Articles By Cyndi Root

41. Gilead's Harvoni For HCV Virus Approved For European Marketing 11/21/2014

    Europe has joined the U.S. and New Zealand and approved Gilead’s Harvoni, a combination of sofosbuvir (brand name Sovaldi) and ledipasvir for the hepatitis C (HCV) virus.

42. Amgen Reports Efficacy Of Evolocumab In Phase 2/3 Trials 11/21/2014

    On the heels of the Food and Drug Administration’s (FDAs) acceptance of its Biological License Application (BLA), Amgen reports new data for evolocumab in high cholesterol.

43. FDA Publishes Guidance On Priority Review Vouchers For Rare Pediatric Diseases 11/20/2014

    Sponsors of treatments for rare pediatric diseases have received draft guidance from the Food and Drug Administration (FDA) as it has published its current thinking on the priority review voucher program.

44. FDA Issues Safety Announcement On Long-Term Antiplatelet Therapy 11/20/2014

    Long-term antiplatelet therapy shows benefits but is also a risk for non-cardiovascular death, according to the Food and Drug Administration’s (FDAs) preliminary evaluation.

45. CDMO Recipharm Acquires CDMO Lusomedicamenta, Gains Access To New Markets 11/20/2014

    Recipharm has acquired Lusomedicamenta Sociedade Técnica Farmacêutica, a contract development and manufacturing organization (CDMO), based in Lisbon, Portugal.

46. Weekly FDA Enforcement Report For Drugs 11/12/14 11/19/2014

    The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for November 12, 2014. The agency publicizes recalls in its weekly report, as press releases are not issued for all recalls.

47. Bristol-Myers Squibb Builds Biologics Manufacturing Facility In Ireland 11/19/2014

    Bristol-Myers Squibb Company (BMS) is banking on a bright future for biological treatments as it is investing in a new, large-scale biologics manufacturing facility in Ireland.

48. Boehringer Ingelheim Initiates Trial Of Idarucizumab To Reverse Pradaxa 11/18/2014

    Boehringer Ingelheim announced that it has started a trial of idarucizumab at U.S. sites. The company announced the study initiation in a press release, stating that the RE-VERSE AD trial is a phase 3 study in over 35 countries with an expected enrollment of 250 patients.

49. GE Healthcare, Takeda Partner To Develop Treatments For Liver Diseases 11/14/2014

    GE Healthcare and Takeda Pharmaceutical Company have partnered to develop treatments for liver diseases.

50. UCB's Generic Subsidiary Kremers Bought By Investors 11/13/2014

    UCB has sold its generic subsidiary, Kremers Urban Pharmaceuticals (KU), to international investors.