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February 21, 2014
09:34 EDTJNJJanssen announces positive CHMP opinion for Vokanamettm in type 2 diabetes
Janssen-Cilag International NV of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use, CHMP, has adopted a positive opinion, recommending marketing authorization in the European Union for the medicinal product VOKANAMETTM, a fixed-dose therapy combining canagliflozin and immediate release metformin in a single tablet, intended for the treatment of type 2 diabetes mellitus. Canagliflozin is currently available as INVOKANATM following approval in the European Union in November 2013. The CHMPís positive opinion recommending the approval of the fixed dose combination of canagliflozin and metformin is now referred to the European Commission. Janssen anticipates receiving the regulatory decision from the European Commission in the coming months.
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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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