Dyne Therapeutics Receives FDA Fast Track Designation for DYNE-251 for the Treatment of Duchenne Muscular Dystrophy
Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, announced that the U.S. Food and Drug Administration (FDA) has granted...
NeoGenomics Provides Update on MolDX Submission for CRC and RaDaR(TM) Commercial Launch
NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of cancer-focused genetics testing services and global oncology contract research services, is providing an update on its discussions with MolDX and on its commercial launch activities for RaDaRTM, its proprietary...
Aphaia Pharma Announces Enrollment of First Patient in Phase 2 Study of APH-012 for Chronic Weight Management in Individuals with Obesity
Aphaia Pharma, a clinical-stage biopharmaceutical company harnessing precision-targeted drug delivery technology for the treatment and prevention of metabolic diseases, announced that it has enrolled the first patient as part of a Phase 2 study evaluating the safety...
Anixa Biosciences Announces Commencement of Phase 1b Trial of its Breast Cancer Vaccine at Cleveland Clinic
Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, announced the initiation of a Phase 1b trial for its preventative breast cancer vaccine. The study is being conducted at...
Pharmaceuticals Translations for Diverse and Emerging Market Clinical Trials
In our most recent Clinical Trials Corner post, we examined the lacking global representation of diverse patient populations in the development of new biopharmaceuticals when compared to consumption of developed drugs by country, highlighting the need to expand and...
Tenon Medical’s Catamaran(TM) SI Joint Fusion System Receives Institutional Review Board Approval for Two Strategic Post Market Studies
Tenon Medical, Inc. (NASDQ:TNON), a company transforming care for patients suffering with certain sacroiliac joint disorders, announced Institutional Review Board (IRB) approval from WCG IRB for two separate Tenon-sponsored post market clinical studies of the...
Point32Health to Pilot Nerivio® Drug-Free Migraine Treatment Device
Theranica Ltd., a prescribed digital therapeutics company developing advanced digitally connected neuromodulation devices for migraine and other pain conditions, announced it has teamed up with Point32Health, the parent organization of Harvard Pilgrim Health Care and...
BriaCell Announces Successful Completion of Phase I Portion of Clinical Study in Advanced Breast Cancer; Randomized Phase II Efficacy Evaluation Progressing
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, is pleased to announce the completion of the Phase I part of the clinical trial of its lead candidate, Bria-IMT™,...
Preclinical Data from iECURE’s GTP-506 Demonstrates Potential for the Treatment of Ornithine Transcarbamylase (OTC) Deficiency
iECURE, a gene editing company focused on developing therapies that utilize mutation-agnostic in vivo gene insertion, or knock-in, editing for the treatment of liver disorders with significant unmet need, announced that data presented at the International Conference...
Theranica Achieves Positive Results in Placebo-Controlled Pivotal Trial of Nerivio® for Preventive Treatment of Migraine
Theranica Bio-electronics, a prescribed digital therapeutics company developing advanced digitally connected neuromodulation devices for migraine and other pain conditions, announced positive top-line results in its double-blind, randomized, placebo-controlled,...
Gilead, MacroGenics Unite Against Hematologic Cancers in $1.7B Biobuck Deal
Gilead Sciences and MacroGenics entered a licensing and collaboration pact worth up to $1.7 billion to develop a bispecific antibody to treat hematological cancers. This comes only two months after the latter announced staff cuts. The partnership includes three...
Clinical Trial Corner: Patient Diversity in Clinical Trials Part 2, Assessing the Proportionality of Countries’ Participation In Pharmaceutical Development Relative to Their Consumption
Clinical Trial Corner is a biweekly series from Dr. Vladimir Misik, founder of LongTaal and CSOFT’s VP of Global Clinical Strategy. In the first part of my blog of this two part series on patient diversity in industry CTs (iCTs), I summarized the importance of the...
Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT2606, a Proposed Biosimilar of Nucala® (mepolizumab)
Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage biopharmaceutical company, announced that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT2606, a proposed biosimilar of Nucala® (mepolizumab), to US-sourced and...
Novavax COVID-19-Influenza Combination Vaccine Candidate Induced Antibody and T-Cell Responses Against SARS-CoV-2 and Homologous and Heterologous Influenza Strains
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced positive results from the Phase 1/2 clinical trial of its COVID-19-Influenza Combination (CIC) vaccine...
Etiometry’s Clinical Decision-Support Software Receives CE Mark
Etiometry, a leader in clinical decision-support software for critical care, announced that the company has obtained the CE Mark under the European Union's medical device regulation, marking the second adult and third pediatric market authorization. Etiometry's...
PDS Biotech Announces Expanded Interim Data in PDS0101 Triple Combination Phase 2 Trial Targeting Advanced HPV-Positive Cancers
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced expanded interim data in the Phase 2 clinical trial investigating the...
Plexision completes development of PlexAPR™, a rapid blood test to predict transplant rejection
Plexision, a biotechnology company, which provides personalized diagnostic testing services for organ transplant patients has completed development of a six-hour blood test to predict organ transplant rejection - PlexAPR™. When combined with other clinical and...
Allogene Initiates First-Ever Phase II Trial of Allogeneic CAR-T Therapy
Allogene Therapeutics is launching what it calls the first pivotal Phase II trial of an allogeneic CAR T product in the industry. The ALPHA2 trial will evaluate ALLO-501A in relapsed/refractory large B-cell lymphoma (LBCL). In addition to the ALPHA2 trial, the company...
New Publication Validates Performance of Natera’s Signatera™ MRD Test in Ovarian Cancer
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, announced the publication of a manuscript in Gynecologic Oncology, found here, validating the performance of its personalized molecular residual disease (MRD) test, Signatera, in epithelial ovarian...
ONWARD Announces Topline Results from the LIFT Home Study Supporting Safety and Feasibility of ARC-EX Therapy to Treat People with Spinal Cord Injury at Home
ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury (SCI), reported topline results from the LIFT Home study, evaluating the safety and...
