(IN BRIEF) AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application for Enhertu plus pertuzumab has been accepted for Priority Review by the FDA for the first-line treatment of HER2-positive metastatic breast cancer. The application is supported by data from the … Read the full press release
Posted in Business, Healthcare, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged ADC, antibody-drug conjugate, AstraZeneca, breakthrough therapy designation, cancer treatment innovation, Daiichi Sankyo, DESTINY-Breast09, Enhertu, Enhertu plus pertuzumab moves closer to first-line approval in HER2-positive metastatic breast cancer after FDA Priority Review acceptance, FDA, FDA grants Priority Review to Enhertu plus pertuzumab for 1st-line HER2-positive metastatic breast cancer following DESTINY-Breast09 success, HER2-positive breast cancer, Ken Takeshita, metastatic breast cancer, oncology, pertuzumab, Priority Review, progression-free survival, Real-Time Oncology Review, Susan Galbraith, THP regimen, trastuzumab deruxtecan
(IN BRIEF) GSK announced a $30 billion investment plan across the United States over the next five years, expanding its research, development, and supply chain infrastructure while creating hundreds of skilled jobs. The plan includes a $1.2 billion investment unveiled … Read the full press release
Posted in Business, Healthcare, Investment, Pharma & Biotech, Science, Technology, United Kingdom
Tagged AI technologies, asthma, biologics flex factory, biopharma manufacturing, cancer medicines, clinical trials, COPD, digital technologies, drug discovery, Emma Walmsley, GSK, GSK strengthens U.S. presence with next-generation biopharma factories and expanded clinical trial network, life sciences, Marietta Pennsylvania, New $1.2 billion Pennsylvania flex factory part of GSK’s five-year plan to expand American life sciences footprint, oncology, supply chain investment, United Kingdom, United States, Upper Merion Pennsylvania, vaccines, workforce expansion
(IN BRIEF) Cyted Health has raised USD 44 million in Series B financing led by EQT Life Sciences with participation from Advent Life Sciences, the British Business Bank, Morningside, BGF, and HCA Healthcare. The funds will accelerate Cyted’s commercial rollout … Read the full press release
Posted in Business, Environment, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, Netherlands, News, Science, Sweden, Technology, United Kingdom
Tagged Advent Life Sciences, BGF, biomarker testing, British Business Bank, Bruno Holthof, Cyted Health, EndoSign, EQT Life Sciences, esophageal cancer, gastroenterology, gastrointestinal diagnostics, HCA Healthcare, Marcel Gehrung, Morningside, NHS, oncology, partnership, Series B funding, sustainability, University of Cambridge, US expansion
(IN BRIEF) Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets) has received accelerated approval in China for patients with advanced NSCLC carrying HER2 mutations who have progressed after prior therapy. The approval is supported by Beamion-LUNG 1 data, which showed a 71% objective … Read the full press release
Posted in Business, Financial, Germany, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged AACR 2025, Beamion-LUNG 1, Beamion-LUNG 2, Boehringer Ingelheim, breakthrough therapy designation, CHINA, HER2 mutations, HERNEXEOS, New England Journal of Medicine, NMPA approval, non-small cell lung cancer, NSCLC, oncology, partnership, Shashank Deshpande, targeted therapy, tyrosine kinase inhibitor, Wu Yilong, zongertinib
(IN BRIEF) GSK has entered into a multi-programme development and licensing agreement with Hengrui Pharma to advance up to 12 innovative therapies, including HRS-9821, a potentially best-in-class PDE3/4 inhibitor currently in clinical trials for COPD. The deal includes $500 million … 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 AI-era medicine, biopharma partnership, Chronic obstructive pulmonary disease, clinical development, cloud healthcare, COPD treatment, drug innovation, drug pipeline, dry powder inhaler, Frank Jiang, global health, GSK, Hart-Scott-Rodino Act, Hengrui Pharma, HRS-9821, immunology, inflammation, licensing agreement, milestone payments, novel therapeutics, oncology, partnership, PDE3/4 inhibitor, pharmaceutical collaboration, phase I trials, respiratory medicine, Tony Wood
(IN BRIEF) AstraZeneca’s Trixeo Aerosphere has received a positive opinion from the EMA’s CHMP for use with a new propellant that offers a 99.9% reduction in Global Warming Potential compared to traditional formulations. Trixeo becomes the first pressurised metered-dose inhaler … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged Ambition Zero Carbon, AMPLIFY Phase III trial, AstraZeneca, Barbara Eichhorst, Breztri, BTK inhibitor, budesonide, Calquence, chemoimmunotherapy, CHMP, chronic lymphocytic leukaemia, climate action in pharma, clinical trial, CLL, COPD, Dave Fredrickson, EMA, environmental sustainability, European approval, European Commission approval, European Union, fixed-duration regimen, formoterol fumarate, Frederik Trinkmann, glycopyrronium, hematologic diseases, hematology, Honeywell, inhalers, leukemia, low GWP, next-generation propellant, obinutuzumab, oncology, pMDI, progression-free survival, Respiratory Care, Ruud Dobber, Susanna Palkonen, Sustainable Healthcare, treatment option, Trixeo Aerosphere, venetoclax
(IN BRIEF) Sanofi has secured European Commission approval for Sarclisa in combination with VRd as an induction treatment for newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant. The decision was based on part one of the GMMG-HD7 … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged autologous stem cell transplant, bortezomib, cancer treatment, clinical trials, dexamethasone, EU approval, front-line therapy, German-speaking Myeloma Multicenter Group, GMMG-HD7, hematologic malignancies, ICARIA-MM, IKEMA, IMROZ, isatuximab, lenalidomide, MRD negativity, Multiple Myeloma, Olivier Nataf, oncology, progression-free survival, Sanofi, Sarclisa, transplant-eligible, VRd
(IN BRIEF) Final overall survival results from AstraZeneca’s FLAURA2 Phase III trial confirm that combining Tagrisso with chemotherapy significantly improves survival for patients with first-line advanced EGFR-mutated NSCLC. The data reinforce Tagrisso as the foundational therapy in this setting, building … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged ADAURA trial, ADAURA2, adjuvant therapy, AstraZeneca, cancer survival, chemotherapy, EGFRm NSCLC, EMA, FDA, FLAURA2 trial, global clinical trial, LAURA trial, lung cancer treatment, NeoADAURA, non-small cell lung cancer, oncology, osimertinib, overall survival, Pasi A. Jänne, pemetrexed, platinum-based treatment, progression-free survival, Susan Galbraith, Tagrisso, targeted therapy
(IN BRIEF) AstraZeneca’s Calquence, in combination with venetoclax, with or without obinutuzumab, has been approved by the European Commission for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). The approval follows the positive results from the … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged AMPLIFY Phase III trial, AstraZeneca, Barbara Eichhorst, BTK inhibitor, Calquence, chemoimmunotherapy, chronic lymphocytic leukaemia, clinical trial, CLL, Dave Fredrickson, European Commission approval, European Union, fixed-duration regimen, hematologic diseases, hematology, leukemia, obinutuzumab, oncology, progression-free survival, treatment option, venetoclax
(IN BRIEF) CVC Strategic Opportunities II has successfully exited its investment in Genetic S.p.A., a pharmaceutical CDMO specializing in Respiratory, Ophthalmic, and Oncology therapeutic products. The exit sees NB Renaissance and NB Aurora joining the Pavese family as shareholders. Under … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Italy, Luxembourg, Management, Marketing, News, Pharma & Biotech, Science, Technology
Tagged CVC Strategic Opportunities II, exit, FRM Tax, Genetic S.p.A., international expansion, investment, NB Aurora, NB Renaissance, oncology, Ophthalmic, partnership, Pavese family, PedersoliGattai, pharmaceutical CDMO, pharmaceutical industry, Product Development, PwC, respiratory, Rocco Pavese, Rothschild & Co., strategic growth
(IN BRIEF) GSK has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Blenrep combinations to treat adults with relapsed or refractory multiple myeloma. The approval follows positive results from the DREAMM-7 and DREAMM-8 phase III trials, … Read the full press release
Posted in Business, Environment, Financial, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged anti-BCMA, antibody-drug conjugate, Blenrep, bortezomib, chemotherapy, clinical efficacy, clinical trials, DREAMM-7, DREAMM-8, global markets, GSK, Japan approval, Multiple Myeloma, oncology, orphan drug designation, overall survival, partnership, PDUFA, pomalidomide, progression-free survival, regulatory approval, sustainability, treatment options
(IN BRIEF) Evotec SE has reached key milestones in its molecular glue degrader collaboration with Bristol Myers Squibb, earning $75 million in performance- and program-based payments. The partnership, built on Evotec’s AI-driven drug discovery platforms and BMS’s CELMoD™ technology, continues … Read the full press release
Posted in Business, Financial, Germany, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology
Tagged AI drug discovery, biotech partnerships, Bristol-Myers Squibb, CELMoD, Cord Dohrmann, E3 ligase, Evotec, first-in-class, milestone payments, molecular glue degraders, oncology, PanOmics, partnership, pharmaceutical R&D, protein degradation, targeted therapies, unmet medical needs
(IN BRIEF) The Bavarian High-Tech Awards were presented for the first time by the Bavarian State Government and the Bavarian Academy of Sciences and Humanities to recognize emerging talents and distinguished researchers. Among the awards, the High-Tech Young Investigator Award, … Read the full press release
Posted in Artificial Intelligence (AI), Awards, Business, Education, Financial, Germany, Government, Healthcare, Industrial, Investment, Management, News, Science, Technology
Tagged 000 euros, 30, AI in Women's Health, Awards, Bavarian Academy of Sciences and Humanities, Bavarian High-Tech Awards, Bavarian State Government, BRCA1, BRCA2, Dr. Jacqueline Lammert, Dr. Markus Söder, Hercules Hall, High-Tech Graduate Award, High-Tech Young Investigator Award, Hightech Agenda Bayern, INNOVATION, large language models, leadership, Munich Residence, oncology, precision medicine, RESEARCH, Science Minister Markus Blume, technology investments, TUM University Hospital
(IN BRIEF) IO Biotech, a Danish med-tech company, has obtained €57.5 million in venture debt financing from the European Investment Bank, with backing from the European Commission’s InvestEU programme. The financing, structured in three committed tranches of up to €37.5 … Read the full press release
Posted in Banks, Denmark, European Union, Financial, Healthcare, Investment, Luxembourg, Pharma & Biotech, Technology
Tagged Amy Sullivan, cancer vaccine, clinical development, EIB, European Commission, immunotherapeutic, InvestEU, IO Biotech, IO102-IO103, Ioannis Tsakiris, market launch, med-tech, melanoma, oncology, Pharmaceutical, regulatory approval, T-Win® platform, venture debt
(IN BRIEF) On World Cancer Day, Servier reaffirms its commitment to the fight against cancer by focusing on oncology as a central part of its Research & Development efforts. The company emphasizes the importance of understanding the personal experiences of … Read the full press release
Posted in Business, Financial, France, Healthcare, Industrial, Investment, Management, News, Science, Technology
Tagged brain tumors, cancer burden, Cancer Prevention, cancer research, cancer treatments, cancer-related deaths, digestive cancers, Early Detection, educational resources, global rankings, hematological cancers, immuno-oncology, oncology, patient experience, patient experiences, PatientView, personalized care, rare cancers, research development, screening, Servier, SHAPE program, targeted therapies, therapeutic solutions, U.S., UICC, Union for International Cancer Control, United by Unique, World Cancer Day, World Cancer Day campaign
(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) UZ Leuven has secured a €230 million loan from the European Investment Bank (EIB) to support its expansion and modernization efforts as part of its “Health Sciences Campus 2.0” masterplan. The funding will be used to upgrade critical … Read the full press release
Posted in Banks, Belgium, Business, Economy, Environment, Financial, Government, Healthcare, Industrial, Infrastructure & Utilities, Investment, Luxembourg, Management, News, Science, Technology
Tagged ambulatory care, EIB, European Investment Bank, Flanders, Health Sciences Campus 2.0, innovation ecosystem, Intensive Care Units, knowledge economy, KU Leuven, nuclear medicine, oncology, operating theatres, partnership, patient care, Paul Herijgers, Pellenberg campus, research facilities, research infrastructure, Robert de Groot, social infrastructure, sustainability, UZ Leuven, VIPA, €230 million loan
(IN BRIEF) Sanofi’s Sarclisa has been approved by the European Union as the first anti-CD38 therapy in combination with VRd to treat adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. This approval is … Read the full press release
Posted in Business, European Union, Financial, France, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged CD38 monoclonal antibody, clinical development, clinical trials, European Union approval, FDA approval, hematologic malignancies, immunoscience, isatuximab, Multiple Myeloma, NDMM, oncology, orphan drug exclusivity, Sanofi, Sarclisa, transplant-ineligible, treatment breakthrough, VRd
(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
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