Antibodies

1 August 2017

Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin, and Irinotecan

1 August 2017

Acceleron Announces First Patient Treated in Phase 2 Clinical Trial of ACE-083 in Charcot-Marie-Tooth Disease

31 July 2017

Amgen Submits Supplemental Biologics License Application For Prolia® (denosumab) In Glucocorticoid-Induced Osteoporosis

31 July 2017

Amgen And Allergan Submit Biosimilar Biologics License Application For ABP 980 To US Food And Drug Administration

31 July 2017

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

31 July 2017

Imfinzi granted Breakthrough Therapy Designation by US FDA for patients with locally-advanced unresectable non-small cell lung cancer

29 July 2017

Publication of Research Article on Foralumab, a Fully Human Anti-CD3 Antibody Being Developed as an Oral Therapy for NASH and Autoimmune Diseases

29 July 2017

Galderma Announces Enrollment of First Patient in Phase IIb Nemolizumab Trial in Atopic Dermatitis

29 July 2017

FDA Grants Priority Review For Amgen’s Supplemental Biologics License Application For Repatha® (evolocumab) To Include Data On Reducing Risk Of Cardiovascular Events

27 July 2017

Boehringer Ingelheim starts clinical study on interchangeability between its adalimumab biosimilar candidate and HUMIRA®

27 July 2017

Compugen Discloses Updates to Collaborative Activities with Bayer in Immuno-Oncology

27 July 2017

AstraZeneca reports initial results from the ongoing MYSTIC trial in Stage IV lung cancer

26 July 2017

First Patient Enrolled in OncoQuest’s Phase 1/2 Study Combining Oregovomab with Hiltonol® in Recurrent Ovarian Cancer

26 July 2017

Bristol-Myers Squibb’s ORENCIA® (abatacept) Receives Second European Commission Approval in Less than a Year – New Approval for Treatment of Active Psoriatic Arthritis (PsA)1

26 July 2017

Santen and TRACON Announce Initiation of a Phase 2a Study of DE-122 for the Treatment of Wet Age-Related Macular Degeneration

25 July 2017

U.S. Food and Drug Administration Accepts Bristol-Myers Squibb’s Applications for Opdivo (nivolumab) Four-Week Dosing Schedule Across All Approved Indications

25 July 2017

Merck Provides Update on Phase 3 Study of KEYTRUDA® (pembrolizumab) Monotherapy in Patients with Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

25 July 2017

UCB and Dermira Announce U.S. and EU Regulatory Submissions for CIMZIA® (certolizumab pegol) for the treatment of Moderate-to-Severe Chronic Plaque Psoriasis

24 July 2017

Seattle Genetics Announces Clinical Collaboration to Expand the Therapeutic Evaluation of SGN-LIV1A in Triple Negative Breast Cancer

24 July 2017

Pfizer Announces Positive Top-Line Results from the Comparative REFLECTIONS B7391003 Study for PF-06439535, a Potential Biosimilar to Avastin®1 (bevacizumab

24 July 2017

U.S. Food and Drug Administration Expands Approval of Yervoy® (ipilimumab) to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma

24 July 2017

Samsung Bioepis Announces RENFLEXIS™ (infliximab-abda) Now Available in the United States

22 July 2017

GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus

22 July 2017

EMA’s CHMP Issues Positive Opinion for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma

22 July 2017

European Medicines Agency’s CHMP Recommends Approval for Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer

22 July 2017

Sanofi and Regeneron Receive Positive CHMP Opinion for Dupixent® (dupilumab) to Treat Adult Patients with Moderate-to-Severe Atopic Dermatitis

22 July 2017

AbbVie Receives CHMP Positive Opinion for HUMIRA® (adalimumab) for the Treatment of Pediatric Patients with Chronic Non-infectious Anterior Uveitis

22 July 2017

Phase II Trial of Investigational Anetumab Ravtansine Does Not Meet Primary Endpoint in Second-Line Mesothelioma

21 July 2017

FDA Accepts Biologics License Application For Aimovig™ (erenumab)

21 July 2017

Chugai Files a New Drug Application for Its Bispecific Monoclonal Antibody “Emicizumab” for the Treatment of Congenital Factor VIII Deficiency (Hemophilia A) with Factor VIII Inhibitors

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