Articles By Cyndi Root

31. FDA Stops Enrollment In CytRx's Aldoxorubicin Cancer Trials 11/21/2014

    CytRx was order by the FDA to stop enrolling patients in its clinical trials for aldoxorubicin in cancer indications.

32. Portola, Bristol-Myers Squibb, Pfizer Report Phase 3 Trial Results Of Andexanet Alfa 11/20/2014

    Portola’s andexanet alfa nearly completely reversed the anticoagulant effect of Eliquis (apixaban) in the Phase 3 ANNEXA-A (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXA Inhibitors – Apixaban) studies.

33. NIH Study Finds Lisinopril, Telmisartan Combination Not Effective In Kidney Disease 11/20/2014

    To slow the progression of autosomal dominant polycystic kidney disease (ADPKD), a combination of two drugs is not more effective than a single drug, according to a new National Institutes of Health (NIH) study.

34. WHO Releases New Guidance On Ebola Clinical Trials 11/19/2014

    The World Health Organization (WHO) delivered guidance to the pharmaceutical industry on its new criteria for clinical trials in the treatment of Ebola virus disease (EVD).

35. Bristol-Myers Squibb, Ono Report Survival Benefit For Opdivo In Melanoma 11/19/2014

    Bristol-Myers Squibb (BMS) and its partner on Opdivo (nivolumab), Ono Pharmaceuticals, report that the immunotherapy boosted overall survival in patients with melanoma.

36. FDA, EMA Grant Orphan Drug Designation To Xeris' Soluble Glucagon 11/18/2014

    Xeris Pharmaceuticals announced in a press release that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) has granted Orphan Drug designation to its soluble glucagon.

37. FDA Fast Tracks Threshold's TH-302 For Soft Tissue Sarcoma 11/18/2014

    Threshold Pharmaceuticals reports that the Food and Drug Administration (FDA) has granted Fast Track designation to TH-302 for treatment-naïve patients with metastatic or locally advanced unresectable soft tissue sarcoma (STS).

38. Gilead Submits NDA For Tenofovir Alafenamide Combination For HIV 11/13/2014

    Gilead Sciences has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for a tenofovir alafenamide (TAF) combination to treat HIV.

39. Teva's QNASL Nasal Aerosol Improves Pediatric PAR Symptoms 11/11/2014

    Teva Pharmaceutical announced in a press release that pediatric patients taking QNASL (beclomethasone dipropionate) saw fewer symptoms after treatment.

40. Boehringer Ingelheim's Pradaxa Safe And Effective, FDA Study Reaffirms 11/10/2014

    Boehringer Ingelheim’s Pradaxa is safe and effective, according to a Food and Drug Administration (FDA) study of 134,000 patients.