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News Breaks
June 1, 2014
16:02 EDTPCYC, JNJImbruvica shows durable, long-term responses for patients with CLL
Pharmacyclics (PCYC) announced that IMBRUVICA, ibrutinib, will be featured in an oral presentation highlighting long-term responses to treatment, with up to three years of follow up in 132 patients with treatment naive or relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, CLL/SLL. The results from this study will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology, ASCO, on June 2, 2014, at 11:33 a.m. CT. This release corresponds to abstract 7014. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech (JNJ)."These results suggest responses to IMBRUVICA are exceptionally durable in patients with CLL with a median observation period past 30 months," said Dr. Susan O'Brien*, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX. "IMBRUVICA is very well tolerated. We are especially encouraged to see that patients showed durable responses regardless of their treatment history."
News For PCYC;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.

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