07 Feb 2019 Arch Oncology Announces First Patient Dosed in Phase 1 Clinical Trial of AO-176, an Anti-CD47 Antibody with a Best-in-Class Profile
07 Feb 2019 Innovent Receives IND Approval of a Bispecific Antibody (IBI318) by the NMPA
06 Feb 2019 FDA approves Cablivi® (caplacizumab-yhdp), the first Nanobody®-based medicine, for adults with acquired thrombotic thrombocytopenic purpura (aTTP)FDA approves Cablivi® (caplacizumab-yhdp), the first Nanobody®-based medicine, for adults with acquired throm
06 Feb 2019 MacroGenics Announces Positive Results from Pivotal Phase 3 SOPHIA Study of Margetuximab
05 Feb 2019 US FDA grants Breakthrough Therapy Designation for potential next-generation RSV medicine MEDI8897
05 Feb 2019 Genentech Submits Supplemental Biologics License Application to FDA for Kadcyla for Adjuvant Treatment of People With HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Treatment
05 Feb 2019 Isatuximab Phase 3 trial meets primary endpoint of prolonging progression free survival in patients with relapsed/refractory multiple myeloma
05 Feb 2019 CHMP recommends EU approval of Roche's Tecentriq in combination with Avastin and chemotherapy as an initial treatment for lung cancer
05 Feb 2019 Surface Oncology Retains Worldwide Rights for its First-in-Class Antibody Targeting IL-27, SRF388
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

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