DIA Biosimilars 2013

Janssen

Janssen, Pharmacyclics collaborate to develop anti-cancer drug

Friday, December 9, 2011 07:56 AM

Janssen Biotech, one of the Janssen Pharmaceutical companies of Johnson & Johnson, has executed an agreement with Pharmacyclics to jointly develop and market the anti-cancer compound, PCI-32765. A number of phase I and II studies with PCI-32765 are ongoing across a panel of B-cell malignancy disorders, including chronic lymphocytic leukemia, mantle cell lymphoma, and diffuse large B-cell lymphoma.

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Cenduit: Now with Patient Reminders

Molecular Partners expands research collaboration with Janssen Biotech

Thursday, December 8, 2011 12:17 PM

Molecular Partners has entered into a strategic research collaboration and option agreement with Janssen Biotech to research, discover and develop DARPin products for the treatment of immunological diseases. The collaboration and expansion of its current agreement with the company and its affiliates aims to explore a defined set of targets, including the use of multispecific DARPins, to address diseases where continued unmet needs for effective treatment options continue to exist.

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CRF Health – eCOA Forum

Bristol Myers enters clinical collaboration with Tibotec

Friday, December 2, 2011 11:35 AM

Bristol-Myers Squibb has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals, one of the Janssen Pharmaceutical companies, to evaluate the utility of daclatasvir (BMS-790052), Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals' investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus (HCV).

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Synexus exceeds expectations in clinical trial recruitment

Tuesday, October 25, 2011 01:53 PM

Synexus’ Pretoria clinical research center has enrolled more patients than any other site across the world in a type 2 diabetes trial for Janssen Pharmaceuticals.

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FDA approves REMICADER for pediatric UC

Tuesday, September 27, 2011 12:02 PM

FDA has approved Janssen Biotech’s REMICADER (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.  This marks the 16th approval of REMICADER in the U.S. and the seventh for the anti-tumor necrosis factor (TNF)-alpha in the treatment of inflammatory bowel disease (IBD) spanning adult and pediatric Crohn's disease and adult and pediatric UC.  It is estimated that 1.4 million Americans have IBD with the number evenly split between UC and Crohn's disease.  An estimated 150,000 children under age 17 are living with symptoms of IBD.

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EMA recommends INCIVO for hepatitis C virus

Friday, July 29, 2011 10:25 AM

Tibotec Virco-Virology BVBA, part of Janssen Pharmaceutical, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of INCIVO (telaprevir), a direct acting antiviral (DAA) for the treatment of chronic genotype-1 hepatitis C virus (HCV), in combination with pegylated-interferon and ribavirin, the previously accepted standard of care.

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FDA advisory committee recommends REMICADER

Friday, July 29, 2011 10:13 AM

Janssen Biotech, formerly Centocor Ortho Biotech, reported the Gastrointestinal Drugs Advisory Committee (GIDAC) of the FDA recommended the approval of REMICADER (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.

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Valeant buys Johnson & Johnson skincare unit for $345 million

Tuesday, July 19, 2011 12:57 PM

Valeant Pharmaceuticals wants to become the world's biggest player in the skincare sector in about five years, its top executive told Reuters. The company has been signaling its intent with a string of recent mid-sized acquisitions in the highly fragmented but lucrative dermatology sector.

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Valeant acquires Ortho Dermatologics

Monday, July 18, 2011 10:03 AM

Valeant Pharmaceuticals International subsidiaries Valeant Pharmaceuticals North America (VPNA) and Valeant International (Barbados) SRL (VIB), have signed an agreement to acquire the assets of the Ortho Dermatologics division of Janssen Pharmaceuticals. Valeant will pay Janssen $345 million for the assets, which includes prescription brands RETIN-A MICRO, ERTACZO, and RENOVA. Total revenue for the product portfolio was approximately $150 million in 2010. The transaction is subject to certain closing conditions and regulatory approvals and is expected to be accretive in 2011.

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FDA eases rules for Alzheimer’s experiments to speed new treatments for dementia

Tuesday, July 12, 2011 12:35 PM

The FDA is making it easier to test new Alzheimer’s drugs, hoping to speed progress toward new treatments for the mind-robbing disease, according to an Associated Press report.

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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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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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