WALTHAM, Mass. — Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced 510(k) clearance of the EXENT® Analyser and Immunoglobulin Isotypes (GAM) Assay**, a first-of-its-kind automated platform for clinical laboratories. The EXENT System combines enhanced sensitivity and automation to provide accurate results, helping clinicians make...
treatment News
LANCASTER, Pa. — On October 27, 2023, the third International Limb Girdle Muscular Dystrophy (LGMD) Conference will be hosted by The Speak Foundation at the Grand Hyatt Washington, DC. The inaugural International LGMD conference was held in Chicago in 2019 and over 400 patients, caregivers, physicians, researchers and advocacy groups...
Wellington, New Zealand – The Malaghan Institute of Medical Research in collaboration with Wellington Zhaotai Therapies Limited today announced results of its phase 1 dose escalation trial of a new third generation anti-CD19 chimeric antigen receptor (CAR) T-cell therapy was presented at the American Society of Hematology (ASH) Annual Meeting...
By Raffaele Pereno STOCKHOLM, Sweden – Reporting at BioEurope 2024, CheckOrphan had the opportunity to meet a promising biotech company, whose lead product seeks to stop the progression of amyotrophic lateral sclerosis (ALS) in its tracks. Tikomed AB is a privately owned pharmaceutical company based in Viken, Sweden. Adam Bruce,...
Primary Endpoint Met: Statistically significant reduction in heavy menstrual bleeding achieved in all dosage of Merigolix groups compared to placebo Broader Therapeutic Potential: Positive Phase 2 results in both uterine fibroids and endometriosis could place Merigolix as a strong best-in-class candidate for novel drug approval and global licensing opportunities Multi-Indication Development: Clinical trials...
SEONGNAM, South Korea — On Friday, 7 November (local time) at the Society for Immunotherapy of Cancer (SITC) 2025 annual meeting, Tiumbio Co., Ltd. (KOSDAQ: 321550), a clinical-stage biopharmaceutical company dedicated to developing novel therapies for rare and intractable diseases, today shared the interim Phase II clinical data for its “first-in-class” Tosposertib...
COPENHAGEN, Denmark — Genmab A/S (Nasdaq: GMAB) and Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic...
TIVDAK® is the first and only antibody-drug conjugate (ADC) approved for patients with advanced or recurrent cervical cancer in Japan Approval is based on results from the global Phase 3 innovaTV 301 trial, in which TIVDAK demonstrated superior overall survival compared to chemotherapy Rising cervical cancer incidence and mortality rates...
FREMONT, Calif. —Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company, today announced it has received, from Statera Biopharma, two investigational new drug applications (INDs) for its lead candidate, Entolimod™. The two INDs cover the use of Entolimod to treat acute radiation syndrome, including both hematopoietic (ARS-H) and gastrointestinal...
Meaningful Fatigue score reduction seen in study is a critically important quality of life (QoL) measure for Multiple Sclerosis patients. All patients experienced stabilization of Expanded Disability Status Scale (EDSS) scores. TSPO-PET imaging showed significant reductions in microglial activation at six months (p<0.05). NEW YORK, NY — Tiziana Life Sciences,...