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News Breaks
January 28, 2014
09:08 EDTJNJCordis announces 'positive' two-year data from INCRAFT trial
Cordis, a unit of Johnson & Johnson, announced the presentation of two-year data from its INNOVATION Trial. Data from the study continues to demonstrate that the INCRAFT System performs well in patients suffering from abdominal aortic aneurysms two years after treatment. The company said, "These positive results are encouraging and build on the favorable short and mid-term outcomes of the INCRAFT System observed in the recently published one-year results of the INNOVATION Trial. Cordisí INCRAFT System has the potential to be a valuable alternative to current devices on the market. The system is designed to offer increased applicability in the broad spectrum of anatomical sizes encountered in patients undergoing endovascular aneurysm repair.Ē The INCRAFT System is approved for investigational device use only and it not for sale anywhere in the world. The device is currently being investigated in a global pivotal clinical study in the U.S. and Japan called the INSPIRATION Trial, which completed enrollment in August 2013. One-year follow-up data from the trial will support a Premarket Approval application to the U.S. Food and Drug Administration and a Shonin application in Japan.
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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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