Category News

PADCEV® with KEYTRUDA® Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer

Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) with KEYTRUDA® (pembrolizumab, a…

Read MorePADCEV® with KEYTRUDA® Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer

argenx Reports Topline Results from ADDRESS Study of Efgartigimod SC in Pemphigus

argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced topline results from the ADDRESS study evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults…

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Decision to Invest over 20 Billion Yen in Bio Drug Substance Manufacturing Building “UK3” to Expand its Production Capacity and towards Realizing Halogenated Hydrocarbon-Free

 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced its decision today to invest in its Bio drug substance (DS) manufacturing facility “UK3” in the Ukima Plant (Kita-ku, Tokyo) of Chugai Pharma Manufacturing Co., Ltd. (Head office: Tokyo, President: Shinya Takuma), a member…

Read MoreDecision to Invest over 20 Billion Yen in Bio Drug Substance Manufacturing Building “UK3” to Expand its Production Capacity and towards Realizing Halogenated Hydrocarbon-Free

Chugai Venture Fund Starts Investment Activities in Drug Discovery Start-Ups to Accelerate Innovation

Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that its corporate venture capital (CVC) subsidiary in the U.S.A., “Chugai Venture Fund, LLC” (CVF) finalized establishment of a $200M venture fund based in the Boston area, MA with a well-experienced head in key…

Read MoreChugai Venture Fund Starts Investment Activities in Drug Discovery Start-Ups to Accelerate Innovation

Aetna Better Health® of Illinois and Mae Health announce partnership to give members access to local doulas for pregnancy and postpartum health support

Aetna Better Health® of Illinois announced a new partnership with digital health platform Mae Health (“Mae”) to support the maternal health needs of its underserved pregnant and postpartum members in Cook and Kane counties. Poor maternal health outcomes take an enormous physical and…

Read MoreAetna Better Health® of Illinois and Mae Health announce partnership to give members access to local doulas for pregnancy and postpartum health support

Vertex Receives CHMP Positive Opinion for the First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™ (exagamglogene autotemcel), for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the conditional approval of CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy, for the treatment…

Read MoreVertex Receives CHMP Positive Opinion for the First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™ (exagamglogene autotemcel), for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

Chugai Files for Additional Indication of Alecensa for Postoperative Adjuvant Therapy for ALK Fusion Gene-Positive Non-Small Cell Lung Cancer

 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) today announced that it filed regulatory application with the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of an ALK inhibitor Alecensa® Capsules 150 mg (Hereafter Alecensa) for Postoperative adjuvant therapy for ALK fusion gene-positive…

Read MoreChugai Files for Additional Indication of Alecensa for Postoperative Adjuvant Therapy for ALK Fusion Gene-Positive Non-Small Cell Lung Cancer

Takeda Receives Positive CHMP Opinion for HYQVIA® as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Takeda (TSE:4502/NYSE:TAK) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance…

Read MoreTakeda Receives Positive CHMP Opinion for HYQVIA® as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

bluebird bio Details Plans for the Commercial Launch of LYFGENIA™ Gene Therapy for Patients Ages 12 and Older with Sickle Cell Disease and a History of Vaso-Occlusive Events

bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “bluebird”) today announced the details of its U.S. commercial infrastructure to support timely, equitable access to LYFGENIA™ (lovotibeglogene autotemcel, also known as lovo-cel), an FDA-approved gene therapy for the treatment of…

Read Morebluebird bio Details Plans for the Commercial Launch of LYFGENIA™ Gene Therapy for Patients Ages 12 and Older with Sickle Cell Disease and a History of Vaso-Occlusive Events

Merck and Eisai Provide Update on Phase 3 LEAP-001 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) as First-Line Treatment for Patients with Advanced or Recurrent Endometrial Carcinoma

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced that the Phase 3 LEAP-001 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by…

Read MoreMerck and Eisai Provide Update on Phase 3 LEAP-001 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) as First-Line Treatment for Patients with Advanced or Recurrent Endometrial Carcinoma