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December 10, 2012
13:43 EDTJNJJanssen says FDA approves broader indication for Zytiga
Janssen announced that the U.S. FDA has approved a broader indication for the oral, once-daily medication Zytiga. Until now, Zytiga with prednisone has only been approved to treat men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel. With this approval, Zytiga, in combination with prednisone, may now be used earlier in the treatment continuum for metastatic castration-resistant disease, before the use of chemotherapy. Zytiga also received a positive opinion for an expanded indication from the European Medicines Agency's Committee for Medicinal Products for Human Use nd is under review by other health authorities worldwide.
News For JNJ From The Last 14 Days
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July 6, 2015
10:02 EDTJNJWi-LAN enters settlement, license agreement with Cordis
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July 1, 2015
16:33 EDTJNJGilead submits NDA to FDA for single tablet regimen for HIV containing R/F/TAF
Gilead Sciences (GILD) announced that it has submitted a New Drug Application, or NDA, to the FDA for an investigational, once-daily single tablet regimen that combines Gileadís emtricitabine 200 mg and tenofovir alafenamide, or TAF, 25 mg with rilpivirine 25 mg, or R/F/TAF, from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), for the treatment of HIV-1 infection in adult and pediatric patients 12 years of age and older. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naÔve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen. A Priority Review voucher acquired from Knight Therapeutics in November 2014 was submitted to the FDA along with the R/F/TAF NDA. Under the Prescription Drug User Fee Act, or PDUFA, the anticipated target action date for the R/F/TAF NDA is six months after the FDAís acceptance of the filing. TAF is a novel, investigational nucleotide reverse transcriptase inhibitor, or NRTI, that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gileadís Viread, as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials in combination with other antiretroviral agents. In addition to R/F/TAF, two other TAF-based HIV treatments are also under FDA review.

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