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...
Connect Biopharma Reports CBP-201 Achieved All Primary and Key Secondary Endpoints in Pivotal Atopic Dermatitis (AD) Trial in China
Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the Company), a global clinical-stage biopharmaceutical company developing T cell-driven therapies to treat inflammatory diseases, announced topline results for the primary analysis population of...
PDS Biotech Announces Successful End-of-Phase 2 Meeting With the FDA and Preparation for the Registrational Trial of PDS0101 in Combination With KEYTRUDA®
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food...
Accuray Announces First CyberKnife® Systems in Africa, Providing a New Option and Hope for Potentially Life-Saving Radiation Treatments for More Cancer Patients
Accuray Inc.(NASDAQ: ARAY) announced the company is expanding its global footprint with the introduction of its CyberKnife® platform in Africa, making it possible for more patients to obtain access to the extremely precise stereotactic radiosurgery (SRS) and...
Multilingual Clinical Trial Translations: How Language Access Can Drive Recruitment and Retention of Diverse Participants
As we started to explore in our latest Clinical Trial Corner post, multilingual clinical trial translations are an essential instrument enabling recruitment of racially and ethnically diverse populations as recommended by the US Food and Drug Administration (FDA) in...
Idera Bolsters Rare Disease Portfolio with Aceragen Buyout
Two rare disease companies - Idera Pharmaceuticals and Aceragen - are merging to pursue the common goal of an FDA approval that could come as early as 2024. For Idera, the merger is something of a lifeline after its top drug candidate flopped last year. On the other...
CRISPR Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to CTX130™ for the Treatment of Cutaneous T-Cell Lymphomas (CTCL)
CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation...