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News Breaks
July 24, 2014
08:39 EDTONVO, JNJOrganovo enters 3D bio-printed tissue agreement with J&J unit
Organovo (ONVO) announced that it has entered into an agreement with Janssen Research and Development, a pharmaceutical company of Johnson & Johnson (JNJ), to evaluate the use of 3D bio-printed tissue in a drug discovery setting, outside of the companyís work in 3D liver tissue for toxicity testing. Terms were not disclosed.
News For ONVO;JNJ 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 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.
June 29, 2015
10:09 EDTONVOOn The Fly: Analyst Initiation Summary
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06:56 EDTONVOOrganovo initiated with a Buy at Jefferies
Target $5.
05:41 EDTONVOOrganovo initiated with an Overweight at Piper Jaffray
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