European Medicines Agency

(IN BRIEF) Pfizer and BioNTech have received a positive recommendation from the EMA’s CHMP for their LP.8.1-adapted monovalent COVID-19 vaccine, COMIRNATY® LP.8.1, for individuals aged six months and older. This updated vaccine offers improved immune protection against prevalent SARS-CoV-2 subvariants, … Read the full press release →

(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 →

(IN BRIEF) Novo Nordisk has received a positive opinion from the European Medicines Agency’s CHMP recommending label expansion for Alhemo® (concizumab) to include adolescents and adults with haemophilia A and B without inhibitors. Backed by robust data from the explorer8 … Read the full press release →

(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 →

(IN BRIEF) The CHMP has recommended EU approval of Sarclisa alongside VRd for transplant-eligible NDMM, based on GMMG-HD7 trial results showing superior MRD negativity and PFS compared to VRd alone. This potential label extension would mark Sarclisa’s fourth EU approval … Read the full press release →

(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 →

(IN BRIEF) In 2023, a historic initiative saw all 27 EU countries, along with Iceland and Norway, collecting and reporting both sales and usage data on veterinary antimicrobials for the first time. The resulting ESUAvet report details that 98% of … Read the full press release →

(IN BRIEF) AstraZeneca’s Imfinzi (durvalumab) has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for approval as a monotherapy to treat limited-stage small cell lung cancer (LS-SCLC) in patients whose disease … Read the full press release →

(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 →

(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 →

(IN BRIEF) Sarclisa, an anti-CD38 treatment developed by Sanofi, has been approved in China for treating adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least one prior therapy. The approval is based on the … Read the full press release →

(IN BRIEF) Roche’s Vabysmo® (faricimab) prefilled syringe has received European Medicines Agency approval for treating three major retinal conditions: neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema caused by retinal vein occlusion (RVO). Serving over nine … Read the full press release →

(IN BRIEF) AstraZeneca’s Tagrisso (osimertinib) has been recommended for approval in the EU for treating adult patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) with EGFR mutations who have not experienced disease progression after platinum-based chemoradiation therapy. This … Read the full press release →

(IN BRIEF) The European Medicines Agency has approved Dupixent as the first treatment for eosinophilic esophagitis (EoE) in young children aged one to 11, marking a significant step in managing this condition in a critical developmental phase. The approval is … Read the full press release →

(IN BRIEF) AstraZeneca and Ionis’ drug Wainzua (eplontersen) has been recommended for approval in the European Union for treating hereditary transthyretin-mediated amyloidosis (ATTRv-PN) in adults with stage 1 or 2 polyneuropathy. Based on the positive results from the NEURO-TTRansform Phase … Read the full press release →

(IN BRIEF) Novo Nordisk’s Alhemo® (concizumab) has been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). If approved, Alhemo® will become the first once-daily subcutaneous prophylactic treatment for people aged 12 … Read the full press release →

(IN BRIEF) Roche has announced positive two-year data from its RAINBOWFISH study, showcasing the effectiveness of Evrysdi® (risdiplam) in treating children with spinal muscular atrophy (SMA) when administered before symptoms appear. The study revealed that most children achieved key motor … Read the full press release →

(IN BRIEF) Roche has announced positive results from its phase III REGENCY study, showing that its drug Gazyva®/Gazyvaro® (obinutuzumab) significantly outperformed standard therapy in treating active lupus nephritis. The study found that patients receiving Gazyva/Gazyvaro, in combination with standard therapies, … Read the full press release →

(IN BRIEF) Pfizer and BioNTech’s Omicron KP.2-adapted COVID-19 vaccine has received a positive recommendation from the European Medicines Agency’s (EMA) CHMP for use in individuals aged six months and older. Pending final approval from the European Commission, the vaccine will … Read the full press release →

(IN BRIEF) Eurojust will participate in the 47th annual World Port Days in Rotterdam from September 6-8, 2024. The event, which highlights the importance of European ports like Rotterdam, will feature Eurojust in the European Pavilion. This space, organized by … Read the full press release →