Innovative Medicine
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IMBRUVICA® (ibrutinib) Supplemental New Drug Application for Treatment-naïve Chronic Lymphocytic Leukemia Submitted to the U.S. FDA
Submission seeking potential fifth indication based on data from the Phase 3 RESONATE™-2 (PCYC-1115) trial -
Johnson & Johnson Announces BARDA Funding Award to Accelerate Ebola Vaccine Program
Prime-boost vaccine regimen in development at the Janssen Pharmaceutical Companies currently in Phase I and II clinical studies in Europe, U.S. and Africa -
U.S. FDA Grants Priority Review to Janssen for Daratumumab as a Treatment for Multiple Myeloma
If approved, daratumumab will offer a new option for double refractory, heavily pre-treated patients -
Data Published in The New England Journal of Medicine Show Single-Agent Daratumumab Demonstrated a 36 Percent Overall Response Rate and Tolerable Safety Profile in Heavily Pre-Treated Multiple Myeloma Patients
Study results also showed 65 percent of responding patients remained in remission at 12 months -
Janssen Submits European Extension Marketing Authorisation Application for Paliperidone Palmitate Once-Every-Three-Months Formulation
First long-acting treatment to be administered four times a year for the treatment of schizophrenia in adults -
Janssen Submits Supplemental New Drug Application to U.S. FDA for All-Oral, Once-Daily OLYSIO® (Simeprevir) in Combination with Sofosbuvir
Filing Supported by Data from the Phase 3 OPTIMIST-1 and -2 Clinical Trials Evaluating OLYSIO® Combination Therapy in Hepatitis C Patients with and without Cirrhosis -
Trabectedin Improves Disease Control in Patients with Advanced Soft Tissue Sarcoma
Oral presentation (abstract 10503) featured at the Annual Meeting of the American Society of Clinical Oncology -
New Clinical Research Program Initiated for the Prevention and Treatment of Life-Threatening Blood Clots in Patients with Cancer
Janssen Expands EXPLORER Cardiovascular Research Program to Include New, Multi-Trial, Prospective Research Program Aimed at Generating New Evidence in Treating and Preventing Cancer-Associated Blood Clots -
Janssen Receives Positive CHMP Opinion Recommending IMBRUVICA® (ibrutinib) for the Treatment of Waldenström’s Macroglobulinemia
A rare B-cell lymphoma with no EMA-approved treatment options available