Articles By Cyndi Root

81. Industry Clinical Trials Proceed Faster Than Academic Trials, Study Finds 9/23/2014

    The National Institute for Health Research (NIHR) in the U.K. reports that industry sets up and completes clinical trials faster than academic entities.

82. Canadian Expert Panel Recommends Including Children In Drug R&D 9/23/2014

    The Council of Canadian Academies, an independent science group, has stated that children should be included in drug development efforts.

83. AstraZeneca Jumps On e-Recruitment Bandwagon 9/17/2014

    As recruitment becomes a more difficult and time-consuming task in the industry, pharma companies have begun searching for alternative methods to speed up clinical trial recruitment in order to ensure drugs get through clinical trial programs more quickly. Indeed, one such solution was announced last week when AstraZeneca and Trialbee partnered up to recruit patients for clinical trials using Trialbee’s web-based software solution.

84. FDA Extends Rixubis Indication For Hemophilia B To Pediatric Patients 9/17/2014

    Baxter International announced in a press release that the Food and Drug Administration (FDA) has approved Rixubis [Coagulation Factor IX (Recombinant)] for pediatric patients.

85. FDA Committee Recommends NPS's Natpara For Hypoparathyroidism 9/16/2014

    NPS Pharmaceuticals announced in a press release that a Food and Drug Administration (FDA) committee has voted 8 to 5 to recommend Natpara (rhPTH [1-84]) for the treatment of Hypoparathyroidism.

86. FDA Approves Orexigen's, Takeda's Contrave For Weight Management 9/16/2014

    Orexigen Therapeutics announced in a press release that the Food and Drug Administration (FDA) has approved Contrave (naltrexone HCI and bupropion HCI), formerly NB32. Orexigen developed the weight management drug and licensed the commercialization rights in the U.S. to Takeda Pharmaceuticals.

87. Pharmaceutical Start-Ups and Clinical Trials Lagging In India 9/15/2014

    ASSOCHAM, an industry group in India, issued a press release stating its concerns about the falling rate of clinical trials in India — an issue that has many in the industry concerned and frustrated. ASSOCHAM studied the Indian Pharmaceutical Industry (IPI) and reports that, in 2013, only 17 clinical trials were approved, in contrast to 2012, when 55 were approved. The industry association cites a lack of awareness about the need for trials in the Indian population. With 16 percent of the world’s population and only 1.5 percent of global trials, the discrepancy is notable, it says.

88. Pharmaceutical Industry Committing To Trial Transparency 9/15/2014

    Citeline, a pharmaceutical industry research authority, issued a press release on the state of clinical trial transparency in the industry today. According to Citeline, a previous study found that 23 to 57 percent of trials were not reported, leaving much to be desired in terms of industry transparency. However, in its new report, Citeline included broader criteria and multiple sources, therefore offering a more accurate result. The study included 7,500 Phase II and III trials from 2008 to 2012. Ms. Shin found the results “surprising,” as the study revealed that 78 percent provided final or interim results to journals, conferences, or clinicaltrials.gov. For Phase III trials, 81 percent disclosed results.

89. FDA Approves Baxter's HyQvia For Primary Immunodeficiency 9/15/2014

    Baxter announced in a press release that the Food and Drug Administration (FDA) has approved HyQvia. The biologic treatment is indicated for adults with primary immunodeficiency (PI), a hereditary disorder wherein part of the immune system is either absent or not functioning properly. Baxter intends to market the drug in the coming weeks. The drug was co-developed with Halozyme Therapeutics.

90. FDA Advisory Committee Supports Novo Nordisk's Liraglutide For Weight Management 9/12/2014

    The Food and Drug Administration advisory committee voted 14-1 that Novo Nordisk’s liraglutide is safe and effective for obese patients with at least one weight-related issue. According to Reuters, it is likely that the FDA will follow the advisory committee’s recommendation, as it has traditionally done so in the past. Should the FDA officially approve the medication, analysts are speculating that opening up liraglutide as a treatment option in this indication could provide a big financial boost to the company—upwards of $1 billion in revenue, Reuters says.