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News Breaks
June 16, 2014
17:19 EDTJNJJ&J: New data shows Invokana reduces blood glucose levels
Janssen Research & Development announced new results from a 104-week Phase 3 clinical study evaluating the long-term effects of INVOKANA, canagliflozin, in patients aged 55 to 80 years with type 2 diabetes inadequately controlled on current antihyperglycemic therapies. The randomized double-blind study showed INVOKANA 100 milligrams, mg ,and 300 mg, compared to placebo, provided greater reductions in blood glucose, A1C, and greater reductions in secondary endpoints of fasting plasma glucose, body weight and systolic blood pressure. In the long-term study, DIA3010, after 104 weeks, levels of A1C, the primary endpoint, were significantly reduced with INVOKANA100 mg and 300 mg, respectively, relative to placebo: -0.49% and -0.60%. A1C, also called hemoglobin A1c, is the percent of red blood cell hemoglobin with glucose attached to it, and is an indicator of average blood glucose over the previous two to three months.3
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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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