Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
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...
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