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Bristol Myers Squibb’s Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL)
PRINCETON, N.J.--(BUSINESS WIRE)--BMS's Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL)...
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IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance
BEIJING--(BUSINESS WIRE)--Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC). IDEAYA expects to begin patient enrollm...
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IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance
BEIJING--(BUSINESS WIRE)--Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC). IDEAYA expects to begin patient enrollm...
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百奥赛图授权IDEAYA的双抗ADC项目IDE034获FDA IND批准,合作取得关键里程碑进展
中国北京--(BUSINESS WIRE)--(美国商业资讯)-- 百奥赛图(北京)医药科技股份有限公司(以下简称“百奥赛图”,HKEX:02315)欣然宣布,其合作伙伴IDEAYA Biosciences, Inc. (Nasdaq: IDYA),一家专注于肿瘤精准治疗药物研发的公司,已获得美国食品药品监督管理局(FDA)的临床试验用新药(IND)批准,推进同类首创B7H3/PTK7双特异性抗体偶联物(ADC)项目的I期临床试验。IDEAYA预计将在2026年第一季度开始患者入组,初步评估B7H3和PTK7共表达的实体瘤类型,包括肺癌、结直肠癌、头颈癌及卵巢/妇科肿瘤。 IDE034是一款潜在同类首创的双靶点B7H3/PTK7 TOP1 ADC,由百奥赛图自主开发,并于2024年7月授权给IDEAYA公司。此次IND获批标志着双方合作迈入重要里程碑,为推进IDE034后续的临床开发奠定基础,同时彰显了百奥赛图在双抗ADC发现与开发领域的技术实力。 百奥赛图董事长兼CEO沈月雷博士表示:“IDE034获批IND,是IDEAYA将首创TOP1 ADC管线拓展至双特异性、精准靶向策略的重要...
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AGCバイオロジクス、細胞株開発のタイムライン短縮に向けてATUMと提携
シアトル--(BUSINESS WIRE)--(ビジネスワイヤ) -- 医薬品開発者が価格の引き下げおよび市場投入までの期間短縮という、ますます大きな圧力に直面する中、グローバルなバイオ医薬品開発製造受託機関(CDMO)であるAGCバイオロジクスは、ATUMと提携し、Leap-In Transposase®発現プラットフォームを自社の提供内容に統合することで、Cell Line Development Center of Excellenceを拡大しています。この提携により、医薬品開発者は、生産性を高め、臨床試験までのプロセスを大幅に短縮するよう設計された技術を利用でき、市場が求めるスピードと効率性に直接応えることができます。 ATUMの最新のトランスポゼースベースのプラットフォームがAGCバイオロジクスを通じて利用可能になったことで、同CDMOは、迅速な開発を要する複雑な分子から、タイムラインの重要性が比較的低いより単純なプロジェクトまで、多様な顧客ニーズに応える細胞株開発オプションを幅広く提供できるようになっています。この提携により、がん細胞を死滅させ、ウイルス感染と闘い、自己免...
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AGC Biologics arbeitet mit ATUM zusammen, um Zeitpläne für die Zelllinienentwicklung zu beschleunigen
SEATTLE--(BUSINESS WIRE)--Da Arzneimittelentwickler zunehmend unter Druck stehen, Preise zu senken und die Markteinführungszeit zu verkürzen, erweitert das weltweit tätige biopharmazeutische Auftragsentwicklungs- und Produktionsunternehmen AGC Biologics sein „Center of Excellence“ für Zelllinienentwicklung durch eine Partnerschaft mit ATUM, um die Leap-In-Transposase®-Expressionsplattform in das Leistungsportfolio zu integrieren. Diese Partnerschaft bietet Arzneimittelentwicklern eine Technolog...
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Neurogene Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
NEW YORK--(BUSINESS WIRE)--Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today announced that the Compensation Committee of the Company’s Board of Directors approved the grant of non-qualified stock options to purchase an aggregate of 4,860 shares of the Company’s common stock to two new employees (the “Inducement Grants”) on December 2, 2025 (the “Grant Date”). The Induce...
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FDA Conditionally Approves Merck Animal Health's EXZOLT™ CATTLE-CA1 for the Prevention and Treatment of New World Screwworm (Cochliomyia hominivorax) Larvae (myiasis)
RAHWAY, N.J.--(BUSINESS WIRE)--Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced the U.S. Food and Drug Administration (FDA) has granted a conditional approval for EXZOLT™ CATTLE-CA1 (fluralaner topical solution). This innovative product is in the newest class of parasiticides known as isoxazolines. The pour-on solution is effective for the prevention and treatment of infest...
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Universidade de Maryland lança programa inovador de treinamento clínico em terapia metabólica cetogênica para saúde mental
SAN MATEO, Califórnia--(BUSINESS WIRE)--O Baszucki Group anunciou hoje uma parceria com a Faculdade de Medicina da Universidade de Maryland para uma iniciativa de treinamento inovadora que ampliará a capacidade de oferecer terapia metabólica cetogênica na área de saúde mental. O programa, intitulado “LIVE IT~LAUNCH IT: Learning How to Implement and Use a Ketogenic Diet to Improve Mental Health in Your Patients For Health Care Workers” (em tradução livre: “VIVA ISSO E COLOQUE EM PRÁTICA: Aprende...
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University of Maryland Launches Innovative Clinician Training Program in Ketogenic Metabolic Therapy for Mental Health
SAN MATEO, Calif.--(BUSINESS WIRE)--Baszucki Group and University of Maryland School of Medicine launch ketogenic metabolic therapy training for mental health clinicians....