Janssen Pharmaceuticals

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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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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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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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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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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