INCHEON, Südkorea–(BUSINESS WIRE)–Celltrion gab heute bekannt, dass der Ausschuss für Humanarzneimittel (CHMP) der Europäischen Arzneimittel-Agentur (EMA) die Marktzulassung für drei Biosimilar-Kandidaten empfohlen hat: Eydenzelt® (CT-P42, Aflibercep…
Author: Business Wire
セルトリオン、欧州連合にて3つのバイオシミラーに関するCHMPからのポジティブ・オピニオンを取得
韓国、仁川–(BUSINESS WIRE)–（ビジネスワイヤ） — セルトリオンは、欧州医薬品庁（EMA）の医薬品委員会（CHMP）が同社のバイオシミラー候補である3製品、Eydenzelt® （CT-P42、アフリベルセプト）、Stoboclo® とOsenvelt® （CT-P41、デノスマブ）、およびAvtozma® （CT-P47、トシリズマブ）に対するポジティブ・オピニオンを採択し、販売承認を推奨したと発表しました。この重要な節目は、バイオシミラーの革新における当社のリーダーシップと…
Celltrion riceve il parere favorevole del CHMP per tre farmaci biosimilari nell'Unione europea
INCHEON, Corea del Sud–(BUSINESS WIRE)–Celltrion ha oggi annunciato che il Comitato per i medicinali per uso umano (CHMP) dell’Agenzia europea per i medicinali (EMA) ha adottato pareri favorevoli e raccomandato l’autorizzazione all’immissione in comm…
Celltrion的三種生物學名藥在歐盟獲得CHMP積極意見
韓國仁川–(BUSINESS WIRE)–(美國商業資訊)– Celltrion今天宣布，歐洲藥品管理局(EMA)人用醫藥產品委員會(CHMP)已給出積極意見，建議核准三種候選生物學名藥上市：Eydenzelt® (CT-P42, aflibercept)、Stoboclo® 和Osenvelt® (CT-P41, denosumab)以及Avtozma® (CT-P47, tocilizumab)。這一重要的里程碑反映了公司在生物學名藥創新領域的領先地位，以及在歐洲擴大生物治療藥物可及性的承…
Celltrion的三种生物仿制药在欧盟获得CHMP积极意见
韩国仁川–(BUSINESS WIRE)–(美国商业资讯)– Celltrion今天宣布，欧洲药品管理局(EMA)人用医药产品委员会(CHMP)已给出积极意见，建议批准三种候选生物仿制药上市：Eydenzelt® (CT-P42, aflibercept)、Stoboclo® 和Osenvelt® (CT-P41, denosumab)以及Avtozma® (CT-P47, tocilizumab)。这一重要的里程碑反映了公司在生物仿制药创新领域的领先地位，以及在欧洲扩大生物治疗药物可及性的承…
Celltrion ontvangt positief CHMP-advies voor drie biosimilars in de Europese Unie
INCHEON, Zuid-Korea–(BUSINESS WIRE)–Celltrion heeft vandaag aangekondigd dat het Comité voor geneesmiddelen voor menselijk gebruik (CHMP) van het Europees Geneesmiddelenbureau (EMA) positieve adviezen heeft aangenomen en marketingautorisaties heeft a…
Celltrion reçoit l’avis favorable du CHMP pour trois médicaments biosimilaires dans l’Union européenne
INCHEON, Corée du Sud–(BUSINESS WIRE)–Celltrion a annoncé aujourd’hui que le Comité des médicaments à usage humain (CHMP) de l’Agence européenne des médicaments (EMA) a adopté des avis favorables et recommandé des autorisations de mise sur le marché …
Celltrion recibe el dictamen positivo del CHMP para tres biosimilares en la Unión Europea
INCHEON, Corea del Sur–(BUSINESS WIRE)–Celltrion anunció hoy que el Comité de Medicamentos de Uso Humano (CHMP, por sus siglas en inglés) de la Agencia Europea de Medicamentos (EMA, por sus siglas en inglés) adoptó dictámenes positivos y recomendó au…
Celltrion Receives Positive CHMP Opinion for Three Biosimilars in the European Union
INCHEON, South Korea–(BUSINESS WIRE)–Celltrion today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions and recommended marketing authorisations for three bios…
Celebrating Its 26th Partnership, Dr. Tom MacMillan and the Family Eye Care Center Team Have Joined Forces With Eye Health America and Clemson Eye in Clinton, S.C.
CLINTON, S.C.–(BUSINESS WIRE)– #clemsoneye–Eye Health America is excited to announce its 26th partnership, welcoming Dr. Tom MacMillan and his dedicated team from Family Eye Care Center. This month, they officially joined Clemson Eye, one of Eye Hea…
Tenpoint Therapeutics Ltd. and Visus Therapeutics, Inc. Join Forces, Building the Next Era of Best- and First-in-Class Ophthalmic Medicines
LONDON & SEATTLE–(BUSINESS WIRE)–Tenpoint Therapeutics, Limited (“Tenpoint”) and Visus Therapeutics, Inc., (“Visus”) announce today the completion of their merger to create an entirely new chapter in ophthalmic therapeutic medicines aimed at rejuvena…
Bausch + Lomb Responds to Rumors of a Potential Sale
VAUGHAN, Ontario–(BUSINESS WIRE)–Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, issued the following statement in response to a request from the Canadian Investme…
Renowned Ophthalmology Leaders to Join CellViva Board of Directors
SAN FRANCISCO–(BUSINESS WIRE)–CellViva, a biopharmaceutical company pioneering the development of an innovative anti-VEGF therapy for pterygium—an unmet medical need in ophthalmology, is proud to announce the appointment of three distinguished leader…
Ora & BlindCAN Evolve Purpose-Driven Initiative, The Blind Canvas Project, in Collaboration With Academy of Music for the Blind
BOSTON–(BUSINESS WIRE)– #blindcanvasproject–Ora announces the next chapter of groundbreaking initiative Blind Canvas Project, in collaboration with the Academy of Music for the Blind (AMB).
Bausch + Lomb Acquires Elios Vision, Significantly Enhances Glaucoma Treatment Capabilities
VAUGHAN, Ontario–(BUSINESS WIRE)–Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced that an affiliate has acquired Elios Vision, Inc., developer of th…
ViaLase and the John A. Moran Eye Center Announce Research Partnership to Accelerate Glaucoma Research and Innovation
ALISO VIEJO, Calif.–(BUSINESS WIRE)– #MoranEyeCenter–ViaLase, Inc., a clinical-stage medical technology company focused on addressing unmet needs in the conventional glaucoma treatment paradigm, today announced a research partnership with the John A…
NovaBay CEO Letter to Stockholders Urges a FOR Vote at Upcoming Reconvened Special Meeting
EMERYVILLE, Calif.–(BUSINESS WIRE)–NovaBay® Pharmaceuticals, Inc. (NYSE American: NBY) (“NovaBay” or the “Company”) announces that Chief Executive Officer Justin Hall has issued the following Letter to Stockholders: To My Fellow Stockholders, You hav…
Children’s Hospital Los Angeles Celebrates 100th Retinal Gene Therapy Procedure
LOS ANGELES–(BUSINESS WIRE)–A national leader in pediatric gene therapy, CHLA has treated more patients with the sight-saving Luxturna than any other center in the country.
Viridian Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
WALTHAM, Mass.–(BUSINESS WIRE)–Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced that a majority of the indep…
World-Renowned Moorfields Eye Hospital to Implement MEDITECH Expanse Electronic Patient Record (EPR)
CANTON, Mass.–(BUSINESS WIRE)–Moorfields Eye Hospital NHS Foundation Trust will implement MEDITECH’s Expanse EPR in their 20 locations.