DIA Biosimilars 2013

Janssen

GNS Healthcare joins Orion Bionetworks to develop predictive models

Monday, March 4, 2013 02:08 PM

GNS Healthcare has joined in the formation of Orion Bionetworks. This unique alliance will work to transform understanding of and accelerate the drug development process for a wide variety of diseases, beginning with multiple sclerosis (MS).

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Cenduit: Now with Patient Reminders

Abbott, Janssen, Pharmacyclics to develop companion test for leukemia therapy

Friday, February 22, 2013 11:16 AM

Global healthcare company Abbott has formed a collaboration with Janssen Biotech and Pharmacyclics, a biopharmaceutical company based in Sunnyvale, Calif., to explore the benefits of Abbott's proprietary FISH (fluorescence in situ hybridization) technology for use in developing a molecular companion diagnostic test to identify patients with a genetic subtype of chronic lymphocytic leukemia (CLL), the most common form of adult leukemia.

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CRF Health – eCOA Forum

Janssen, Bayer, Portola form clinical collaboration

Friday, February 8, 2013 11:17 AM

Janssen Pharmaceuticals has signed a clinical collaboration agreement with Portola Pharmaceuticals and Bayer HealthCare to evaluate the safety of PRT4445—an investigational-stage antidote for Factor Xa inhibitors—in healthy volunteers who have been administered the oral anticoagulant Xarelto (rivaroxaban). The study will evaluate several dosage strengths of PRT4445 and its ability to reverse the anticoagulant activity of Xarelto in emergency situations.

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$262M Pan-European drug discovery platform launched

Friday, February 8, 2013 10:48 AM

The European Lead Factory, a novel platform for innovative drug discovery, was launched Feb. 7 by an international consortium of 30 partners. The partnership, the first of its kind, is supported by the Innovative Medicines Initiative (IMI) and creates opportunities for the discovery of new medicines by providing public partners with an “industry-like” discovery platform to translate cutting-edge academic research into high-quality drug lead molecules on a scale and speed that was not possible previously.

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Janssen Labs at San Diego adds concept lab, open collaboration space

Wednesday, February 6, 2013 10:43 AM

Janssen Labs at San Diego, part of Janssen Research & Development, is adding a concept lab and an open collaboration space, just one year after opening.

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Idenix Pharmaceuticals cancels IDX184 and IDX19368 programs for HCV

Wednesday, February 6, 2013 09:45 AM

Idenix Pharmaceuticals, a Cambridge, Mass.-based biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, has elected not to continue its clinical development program for IDX184, a nucleotide polymerase inhibitor in phase IIb testing for the treatment of hepatitis C virus (HCV) infection, or to continue its development of IDX19368, an HCV nucleotide polymerase inhibitor for which the company had previously filed an IND but had not initiated patient dosing.

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FDA grants accelerated approval for Sirturo for multi-drug resistant TB

Wednesday, January 2, 2013 03:13 PM

The FDA has granted accelerated approval to Janssen Therapeutics’ Sirturo (bedaquiline) tablets for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults. The accelerated approval is based on the surrogate endpoint of time to sputum culture conversion.

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Phenex, Janssen form research collaboration on autoimmune, inflammatory disorders

Monday, December 17, 2012 02:09 PM

Phenex Pharmaceuticals, a privately held drug discovery and development company based in Germany, has entered into an agreement with Janssen Biotech and its affiliates to jointly discover compounds that target the nuclear hormone receptor RORγT and may have utility in the treatment of chronic autoimmune and inflammatory disorders including rheumatoid arthritis, psoriasis and inflammatory bowel disease.

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Janssen R&D establishes global cross-pharma clinical trial Investigator Databank

Monday, November 19, 2012 10:18 AM

Janssen Research & Development, based in Raritan, N.J., has established a global cross-pharmaceutical Investigator Databank designed to improve efficiencies of industry-sponsored clinical trials. Merck and Eli Lilly are the first two companies to join Janssen in this effort.

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Prezista receives E.C. approval for young children with HIV-1 infection

Friday, October 26, 2012 10:46 AM

The European Commission (E.C.) has approved Janssen/Cilag International’s 100mg/ml oral suspension of Prezista (darunavir), and the use of darunavir co-administered with low dose ritonavir, for the treatment of human immunodeficiency virus (HIV-1) infection in antiretroviral therapy (ART)-experienced pediatric patients age three and above, weighing at least 15kg. The drug must be taken in combination with other ARTs.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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