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Antibodies

04 Feb 2019 Chugai’s Hemlibra® Gains Positive CHMP Opinion in Severe Hemophilia A Without Inhibitors
04 Feb 2019 European Medicines Agency Adopts Positive Opinion for Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Adults with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
04 Feb 2019 CHMP recommends approval of Praluent® (alirocumab) to reduce cardiovascular risk in people with established atherosclerotic cardiovascular disease
02 Feb 2019 Teva Receives Positive Committee for Medicinal Products for Human Use (CHMP) Opinion for AJOVY® (fremanezumab) for the Prophylaxis of Migraine in Adults
30 Jan 2019 Genentech to Discontinue Phase III CREAD 1 and 2 Clinical Studies of Crenezumab in Early Alzheimer’s Disease (AD) - Other Company Programs in AD Continue
29 Jan 2019 Pfizer and Lilly Announce Top-Line Results From Second Phase 3 Study of Tanezumab in Osteoarthritis Pain
29 Jan 2019 Momenta Pharmaceuticals Announces First Subject Dosed in Phase 1/2 Clinical Trial of M254, Hypersialylated Immunoglobulin G
29 Jan 2019 EpimAb Biotherapeutics Achieves Key Milestone with Lead Cancer Program EMB01
29 Jan 2019 Alexion Announces Positive Top-Line Results from Phase 3 Study of ULTOMIRIS™ (Ravulizumab-cwvz) in Complement Inhibitor-Naïve Patients with atypical Hemolytic Uremic Syndrome (aHUS)
26 Jan 2019 MacroGenics Announces Removal of Partial Clinical Hold on MGD009 Program by FDA
25 Jan 2019 Coherus BioSciences Announces Global Settlement with AbbVie Securing Rights to Commercialize its Adalimumab Biosimilar Candidate, CHS-1420
24 Jan 2019 Amgen And Allergan Announce Positive Top-Line Results From Phase 1/ Phase 3 Study Of ABP 798, Biosimilar Candidate To Rituximab
24 Jan 2019 Long-term survival analysis of the randomised Phase III study shows a clear clinical benefit of inolimomab in SR-aGvHD
23 Jan 2019 Bio-Thera Solutions Announces Initiation of Phase III Clinical Trial for BAT1806, a Proposed Biosimilar of Actemra® (Tocilizumab)
23 Jan 2019 I-Mab Biopharma Receives U.S. FDA IND Clearance for Proprietary CD73 Antibody TJD5
23 Jan 2019 Genmab Announces Initiation of U.S. FDA Regulatory Submission for Label Expansion of Daratumumab in Combination with Lenalidomide and Dexamethasone in Front Line Multiple Myeloma
23 Jan 2019 European Commission Approves BLINCYTO® (blinatumomab) In Patients With Philadelphia Chromosome Negative Minimal Residual Disease-Positive B-cell Precursor Acute Lymphoblastic Leukemia
21 Jan 2019 BerGenBio Announces Start of Phase I Trial Evaluating ADCT-601, a Novel Anti-AXL ADC, in Patients With Advanced Solid Tumours
21 Jan 2019 US FDA Approves ONTRUZANT® (trastuzumab-dttb), Samsung Bioepis’ First Oncology Medicine in the United States
18 Jan 2019 Lilly Reports Results of Phase 3 Soft Tissue Sarcoma Study of LARTRUVO®
18 Jan 2019 Zymeworks Reports Second Investigational New Drug (IND)-Submission Milestone Achieved in Lilly Collaboration
18 Jan 2019 Immunomedics Receives Complete Response Letter From FDA for Sacituzumab Govitecan Biologics License Application
17 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 Gastric Cancer
17 Jan 2019 Vaccinex, Inc. Announces Completion of Enrollment for Its “SIGNAL” Huntington’s Disease Trial
17 Jan 2019 FDA Accepts Genentech’s Supplemental Biologics License Application for Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

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