News and Trends 14 Nov 2022 New therapy transitions toxic immune cells from harmful to healing to fight effects of hyperinflammation in children When we think about acute kidney injury (AKI) and multi-organ failure, we don’t often think about children. But approximately 4,000 pediatric patients in the U.S. each year have AKI requiring continual kidney replacement therapy (CKRT). These patient profiles are associated with long hospital stays, high morbidity and mortality (50%), and children who survive an AKI […] November 14, 2022 - 5 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
More News! 8 Nov 2022 JelloX Biotech helps doctors diagnose and treat cancer tumors with speed and accuracy Taiwan-based start-up, JelloX Biotech, says its products will help doctors diagnose and treat cancer tumors with speed and accuracy without an added strain on budgets. The company made its debut at Intel Innovation in September. JelloX has gained the attention of healthcare experts and pharmaceutical brands for its potential for the future of cancer pathology using […] November 8, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 8 Nov 2022 MedinCell’s partner AIC registers trial for drug for total knee replacement pain A partner of MedinCell, Arthritis Innovation Corporation (AIC), has registered a phase 3 trial to look into an alternative drug to deal with pain after total knee replacement (TKR). Arthritis Innovation Corporation conducts and finances all development activities of the drug F14, or mdc-CWM, being trialed. It was registered with the safety and efficacy study […] November 8, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
More News! 7 Nov 2022 Sensorion granted rare pediatric disease designation by FDA for lead therapy gene Sensorion has announced that the US Food and Drug Administration (FDA) has granted rare pediatric disease designation to its lead therapy gene candidate, OTOF-GT. The gene therapy is intended for the treatment of otoferlin gene mediated hearing loss. Sensorion’s OTOF-GT gene therapy development program aims to restore hearing in people living with otoferlin deficiency, one […] November 7, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 7 Nov 2022 TMRW Life Sciences FDA-approved tech will help more people start families Fertility technology company, TMRW Life Sciences Inc., has received FDA clearance for its latest technology that will help more people build families. The CryoRobot Select marks the latest milestone in the company’s expansion of its technology-enabled portfolio. USA-based TMRW says advances like theirs in assisted reproductive technology are helping people start families when they otherwise […] November 7, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 20 Oct 2022 Partnership formed to make drug for MoCD Type A available sooner Inceptua Early Access and Sentynl Therapeutics Inc., a U.S.-based biopharmaceutical company bringing therapies to patients living with rare diseases, have entered into a partnership. The partnership is to make Sentynl’s Nulibry available via an early access program for eligible patients with molybdenum cofactor deficiency (MoCD) Type A. MoCD Type A is a rapidly progressive autosomal […] October 20, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 20 Oct 2022 Healthy volunteer study for tablet to treat brain cancer open for recruitment A clinical stage drug company developing sulforaphane-based medicines for cancer treatment has started recruiting for a pharmacokinetic / pharmacodynamic trial in healthy volunteers (HV). Evgen Pharma plc also announced the start an investigator sponsored clinical study (ISS) for a glioblastoma program. The purpose of the HV study is to examine the performance of Evgen’s new […] October 20, 2022 - 4 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 13 Oct 2022 Plan launched to improve diversity of clinical trials Help to improve the equity of clinical trials by providing site-level participant demographic data including race, sex, age and ethnicity has been revealed. Medidata, a Dassault Systèmes company, has launched the intelligent trials diversity module. The new module will help sponsors and clinical research organizations (CROs) benchmark the diversity of their trials and identify sites […] October 13, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 12 Oct 2022 Boston Cell Standards wins FDA $510K clearance for anatomic pathology controls A company standardizing cancer diagnostic tissue testing with the first immunohistochemistry (IHC) laboratory reference standards has received $510,000 clearance from the U.S. Food and Drug Administration (FDA). The money will go towards Boston Cell Standards IHControls panel for evaluating breast cancers. The clearance represents regulatory approval. “IHControls represent a giant step forward in standardization in […] October 12, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 12 Oct 2022 SiSaf takes steps with FDA for RNA therapeutic to treat rare genetic skeletal disorders SiSaf Ltd, an RNA delivery and therapeutics company, is initiating the U.S. FDA Regulatory process to obtain orphan drug designation for SIS-101-ADO. SIS-101-ADO is a siRNA therapeutic for patients with autosomal dominant osteopetrosis type 2 (ADO2), a rare genetic skeletal disorder. The request for orphan drug designation and advancement through the regulatory process that SIS-101-ADO […] October 12, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 5 Oct 2022 FDA fast tracks Immutep non-small cell lung cancer candidate Immutep Limited says the United States Food and Drug Administration (FDA) has granted fast track designation to eftilagimod alpha (efti or IMP321) in combination with pembrolizumab for the treatment of first line non-small cell lung cancer (NSCLC). Efti is the company’s first-in-class soluble LAG-3 clinical stage candidate, which activates antigen presenting cells (APC) to engage […] October 5, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 5 Oct 2022 Transcenta monoclonal antibody gets FDA clearance Transcenta Holding Limited says its TST004 humanized monoclonal antibody targeting MASP2, has received IND clearance from the U.S. Food and Drug Administration (FDA). MASP2, mannose-binding protein-associated serine protease 2, is a key enzyme in the lectin pathway initiation of complement activation. Studies have shown that lectin pathway activation contributes to multiple human diseases such as […] October 5, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email