Tuesday, May 21, 2013 Last update: 4:38 PM
Company Tech News as it Breaks
Janssen Research & Development, LLC
News articles for Janssen Research & Development, LLC:
Wednesday, May 15, 2013
- Janssen Oncology Data to be Presented at 2013 American Society of Clinical Oncology (ASCO) Annual Meeting, Including ZYTIGA®, Ibrutinib and Daratumumab DataRARITAN, N.J., May 15, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced that data related to three Janssen Oncology compounds have been selected for presentation at the 49(th) Annual Meeting of the American Society of Clinical Oncology (ASCO) being held May 31-June 4, 2013 in Chicago, IL. Fourteen ... read more
Monday, May 13, 2013
- U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis CRARITAN, N.J., May 13, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered as a 150 mg capsule ... read more
Monday, May 6, 2013
- Ibrutinib Expanded Access Program Open to Eligible U.S. Patients with Relapsed or Refractory Mantle Cell LymphomaRARITAN, N.J., May 6, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced patients are now enrolling in a multicenter, open-label expanded access program (EAP) in the United States for the investigational oral Bruton's Tyrosine Kinase (BTK) inhibitor ibrutinib, which is being jointly developed by ... read more
Thursday, March 28, 2013
- Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis CRARITAN, N.J., March 28, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor, administered as a 150 mg ... read more
Monday, March 4, 2013
- FDA Issues Complete Response Letter for XARELTO® (rivaroxaban) for the Reduction of Cardiovascular Events in Patients with Acute Coronary SyndromeRARITAN, N.J., March 4, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today the U.S. Food and Drug Administration (FDA) issued a second complete response letter regarding a supplemental New Drug Application (sNDA) for XARELTO(®) (rivaroxaban) for the reduction of the risk of cardiovascular events in patients with ... read more
Tuesday, February 12, 2013
- Follow-up Data Show ZYTIGA® Plus Prednisone Continues to Delay Progression of Metastatic Castration-Resistant Prostate Cancer in Patients without Prior ChemotherapyORLANDO, Fla., Feb. 12, 2013 /PRNewswire/ -- Janssen Research & Development, LLC [Janssen] announced today updated results showing ZYTIGA(®) (abiraterone acetate) plus prednisone continued to provide statistically significant improvements in disease progression compared to placebo plus prednisone, and longer overall survival in men with metastatic castration-resistant prostate cancer. The Phase 3, ... read moreIbrutinib Receives Two Oncology Breakthrough Therapy Designations from U.S. Food and Drug AdministrationRARITAN, N.J., Feb. 12, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen), today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designations for the investigational oral agent ibrutinib as a monotherapy for two B-cell malignancies: in patients with relapsed or refractory ... read more
Tuesday, February 5, 2013
- Janssen Neuroscientists and Colleagues Challenge Healthcare Industry to Create Integrated Approaches to Healthcare Innovation in Newly Published ArticleTITUSVILLE, N.J., Feb. 5, 2013 /PRNewswire/ -- Janssen Research & Development, LLC, ("Janssen") announced today the publication of a new article that addresses integrated approaches to healthcare solutions. The authors challenge the healthcare industry to expand its thinking beyond product-focused, "magic bullet" drug development and discuss ... read moreJanssen Labs at San Diego Expands to Add Concept Lab and Open Collaboration Space to Accommodate Individual Entrepreneurs and Additional Life Science Start-UpsSAN DIEGO, Feb. 5, 2013 /PRNewswire/ -- Janssen Labs at San Diego, part of Janssen Research & Development, LLC (Janssen), today announced the addition of a Concept Lab and an Open Collaboration Space. The Concept Lab is a shared laboratory that offers entrepreneurs affordable access to single bench spaces to ... read more
Thursday, January 10, 2013
- FDA Advisory Committee Recommends Approval of Canagliflozin for Treatment of Adults with Type 2 DiabetesRARITAN, N.J., Jan. 10, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 10-5 to recommend approval for canagliflozin, proposed trade name INVOKANA(TM), to treat type 2 diabetes ... read more
Wednesday, December 12, 2012
- The New England Journal of Medicine Publishes Efficacy Data for ZYTIGA® Plus Prednisone in Metastatic Castration-Resistant Prostate Cancer in Patients Who Have Not Received ChemotherapyRARITAN, N.J., Dec. 12, 2012 /PRNewswire/ -- Janssen Research & Development, LLC announced today that results from analyses of COU-AA-302, a Phase 3, randomized, placebo-controlled study of ZYTIGA(® )(abiraterone acetate) plus prednisone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) prior to chemotherapy, have been ... read moreJanssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 DiabetesRARITAN, N.J., Dec. 12, 2012 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat patients with ... read more
Tuesday, December 11, 2012
- Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, in Relapsed/Refractory Mantle Cell Lymphoma Presented at American Society of Hematology Annual MeetingATLANTA, Dec. 11, 2012 /PRNewswire/ -- Janssen Research & Development, LLC, today announced follow-up findings from an ongoing, open-label, Phase 2, single-agent study showing that in patients with relapsed or refractory mantle cell lymphoma (MCL), the investigational oral agent ibrutinib (PCI-32765) resulted in an overall response ... read more
Wednesday, December 5, 2012
- New Long-Term Study Suggests Lower Mortality in Alzheimer's Patients Treated with Galantamine Versus PlaceboHOLLYWOOD, Fla., Dec. 5, 2012 /PRNewswire/ -- New study findings presented today showed a significantly lower mortality rate in patients who were treated with galantamine, a prescription medicine for mild to moderately severe Alzheimer's disease, versus those who received placebo. Patients treated with galantamine also had ... read more