Tag Archives: GSK

Pertussis Rebounds Across Europe as Infant Risk Rises With Falling Immunity and Maternal Vaccine Uptake

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

GSK Receives EMA Orphan Drug Designation for GSK’227 in Small-Cell Lung Cancer, Strengthening Its ADC Oncology Pipeline

(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

GSK Acquires Global License for Empirico’s Phase I siRNA Candidate EMP-012 Targeting Novel Inflammatory Pathway in COPD

(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

GSK Achieves Landmark NMPA Approval for Shingrix as First Shingles Vaccine for Immunosuppressed Patients in China

(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

GSK announces $30 billion U.S. investment to advance biopharma R&D and manufacturing with AI-powered facilities

(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

GSK and Hengrui Pharma Sign Strategic $12 Billion Deal to Advance Up to 12 Innovative Therapeutics

(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

GSK Submits Linerixibat for European Approval to Treat Debilitating PBC Pruritus

(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

GSK’s Blenrep Combinations Receive Approval in Japan for Relapsed or Refractory Multiple Myeloma Treatment

(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

New FOxTROT 5 Trial by University of Glasgow, University of Leeds, and University of Birmingham Aims to Transform Colon Cancer Treatment for Elderly Patients with Promising Immunotherapy Approach

(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

Patients as Partners® Europe Launches the 9th Annual Event with 2025 Keynotes, Featured Speakers and Topics

(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

GSK and ViiV Healthcare Secure European Commission Approval for Long-Acting HIV Treatment for Adolescents

(IN BRIEF) ViiV Healthcare has secured European Commission approval for its long-acting HIV treatment, Vocabria + Rekambys, for adolescents aged 12 and older. This approval offers a significant advancement in HIV care, providing an injectable treatment option that reduces the … Read the full press release

GSK Announces EMA Review of Prefilled Syringe Presentation for Shingrix Vaccine

(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

GSK and University of Oxford Launch Cancer Prevention Research Program with £50 Million Investment

(IN BRIEF) GSK and the University of Oxford have launched the GSK-Oxford Cancer Immuno-Prevention Programme, a new research initiative focused on cancer prevention through vaccination. GSK is investing up to £50 million to explore how precancerous cells develop into cancer, … Read the full press release

GSK Announces FDA Review of Convenient Prefilled Syringe for Shingrix Shingles Vaccine

(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

GSK and Cambridge University Join Forces with £50 Million Investment to Tackle Kidney and Respiratory Diseases Using AI

(IN BRIEF) GSK and the University of Cambridge have announced a £50 million, five-year collaboration called the Cambridge-GSK Translational Immunology Collaboration (CG-TIC) to accelerate research and development in kidney and respiratory diseases. The initiative combines GSK’s expertise in immunology and … Read the full press release

GSK Reports Promising Phase III Findings for Depemokimab in Treating Chronic Rhinosinusitis with Nasal Polyps

(IN BRIEF) GSK plc has announced positive results from its Phase III ANCHOR trials for depemokimab, a biologic treatment for chronic rhinosinusitis with nasal polyps (CRSwNP). The trials demonstrated a significant reduction in nasal polyp size and nasal obstruction after … Read the full press release

GSK’s mRNA Flu Vaccine Candidate Moves to Phase III After Positive Phase II Results

(IN BRIEF) GSK has reported positive results from its phase II trial for an mRNA seasonal influenza vaccine candidate, showing strong immune responses against influenza A and B strains in both younger and older adults. The trial met success criteria … Read the full press release

GSK’s Depemokimab Cuts Severe Asthma Attacks by Over 50% in Phase III Trials

(IN BRIEF) GSK’s depemokimab, a new ultra-long-acting biologic, showed a 54% reduction in severe asthma exacerbations in the SWIFT-1 and SWIFT-2 phase III trials. Administered every six months, it also demonstrated a 72% reduction in hospitalizations and emergency visits, offering … Read the full press release

GSK to Showcase Transformative Respiratory Research at ERS Congress 2024

(IN BRIEF) GSK will present significant research at the 2024 European Respiratory Society (ERS) Congress, including data from phase III trials of its new biologic, depemokimab, for severe asthma. The presentations highlight GSK’s commitment to advancing respiratory medicine, with a … Read the full press release

Patients as Partners® Europe Announces the Launch of 8th Annual Meeting with 2024 Keynotes and Topics

(IN BRIEF) The Conference Forum announced the launch of the 8th annual Patients as Partners® Europe meeting, scheduled for May 14-15, 2024, at Plaisterers’ Hall in London, England. This event brings together pharma R&D and patient advocacy to discuss patient … Read the full press release