Janssen Pharmaceutica

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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Janssen R&D gains FDA priority review for TB drug

Wednesday, September 5, 2012 11:32 AM

The FDA has granted Janssen Research & Development priority review to the New Drug Application (NDA) for bedaquiline (TMC207) to treat pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults as part of combination therapy.

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Janssen buys exclusive access to Evotec's insulin-producing beta cells

Tuesday, July 10, 2012 04:25 PM

Evotec, a drug discovery alliance and development partnership company, has licensed a portfolio of small molecules and biologics designed to trigger the regeneration of insulin-producing beta cells to Janssen Pharmaceuticals.

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Janssen’s Nucynta meets primary endpoint in diabetic peripheral neuropathy study

Monday, May 21, 2012 02:46 PM

Janssen Pharmaceuticals has issued results from an investigational phase III study suggesting Nucynta ER (tapentadol) extended-release tablets were significantly more effective than placebo in providing pain management among adults with chronic moderate to severe, painful diabetic peripheral neuropathy (DPN).

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Index Ventures launches $198 million life sciences fund

Wednesday, March 21, 2012 09:26 AM

Index Ventures, a venture capital firm, has launched its first fund solely dedicated to making investments in the life sciences sector.

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Academic-industry collaboration seeks new drugs, treatments for autism

Monday, March 19, 2012 02:41 PM

An international consortium of scientists led by Roche, King's College London and Autism Speaks is collaborating on one of the largest ever academic-industry research projects, to find new methods for the development of drugs for autism spectrum disorder (ASD), which affects 1% of children worldwide.

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Pepscan achieves milestones from Janssen

Saturday, February 11, 2012 07:53 AM

Pepscan Therapeutics, a Netherlands-based biotechnology firm focusing on protein mimicry technology, has achieved two milestones in the research collaboration with Janssen R&D Ireland, formerly Tibotec Pharmaceuticals, and received undisclosed payments. 

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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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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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December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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