(IN BRIEF) Rilzabrutinib, an investigational oral BTK inhibitor, has received orphan drug designation from the FDA for treating warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD), two rare conditions with no approved treatments. This designation, aimed at addressing unmet … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged BTK inhibitor, clinical trials, FDA, IgG4-RD, IgG4-related disease, immune thrombocytopenia, ITP, multi-immune modulation, orphan drug designation, phase 2a study, phase 2b study, rare diseases, regulatory review, rilzabrutinib, Sanofi, unmet medical need, wAIHA, warm autoimmune hemolytic anemia
(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
(IN BRIEF) Roche has announced that the FDA has expanded the approval of its PATHWAY® HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test to identify HER2-ultralow status in HR-positive, HER2-negative metastatic breast cancer patients. This new approval offers a potential treatment … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged breast cancer, DESTINY-Breast06 trial, diagnostic solutions, Enhertu, FDA, FDA approval, HER2-Low, HER2-targeted therapy, HER2-Ultralow, HR-positive, metastatic breast cancer, PATHWAY HER2, Personalized Treatment, Roche, treatment options
(IN BRIEF) Sarclisa (isatuximab) has been approved in China for use in combination with the VRd regimen to treat newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant. The approval is based on positive results from … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged Approval, cancer treatment, CHINA, clinical trials, EU, FDA, global health, IMROZ study, isatuximab, Japan, Multiple Myeloma, Multiple Myeloma Treatment, new approvals, NMPA, oncology, Sanofi, Sarclisa, transplant-ineligible, VRd
(IN BRIEF) Henkel has launched two new light cure adhesives, Loctite AA 3952 and Loctite SI 5057, designed to address the challenges of bonding thermoplastic elastomers (TPEs) for medical devices. These adhesives ensure strong and reliable connections, meet stringent EU … Read the full press release
Posted in Business, Chemicals, Financial, Government, Healthcare, Industrial, Investment, Management, News, Science, Technology
Tagged Adhesive Solutions, Anaheim, biocompatibility, DEHP, EU MDR 2017, FDA, heat resistance, Henkel, humidity aging, industrial adhesives, ISO 10993, light cure adhesives, Loctite AA 3952, Loctite SI 5057, MD&M West 2025, medical device assembly, medical devices, patient safety, PVC alternatives, regulatory compliance, thermoplastic elastomers, TPE, TPE bonding
(IN BRIEF) GSK has announced that the European Medicines Agency (EMA) has accepted its regulatory application for a prefilled syringe presentation of Shingrix, its recombinant zoster vaccine (RZV) for preventing shingles. This new presentation simplifies administration for healthcare providers by … Read the full press release
Posted in Business, Healthcare, Pharma & Biotech, United Kingdom
Tagged adult immunisation, adult vaccination, EMA, European Medicines Agency, European Union, FDA, GSK, healthcare professionals, herpes zoster, herpes zoster prevention, liquid adjuvant, lyophilised antigen, post-herpetic neuralgia, post-herpetic neuralgia prevention, Prefilled Syringe, Recombinant Zoster Vaccine, reconstitution, regulatory application, RZV, Shingles, Shingrix, submission, U.S. FDA, vaccination, vaccine
(IN BRIEF) AstraZeneca’s Calquence (acalabrutinib) has been approved by the U.S. FDA for the first-line treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. The approval is based on … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged acalabrutinib, AstraZeneca, autologous hematopoietic stem cell transplantation, bendamustine, blood cancers, Bruton’s tyrosine kinase, BTK inhibitor, Calquence, chemoimmunotherapy, COVID-19, Dave Fredrickson, ECHO Phase III trial, FDA, global regulatory review, international markets, Lymphoma Research Foundation, mantle cell lymphoma, MCL, Meghan Gutierrez, Michael Wang, oncology, PFS, progression-free survival, Project Orbis, regulatory submission, rituximab, safety profile, U.S. approval
(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan has been accepted by the U.S. FDA for treating advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in patients who have previously received systemic therapies. The … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged advanced NSCLC, antibody-drug conjugate, AstraZeneca, Biologics License Application, BLA, breakthrough therapy designation, Daiichi Sankyo, datopotamab deruxtecan, drug approval, EGFR-mutated, EGFR-tyrosine kinase inhibitors, FDA, metastatic NSCLC, non-small cell lung cancer, NSCLC, objective response rate, oncology, partnership, Phase III Trials, Priority Review, safety profile, systemic therapies, TROP2-directed, TROPION-Lung01, TROPION-Lung05, TROPION-Lung14, TROPION-Lung15
(IN BRIEF) GSK has announced that the FDA has accepted its application to review a prefilled syringe version of Shingrix, its shingles vaccine. This new version, expected to be available from January 2025, eliminates the need for reconstitution, offering a … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged administration, adults 50 and over, antigen, AS01B adjuvant system, chickenpox, FDA, glycoprotein E, GSK, healthcare community, healthcare professionals, immune response, immunodeficiency, immunosuppression, liquid adjuvant, lyophilised, non-live vaccine, Prefilled Syringe, recombinant subunit vaccine, Recombinant Zoster Vaccine, reconstitution, RZV, safety, Shingles, shingles prevention, shingles vaccine, Shingrix, Shingrix approval, vaccine composition, Vaccine Innovation, vaccine presentation, vaccine safety, varicella, varicella-zoster virus
(IN BRIEF) The FDA has granted Breakthrough Therapy designation to tolebrutinib for treating adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS), following positive results from the HERCULES phase 3 study. The study showed tolebrutinib delayed disability progression by 31% and … Read the full press release
Posted in Business, Financial, France, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology
Tagged Dr. Erik Wallström, FDA, Progressive Multiple Sclerosis, safety, Sanofi, tolebrutinib
(IN BRIEF) AstraZeneca’s Imfinzi (durvalumab) has been granted Priority Review by the FDA for the treatment of muscle-invasive bladder cancer (MIBC), potentially becoming the first perioperative immunotherapy in this curative-intent setting. Supported by results from the NIAGARA Phase III trial, … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged AstraZeneca, bladder cancer, FDA, Imfinzi, Perioperative Immunotherapy, safety, Susan Galbraith
(IN BRIEF) QIAGEN’s QIAstat-Dx Meningitis/Encephalitis Panel has received FDA clearance, enabling faster and more accurate diagnosis of critical CNS infections like meningitis and encephalitis. This panel, the fourth QIAstat-Dx test approved in the U.S. in 2024, uses real-time PCR to … Read the full press release
(IN BRIEF) FluMist, a needle-free nasal spray influenza vaccine, has been approved by the FDA for self-administration in the US, making it the first flu vaccine of its kind to be used at home. Adults up to 49 years old … Read the full press release
(IN BRIEF) AstraZeneca’s Fasenra (benralizumab) has been approved by the US FDA for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated vasculitis that can be fatal without treatment. The approval is based on results from the MANDARA … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged Adrian Kemp, AstraZeneca, Dr. Michael Wechsler, Eosinophilic Granulomatosis with Polyangiitis (EGPA), Fasenra, FDA, Joyce Kullman, Ruud Dobber, safety, vasculitis
(IN BRIEF) Royal Philips announces the final agreement on a consent decree for its subsidiary, Philips Respironics, with the US Department of Justice (DOJ) and the US Food and Drug Administration (FDA). The decree primarily focuses on Respironics’ US operations, … Read the full press release
Posted in Business, Electronics & Machinery, Financial, Government, Healthcare, Industrial, Investment, Management, Netherlands, News, Security & Safety, Technology
Tagged DOJ, FDA, Philips, Philips Respironics, Roy Jakobs, safety, Steve C. de Baca
(IN BRIEF) Basilea Pharmaceutica Ltd, a biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for ZEVTERA® (ceftobiprole medocaril sodium for injection). The approval covers its use in adult patients with Staphylococcus aureus bloodstream infections (bacteremia), … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged Adesh Kaul, Basilea, David Veitch, Dr. Marc Engelhardt, FDA, Pediatric Use, safety, Severe Bacterial Infections, Thomas Holland, Vance G. Fowler, Zevtera®
(IN BRIEF) Borealis has received Letters of No Objection (LNOs) from the US Food & Drug Administration (FDA) for specific grades of its Borcycle™ M post-consumer recycled plastics (PCR) to be used in food-grade packaging. This milestone underscores Borealis’ commitment … Read the full press release
(IN BRIEF) Fresenius Kabi announces FDA approval of Tyenne® (tocilizumab-aazg), the first tocilizumab biosimilar offering both IV and subcutaneous formulations. This marks a significant milestone in the company’s growth strategy (#FutureFresenius) and expands treatment options for inflammatory, autoimmune diseases, and … Read the full press release
Posted in Business, Germany, Healthcare, Pharma & Biotech
Tagged #FutureFresenius, Actemra®, autoimmune diseases, Biosimilar, Cancer, cancer treatment, FDA, Food and Drug Administration, Fresenius Kabi, Genentech, Idacio®, inflammatory, inflammatory diseases, IV, IV formulation, Stimufend®, Subcutaneous formulation, subcutaneous tocilizumab biosimilar, tocilizumab, tocilizumab biosimilar, tocilizumab-aazg, Tyenne®
(IN BRIEF) In early 2024, Europe’s medical and research communities announced major breakthroughs in cancer care, highlighting new treatments like AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for lung and breast cancer, and AstraZeneca’s Tagrisso for EGFR-mutated lung cancer. Diagnostic advancements … Read the full press release
Posted in Finland, Germany, Healthcare, Insurance, News, Pharma & Biotech, Science, Society, Switzerland, Technology, United Kingdom
Tagged accessible cancer solutions, AstraZeneca, Aviva, BioNTech, breast cancer, breast cancer screening, cancer care, cancer diagnostics, cancer prevention awareness, cancer research, cancer treatment, colorectal cancer, Daiichi Sankyo, datopotamab deruxtecan, Duality Biologics, Eckert & Ziegler, EMA, FDA, genetic risk information, Inspirna, lung cancer, Merck KGaA, multi-cancer early detection, neuroendocrine neoplasms diagnostics, Novartis, ompenaclid, oncology, polygenic risk score, preventive healthcare, Professor Tim Maughan, ReSisTrace methodology, Stage III EGFR-mutated lung cancer, Swiss Re Institute, Tagrisso, treatment-resistant cancer cells, University of Helsinki, University of Liverpool
(IN BRIEF) AstraZeneca’s Tagrisso receives FDA approval for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) following a Priority Review. The decision is based on FLAURA2 Phase III trial results demonstrating that Tagrisso plus … Read the full press release
Posted in Business, Education, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged Adrian Kemp, AstraZeneca, chemotherapy, Dave Fredrickson, EGFR-mutated lung cancer, FDA, Laurie Ambrose, Pasi A. Jänne, Tagrisso
EuropaWire (EW) is the first truly pan-European and leading press release distribution and newswire service for Europe and the European Union working towards consolidating Europe’s voice on the global newswire and media scene. The newswire service comes with advanced submission forms, flexible pricing and PR budgeting, granular targeting, nearly uncapped reach across countries, markets, verticals, industries, audiences, languages, etc., translation and localisation for greater local PR impact, in-depth distribution reporting, metrics and insights including measured PR reach, reads, engagements, impact, etc., no cap on words, images and multimedia to go along with your release, among others. Your press releases will be seen among the releases of Europe’s biggest and most prominent companies, brands and institutions.
HOW TO GET STARTED?