Antibodies

20 July 2017

Emergent BioSolutions to Acquire Raxibacumab, an FDA-Approved Anthrax Monoclonal Antibody, From GSK

20 July 2017

Kyntheum approved in the EU for the treatment of adults with moderate-to-severe plaque psoriasis

19 July 2017

FDA Accepts CSL Behring’s Supplemental Biologics License Application for Hizentra® Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Indication

19 July 2017

OSE Immunotherapeutics Receives €9.2 million Grant from Bpifrance “Invest in the Future Program” for Development of New Immune Checkpoint Inhibitor OSE-172 (Effi-DEM)

18 July 2017

Five Prime Therapeutics Initiates Patient Dosing in Phase 1 Clinical Safety Trial Evaluating FPA144 in Gastric Cancer in Japan in Preparation for Future Global Late-Stage Development

17 July 2017

New Evidence of Sutro ADC’s Potency in Human Tumor Xenografts

17 July 2017

China’s First Fully Human, Full-length Anti-PD-L1 Monoclonal Antibody Receives Approval to Initiate Clinical Trials by the China Food and Drug Administration

17 July 2017

Apexigen, Inc. Announces First Patient Dosed in Phase 1b/2 Clinical Trial of APX005M in Combination with Opdivo (nivolumab) in Advanced Solid Tumors

17 July 2017

Amgen And UCB Provide Update On Regulatory Status Of EVENITY™ (romosozumab) In The US

14 July 2017

Janssen announces u.s. FDA approval of Tremfya™ (guselkumab) for the treatment of moderate to severe plaque psoriasis

14 July 2017

Aduro Announces Milestone Achieved Relating to Collaboration with Merck for Development of Anti-CD27 Antibody for the Treatment of Cancer

14 July 2017

FDA Oncologic Drugs Advisory Committee Unanimously Recommends Approval of Mylan and Biocon’s Proposed Biosimilar Trastuzumab

12 July 2017

FDA Advisory Committee Votes in Favor of Pfizer’s MYLOTARG (gemtuzumab ozogamicin) for Acute Myeloid Leukemia

12 July 2017

FDA Grants Full Approval for BLINCYTO® (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children

11 July 2017

Valerion Initiates VAL-1221 Dosing in Patients with Pompe Disease

10 July 2017

PDS Biotechnology Corp. Announces Clinical Collaboration with Merck to Evaluate Combination of Versamune® PDS0101 and KEYTRUDA® (pembrolizumab) for Metastatic Head and Neck Cancer

10 July 2017

Exelixis and Bristol-Myers Squibb Initiate Phase 3 Trial of Opdivo® in Combination with CABOMETYX™ or Opdivo and Yervoy® in Combination with CABOMETYX, Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

10 July 2017

Positive Phase III Results for Genentech’s Emicizumab in Hemophilia A Published in The New England Journal of Medicine

10 July 2017

FDA Grants Priority Review for Lilly’s Abemaciclib for the Treatment of Advanced Breast Cancer

6 July 2017

Bristol-Myers Squibb’s ORENCIA (abatacept) Receives FDA Approval for Treatment of Active Psoriatic Arthritis (PsA) in Adults

6 July 2017

Merck Provides Further Update on Three Multiple Myeloma Studies Evaluating KEYTRUDA® (pembrolizumab) in Combination with Pomalidomide or Lenalidomide

6 July 2017

Novartis receives approval in the EU for Cosentyx label update, includes long term superiority data versus Stelara in psoriasis

6 July 2017

Immunocore Announces Third Oncology Target Selected in Discovery Collaboration with GlaxoSmithKline

5 July 2017

Phase 3 Study Evaluating the Safety and Efficacy of Adjuvant Opdivo in Resected High-Risk Melanoma Patients Meets Primary Endpoint

5 July 2017

Daiichi Sankyo Announces Discontinuation of Etanercept Biosimilar (CHS-0214) Development in Japan

2 July 2017

FDA Grants Priority Review to HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab

30 June 2017

BESPONSA® Approved in the EU for Adult Patients with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

30 June 2017

CytomX Achieves Development Milestone in Strategic Oncology Collaboration with AbbVie for CD71-Targeting Probody Drug Conjugate

30 June 2017

FDA Approves Vectibix® (Panitumumab) For Use In Wild-Type RAS Metastatic Colorectal Cancer

30 June 2017

Celltrion and Teva Announce U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar to Rituxan® (rituximab)

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