(IN BRIEF) Montes del Plata, a joint operation between Stora Enso and Arauco, has moved to fully talc-free pulp production since spring 2026, following a process that began in 2023 to identify alternatives to talc for controlling pitch formation in … Read the full press release
Posted in Agriculture, Business, Chemicals, Environment, Finland, Industrial, Law
Tagged 2023 initiative, 2024 testing, Arauco, BfR, Carolina Lima, cleaner product, customer response, eucalyptus pulp, eucalyptus resins, Europe, FDA, fibre products, Food and Drug Administration, food-contact regulations, forerunner position, future-proof solution, German Federal Institute for Risk Assessment, health expectations, industrial trials, laboratory testing, Montes del Plata, Montes del Plata Responds to Regulatory Expectations With Talc-Free Pulp, natural resins, organic pitch control additive, pitch control, pitch formation, process adjustments, product quality, production process, Pulp Industry, pulp production, regulatory expectations, regulatory scrutiny, safer pulp solution, Spring 2026, Stora Enso, Stora Enso and Arauco Replace Talc in Eucalyptus Pulp Production Process, sustainable materials, talc-free pulp, talc-free pulp production, Talc-Free Pulp Production at Montes del Plata Supports Cleaner Product Quality
(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) GSK licensor Hansoh Pharma has reported positive results from ARTEMIS-011, a pivotal phase III trial of risvutatug rezetecan, or Ris-Rez, in patients in China with relapsed osteosarcoma after at least two prior lines of systemic therapy. The trial … Read the full press release
Posted in Business, Healthcare, Pharma & Biotech, Science, United Kingdom
Tagged ADC, advanced sarcoma, ARTEMIS-011, B7-H3, B7-H3-targeted antibody-drug conjugate, breakthrough therapy designation, cancer treatment, chemotherapy, CHINA, EMA, EMBOLD Sarcoma-202, ES SCLC, Europe, European Medicines Agency, extensive-stage small-cell lung cancer, FDA, GSK, GSK Highlights Growing Late-Stage Evidence for B7-H3-Targeted ADC Ris-Rez, GSK plc, Hansoh Pharma, Hansoh Pharmaceutical Group Co Ltd, Hansoh Pharma’s ARTEMIS-011 Trial Shows Progression-Free Survival Benefit for Ris-Rez, Hesham Abdullah, Japan, Japan Ministry of Health Labour and Welfare, lung cancer, metastatic sarcoma, monoclonal antibody, oncology, orphan drug designation, osteosarcoma, overall survival, PFS, phase Ib II trial, Phase III Trial, pivotal trial, PRIME designation, Priority Medicines, progression-free survival, prostate cancer, pulmonary neuroendocrine carcinoma, refractory osteosarcoma, relapsed osteosarcoma, Ris Rez, Ris-Rez Delivers Positive Phase III Outcomes in Relapsed Osteosarcoma and Small-Cell Lung Cancer, risvutatug rezetecan, SCLC, Small cell lung cancer, solid tumours, topoisomerase inhibitor payload, United Kingdom, United States, unresectable sarcoma, US Food and Drug Administration
(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) The US Food and Drug Administration has accepted and granted Priority Review to Roche’s supplemental Biologics License Application for Enspryng, or satralizumab, in thyroid eye disease. The application is supported by data from the Phase 3 SatraGO-1 and … Read the full press release
Posted in Healthcare, Pharma & Biotech, Science, Switzerland, Technology
Tagged at-home treatment, autoimmune disease, Chugai, clinical activity score, clinical development, diplopia, Enspryng, Enspryng Could Become At-Home Subcutaneous Treatment Option for Thyroid Eye Disease, Enspryng Phase 3 Programme Shows Improvements in Key Thyroid Eye Disease Measures, FDA, FDA Priority Review Supports Roche’s Planned Expansion of Enspryng Into Thyroid Eye Disease, Graves’ ophthalmopathy, IL-6 receptor, Levi Garraway, neuromyelitis optica spectrum disorder, NMOSD, ophthalmology, Phase 3 clinical trial, Priority Review, proptosis, rare disease, regulatory submission, Roche, SatraGO-1, SatraGO-2, satralizumab, sBLA, subcutaneous treatment, supplemental Biologics License Application, TED, thyroid eye disease, US Food and Drug Administration
(IN BRIEF) The Institute of Cancer Research, London, has welcomed the US FDA approval of capivasertib for patients with PTEN-deficient advanced prostate cancer, marking the first regulatory approval of the targeted drug in prostate cancer. Capivasertib blocks AKT, a cancer-driving … Read the full press release
Posted in Business, Education, European Union, Healthcare, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged 3D protein structure, abiraterone, advanced cancer, advanced prostate cancer, AKT inhibitor, AKT pathway, AKT1 mutations, Astex Pharmaceuticals, AstraZeneca, breast cancer, cancer cell growth, cancer cell survival, cancer progression, Cancer Research Technology Limited, Cancer Research UK, CAPItello-281 trial, CAPItello-291 trial, capivasertib, Capivasertib Gains First Prostate Cancer Approval Following Decades of ICR-Led AKT Research, Centre for Cancer Drug Discovery, drug discovery, European Union, FDA, FDA Approval of Capivasertib Marks New Targeted Treatment Option for Advanced Prostate Cancer, fragment-based drug design, fulvestrant, HER2-negative breast cancer, HR-Positive Breast Cancer, ICR, ICR Welcomes FDA Approval of Capivasertib for PTEN-Deficient Advanced Prostate Cancer, ICR Welcomes Milestone FDA Decision for Targeted Therapy in PTEN-Deficient Prostate Cancer, Nature Communications, Nice, oncology research, overall survival, Phase III Trial, PI3 kinase pathway, PIK3CA mutations, precision oncology, Professor Kristian Helin, Professor Paul Workman, prostate cancer patients, prostate cancer treatment, PTEN-deficient prostate cancer, PTEN-deficient tumours, regulatory approval, small molecule inhibitors, targeted therapy, The Institute of Cancer Research, United Kingdom
(IN BRIEF) Roche has announced that the US FDA has accepted its supplemental Biologics License Application for Lunsumio VELO, a subcutaneous formulation of mosunetuzumab, in combination with Polivy for adults with relapsed or refractory large B-cell lymphoma, including diffuse large … Read the full press release
Posted in Business, European Union, Healthcare, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged antibody-drug conjugate, ASCO Annual Meeting, Basel, CD20xCD3 bispecific antibody, CD79b, CELESTIMO, chemotherapy-free regimen, community oncology, crs, cytokine release syndrome, diffuse large B-cell lymphoma, DLBCL, European Hematology Association Congress, FDA, FDA Filing Acceptance Brings Roche’s Chemotherapy-Free Lymphoma Combination Closer to Potential Approval, follicular lymphoma, gemcitabine, haematology, LBCL, Levi Garraway, Lunsumio, Lunsumio VELO, Lunsumio VELO and Polivy Combination Shows 59 Percent Risk Reduction in Roche’s FDA Filing for LBCL, lymphoma care, Lymphoma Research Foundation, MabThera®, Meghan Gutierrez, Mission Cancer and Blood, MorningLyte, mosunetuzumab, Non-Hodgkin lymphoma, outpatient-ready treatment, oxaliplatin, PFS, Phase III Trial, polatuzumab vedotin, Polivy, progression-free survival, R-GemOx, relapsed or refractory large B-cell lymphoma, Rituxan, rituximab, Roche, Roche Reports FDA Acceptance of sBLA Based on SUNMO Study Results in Relapsed or Refractory Large B-Cell Lymphoma, sBLA, SUNMO study, supplemental Biologics License Application, Switzerland, T-cell engaging bispecific antibody, Tara M Graff
(IN BRIEF) Comotomo is using BASF’s color-matched Ultrason® P 2010 in its next-generation baby bottle, combining the material performance of PPSU with Avient’s Colorant Chromatics™ high-temperature blue color formulation. The bottle features a silicone body with an over-molded ring made … Read the full press release
Posted in Apparel, Fashion & Beauty, Automotive, Aviation & Aerospace, Business, Chemicals, Food & Beverage, Healthcare, Industrial, Retail, Technology
Tagged aerospace components, automotive components, Avient, baby bottle, BASF, BASF Ultrason® P 2010 Helps Comotomo Enhance Safety, catering applications, chemical resistance, CHINA, Colorant Chromatics™, colored PPSU, Comotomo, Comotomo R&D Center, Comotomo Uses BASF Ultrason® and Avient Color Technology in Next-Generation Baby Bottle, consumer goods, dimensional stability, Durability and Design in New Baby Bottle, FC, FDA, food contact approval, GB, Hank Choi, heat resistance, high performance thermoplastics, high-temperature color formulation, household applications, impact strength, infant care products, next-generation baby bottle, over-molded ring, Performance Materials division, plastics industry, polyethersulfone, polyphenylsulfone, polysulfone, PPSU, silicone body, silicone overmolding, South Korea, superheated steam resistance, Ultrason®, Ultrason® P 2010
(IN BRIEF) GSK has announced that momelotinib, a differentiated JAK inhibitor marketed as Ojjaara or Omjjara in approved indications, has received orphan drug designations from the US Food and Drug Administration and the European Medicines Agency for the treatment of … Read the full press release
Posted in Business, European Union, Government, Healthcare, Law, Pharma & Biotech, Science, Technology, United Kingdom
Tagged activin A receptor type I, ACVR1, anaemia, ATLAS trial, bone marrow failure, clinical trial, clonal myeloid disorder, EHA Congress, EMA, European Hematology Association Congress, European Medicines Agency, FDA, GSK, GSK Advances Momelotinib Development Programme With Orphan Drug Designations for VEXAS Syndrome, GSK’s Momelotinib Receives US and EU Orphan Drug Designations for Rare VEXAS Syndrome, haemato-inflammatory condition, haematologic features, haematologic malignancy, hepcidin, JAK inhibitor, JAK1, JAK2, Janus kinase 1, Janus kinase 2, life-threatening disease, lung involvement, macrocytic anaemia, momelotinib, Momelotinib Gains Regulatory Support in US and EU as GSK Targets High Unmet Need in VEXAS Syndrome, myelofibrosis, neutrophilic dermatosis, ODD, Ojjaara, Omjjara, orphan drug designation, phase II/III trial, rare disease, rare disorder treatment, regulatory submissions, relapsing chondritis, rheumatologic features, splenomegaly, thrombocytopenia, UBA1 gene mutation, US Food and Drug Administration, uveitis, Vacuoles E1 enzyme X-linked Autoinflammatory Somatic syndrome, vasculitis, VEXAS syndrome
(IN BRIEF) Roche has received FDA acceptance under Priority Review for its New Drug Application for giredestrant as an adjuvant treatment for adults with ER-positive, HER2-negative stage I-III breast cancer. The FDA is expected to decide on the application by … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged adjuvant treatment, American Society of Clinical Oncology Congress, ASCO 2026, Basel, breast cancer research, CDK4/6 inhibitor, early stage breast cancer, endocrine therapy, ER-positive breast cancer, ESR1-mutated breast cancer, evERA Breast Cancer, everolimus, FDA, FDA Accepts Roche’s Giredestrant Application as Potential New Adjuvant Treatment for Early-Stage Breast Cancer, FDA Sets November 2026 Decision Date for Roche’s Giredestrant in Early-Stage ER-Positive Breast Cancer, giredestrant, HER2-negative breast cancer, hyaluronidase, iDFS, invasive disease-free survival, Levi Garraway, lidERA Breast Cancer, NDA, New Drug Application, oncology, overall survival, Palbociclib, PDUFA, pertuzumab, Phesgo, Prescription Drug User Fee Act, Priority Review, Roche, Roche Moves Forward With Giredestrant Filing in Curative-Intent Breast Cancer Treatment Setting, Roche Secures FDA Priority Review for Giredestrant in Early-Stage ER-Positive Breast Cancer, selective oestrogen receptor degrader, SERD, stage I breast cancer, stage II breast cancer, stage III breast cancer, targeted therapy, trastuzumab, United States Food and Drug Administration
(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
(IN BRIEF) GSK plc has received Orphan Drug Designation in Japan for its investigational antibody-drug conjugate risvutatug rezetecan (Ris-Rez) for the treatment of small-cell lung cancer, supported by early clinical data showing durable responses in patients with extensive-stage disease. SCLC, … Read the full press release
Posted in Business, Healthcare, Marketing, Pharma & Biotech, Science, Security & Safety, United Kingdom
Tagged antibody-drug conjugate, ARTEMIS-001, B7-H3, breakthrough therapy designation, clinical trials, colorectal cancer, EMA, ES SCLC, extensive stage SCLC, FDA, GSK, GSK advances investigational cancer therapy risvutatug rezetecan with sixth global designation supporting development in solid tumours, Hansoh Pharma, Japan Ministry of Health Labour and Welfare, lung cancer, oncology, orphan drug designation, Phase III Trial, PRIME designation, prostate cancer, Ris Rez, risvutatug rezetecan, SCLC, Small cell lung cancer
(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) Roche reported that its phase III MAJESTY trial met its primary endpoint, showing that treatment with Gazyva/Gazyvaro enabled significantly more patients with primary membranous nephropathy to achieve complete remission at two years compared with tacrolimus. The study also … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Security & Safety, Switzerland, Technology
Tagged anti-CD20 monoclonal antibody, autoimmune kidney disease, B cell depletion therapy, clinical trial phase III, European Medicines Agency, FDA, Gazyva, Gazyvaro, idiopathic nephrotic syndrome, immunology pipeline, kidney function preservation, lupus nephritis, MAJESTY study, MAJESTY Trial Success Positions Gazyva for Possible First Approval in Primary Membranous Nephropathy Treatment, obinutuzumab, primary membranous nephropathy, remission outcomes, renal disease research, Roche, systemic lupus erythematosus
(IN BRIEF) Sanofi has received Breakthrough Therapy designation from the U.S. FDA and orphan drug designation from Japan’s Ministry of Health, Labour and Welfare for rilzabrutinib (Wayrilz) in warm autoimmune hemolytic anemia, based on data from the ongoing LUMINA 2 … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Retail, Science, Security & Safety, Technology
Tagged Breakthrough Therapy, BTK inhibitor, clinical trials, FDA, FDA Grants Breakthrough Status to Sanofi’s Rilzabrutinib for Rare Blood Disorder, IgG4-related disease, immune thrombocytopenia, Japanese Ministry of Health Labour and Welfare, Karin Knobe, LUMINA 2, LUMINA 3, orphan drug, rare diseases, rilzabrutinib, Sanofi, Sanofi Advances Rilzabrutinib with Breakthrough and Orphan Designations in wAIHA, sickle cell disease, Tailored Covalency®, wAIHA, warm autoimmune hemolytic anemia, Wayrilz
(IN BRIEF) GSK announced that its B7-H3-targeted antibody-drug conjugate GSK5764227 (GSK’227) has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the treatment of pulmonary neuroendocrine carcinoma, including small-cell lung cancer (SCLC). The designation is supported … Read the full press release
Posted in Business, Healthcare, Investment, Pharma & Biotech, Science, Technology, United Kingdom
Tagged ADC, antibody-drug conjugate, ARTEMIS-001, B7-H3, breakthrough therapy designation, cancer research, EMA, EMA Grants Orphan Drug Designation to GSK’s B7-H3 Antibody-Drug Conjugate for Pulmonary Neuroendocrine Carcinoma, FDA, GSK, GSK Strengthens Oncology Pipeline With EMA Orphan Drug Status for GSK’227 in Small-Cell Lung Cancer, GSK5764227, GSK’227, immuno-oncology, lung cancer, NEC, ODD, oncology, oncology pipeline, orphan drug designation, PRIME designation, pulmonary neuroendocrine carcinoma, relapsed or refractory, SCLC, Small cell lung cancer, solid tumours, targeted therapy
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