European Medicines Agency

(IN BRIEF) AstraZeneca’s Truqap, in combination with Faslodex, has received a positive recommendation from the European Medicines Agency (EMA) for treating estrogen receptor-positive, HER2‑negative locally advanced or metastatic breast cancer with specific genetic alterations. The recommendation follows promising results from … Read the full press release →

(IN BRIEF) AstraZeneca and Sanofi celebrate the approval of Beyfortus (nirsevimab) in Japan by the Ministry of Health, Labour, and Welfare for preventing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in neonates, infants, and children entering … Read the full press release →

(IN BRIEF) DPI, BII, and the EBRD have reached a binding agreement to fully exit their investment in KELIX bio, a pan-African biopharmaceutical platform, through its acquisition by Mubadala Investment Company. Founded in 2020, KELIX bio has rapidly grown to … Read the full press release →

(IN BRIEF) Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting marketing authorization for Fabhalta® (iptacopan) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) who … Read the full press release →

(IN BRIEF) The European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for datopotamab deruxtecan (Dato-DXd), developed by AstraZeneca and Daiichi Sankyo, for the treatment of nonsquamous non-small cell lung cancer (NSCLC) and hormone receptor (HR)-positive, HER2-negative breast … Read the full press release →

(IN BRIEF) Voydeya (danicopan), a first-in-class oral Factor D inhibitor, has been recommended for marketing authorization in the European Union (EU) as an add-on to ravulizumab or eculizumab for adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who experience residual haemolytic … Read the full press release →

(IN BRIEF) Boehringer Ingelheim has reported compelling results from its Phase II trial of Survodutide, a novel glucagon/GLP-1 receptor dual agonist, indicating its potential to become a leading treatment for Metabolic Dysfunction-Associated Steatohepatitis (MASH). In the trial, up to 83.0% … Read the full press release →

(IN BRIEF) GSK has submitted a regulatory application to the European Medicines Agency (EMA) to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease. The … Read the full press release →

(IN BRIEF) The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Voydeya (danicopan), a groundbreaking oral Factor D inhibitor, for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). Voydeya is indicated in Japan for use in combination … Read the full press release →

(IN BRIEF) The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMAs) have jointly released a comprehensive Artificial Intelligence (AI) workplan outlining their collaborative strategy through 2028. This initiative aims to maximize the benefits of AI for stakeholders … Read the full press release →

(IN BRIEF) In a significant development, the second investigational Phase 3 trial of Dupixent® (dupilumab) for chronic obstructive pulmonary disease (COPD), known as NOTUS, has demonstrated promising results. The trial found that Dupixent reduced COPD exacerbations by 34% compared to … Read the full press release →

(IN BRIEF) The European Society of Cardiology (ESC) has issued a statement regarding the proposed Reform of the EU Pharmaceutical Legislation by the European Commission, currently in negotiation in the European Parliament and the Council. While the ESC supports the … Read the full press release →

(IN BRIEF) GSK has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Jemperli (dostarlimab) in combination with chemotherapy as a frontline treatment for adult … Read the full press release →

(IN BRIEF) AstraZeneca is set to present new data at the 12th annual IDWeek conference, emphasizing the role of long-acting antibodies and vaccines in safeguarding at-risk individuals from common infectious respiratory diseases. The company will share 15 abstracts, including oral … Read the full press release →

(IN BRIEF) Roche has reported positive outcomes from the RAINBOWFISH study, an investigation into the efficacy and safety of Evrysdi® (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA). The study, which included 26 infants aged from birth to six … Read the full press release →

(IN BRIEF) The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for ALTUVIIIO, a novel factor VIII replacement therapy used to control bleeding in patients with hemophilia A. ALTUVIIIO, also known as efanesoctocog alfa, stands out … Read the full press release →

(IN BRIEF) The European Union Commission has given the green light for the use of the adapted Comirnaty XBB.1.5 COVID-19 vaccine, developed by BioNTech-Pfizer, in Member States’ upcoming fall vaccination campaigns. This marks the third adaptation of the Comirnaty vaccine … Read the full press release →

(IN BRIEF) Pfizer and BioNTech have received a recommendation for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. The recommendation includes the administration of a single … Read the full press release →

(IN BRIEF) EMA proposes Comirnaty Omicron XBB.1.5 vaccine for ages 6 months+, tailored to combat Omicron XBB.1.5 variant. One dose suffices for ages 5+, while kids 6 months to 4 years may need 1 or 3 doses based on prior … Read the full press release →

(IN BRIEF) AstraZeneca is set to present data on its Vaccines and Immune Therapies portfolio at the European Congress of Clinical Microbiology & Infectious Diseases. Among the data to be presented will be details on the progress of AstraZeneca’s Vaccines … Read the full press release →