA to lead U.S. clinical development efforts for Leukocyte Adhesion Deficiency-I and Infantile Malignant Osteopetrosis programs - -Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (“Rocket”), a leading U.S.-based multi-platform gene therapy...
ConSynance Joins the Prader-Willi Syndrome Clinical Trial Consortium
ConSynance Therapeutics, Inc., a clinical-stage biotechnology company developing two innovative treatments for Prader-Willi Syndrome (PWS), today announced that they joined the PWS Clinical Trial Consortium. The PWS Clinical Trial Consortium (https://www.pwsctc.org/)...
Tenax Therapeutics Enrolls First Patient for Phase 2 Pulmonary Hypertension Clinical Trial
Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that the first patient has been...
CyMedica Orthopedics® Announces Successful Clinical Trial Utilizing e-vive™
Patients experience earlier returns to function following total knee replacement surgery by using new app-driven muscle strengthening device CyMedica Orthopedics®, the leading combined digital health and muscle strengthening therapy developer, today announced...
ExThera Medical Creates Scientific Advisory Board to Advance the Organization’s Global Clinical Trial Program
ExThera Medical Corporation (ExThera) today announced the formation of its Scientific Advisory Board. Led by chairman Lakhmir (Mink) Chawla, MD, current Chief Medical Officer of La Jolla Pharmaceutical Company, the Scientific Advisory Board will include several...
ProQR Doses First Patient in Phase 1/2 STELLAR Trial of QR-421a for Usher Syndrome Type 2
ProQR Therapeutics N.V. (Nasdaq:PRQR), a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, today announced the first patient dosed in the Phase 1/2 STELLAR clinical trial for...
Axovant Reports Positive Interim Results from First Cohort of SUNRISE-PD Phase 2 Trial of AXO-Lenti-PD Gene Therapy in Parkinson’s Disease
25-point (42%) mean improvement in the UPDRS Part III (motor) OFF score, with individual patient improvements of 14 points and 36 points respectively Benefit seen across all UPDRS OFF subscales at 3 months Reductions in ON state dyskinesias seen on the Rush...
Rubius Therapeutics Announces FDA Clearance of Investigational New Drug Application for First-Ever Red Cell Therapeutic, RTX-134, for Treatment of Phenylketonuria
Rubius Therapeutics, Inc. (Nasdaq:RUBY), a biopharmaceutical company that is generating red blood cells and bioengineering them into an entirely new class of cellular medicines, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s...
Forbius Announces First Patient Dosed in Phase 2a Squamous Cell Carcinoma of the Head and Neck (SCCHN) Trial of AVID100, a Novel Anti-EGFR ADC
This trial will evaluate the efficacy of AVID100 in SCCHN patients with EGFR IHC 3+ tumors AVID100 is the most advanced, broadly active anti-EGFR ADC in clinical development 20% of SCCHN patients highly overexpress EGFR; no therapy is approved for these patients...
TB medicine pretomanid enters regulatory review process in the United States
TB Alliance's new drug application (NDA) for the novel tuberculosis (TB) drug candidate pretomanid has been accepted for review by the United States Food and Drug Administration (FDA). The application is for the use of pretomanid as part of a new regimen, in...
FDA Regulations Allow Medical Devices Clinical Trials to Differ From Pharmaceutical Trials
Clinical trials are the pathway for new drugs or devices to enter the U.S. and other worldwide markets. However, not all clinical trials are the same. A recent article by a 20+ year insider in the clinical trial industry said: "While clinical trials for medical...
SOTIO to Present Final Phase II DCVAC/OvCa Data at the 2019 SGO Annual Meeting on Women’s Cancer
SOTIO, a biotechnology company owned by the PPF Group, today announces that final data from the SOV02 Clinical Trial with DCVAC/OvCa will be presented in the plenary session as an oral presentation at the 2019 SGO’s 50th Annual Meeting on Women's Cancer. Final...
Email
Text