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Stock Market & Financial Investment News

News For JNJ;AGN From The Last 14 Days
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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 Gilead’s 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-naïve 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 FDA’s 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 Gilead’s 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.
June 29, 2015
17:22 EDTAGNAllergan reports 6.7% stake in KYTHERA
June 25, 2015
08:13 EDTAGNAllergan CEO: Irvine campus ‘crucial’ to company, L.A. Times reports
New Allergan CEO Brent Saunders said that the company’s Irvine, California campus is “crucial” to the recently purchased organization, the L.A. Times reports, citing comments from Saunders in an interview. Allergan was purchased in March by Actavis, a move which led to the layoff of roughly 600 employees from the Irvine offices, the report says. Saunders said that the “bleeding has stopped” after a round of layoffs, the L.A. Times says. Reference Link

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