Janssen

Mylan confirms Zytiga-related patent challenge

Wednesday, August 19, 2015

Mylan has been sued by BTG International, Janssen Biotech, Janssen Oncology and Janssen R&D in connection with the filing of an Abbreviated New Drug Application (ANDA) with the FDA for Abiraterone Acetate Tablets, 250mg. This product is the generic version of Zytiga, which is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.

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Hybrigenics’ inecalcitol gets FDA Orphan designation for AML

Wednesday, August 12, 2015

Hybrigenics, a Paris-based biopharmaceutical company, has received Orphan Drug designation by the FDA for inecalcitol for the treatment of acute myeloid leukemia (AML) in the U.S. Orphan designation qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including tax credits for qualified clinical testing.

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Epizyme appoints Robert Bazemore president and CEO

Thursday, August 6, 2015

Epizyme, a clinical stage biopharmaceutical R&D company creating novel epigenetic therapeutics for cancer patients, has announced Robert Bazemore will succeed Robert Gould, Ph.D., as president and chief executive officer of Epizyme, effective Sept. 10. Bazemore also will join the Epizyme board of directors. Following the transition, Gould will continue to sit on the board and work as a consultant to the company.

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Report: Innovation trends in treatments for rare diseases and widespread conditions

Wednesday, June 17, 2015

The antibiotics market is at risk of losing another decade to inadequate levels of research and innovation, according to international intellectual property firm Marks & Clerk’s new report From rare to routine—medicines for rare diseases, vaccines and antibiotics. Research highlights the striking difference between research levels into rare diseases, vaccines and antibiotics across the globe.

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Johnson & Johnson Innovation inks 17 collaborations

Friday, June 12, 2015

Johnson & Johnson Innovation has announced 17 new collaborations with research institutions and healthcare companies, bringing the total number of collaborations formed since the 2013 launch of Johnson & Johnson Innovation to more than 200. Johnson & Johnson Innovation seeks to identify and advance scientific innovation across the Johnson & Johnson segments of Pharmaceutical, Medical Devices and Consumer businesses.

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FDA approves Invega Trinza, only four-times-a-year treatment for schizophrenia

Thursday, May 21, 2015

The FDA has approved under Priority Review Janssen Pharmaceuticals’ New Drug Application (NDA) for the three-month long-acting atypical antipsychotic Invega Trinza. Invega Trinza, a three-month injection, is an atypical antipsychotic indicated to treat schizophrenia. Before starting Invega Trinza, patients must be adequately treated with Invega Sustenna (one-month paliperidone palmitate) for at least four months. Priority Review is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.

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ViiV Healthcare begins phase III dolutegravir/rilpivirine program for HIV maintenance therapy

Thursday, May 7, 2015

ViiV Healthcare has started a phase III clinical trial program to evaluate the safety and efficacy of dolutegravir (Tivicay) and rilpivirine (Edurant) as maintenance therapy for adult patients with HIV. The phase III program comprises two replicate studies evaluating 48 week viral suppression with a two drug regimen combining an integrase inhibitor (dolutegravir) and a non-nucleoside reverse transcriptase inhibitor (rilpivirine) in patients with HIV who already have achieved viral suppression with a three drug regimen.

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