(IN BRIEF) QIAGEN has received U.S. FDA clearance for the QIAstat-Dx BCID GPF Plus AMR Panel, its first QIAstat-Dx bloodstream infection panel cleared for the U.S. market. The panel detects 20 gram-positive bacterial and fungal pathogen targets, a broad pan … Read the full press release
Posted in Business, Germany, Government, Healthcare, Netherlands, Pharma & Biotech, Science, Technology
Tagged 100 countries, 200 placements, 5, AMR, antibiotic use, antimicrobial resistance markers, antimicrobial stewardship, bloodstream infection diagnostics, bloodstream infections, clinical decision making, data analysis, FDA, FDA Clears QIAGEN QIAstat-Dx Panel for Rapid Bloodstream Infection Testing, FDA review, Frankfurt Prime Standard, fungal pathogens, gastrointestinal panel, genetic resistance markers, Germantown, gram-positive bacteria, infection prevention, infectious disease testing, laboratory diagnostics, Maryland, meningitis encephalitis panel, Molecular Diagnostics, multiplex PCR, Netherlands, Nitin Sood, one-hour results, pan gram-negative target, pathogen detection, positive blood cultures, QGEN, QIA, QIAGEN, QIAGEN Launches First FDA-Cleared QIAstat-Dx BCID Panel for U.S. Laboratories, QIAstat-Dx, QIAstat-Dx BCID GN Plus AMR Panel, QIAstat-Dx BCID GPF Plus AMR Panel, QIAstat-Dx BCID GPF Plus AMR Panel Detects Pathogens and Resistance Markers in About One Hour, QIAstat-Dx Gastrointestinal Panel 2, QIAstat-Dx GI Panel 2 Mini B, QIAstat-Dx GI Panel 2 Mini B&V, QIAstat-Dx Meningitis/Encephalitis Panel, QIAstat-Dx Respiratory Panel Mini, QIAstat-Dx Respiratory Panel Plus, rapid testing, respiratory panel, sample preparation, SEPSIS, syndromic testing, U.S. Food and Drug Administration, U.S. laboratories, Venlo
(IN BRIEF) Fresenius Kabi, an operating company of Fresenius, has announced that the U.S. FDA has approved a rituximab biosimilar developed by Dr. Reddy’s Laboratories for the U.S. market. Under an exclusive commercialisation agreement, Fresenius Kabi holds the U.S. commercialisation … Read the full press release
Posted in Business, Germany, Government, Healthcare, Pharma & Biotech, Science
Tagged #FutureFresenius, affordable biologic therapies, analytical data, autoimmune diseases, B cells, B lymphocytes, B-cell malignancies, Bad Homburg v. d. Höhe, biologic medicines, biopharma, biopharmaceuticals, Biosimilar, biosimilars portfolio, CD20 antigen, chronic lymphocytic leukemia, clinical data, clinical nutrition, Dr. Eduard Fresenius, Dr. Reddy’s, Dr. Reddy’s Laboratories, Dr. Sang-Jin Pak, Else Kröner, Else Kröner Fresenius Foundation, exclusive commercialisation agreement, FDA, FDA approval, FDA Approves Dr. Reddy’s Rituximab Biosimilar for U.S. Commercialisation by Fresenius Kabi, Fresenius, Fresenius Helios, Fresenius Kabi, Fresenius Kabi Announces FDA Approval of Rituximab Biosimilar for U.S. Market, Fresenius Kabi Strengthens U.S. Biosimilars Portfolio With Rituximab Approval, Fresenius Medical Care, Fresenius SE & Co KGaA, Genentech, Germany, GPA, granulomatosis with polyangiitis, hematologic malignancies, immunology, intravenous generic drugs, medical technology, microscopic polyangiitis, monoclonal antibody, MPA, Nicole Meier, non-clinical data, Non-Hodgkin lymphoma, oncology, patient access, pharmacokinetic studies, rheumatoid arthritis, Rituxan, rituximab, rituximab biosimilar, totality of the evidence, U.S. Food and Drug Administration, U.S. market
(IN BRIEF) Basilea Pharmaceutica has received an additional USD 30 million from BARDA to support the ongoing phase 3 development of fosmanogepix, its novel first-in-class broad-spectrum antifungal candidate. The funding was awarded after Basilea met a prespecified enrolment milestone and … Read the full press release
Posted in Business, Financial, Government, Healthcare, Pharma & Biotech, Science, Switzerland
Tagged Administration for Strategic Preparedness and Response, agreement number 75A50124C00033, Allschwil, antifungal treatment, aspergillosis, Aspergillus, ASPR, azole-resistant strains, BAL2062, BARDA, Basilea Pharmaceutica, Basilea Pharmaceutica Ltd, Basilea Secures New BARDA Tranche After Phase 3 Enrolment Milestone, Basilea Strengthens Antifungal Pipeline Funding Under Existing BARDA Agreement, Biomedical Advanced Research and Development Authority, broad-spectrum antifungal, Candida glabrata, Candida auris, candidemia, candidiasis, David Veitch, FAST study, Fast Track Designation, FDA, first in class antifungal, FORWARD study, fosmanogepix, Fosmanogepix Development Advances With Additional USD 30 Million BARDA Support, Fusarium, HHS, immunocompromised patients, invasive aspergillosis, invasive candidiasis, invasive fungal infections, Mucorales, multidrug-resistant fungal infections, orphan drug designation, OTA, Other Transaction Agreement, Phase 3 development, QIDP, Qualified Infectious Disease Product, Scedosporium, Switzerland, U.S Department of Health and Human Services, U.S. Food and Drug Administration, United States, USD 268 million potential non-dilutive funding, USD 30 million funding, USD 93 million committed funding
(IN BRIEF) Novartis has received FDA traditional approval for Fabhalta® (iptacopan) to slow kidney function decline in adults with primary IgA nephropathy at risk of disease progression. Fabhalta is a first-in-class complement inhibitor targeting the alternative complement pathway. The approval … Read the full press release
Posted in Business, Healthcare, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged accelerated approval, alternative complement pathway, APPLAUSE-IgAN, atrasentan, autoimmune kidney disease, Bonnie Schneider, Chronic kidney disease, complement inhibitor, Dana Rizk, dialysis, EGFR, encapsulated bacteria, Fabhalta, Fabhalta Approval Expands Targeted Treatment Options for Patients With Primary IgAN, Fabhalta Becomes First Complement Inhibitor Approved to Significantly Slow Kidney Function Decline in Primary IgAN, Factor B inhibitor, FDA, glomerular inflammation, IgA nephropathy, IgA Nephropathy Foundation, IgAN, iptacopan, kidney failure, kidney function decline, kidney transplantation, nephrology, Novartis, Novartis Highlights Kidney Function Preservation Data Behind Fabhalta FDA Approval, primary IgAN, Priority Review, proteinuria, rare kidney conditions, REMS programme, traditional approval, U.S. Food and Drug Administration, University of Alabama at Birmingham, Vanrafia, Victor Bultó, zigakibart
(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) AstraZeneca has secured FDA approval for a new subcutaneous autoinjector version of Saphnelo, enabling once-weekly self-administration for adults with systemic lupus erythematosus. The approval is based on Phase III trial results showing significant reductions in disease activity compared … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged anifrolumab, AstraZeneca, AstraZeneca introduces new subcutaneous Saphnelo delivery method to improve convenience and outcomes in lupus care, autoimmune disease, autoinjector, biologic therapy, Bristol-Myers Squibb, clinical trials, FDA, Healthcare Innovation, Louise Vetter, Lupus Foundation of America, Medarex, Ruud Dobber, Saphnelo, SLE, Susan Manzi, systemic lupus erythematosus, TULIP-SC, U.S. Food and Drug Administration
(IN BRIEF) Roche has reached a key regulatory milestone with the FDA’s acceptance of its application for Gazyva/Gazyvaro as a treatment for systemic lupus erythematosus. The submission is based on strong phase III trial data showing significant improvements in disease … Read the full press release
Posted in Healthcare, Industrial, Pharma & Biotech, Science, Switzerland, Technology
Tagged Albert T. Roy, ALLEGORY study, anti-CD20 therapy, autoimmune disease, B cells, biologics, clinical research, disease activity, FDA, FDA Filing Acceptance Marks Significant Step for Roche in Developing Targeted Therapy for Lupus Patients, Gazyva, Gazyvaro, Healthcare Innovation, immunology, Levi Garraway, lupus nephritis, Lupus Research Alliance, obinutuzumab, Phase III Trial, remission, Roche, Roche Advances New Treatment Option for Lupus as FDA Accepts Filing for Gazyva Based on Phase III Data, SLE, systemic lupus erythematosus, U.S. Food and Drug Administration
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