European Medicines Agency

(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 →

Not intended for U.S. and UK Media (IN BRIEF) The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended darolutamide, an oral androgen receptor inhibitor, for marketing authorization in the European Union as a treatment for patients … Read the full press release →

Ad hoc announcement pursuant to Art. 53 LR (PRESS RELEASE) BASEL, 19-Jan-2023 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY), a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives, announced that their combination treatment … Read the full press release →

(PRESS RELEASE) CAMBRIDGE, 13-Jan-2023 — /EuropaWire/ — AstraZeneca (LSE/STO/Nasdaq: AZN), a British-Swedish multinational pharmaceutical and biotechnology company, has announced that its drug Tezspire (tezepelumab) has been given the green light for self-administration by the European Medicine Agency’s Committee for Medicinal … Read the full press release →

(COMUNICADO DE PRENSA) CAMBRIDGE, 13-Jan-2023 — /EuropaWire/ — AstraZeneca (LSE/STO/Nasdaq: AZN), una multinacional británica-sueco-farmacéutica y biotecnológica, ha anunciado que su fármaco Tezspire (tezepelumab) ha recibido luz verde para la autoadministración por parte del Comité de Medicamentos de Uso Humano (CHMP) … Read the full press release →

(PRESS RELEASE) BASEL, 12-Jan-2023 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY), a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives, has announced that the European Commission has approved Xofluza (baloxavir marboxil), a … Read the full press release →

(COMUNICADO DE PRENSA) BASEL, 12-Jan-2023 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY), un pionero mundial en productos farmacéuticos y diagnóstico centrado en el avance de la ciencia para mejorar la vida de las personas, ha anunciado que la … Read the full press release →