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January 21, 2013
19:26 EDTJNJJ&J's Cordis announces two-year results from STROLL trial
Cordis, a unit of Johnson & Johnson, announced the presentation of the two-year STROLL study results. In the study, the average lesion length was 77 mm, 23.6% of patients presented with total occlusions and 47% of patients were diabetic. Freedom from clinically driven target lesion revascularization at two years was 80.3%. The 24-month primary patency rate for the S.M.A.R.T. Stent was 74.9% by Kaplan Meier estimate. The primary duplex patency rate was 83.5%. There were no major adverse events at 30 days after the initial index procedure, Cordis added. There was also a low rate of stent fractures noted at 12 months with no additional fractures reported out to 24 months, the company said. All stent fractures were Type I, least severe, and there were no incidents of more severe stent fractures. STROLL is a multicenter, non-randomized, single-arm, prospective trial comparing the safety and efficacy of the S.M.A.R.T. Stent with a previously published objective performance goal.
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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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