News and Trends 4 Oct 2022 HumanFirst launches industry’s largest decentralized clinical trial database HumanFirst has launched two new versions of the Atlas platform designed specifically for researchers in industry (AtlasPro) and academia (AtlasEDU). Atlas was created by HumanFirst to unlock better research for all humans sooner, and has been used for planning and deployment of trustworthy hybrid and at-home clinical trials by 22 of the 25 largest pharmaceutical […] October 4, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 3 Oct 2022 FDA clears Kira Pharmaceuticals’ phase 2 trial for SLE-TMA treatment Kira Pharmaceuticals says the US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for KP104, a first-in-class bifunctional biologic that selectively and synergistically targets the alternative and terminal complement pathways. A phase 2 trial will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with […] October 3, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 29 Sep 2022 Kling Biotherapeutics doses first patient in advanced solid tumor trial Kling Biotherapeutics BV has dosed the first patient with KBA1412 in its phase 1b trial to evaluate the safety, tolerability, PK/PD, and potential efficacy of KBA1412 in adult patients with advanced solid tumors not responding to standard of care. KBA1412 is a first in class fully human anti-CD9 antibody based on an antibody produced by […] September 29, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 29 Sep 2022 Positive results from study of drug to treat patients with breast cancer published Results from a phase 1b study of a drug to treat patients with androgen receptor positive (AR+) metastatic breast cancer (mBC) in China were published yesterday (September 28). Kintor Pharmaceutical Limited, a clinical stage biotech company has developed Pruxelutamide, an oral new generation AR antagonist which has shown promising activity in heavily pretreated AR+ mBC […] September 29, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 29 Sep 2022 Treatment for adults with chronic skin condition approved by FDA The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases […] September 29, 2022 - 4 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
More News! 29 Sep 2022 Positive results from Eisai and Biogen Alzheimer’s trial Eisai Co., Ltd. and Biogen Inc. have announced positive topline results from Eisai’s large global phase 3 confirmatory Clarity AD clinical trial of lecanemab to treat mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. Lecanemab is an […] September 29, 2022 - 6 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 28 Sep 2022 Ilya Pharma enrols first patient in diabetic foot ulcer study Ilya Pharma AB says the first patients have been enrolled in a phase II study for its lead candidate ILP100-Topical in patients with diabetic foot ulcers. Overall, up to 13% of patients with diabetes mellitus of any type develop non-healing ulcers, a physical and psychological disabling condition, where infection of such wound results in a […] September 28, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 27 Sep 2022 Protocol for treatment of neurotrophic keratopathy submitted to FDA by ReGenTree Protocol for a second phase 3 clinical trial for a treatment for neurotrophic keratopathy (NK) – a degenerative disease of the corneal epithelium resulting from impaired corneal innervation, has been submitted. RegeneRx Biopharmaceuticals reported that its U.S. joint venture partner and licensee, HLB Therapeutics, together called ReGenTree, made the submission to the U.S. Food and […] September 27, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 27 Sep 2022 Bioheng Biotech has positive CAR-T cell therapy results published in academic journal Positive results from a phase 1 clinical study of RD13-01, an anti-CD7 universal CAR-T therapy product, have been published in reputable academic journal, Cell Research. China-based Bioheng Biotech Co. Ltd, a clinical-stage biotechnology company focused on developing novel cellular immunotherapy made the announcement today (September 27). The results published with the title of ‘CD7-targeted allogeneic CAR-T […] September 27, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 27 Sep 2022 Angel Pharma announces approval of IND application for clinical trial of mupadolimab Approval of an investigational new drug (IND) application for mupadolimab has been granted by the Center for Drug Evaluation (CDE) to initiate a phase 1/1b clinical trial in China. Angel Pharma, a clinical stage biopharmaceutical company owns the rights to mupadolimab in Greater China. Mupadolimab is a humanized monoclonal antibody directed against CD73. In preclinical […] September 27, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 26 Sep 2022 Acticor Biotech enrolls first U.S. patient in study for people with acute ischemic stroke The first U.S. patient was enrolled in a study evaluating glenzocimab in those with acute ischemic stroke. Acticor Biotech, a clinical stage biotech company, made the announcement today (September 26). The patient was enrolled at the CHI Memorial Stroke and Neuroscience Center, Chattanooga, Tennessee, by neurologist, Ruchir Shah. Significant potential He said: “I am very […] September 26, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 26 Sep 2022 TILT and MSD working on immunotherapy trial for non-small cell lung cancer TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapies, has signed a second clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ, USA, for a new clinical trial evaluating TILT-123, its oncolytic adenovirus armed with two human cytokines, in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy. The […] September 26, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email