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May 12, 2014
08:25 EDTPTLA, JNJ, BAYRYPortola Pharmaceuticals begins enrollment in Phase 3 study for Xarelto
Portola Pharmaceuticals (PTLA) announced that enrollment has begun in a Phase 3 study to evaluate the safety and efficacy of andexanet alfa, the company's investigational recombinant Factor Xa inhibitor reversal agent, with Bayer (BAYRY) and Janssen Pharmaceuticals' (JNJ) Factor Xa inhibitor XARELTO. Portola is developing andexanet alfa, an FDA-designated breakthrough therapy, as a potential first-in-class agent to reverse the anticoagulation activity of Factor Xa inhibitor-treated patients who are experiencing a major bleeding episode or who require emergency surgery.
News For PTLA;BAYRY;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 26, 2015
05:25 EDTBAYRYRegeneron reports approval of Eylea by Japan
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June 25, 2015
14:01 EDTBAYRYBayer initiated with a Buy at HSBC
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08:00 EDTBAYRYBayer to hold a meeting
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June 24, 2015
14:34 EDTPTLAPortola Pharmaceuticals says andexanet alfa 'significantly' reduces bleeding
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07:02 EDTPTLAPortola Pharmaceuticals coverage assumed with an Outperform at Credit Suisse
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June 23, 2015
10:31 EDTBAYRYMonsanto says Bayer crop chemicals unit an option, Bloomberg reports
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June 22, 2015
08:52 EDTPTLAPortola, Bristol-Myers, and Pfizer announce results from Phase 3 ANNEXA study
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