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China’s Center for Drug Evaluation Accepts Merck’s Application for Marketing Authorization of Pimicotinib for Treatment of Tenosynovial Giant Cell Tumor

DARMSTADT, Germany--(BUSINESS WIRE)--Merck, a leading science and technology company, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) officially accepted the company’s application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with tenosynovial giant cell tumors (TGCT) requiring systemic treatment. The submission follows the granting of Priority Review to pimicotinib by the CDE in...
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China’s Center for Drug Evaluation Accepts Merck KGaA, Darmstadt, Germany’s Application for Marketing Authorization of Pimicotinib for Treatment of Tenosynovial Giant Cell Tumor

DARMSTADT, Germany--(BUSINESS WIRE)--Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) officially accepted the company’s application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with tenosynovial giant cell tumors (TGCT) requiring systemic treatment. The submission follows the granting of Priority Review to p...
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U.S. FDA Approves Merck’s ENFLONSIA™ (clesrovimab-cfor) for Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV Season

RAHWAY, N.J.--(BUSINESS WIRE)--U.S. FDA Approves Merck’s ENFLONSIA for Prevention of RSV Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV Season...
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Alliance for Food and Farming: “Dirty Dozen” List Recommendations Cannot Be Substantiated

WATSONVILLE, Calif.--(BUSINESS WIRE)--Peer reviewed research published in the Journal of Toxicology found that the recommendation in the “Dirty Dozen” list to substitute organic forms of produce for conventional does not result in any decrease in risk for consumers because residues on conventionally grown are so low, if present at all. The research also found that the list authors follow no scientifically established methodology in the development of their list. In fact, the “Dirty Dozen” list...
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Sesen Launches with a Singular Mission: Advancing Life Sciences Globally Through Specialized Language Solutions

BOSTON--(BUSINESS WIRE)--Today marks the official launch of Sesen, a next-generation language services company purpose-built to meet the complex demands of the life sciences industry. Specializing exclusively in translation, localization, and AI-enhanced linguistic solutions for pharmaceutical, biotechnology, medical device, CRO, and regulatory organizations, Sesen combines industry expertise with cutting-edge technology to deliver fast, accurate, and fully compliant multilingual communications...
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Harrow Acquires U.S. Commercial Rights to BYQLOVI™ (Clobetasol Propionate Ophthalmic Suspension) 0.05% from Formosa Pharmaceuticals

NASHVILLE, Tenn. & TAIPEI, Taiwan--(BUSINESS WIRE)--Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, and Taiwan-based Formosa Pharmaceuticals (“Formosa”, 6838.TW), today announced a licensing agreement, whereby Harrow has acquired the exclusive U.S. commercial rights for BYQLOVI™ (clobetasol propionate ophthalmic suspension) 0.05%. BYQLOVI was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of post-operative inflammation and pain...
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ヒストソニックス、腎腫瘍を対象とした非侵襲的ヒストトリプシー治療を評価する「#HOPE4KIDNEY試験」の登録を完了

ミネアポリス--(BUSINESS WIRE)--（ビジネスワイヤ） -- Edison®ヒストトリプシー・システムおよび新規ヒストトリプシー治療プラットフォームの開発企業であるヒストソニックスは、重要な「#HOPE4KIDNEY試験」において、全患者の登録を完了したことを発表しました。本試験は、前向き・多施設・単群試験として、Edisonシステムを用いて原発性の腎実質性腫瘍を治療することで腎組織を破壊する際の安全性および有効性を評価することを目的としています。 本試験では、画像診断および生検により確認された最大径3cm以下の単一で非転移性の腎腫瘍を有する患者が登録されました。被験者は、治療後14日、30日、90日、180日、および年1回の評価を含む複数の時点で、最長5年間の追跡調査を受けます。Edisonシステムは、腎臓への使用については現在も治験中であり、この適応でのFDA承認は得られていません。#HOPE4KIDNEY試験のデータは、今後の規制承認申請において、ヒストトリプシーの腎組織・腎腫瘍への適応拡大を裏付ける根拠となることが期待されています。 Edisonシステムは、ヒス...
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Resumen: HistoSonics completa el registro de pacientes en el ensayo #HOPE4KIDNEY que evalúa la histotripsia no invasiva para el tratamiento de tumores renales

MINNEAPOLIS--(BUSINESS WIRE)--HistoSonics, Inc., fabricante del sistema de histotripsia Edison® y de nuevas plataformas terapéuticas de histotripsia, ha anunciado que ha completado el registro de pacientes en su ensayo fundamental #HOPE4KIDNEY. Este ensayo prospectivo, multicénto y de grupo único está diseñado para evaluar la seguridad y eficacia del Sistema Edison en la destrucción de tejido renal mediante el tratamiento de tumores renales sólidos primarios. El ensayo incluyó a pacientes con u...
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HistoSonics vervollständigt die Anmeldungen zur #HOPE4KIDNEY-Studie über nicht invasive Histotripsie in der Behandlung von Nierentumoren

MINNEAPOLIS--(BUSINESS WIRE)--HistoSonics, Inc., der Hersteller des Edison® Histotripsie-Systems und Anbieter neuartiger Therapie-Plattformen für Histotripsie, kündigte heute die abgeschlossene Anmeldung der Patienten für seine wichtige Studie #HOPE4KIDNEY an. Diese vorausblickende, einarmige und multizentrische Studie untersucht die Sicherheit und Wirkung des Edison-Systems beim Zerstören von Nierengewebe in der Behandlung primärer solider Nierentumore. An der Studie nehmen Patienten mit durch...
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HistoSonics achève le recrutement pour l’essai #HOPE4KIDNEY évaluant l’histotripsie non invasive pour le traitement des tumeurs rénales

MINNEAPOLIS--(BUSINESS WIRE)--HistoSonics, Inc., fabricant de l’Edison® Histotripsy System et de nouvelles plateformes thérapeutiques d’histotripsie, a annoncé aujourd’hui la fin du recrutement des patients pour son essai pivot #HOPE4KIDNEY. Cet essai prospectif, multicentrique et à un seul volet est conçu pour évaluer la sécurité et l’efficacité de l’Edison System dans la destruction des tissus rénaux par le traitement des tumeurs rénales solides primaires. L’essai a recruté des patients prése...