Antibodies

15 Jan 2019 Merck’s KEYTRUDA® (pembrolizumab) Reduced Risk of Death by 31 Percent Compared to Chemotherapy in Previously Treated Patients with Advanced Esophageal or Esophagogastric Junction Carcinoma Whose Tumors Expressed PD-L1 (CPS ≥10)
15 Jan 2019 European Commission Approves Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) for First-Line Treatment of Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma
15 Jan 2019 Daiichi Sankyo Initiates Pivotal Phase 3 Trial of [Fam-] Trastuzumab Deruxtecan (DS-8201) in HER2 Low Metastatic Breast Cancer
12 Jan 2019 OncoImmune Announces Completion of Phase II Trial
10 Jan 2019 BerGenBio Announces Start of Phase I Trial Evaluating First-in-Class Anti-AXL Antibody BGB149
08 Jan 2019 Novartis investigational therapy crizanlizumab (SEG101) receives FDA Breakthrough Therapy designation for the prevention of vaso-occlusive crises in sickle cell disease
07 Jan 2019 Xencor Regains ex-U.S. Commercial Rights to XmAb®13676, CD20 x CD3 Bispecific Antibody
07 Jan 2019 Merus Announces IND Clearance for MCLA-145
07 Jan 2019 CytomX Therapeutics Announces Technology Acquisition From Agensys, Inc., an Affiliate of Astellas Pharma Inc.
07 Jan 2019 Checkpoint Therapeutics Initiates Registrational Development Programs for Anti-PD-L1 Antibody CK-301
07 Jan 2019 Stemline Therapeutics Announces Submission of European Marketing Authorization Application (MAA) for ELZONRIS
07 Jan 2019 Janssen Submits Application to European Medicines Agency Seeking Approval of STELARA® (ustekinumab) for Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis
07 Jan 2019 Regeneron and Sanofi Restructure Immuno-Oncology Collaboration for Discovery and Development Programs
03 Jan 2019 Sesen Bio Announces Positive Preliminary 12-Month Data from Registration Phase 3 VISTA Trial of Vicinium for Non-Muscle Invasive Bladder Cancer
03 Jan 2019 Viela Bio Announces Inebilizumab Achieved Primary and Key Secondary Endpoints in Pivotal Trial in Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD)
03 Jan 2019 First Patient Enrolled in Biogen’s Phase 3b Study to Evaluate Extended Interval Dosing (EID) with Natalizumab in Multiple Sclerosis
03 Jan 2019 Harpoon Therapeutics Announces Preliminary Safety and Pharmacology Data from its HPN424 Phase 1 Trial in Prostate Cancer
03 Jan 2019 Innovent Announces First Patient Dosed in a Phase III Clinical Trial of Anti-PD-1 Antibody Tyvyt® (Sintilimab injection) as First-line Treatment for Patients with Advanced Esophageal Cancer
28 Dec 2018 JHL Biotech Announces First Patient Randomized in the Phase III Study of JHL1101 to Treat Diffuse Large B-Cell Lymphoma
27 Dec 2018 Bio-Thera Solutions Files IND for Phase 1 Clinical Trial with BAT8003 (Trop2-ADC) as Treatment for Trop2 Positive Cancers
27 Dec 2018 China's NMPA Approves Innovent's Anti-PD-1 Antibody Tyvyt® (Sintilimab injection) for Hodgkin's Lymphoma
27 Dec 2018 TRACON Pharmaceuticals Announces Submission of IND Application for TJ4309 (CD73 Antibody TJD5) for Treatment of Advanced Solid Tumors
27 Dec 2018 TRACON Pharmaceuticals Presents Positive Top-line Clinical Data from Dose Escalation Portion of Phase 1 Trial of TRC105 and Opdivo® for Treatment of Non-Small Cell Lung Cancer
26 Dec 2018 I-Mab Receives U.S. FDA IND Approval for Proprietary Anti-GM-CSF Monoclonal Antibody TJM2
22 Dec 2018 Kodiak Sciences Announces Completion of 12-Week Phase 1a Study of KSI-301 in Patients with Diabetic Macular Edema Demonstrating Safety and Durability of Responses Following Single Dose of Intravitreal Anti-VEGF Antibody Biopolymer Conjugate

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