(IN BRIEF) Basilea Pharmaceutica has received an additional USD 13.3 million from BARDA to continue development of ceftibuten-ledaborbactam etzadroxil, an investigational oral beta-lactam/beta-lactamase inhibitor antibiotic being developed for complicated urinary tract infections, including pyelonephritis. The latest tranche brings BARDA’s total … Read the full press release
Posted in Business, Economy, Financial, Government, Healthcare, Industrial, Management, Marketing, Pharma & Biotech, Science, Switzerland, Technology, Transportation & Logistics
Tagged Administration for Strategic Preparedness and Response, Allschwil, antibiotic resistance, antimicrobial resistance, ASPR, BARDA, BARDA Funding Supports Basilea’s Efforts to Address Unmet Need in Oral Treatment of Complicated Urinary Tract Infections, Basilea, Basilea Pharmaceutica Ltd, Basilea Receives Additional USD 13.3 Million BARDA Funding to Advance Novel Oral Antibiotic Development, Basilea Secures Additional Non-Dilutive Funding to Prepare Ceftibuten-Ledaborbactam for Phase 3 Development, Basilea Secures Additional USD 13.3 Million BARDA Funding to Advance Development of Novel Oral Antibiotic Ceftibuten-Ledaborbactam, beta-lactam, beta-lactamase inhibitor, Biomedical Advanced Research and Development Authority, BL/BLI combination, carbapenemases, ceftibuten, ceftibuten ledaborbactam etzadroxil, ceftibuten-ledaborbactam, cephalosporinases, complicated urinary tract infections, cUTI, David Veitch, Enterobacterales, ESBL, extended spectrum beta-lactamases, Fast Track Designation, Gram-negative bacteria, infectious diseases, KPC, ledaborbactam etzadroxil, MDR Enterobacterales, multidrug resistant bacteria, non-dilutive funding, novel oral antibiotic, OXA-48, phase 3 programme, pyelonephritis, QIDP designation, Qualified Infectious Disease Product, SIX: BSLN, Switzerland, U.S Department of Health and Human Services, U.S. FDA
(IN BRIEF) Sanofi has received FDA priority review for the new drug application for venglustat, an investigational oral glucosylceramide synthase inhibitor being developed for type 3 Gaucher disease. The FDA’s target action date is 25 November 2026. If approved, venglustat … Read the full press release
Posted in European Union, France, Healthcare, Marketing, Pharma & Biotech
Tagged adult patients, ataxia, biopharma, blood-brain barrier, breakthrough therapy designation, central nervous system, cerebrospinal fluid, cognitive deficits, enzyme replacement therapy, ERT, EURONEXT: SAN, Fabry disease, Fast Track Designation, FDA, Gaucher disease, GCSi, GD3, GL1, glucosylceramide synthase inhibitor, glycosphingolipids, GSL, haemoglobin, LEAP2MONO, liver volume, lyso-GL1, lysosomal storage disease treatments, lysosomal storage disorder, Nasdaq SNY, NCT05222906, NDA, neuroinflammation, neurological manifestations, New Drug Application, orphan designation, paediatric patients, Paris, phase 3 study, platelet count, Priority Review, rare diseases, Sanofi, Sanofi Builds Rare Disease Pipeline as FDA Accepts Venglustat Application for Priority Review in GD3, Sanofi’s Venglustat Could Become First U.S. Treatment Targeting Neurological Symptoms of Type 3 Gaucher Disease, Sanofi’s Venglustat Receives FDA Priority Review for Potential Treatment of Type 3 Gaucher Disease, Sanofi’s Venglustat Receives FDA Priority Review for Type 3 Gaucher Disease Treatment in the United States, spleen volume, type 3 Gaucher disease, U.S. Food and Drug Administration, venglustat, WORLDSymposium
(IN BRIEF) Sanofi has received Breakthrough Therapy designation from the US FDA for venglustat, an investigational oral drug targeting neurological symptoms of type 3 Gaucher disease, a rare genetic disorder with no approved treatments for its neurological manifestations. The designation … Read the full press release
Posted in European Union, France, Healthcare, Marketing, Pharma & Biotech
Tagged biotechnology, clinical trials, enzyme replacement therapy, Fast Track Designation, FDA, Gaucher disease type 3, GD3, imiglucerase, Karin Knobe, LEAP2MONO, lysosomal storage disorder, orphan drug, rare disease, Sanofi, Sanofi Strengthens Pipeline with Venglustat Following FDA Breakthrough Designation for Rare Neurological Disorder, US Food and Drug Administration, venglustat
(IN BRIEF) Novartis has reported landmark Phase III results showing that ianalumab significantly reduced disease activity in patients with Sjögren’s disease, meeting primary endpoints in both the NEPTUNUS-1 and NEPTUNUS-2 trials. The treatment, which combines B-cell depletion and BAFF-R inhibition, … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged autoimmune disease, B cell depletion, BAFF-R inhibition, biopharmaceuticals, clinical trial results, ESSDAI, Fast Track Designation, ianalumab, immunology research, MorphoSys AG, NEPTUNUS-1, NEPTUNUS-2, Novartis, Shreeram Aradhye, Sjögren’s disease, systemic autoimmune disorder, targeted therapy, US FDA, VAY736
(IN BRIEF) Sanofi’s mRNA vaccine candidate for chlamydia has been granted fast track designation by the US FDA, reflecting its promising potential to address a significant public health issue. Designed to protect against primary and recurrent infections caused by Chlamydia … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged asymptomatic infection, chlamydia, Chlamydia trachomatis, Fast Track Designation, Griffith University, immunogenicity, infertility, Jean-François Toussaint, mRNA vaccine candidate, pelvic inflammatory disease, phase 1/2 clinical study, pregnancy complications, public health need, Queensland Government, safety, Sanofi, Translational Science Hub, University of Queensland, US Food and Drug Administration
(IN BRIEF) Novartis has announced its acquisition of Anthos Therapeutics, a Boston-based biopharmaceutical company focused on developing abelacimab, an investigational monoclonal antibody currently in Phase 3 trials for preventing stroke and systemic embolism in patients with atrial fibrillation. This acquisition … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged abelacimab, acquisition, Anthos Therapeutics, anticoagulation, atrial fibrillation, biopharmaceutical company, Blackstone Life Sciences, bleeding reduction, Boston, cancer-associated thrombosis, cardiovascular, cardiovascular therapeutic area, clinical-stage, David Soergel, Factor XI inhibition, Fast Track Designation, FDA, medical research, Novartis, partnership, Phase 3 trials, regulatory milestones, Shreeram Aradhye, stroke prevention, systemic embolism, therapeutic focus, thrombosis
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