GSK

(IN BRIEF) GSK has announced that China’s National Medical Products Administration has accepted for review a New Drug Application for bepirovirsen, an investigational antisense oligonucleotide designed to treat adults with chronic hepatitis B. The submission is supported by Phase III … Read the full press release →

(IN BRIEF) GSK has secured approval in China for Exdensur (depemokimab), a first-of-its-kind ultra-long-acting biologic for treating severe eosinophilic asthma in patients aged 12 and above. Approved by China’s National Medical Products Administration, the therapy offers a novel treatment approach … Read the full press release →

(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 →

(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 →

(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 →

(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 →

(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 →

(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 →

(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 →

(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 →

(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 →

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 →

(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 →

(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 →

(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 →