Latest News on Clinical Trials
Per the FDA Guideline on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic
It is more important than ever to take care of one another and be diligent and wise in our daily activities. This press release was orginally distributed by SBWire Santa Ana, CA -- (SBWIRE) -- 03/24/2020 -- Per the FDA Guideline on Conduct of Clinical Trials of...
UCHealth Leads Investment Into ClinOne – a Remote Clinical Trial Patient Management Technology Company
ClinOne, an industry leader in remote clinical trial patient management, added the CU Healthcare Innovation Fund as the lead investor for their Series-A financing, with a first closing of $3.6 million. The fund is affiliated with the Anschutz Medical Campus in Denver...
US clinical trial site concerns over COVID-19 impact on enrollment jumps by 124% over past week
European site enrollment concerns grow to 85% Over the course of just one week, US clinical research study sites’ concern about COVID-19-related interruptions to recruitment and retention has increased by 124%, jumping from 25% to 56% according to an ongoing...
Novavax’ NanoFlu Achieves All Primary Endpoints In Phase 3 Clinical Trial
Trial also achieves statistical significance in key secondary endpoints Novavax to submit a U.S. BLA under FDA’s accelerated approval pathway Company to host investor conference call today at 8:30 a.m. EDT GAITHERSBURG, Md., March 24, 2020 (GLOBE NEWSWIRE) -- Novavax,...
ProtoKinetix Ready to Ship AAGP® to the University of Alberta for the Continuation of Phase 1 Human Trials
ProtoKinetix, Incorporated ( www.protokinetix.com ) (the "Company" or "ProtoKinetix") (OTCQB: PKTX ), a clinical-stage biomedical company, today announced an update to the Press Release of January 24, 2020. We have now completed the sterilization, quality assurance,...
OncoQuest Announces Publication of Two Reports Related to Oregovomab Phase 2 Clinical Trial, the Company’s Lead Investigational Drug in Frontline Ovarian Cancer
EDMONTON, March 24, 2020 /PRNewswire/ - OncoQuest Inc. ("OncoQuest" or the "Company"), a privately held, cancer immunotherapy company today announced the publication of two reports relating to the recently completed Phase 2 trial conducted in the US...
Esperion Announces Pooled Analyses from Phase 3 LDL-C Lowering Development Program of the NEXLETOL™ (bempedoic acid) Tablet and Phase 2 Study Results of the NEXLIZET™
ANN ARBOR, Mich., March 23, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that two pooled analyses from four Phase 3 clinical trials of NEXLETOL and results from the Phase 2 (1002-058) study of NEXLIZET will be presented at the American College of...
Co-Diagnostics, Inc Completes Successful Clinical Evaluation Required for FDA Emergency Use Authorization
Co-Diagnostics, Inc. (Nasdaq:CODX), a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced today that following a successful clinical evaluation of its Logix Smart™ COVID-19 Test, the Company will begin...
PRA Health Sciences Launches COVID-19 Monitoring Program
RALEIGH, N.C., March 20, 2020 (GLOBE NEWSWIRE) -- PRA Health Sciences announced today the commercial availability of the COVID-19 Monitoring Program, a mobile app-driven, tiered initiative that allows employers, payers, providers and health systems to track the health...
Pliant Therapeutics Initiates First-in-Human Clinical Trial of PLN-1474 for the Potential Treatment of Liver Fibrosis
SOUTH SAN FRANCISCO, Calif., March 23, 2020 /PRNewswire/ -- Pliant Therapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of serious fibrotic diseases, today announced that it has dosed...
Soliton to Present Pivotal Cellulite Clinical Trial Results at Virtual AAD 2020 Annual Meeting
Soliton, Inc. is a medical device company with a novel and proprietary platform technology licensed from MD Anderson. The Company’s first planned commercial product is designed to use rapid pulses of designed acoustic shockwaves in conjunction with existing lasers to...
Phase 3 Trial to Evaluate Tocilizumab for Severe COVID-19 Pneumonia
Genentech is launching a phase 3 clinical trial evaluating tocilizumab (Actemra) plus standard of care for use in hospitalized adult patients with severe COVID-19 pneumonia, according to a company press release. Tocilizumab, a humanized interleukin-6 (IL-6) receptor...
Humanigen Planning Phase III Study of Coronavirus Treatment
Study to Tackle Leading Cause of Death in COVID-19 Patients Lenzilumab is a monoclonal antibody that neutralizes GM-CSF, a cytokine up-regulated in COVID-19 patients that can cause a harmful immune response Clinical evidence suggests that this response contributes to...
Mersana Therapeutics to Report Updated Data from the XMT-1536 Phase 1 Dose Escalation Study
Conference call on Monday, March 30, 2020, at 5:00 p.m. ET featuring study investigator Debra L. Richardson, MD CAMBRIDGE, Mass., March 20, 2020 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (MRSN), a clinical-stage biopharmaceutical company focused on discovering...
Chinese Center for Drug Evaluation (CDE) Cleared Taletrectinib IND and Issued Clinical Trial Authorizations for Two Phase 2 Clinical Trials in China
HANGZHOU, China, March 23, 2020 (GLOBE NEWSWIRE) -- AnHeart Therapeutics, Co., Ltd. (“AnHeart”), a clinical stage oncology company focused on underserved patients in global markets, today announced that its new drug candidate taletrectinib has received IND clearance...
Axsome Therapeutics Accelerates Completion of the ADVANCE-1 Phase 2/3 Trial of AXS-05 in Alzheimer’s Disease Agitation
Randomizations concluded and trial participation in process of concluding to ensure patient safety during COVID-19 pandemic AXS-05 and placebo arms fully enrolled with estimated completion rate of more than 90% Topline results now expected early 2Q 2020 NEW...
Algernon Appoints Novotech as CRO For Phase 2 Coronavirus Ifenprodil Trial
VANCOUVER, British Columbia, March 20, 2020 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company is pleased to announce today that it has chosen...
Feinstein Institutes begins enrolling patients in multiple COVID-19 clinical trials
The Feinstein Institutes for Medical Research, the research arm of Northwell Health, announced today the enrollment of three clinical trials in the ongoing effort to combat COVID-19, the novel coronavirus. Feinstein Institutes researchers are teaming up with Gilead...
FDA Grants Bellerophon Emergency Expanded Access for INOpulse® for the Treatment of COVID-19 Virus
WARREN, N.J., March 20, 2020 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted emergency expanded access...
Novartis commits to donate up to 130 million doses of hydroxychloroquine to support the global COVID-19 pandemic response
Hydroxychloroquine and a related drug, chloroquine, are currently under evaluation in clinical trials for the treatment of COVID-19. Novartis Sandoz division will pursue appropriate regulatory authorizations and, upon approval, will work with stakeholders to determine...