News from janssen biotech, inc A wide array of domestic and global news stories; news topics include politics / government, business, technology, religion, sports/entertainment, science/nature, and health/lifestyle. Articles that appear in this section may be written in English or other languages, as well.

Dec 07, 2015, 16:30 ET

IMBRUVICA® (ibrutinib) Phase 2 RESONATE-17 Data Show Robust Clinical Activity and Promising Survival Outcomes in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia with del 17p

 Results from a sub-analysis of the Phase 2 RESONATE-17 (PCYC-1117) study showed IMBRUVICA® (ibrutinib) was associated with robust...

Dec 07, 2015, 08:35 ET

IMBRUVICA® (ibrutinib) Phase 3 RAY Data Show Significant Improvements in Progression-Free Survival Versus Temsirolimus in Patients with Relapsed or Refractory Mantle Cell Lymphoma

 Data from the Phase 3 RAY (MCL3001) study, an investigational clinical trial, showed oral IMBRUVICA® (ibrutinib) significantly improved...

Dec 01, 2015, 08:39 ET

Janssen envía aplicaciones buscando la aprobación de STELARA® en Estados Unidos y la UE para la enfermedad de Crohn

Janssen Biotech, Inc. y Janssen-Cilag International NV (Janssen) anunciaron hoy el envío de una Biologics License Application (BLA) a la...

Nov 30, 2015, 21:34 ET

Janssen beantragt Zulassung von STELARA® in den USA und der Europäischen Union zur Behandlung von Morbus Crohn

Wie Janssen Biotech, Inc. und Janssen-Cilag International NV (Janssen) heute bekanntgaben, wurde bei der US-amerikanischen Food and Drug...

Nov 30, 2015, 18:48 ET

Janssen soumet des demandes en vue de faire approuver STELARA® aux États-Unis et dans l'Union européenne pour le traitement de la maladie de Crohn

Janssen Biotech, Inc. et Janssen-Cilag International NV (Janssen) ont annoncé aujourd'hui qu'ils ont soumis une demande de licence de produits...

Nov 30, 2015, 08:00 ET

Janssen Submits Applications Seeking Approval Of STELARA® In United States And European Union For Crohn's Disease

 Janssen Biotech, Inc. and Janssen-Cilag International NV (Janssen) announced today the submission of a Biologics License Application (BLA) to...

Nov 16, 2015, 16:58 ET

DARZALEX® (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma

Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson, announced today the U.S. Food and Drug Administration (FDA) has...

Nov 13, 2015, 08:05 ET

Additional Efficacy and Safety Data for IMBRUVICA® (Ibrutinib) Submitted to FDA

 Janssen Biotech, Inc. announced a supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) has been submitted to the U.S. Food...

Nov 12, 2015, 08:00 ET
Gut Check

Janssen Launches New Platform Focused On Improving Disease Monitoring For People Living With Inflammatory Bowel Diseases (IBD)

 Janssen Biotech, Inc. today announced the launch of Gut Check™, a new platform to help improve disease monitoring for the 1.6 million...

Nov 04, 2015, 08:21 ET

Janssen Data Presentations At American College of Rheumatology Meeting Showcase Commitment To Rheumatologic Diseases

 Janssen Biotech, Inc. announced today that more than 35 abstracts from the Janssen Pharmaceutical Companies will be presented at the 2015...

Oct 23, 2015, 13:42 ET

U.S. FDA Approves YONDELIS® (trabectedin) for the Treatment of Patients with Unresectable or Metastatic Liposarcoma or Leiomyosarcoma, Two Common Subtypes of Soft Tissue Sarcoma

 Janssen Biotech, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved YONDELIS® (trabectedin) for the treatment...

Sep 14, 2015, 08:40 ET

IMBRUVICA® (ibrutinib) Supplemental New Drug Application for Treatment-naive Chronic Lymphocytic Leukemia Submitted to the U.S. FDA

A supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) has been submitted to the U.S. Food and Drug Administration (FDA) for...

Sep 02, 2015, 09:06 ET
SIMPONI ARIA(R) (golimumab for infusion)

U.S. FDA Approves Update of SIMPONI ARIA® (golimumab for infusion) Label to Include Improvement in Both Physical and Emotional Measures of Health When Treating Moderately to Severely Active Rheumatoid Arthritis

 Janssen Biotech, Inc. announced today the approval of a U.S. Food and Drug Administration (FDA) Supplemental Biologics License Application...

Aug 12, 2015, 03:05 ET

Johnson & Johnson Innovation Announces Collaboration on Immuno-Oncology Antibody ADC-1013 with Alligator Bioscience

Janssen Biotech, Inc. (Janssen), one of the Janssen pharmaceutical companies of Johnson & Johnson announced today an exclusive, worldwide...

Jul 06, 2015, 08:20 ET

Daratumumab Expanded Access Program Open to Eligible U.S. Patients with Heavily Pre-Treated Multiple Myeloma

 Janssen Biotech, Inc. (Janssen) announced today the opening of a daratumumab expanded access program (EAP) for eligible U.S. patients....

Jun 03, 2015, 08:07 ET
Television and film actress Megan Park announced that she lives with rheumatoid arthritis (RA), marking the first time she has publicly disclosed living with a chronic autoimmune disease. Park made the announcement in partnership with Joint Decisions.

Actress Megan Park Shares Private Struggle With Rheumatoid Arthritis For The First Time Through "Joint Decisions" Educational Program

 Television and film actress Megan Park today announced that she lives with rheumatoid arthritis (RA), marking the first time she has publicly...

Jan 29, 2015, 11:48 ET

U.S. FDA Approves IMBRUVICA® (ibrutinib) for the Treatment of Waldenstrom's Macroglobulinemia: First FDA-Approved Therapy for This Disease

Janssen Biotech, Inc. ("Janssen") today announced that the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA®...

Oct 27, 2014, 08:00 ET
Sunny Anderson, celebrity cook, television host and ulcerative colitis patient

Celebrity Cook Sunny Anderson Teams Up With Janssen And Crohn's & Colitis Foundation Of America To Launch Educational Campaign

Janssen Biotech, Inc. and the Crohn's & Colitis Foundation of America (CCFA) announced today the launch of Get Your Full Course, an educational...

Jul 28, 2014, 13:24 ET
IMBRUVICA(R) (ibrutinib) 140mg capsules. (PRNewsFoto/Janssen Biotech, Inc.)

IMBRUVICA® (ibrutinib) Receives Regular Approval by U.S. FDA in Chronic Lymphocytic Leukemia (CLL) and CLL patients with del 17p

The U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) capsules for...

Apr 23, 2014, 17:17 ET
SYLVANT 100 and 400 mg Vials (PRNewsFoto/Janssen Biotech, Inc.)

SYLVANT™ (siltuximab) Receives FDA Approval to Treat Multicentric Castleman's Disease (MCD)

 Janssen Biotech, Inc. ["Janssen"] today announced the U.S. Food and Drug Administration (FDA) has approved SYLVANT™ (siltuximab) for the...