MELBOURNE, Australia – Neuren Pharmaceuticals Limited (ASX: NEU) has received clear and constructive guidance from the FDA Office of Neuroscience in pre-IND meetings for Phase 2 clinical trials of NNZ-2591 in Phelan-McDermid, Angelman and Pitt Hopkins syndromes. All three syndromes are serious neurological disorders that emerge in early childhood and have no...
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New York, NY – OS Therapies Inc. (NYSE American: OSTX)(“OS Therapies” or “the Company”), the world leader in listeria-based cancer immunotherapies, today announced that it held a successful Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the Phase 2b human clinical trial of OST-HER2 in the...
Data demonstrates the potential for INCA033989 to modify disease by directly inhibiting and eliminating oncogenic mutCALR cells, while sparing healthy cells and restoring normal blood cell production In high-risk patients with essential thrombocythemia (ET) with a CALR mutation (mutCALR), 86% of INCA033989-treated patients at doses 400 mg and above achieved...
Announcing the results of the TALENTACE study for unresectable hepatocellular carcinoma eligible for transarterial chemoembolization (TACE) without prior systemic treatment The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS), and overall survival (OS) is immature at the prespecified first interim...
STOCKHOLM – Swedish Orphan Biovitrum AB (publ) (Sobi™) and Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) (GLOBE NEWSWIRE) today reported positive top-line results from the phase 3 PRINCE study evaluating the efficacy and safety of pegcetacoplan in adults with paroxysmal nocturnal haemoglobinuria (PNH) who are treatment naïve, meaning they had not received a...
Bone marrow is the spongy tissue inside bone responsible for making red blood cells, white blood cells and platelets. Bone marrow failure syndromes lead to an increased risk of developing dangerous infections, anemia and an increased risk of blood cancers. Research led by Washington University School of Medicine in St....
Munich, Germany – Immune cells must learn not to attack the body itself. A team of researchers from the Technical University of Munich (TUM) and the Ludwig Maximilian University of Munich (LMU) has discovered a previously unknown mechanism behind this: other immune cells, the B cells, contribute to the “training”...
ATLANTA — UCB, a global biopharmaceutical company, will present a post hoc analysis of the EXXELERATE trial examining the efficacy of CIMZIA® (certolizumab pegol) and adalimumab in patients with rheumatoid arthritis (RA) with high rheumatoid factor (RF) levels. The data are being presented at the American College of Rheumatology (ACR)...
JERSEY CITY, N.J. – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced a post-hoc analysis of its Phase 3 edaravone study reviewing the results of intravenous (IV) edaravone treatment on disease progression milestones and events among people with amyotrophic lateral sclerosis (ALS). In the analysis, a risk reduction was observed...
Toronto, Canada – Researchers at Sinai Health have unearthed vital information about the relationship between insulin levels after eating and long-term heart and metabolic health. The research upends the notion that insulin surge following food intake is a bad thing. On the contrary – it could be an indicator of...