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PARIS--(BUSINESS WIRE)--Regulatory News: Vivendi (Paris:VIV) annonce avoir conclu un accord avec Poste Italiane pour la cession de 15,00 % des actions ordinaires et des droits de vote de TIM au prix de 0,2975 euro par action pour un montant total de 684 millions d’euros. A l’issue de cette opération, qui interviendra peu après sa notification auprès de l’Autorité de la concurrence italienne, Vivendi conservera une participation résiduelle de 2,51 % des actions ordinaires et des droits de vote d...

PARIS--(BUSINESS WIRE)--Regulatory News: Vivendi (Paris:VIV) announced today that it signed an agreement with Poste Italiane for the sale of 15.00% of TIM’s ordinary shares and voting rights at a price of €0.2975 per share for a total consideration of €684 million. Upon completion of this transaction, which will occur shortly after its notification to the Italian competition authority, Vivendi will keep a minority interest representing 2.51% of ordinary shares and voting rights of the Italian t...

NEW YORK & NEW ORLEANS--(BUSINESS WIRE)--Kahn Swick & Foti, LLC (“KSF”) and KSF partner, former Attorney General of Louisiana, Charles C. Foti, Jr., remind investors that they have until May 27, 2025 to file lead plaintiff applications in a securities class action lawsuit against Solaris Energy Infrastructure, Inc. (“Solaris” or the “Company”) (NYSE: SEI), if they purchased the Company’s securities between July 9, 2024 and March 17, 2025, inclusive (the “Class Period”). This action is pendi...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced moderated poster presentations of new data from the landmark HELIOS-B Phase 3 clinical trial, which evaluated vutrisiran for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM) in a population representative of today’s patients. Data were presented at the American College of Cardiology’s Annual Scientific Session (ACC.25) held in Chicago, Illinois....

中国上海和新泽西州泽西市--(BUSINESS WIRE)--(美国商业资讯)-- Shanghai Henlius Biotech, Inc. (2696.HK)与Organon (NYSE: OGN)今日宣布，欧洲药品管理局(EMA)已受理处于研究阶段的帕捷特® （帕妥珠单抗）生物类似药HLX11的上市许可申请(MAA)。帕妥珠单抗已在多个国家和地区获批，与曲妥珠单抗及化疗联合，用于HER2阳性、局部晚期、炎性或早期乳腺癌患者的新辅助治疗，以及某些HER2阳性早期乳腺癌的辅助治疗等适应症。 此次申报基于一项多中心、随机、双盲、平行对照的3期临床研究(NCT05346224)，该研究旨在比较HLX11与参照药帕捷特®（帕妥珠单抗）作为新辅助疗法，联合完整治疗方案在HER2阳性、HR阴性早期或局部晚期乳腺癌患者中的有效性和安全性。HLX11达到了主要终点，即由独立评审委员会(IRC)评估的总体病理完全缓解(tpCR)率。两组间的其他次要终点指标也具有可比性。 2022年，Henlius与Organon签订了一份许可和供应协议，授予Organon包括HLX11在内的两种生物类似药候选产品...

XANGAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) e Organon (NYSE: OGN) anunciaram hoje que a Agência Europeia de Medicamentos (EMA) validou o pedido de autorização de comercialização (MAA) para HLX11, um biossimilar experimental do Perjeta® (pertuzumabe). O pertuzumabe foi aprovado em diversos países e regiões em combinação com trastuzumabe e quimioterapia para tratamento neoadjuvante de pacientes com câncer de mama HER2-positivo, localmente avançado,...

SHANGHÁI (China) y JERSEY CITY (Nueva Jersey)--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) y Organon (NYSE: OGN) anuncian que la Agencia Europea de Medicamentos (EMA) ha validado la solicitud de autorización de comercialización (MAA) de HLX11, un biosimilar de Perjeta® (pertuzumab) en investigación. Pertuzumab ha sido aprobado en varios países y regiones en combinación con trastuzumab y quimioterapia para el tratamiento neoadyuvante de pacientes con cáncer de mama HER2-positivo, l...

SHANGHAI, Cina e JERSEY CITY, N.J.--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) e Organon (NYSE: OGN) oggi hanno annunciato che l'Agenzia europea per i medicinali (EMA) ha convalidato la domanda di autorizzazione all'immissione in commercio (AIC) per HLX11, un farmaco sperimentale biosimilare di Perjeta® (pertuzumab). Il pertuzumab è stato approvato in vari Paesi e regioni in combinazione con trastuzumab e chemioterapia per il trattamento neoadiuvante di pazienti con tumore al sen...

中國上海和紐澤西州澤西市--(BUSINESS WIRE)--(美國商業資訊)-- Shanghai Henlius Biotech, Inc. (2696.HK)與Organon (NYSE: OGN)今日宣布，歐洲藥品管理局(EMA)已受理處於研究階段的Perjeta® (pertuzumab)生物類似藥HLX11的上市授權申請(MAA)。Pertuzumab已在多個國家和地區獲准，與trastuzumab及化療聯合，用於HER2陽性、局部晚期、炎性或早期乳癌病患的新輔助治療，以及某些HER2陽性早期乳癌的輔助治療等適應症。 此次申報以一項多中心、隨機、雙盲、平行對照的3期臨床研究(NCT05346224)為基礎，該研究旨在比較HLX11與參照藥Perjeta® (pertuzumab)做為新輔助療法，聯合完整治療方案在HER2陽性、HR陰性早期或局部晚期乳癌病患中的有效性和安全性。HLX11達到了主要終點，即由獨立評審委員會(IRC)評估的整體病理完全緩解(tpCR)率。兩組間的其他次要終點指標也具有可比性。 2022年，Henlius與Organon簽署了一份授權和供應協議，授...

SHANGHAI, Chine et JERSEY CITY, New Jersey--(BUSINESS WIRE)--Shanghai Henlius Biotech, Inc. (2696.HK) et Organon (NYSE : OGN) ont annoncé aujourd’hui que l’Agence européenne des médicaments (EMA) a validé la demande d’autorisation de mise sur le marché (MAA) de HLX11, un médicament biosimilaire expérimental de Perjeta® (pertuzumab). Le pertuzumab a été approuvé dans plusieurs pays et régions en association avec le trastuzumab et la chimiothérapie pour le traitement néoadjuvant des patientes att...