Expanding eligibility criteria for early-phase ALS clinical trials could benefit both patients and therapeutic progress, according to experts. Currently, 60% of ALS patients are excluded from clinical trials by the time they are diagnosed, which has ethical and drug development implications. Angela Genge, chief medical officer at QurAlis, believes that expanding eligibility is necessary to allow..
Jubilant Therapeutics, a precision oncology and immunology-focused biotech, is set to begin Phase II and first-in-human trials in 2023 with two Orphan Drug Designations. Their pipeline is generated entirely in-house using their unique discovery engine called the Therapeutic Index and Brain Exposure Optimization (TIBEO) which identifies candidate molecules with enhanced therapeutic indices that c..
GSK has announced positive results from its clinical trial of AREXVY, a vaccine for respiratory syncytial virus (RSV) in older adults. The AReSVi-006 phase III trial found that the vaccine provided protection against RSV-lower respiratory tract disease and severe disease over two full RSV seasons, including in participants with underlying medical conditions. Safety and reactogenicity data were c..
Rani Therapeutics has won the Presidential Poster Competition in the Bone and Mineral Metabolism category at the 105th annual meeting of The Endocrine Society (ENDO 2023) with its presentation on oral delivery of PTH for osteoporosis. The company's robotic pill, RaniPill, is designed to deliver any injectable biologic drug painlessly and is being tested as an oral alternative for a range of inje..
Blue Earth Diagnostics and PETNET Solutions Inc, A Siemens Healthineers Company have announced the commercial availability of POSLUMA® (flotufolastat F 18) in the United States. POSLUMA is an optimized, high-affinity radiohybrid (rh) Prostate-Specific Membrane Antigen (PSMA)-targeted PET imaging agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) p..
Cardio Diagnostics Holdings, Inc has launched PrecisionCHD™, a blood-based detection test for coronary heart disease (CHD) that integrates epigenetic and genetic biomarkers with artificial intelligence. The test is the only detection technology that combines these elements and offers remote and scalable deployment capabilities across the US. It requires only a simple blood sample, making it far ..
CorMedix Inc. has announced that the US Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application for DefenCath, a catheter lock solution that is being developed to reduce catheter-related bloodstream infections in patients with kidney failure who are receiving chronic hemodialysis via a central venous catheter. The FDA considers the resubmission as a complete,..
