(IN BRIEF) GSK has formed an exclusive partnership with Sino Biopharmaceutical subsidiary Chia Tai Tianqing Pharmaceutical Group to accelerate the launch of bepirovirsen, a potential first-in-class treatment for chronic hepatitis B, in mainland China. The agreement combines GSK’s drug innovation … Read the full press release
Posted in Healthcare, Marketing, Pharma & Biotech, Science, United Kingdom
Tagged antisense oligonucleotide, B-Well 1, B-Well 2, Bepirovirsen, biotechnology, breakthrough therapy designation, Chia Tai Tianqing Pharmaceutical Group, China healthcare, chronic hepatitis B, CTTQ, Exclusive GSK Agreement with SBP Group Targets Faster Rollout of Investigational Hepatitis B Therapy, functional cure, global biopharma, GSK, GSK and CTTQ Form Strategic Collaboration to Expand Access to Bepirovirsen Across China, healthcare partnerships, hepatitis B treatment, hepatitis B virus, hepatology, Ionis Pharmaceuticals, liver cancer, liver disease, Mike Crichton, pharmaceutical collaboration, Phase III Trials, Priority Review, regulatory review, SBP Group, Sino Biopharmaceutical, viral hepatitis
(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) GSK and Alfasigma have signed a licensing agreement granting Alfasigma worldwide exclusive rights to develop, manufacture and commercialise linerixibat, an investigational IBAT inhibitor for the treatment of cholestatic pruritus in patients with primary biliary cholangitis. The therapy is … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Italy, Management, Marketing, Pharma & Biotech, Science, Technology, United Kingdom
Tagged Alfasigma, Alfasigma secures worldwide rights to linerixibat as GSK advances strategy in liver disease innovation, cholestatic pruritus therapy, drug development partnership, EU UK regulatory review, FDA approval process, Francesco Balestrieri, GLISTEN Phase III trial, global pharmaceutical collaboration, GSK, GSK partners with Alfasigma to advance linerixibat therapy for patients with primary biliary cholangitis, hepatology treatments, IBAT inhibitor, linerixibat, liver disease innovation, orphan drug designation, PBC treatment, pharmaceutical licensing agreement, primary biliary cholangitis, rare liver diseases, Tony Wood
(IN BRIEF) GSK has entered an agreement to acquire Canadian biotechnology company 35Pharma for $950 million in order to strengthen its pipeline of therapies for pulmonary hypertension and related cardiopulmonary diseases. The acquisition includes HS235, an investigational activin signalling inhibitor … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Technology, United Kingdom
Tagged 35Pharma, activin signalling inhibitor, biotechnology acquisition, CANADA, cardiopulmonary diseases, clinical trials, drug development, GSK, GSK Targets Next Generation Pulmonary Hypertension Treatments with Acquisition of 35Pharma, GSK to Acquire 35Pharma for 950 Million Dollars to Strengthen Pulmonary Hypertension Drug Pipeline, HS235, Ilia Tikhomirov, PH-HFpEF, pharmaceutical industry, pulmonary arterial hypertension PAH, pulmonary hypertension, Respiratory Immunology and Inflammation portfolio, Tony Wood
(IN BRIEF) GSK announced that the European Commission has approved Nucala (mepolizumab) as an add-on maintenance treatment for adults in the EU with uncontrolled COPD characterised by raised blood eosinophils who are already receiving inhaled triple therapy, making it the … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged American Thoracic Society, blood eosinophils, COPD, CRSwNP, EGPA, emergency department visits, eosinophilic phenotype, European Commission, European Federation of Allergy and Airways Diseases Patients’ Associations, Exacerbations, GSK, GSK Expands Nucala’s European Indications with Landmark Approval for Uncontrolled COPD, GSK Strengthens Its Respiratory Portfolio as Nucala Receives EU Approval for Add-On COPD Treatment, HES, hospitalisations, IL-5, inhaled triple therapy, Kaivan Khavandi, MATINEE trial, mepolizumab, New England Journal of Medicine, Nucala, Phase III, respiratory medicine, Severe Asthma, Susanna Palkonen, type 2 inflammation
(IN BRIEF) GSK has secured approval in China for Trelegy Ellipta as a maintenance treatment for adults with asthma, adding to its existing indication in COPD and making it the only single inhaler triple therapy approved for both conditions in … Read the full press release
Posted in Healthcare, Pharma & Biotech, Science, Technology, United Kingdom
Tagged asthma treatment China, CAPTAIN study, chronic respiratory disease, COPD treatment, FF UMEC VI, GSK, GSK Expands Respiratory Portfolio in China with Asthma Approval for Trelegy Ellipta, inhaled therapy, National Medical Products Administration, respiratory medicine, single inhaler triple therapy, Trelegy Ellipta, uncontrolled asthma
(IN BRIEF) GSK and Shionogi have agreed with Pfizer to restructure ViiV Healthcare’s shareholder base, with Shionogi replacing Pfizer’s 11.7 percent economic interest and increasing its stake to 21.7 percent, while GSK maintains a 78.3 percent majority holding. The transaction, … Read the full press release
Posted in Business, Healthcare, Investment, Pharma & Biotech, Science, Technology, United Kingdom
Tagged biopharma partnership, cabotegravir, David Redfern, dolutegravir, GSK, HIV prevention, HIV treatment, integrase inhibitors, John Keller, long acting injectables, Pfizer, pharmaceutical industry, shareholder restructuring, Shionogi, strategic investment, ViiV Healthcare, ViiV Healthcare Ownership Streamlined with Expanded Shionogi Investment and GSK Majority
(IN BRIEF) GSK has agreed to acquire RAPT Therapeutics in a transaction valued at approximately $2.2 billion, adding ozureprubart, a phase IIb long-acting anti-IgE antibody for food allergy prevention, to its Respiratory, Immunology & Inflammation pipeline. Designed to offer sustained … Read the full press release
Posted in Business, Healthcare, Investment, Pharma & Biotech, Science, Technology, United Kingdom
Tagged anti IgE therapy, biopharmaceutical acquisition, Brian Wong, clinical-stage biotech, Food allergy, GSK, GSK Expands Food Allergy Portfolio with Acquisition of RAPT and Ozureprubart Asset, Healthcare Innovation, immunology, monoclonal antibody, ozureprubart, pediatric allergy, phase IIb trial, prestIgE study, RAPT Therapeutics, respiratory and inflammation pipeline, Tony Wood
(IN BRIEF) GSK has secured approval in Japan for Exdensur (depemokimab), the country’s first ultra-long-acting biologic for severe asthma and chronic rhinosinusitis with nasal polyps. Approved by Japan’s Ministry of Health, Labour and Welfare, the therapy delivers sustained disease control … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Pharma & Biotech, Science, Technology, United Kingdom
Tagged ANCHOR trials, asthma exacerbations, chronic rhinosinusitis with nasal polyps, CRSwNP, Depemokimab, Exdensur, Exdensur Gains Approval in Japan, Expanding GSK’s Respiratory Biologic Portfolio, GSK, GSK’s Depemokimab Approved in Japan, interleukin 5, Introducing New Option for Severe Asthma Care, Japan Ministry of Health Labour and Welfare, Kaivan Khavandi, Nasal Polyps, respiratory medicine, Severe Asthma, SWIFT trials, type 2 inflammation, ultra long acting biologic
(IN BRIEF) GSK has received approval from China’s National Medical Products Administration for Nucala as an add-on maintenance therapy for adults with inadequately controlled COPD and elevated blood eosinophils. Supported by positive MATINEE and METREX phase III trial data, the … Read the full press release
Posted in Business, Healthcare, Pharma & Biotech, Science, Technology, United Kingdom
Tagged biologic therapy, blood eosinophil count, China Approves GSK’s Nucala to Reduce Exacerbations in Adults with COPD, China NMPA approval, Chronic obstructive pulmonary disease, COPD treatment, eosinophilic COPD, exacerbation reduction, GSK, IL-5 monoclonal antibody, Kaivan Khavandi, MATINEE trial, mepolizumab, METREX trial, Nucala, respiratory medicine
Pertussis cases surge: Over 60,000 reported in Europe; infants most at risk. Maternal vaccination expands: Finland, Norway, and UK updated pregnancy vaccine strategies. BioNet advances: Submitted recombinant pertussis vaccine to EMA; secured EU-GMP approval. Nasal vaccine progresses: ILiAD’s BPZE1 granted … Read the full press release
Posted in Denmark, European Union, Finland, France, Germany, Healthcare, Ireland, News, Norway, Pharma & Biotech, Science, United Kingdom
Tagged acellular pertussis vaccine, Adacel, antibody avidity, antigen dose, ASEAN, Bio Farma, BioNet, biotechnology, booster dose, Boostrix-IPV, BPZE1, certification, Chulalongkorn University, clinical trial, compliance, Dario Cresci, dTap, ECDC, EMA, EU-GMP, EU-GMP certification, EU/EEA, Europe Confronts Pertussis Resurgence as Infant Cases Rise Amid Falling Immunity and Vaccination Gaps, Europe Faces Pertussis Resurgence Amid Waning Immunity and Falling Maternal Vaccination Rates, European Medicines Agency, European Union, European Union Good Manufacturing Practice, Europe’s Pertussis Vaccine Market Opens to New Entrants as Demand Rises, From EU-GMP Certification to ASEAN Partnerships BioNet Broadens Its Global Vaccine Strategy, GMP production facilities, GSK, Hanna Nohynek, health policy, HPRA, human challenge trial, hVIVO, ILiAD Biotechnologies, immunization strategy, infant protection, Innovation Passport, Institut Pasteur, intranasal vaccine, Ireland Health Products Regulatory Authority, Lancet Infectious Diseases, maternal vaccination, MHRA, mucosal immunity, outbreak, pandemic recovery, Pertagen®, pertussis, pertussis vaccine, Pertussis Vaccine Manufacturing, pharmaceutical quality, Phase 3, Philippe Guillot-Chêne, pregnancy immunization, public health, recombinant pertussis vaccine, recombinant pertussis vaccines, regulatory approval, Sanofi, Tdap, TdaP combination vaccine, V, vaccine, vaccine blunting, vaccine development, Vaccine Hesitancy, vaccine pipeline, vaccine rollout, vaccine shortage, vaccine supply, vaccine uptake, VacPertagen, whooping cough
(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
(IN BRIEF) GSK has signed an exclusive global licensing agreement with Empirico Inc. for EMP-012, a first-in-class siRNA candidate currently in Phase I trials for chronic obstructive pulmonary disease (COPD). EMP-012 targets a distinct inflammatory pathway, offering potential therapeutic benefit … Read the full press release
Posted in Business, Healthcare, Investment, Pharma & Biotech, Science, Technology, United Kingdom
Tagged biologics, Chronic obstructive pulmonary disease, COPD, drug development, EMP-012, Empirico, gene expression, genetic medicine, GSK, GSK Acquires Global Rights to Empirico’s siRNA Candidate EMP-012 for Chronic Obstructive Pulmonary Disease, GSK and Empirico Partner on First-in-Class siRNA Therapy EMP-012 to Address Unmet Needs in COPD, Healthcare Innovation, inflammation, inflammation pathway, Kaivan Khavandi, licensing agreement, oligonucleotide therapeutics, Omri Gottesman, Phase I clinical trial, precision medicine, respiratory diseases, respiratory pipeline, siRNA, type 2 inflammation
(IN BRIEF) GSK’s Shingrix vaccine has been approved by China’s NMPA for adults aged 18 and over who are immunocompromised or immunosuppressed, marking the first shingles vaccine available for this group in the country. Affecting about six million people annually … Read the full press release
Posted in Business, Healthcare, Investment, Pharma & Biotech, Science, Technology, United Kingdom
Tagged CHINA, China National Medical Products Administration, clinical studies, global health, GSK, GSK Expands Shingrix Approval in China to Include Immunocompromised Adults at Risk of Shingles, GSK Strengthens Vaccine Portfolio with Shingrix Approval for High-Risk Adult Populations in China, GSK Wins China Approval for Shingrix in Immunocompromised Adults Expanding Protection Against Shingles, Healthcare, herpes zoster, immunocompromised adults, immunodeficiency, immunosuppression, infectious diseases, NMPA, preventive medicine, public health, Recombinant Zoster Vaccine, RZV, Sanjay Gurunathan, Shingles, Shingrix, vaccine approval, Vaccine Innovation
(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) 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) GSK’s marketing authorisation application for linerixibat, an investigational ileal bile acid transporter inhibitor, has been accepted for review by the European Medicines Agency. The submission is supported by GLISTEN Phase III trial data showing that linerixibat rapidly and … Read the full press release
Posted in Business, Healthcare, Pharma & Biotech, United Kingdom
Tagged alcohol-related liver disease, bile acid transporter, cholestatic pruritus, chronic hepatitis B, EASL Congress, EMA, European Medicines Agency, FDA, GLISTEN trial, GSK, IBAT inhibitor, itch-related sleep interference, Kaivan Khavandi, linerixibat, Marketing Authorisation Application, MASH, NCT04950127, orphan drug designation, PBC, Phase III, primary biliary cholangitis, UK regulatory review
(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) The University of Glasgow is leading the innovative FOxTROT 5 trial, which is offering elderly colon cancer patients the opportunity to participate in a groundbreaking immunotherapy study. The trial will administer dostarlimab before surgery, targeting a specific type … Read the full press release
Posted in Business, Education, Financial, Healthcare, Industrial, Investment, Management, News, Science, Technology, United Kingdom
Tagged cancer research, cancer treatment, chemotherapy, clinical trial, clinical trial protocol, colon cancer, deficient mismatch repair, dMMR, dostarlimab, Elderly Patients, FOxTROT 5, frail patients, GSK, immunotherapy, partnership, precision oncology, surgery, UK hospitals, University of Birmingham, University of Glasgow, University of Leeds
(IN BRIEF) The Conference Forum has announced the 9th annual Patients as Partners® Europe event, scheduled for May 20-21, 2025, at the Royal National Hotel in London. This event offers a platform for pharma R&D and patient advocacy to discuss … Read the full press release
Posted in France, Healthcare, Marketing, Pharma & Biotech, Science, Switzerland, United Kingdom
Tagged Alfred Samuels, AstraZeneca, Azafaros, Beyza Klein, Biotech, Biotechnology Conference, Boehringer Ingelheim, Bre Bugbee-Barrett, Catherine Coulouvrat MD, Chiesi Farmaceutici SpA, clinical development, clinical operations, clinical research, clinical research enterprise, clinical trial, clinical trials, Conference Forum, decentralized clinical trials, Gisela Linthorst, GSK, Harry Verbunt, HTA/Regulatory requirements, Johnson & Johnson Innovative Medicine, Lea-Isabelle Proulx PhD, life post-cancer diagnosis, Marisa Minetti, Medicine Development, Patient Advocacy, patient engagement, patient engagement in drug development, patient experience, Patient Recruitment, Patient Retention, Patients as Partners, Patients as Partners Europe, Peter DiBiaso, pharma, Pharmaceutical Conference, Regeneron, research and development, Roche, Royal National Hotel, Sanofi, Temi Olonisakin MD, The Conference Forum, Valerie Bowling
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