Antibodies

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
22 Dec 2018 FDA Approves ELZONRIS (tagraxofusp), the First Treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm and First CD123-Targeted Therapy
22 Dec 2018 Merck and Pfizer Provide Update on JAVELIN Ovarian 100 Trial of Avelumab in Previously Untreated Advanced Ovarian Cancer
22 Dec 2018 Alexion Receives Early FDA Approval for ULTOMIRIS™ (Ravulizumab-cwvz) in Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
21 Dec 2018 Oxford BioTherapeutics Receives US FDA IND Clearance for OBT076
21 Dec 2018 Janssen Submits Application To U.S. FDA Seeking Approval Of STELARA® (ustekinumab) For Treatment Of Moderately To Severely Active Ulcerative Colitis
21 Dec 2018 CStone Pharmaceuticals announces initiation of CS1001 Phase I Study in U.S., patient enrollment under way
21 Dec 2018 OSE Immunotherapeutics Announces First Healthy Volunteers Dosed in Phase 1 Clinical Trial of OSE-127
21 Dec 2018 TRACON Pharmaceuticals Announces Top-line Data from Phase 2 TRAXAR Clinical Trial in Renal Cell Carcinoma
20 Dec 2018 Janssen Announces European Commission Approval of Darzalex (daratumumab) Split Dosing Regimen
20 Dec 2018 Chugai’s Satralizumab Meets Primary Endpoint in Phase III Monotherapy Study in NMOSD
20 Dec 2018 Chugai’s Satralizumab Receives FDA Breakthrough Therapy Designation for Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
20 Dec 2018 FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Adult and Pediatric Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma, a Rare Form of Skin Cancer
19 Dec 2018 I-Mab and CSPC Pharma Announce Strategic Partnership for Long-acting GLP-1 Fc Program
19 Dec 2018 NeuClone Announces its Sixth Biosimilar Candidate Perjeta(R) (Pertuzumab) for use in Combination Therapy with Herceptin(R) (Trastuzumab)
19 Dec 2018 BeiGene Initiates Two Global Phase 3 Front-Line Clinical Trials of Tislelizumab, in Patients with Gastric Cancer and in Patients with Esophageal Cancer
19 Dec 2018 Surface Oncology Resets Portfolio Priorities, Extends Cash Runway Through 2021
19 Dec 2018 Xbrane Biopharma has submitted the first application for start of Xlucane clinical trial
19 Dec 2018 Lilly announces positive top-line results for Taltz® (ixekizumab) vs. Humira® (adalimumab) in a head-to-head superiority study (SPIRIT-H2H) in patients with active psoriatic arthritis
17 Dec 2018 European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Adults with Resected Stage III Melanoma
17 Dec 2018 Amgen Submits Biologics License Application for ABP 710 (Biosimilar Infliximab) To US Food And Drug Administration
15 Dec 2018 Celltrion and Teva Announce FDA Approval of HERZUMA® (trastuzumab-pkrb), a Biosimilar to HERCEPTIN®, for the Treatment of HER2-Overexpressing Breast Cancer for Certain Indications
15 Dec 2018 FDA Approves Nplate® (Romiplostim) For Use In Pediatric Patients With Immune Thrombocytopenia
14 Dec 2018 Pfizer Receives Positive CHMP Opinion for Oncology Biosimilar, ZIRABEV™ (bevacizumab)
14 Dec 2018 Takeda Receives Positive CHMP Opinion for ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma in Combination with AVD

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