Articles By Cyndi Root

41. Aradigm's Pulmaquin Antibiotic Granted FDA QIDP Status 5/21/2014

    Aradigm Corporation announced in a press release that the Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) status to its antibiotic Pulmaquin. The inhaled antibiotic candidate is for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE) patients with chronic lung infections with Pseudomonas aeruginosa. QIDP designation confers certain benefits to Aradigm including priority review, fast-track eligibility, and marketing exclusivity.

42. Takeda and ASKA To Distribute Hypertension Treatment 5/21/2014

    Takeda Pharmaceutical announced in a press release that it has agreed to distribute a hypertension treatment with ASKA Pharmaceutical. The drug is called Candesartan “ASKA” (candesartan cilexetil), a generic for the branded drug, Blopress, which came off patent protection in 2008. Takeda said that it recognizes the need for generic drugs and that Candesartan “ASKA” can meets the diverse needs of patients and healthcare professionals.

43. Reckitt Benckiser To Develop Heroin Overdose Nasal Spray And Alcohol Abuse Drug 5/21/2014

    Reckitt Benckiser Group announced that it will develop a heroin overdose nasal spray with AntiOp Inc. The AntiOp deal is the second move that Reckitt made in one week. Reckitt and XenoPort announced last week in a press release that they had entered into a licensing agreement for a drug for alcohol abuse, arbaclofen placarbil.

44. Purdue Pharma's Bottle-Tracking Program Helps Law Enforcement With Drug Thieves 5/20/2014

    Law enforcement officials in New York City were able to stop thieves from stealing drugs from a pharmacy by using GPS-enabled decoy bottles. Purdue Pharma’s bottle tracking program is used in 33 states, but the robbery thwarting in NYC made national news as it was the first time it was used successfully in the Big Apple.

45. Pfizer Joins With The American College of Physicians To Immunize Adults 5/20/2014

    Pfizer announced in a press release that it has joined with the American College of Physicians (ACP) and CECity to raise the rates of immunized adults.

46. FDA Expands Pharma Quality Collaboration With EC And EMA 5/20/2014

    The Food and Drug Administration (FDA) announced in its blog, the FDA Voice, that it intends to deploy a team to work with the European Commission (EC) and the European Medicines Agency (EMA). The initiative expands on the existing collaboration in an attempt to regulate drugs on a global scale, which the FDA calls “a tall order.” The FDA team, along with its counterparts at the European agencies, will focus full-time on pharmaceutical quality. The federal agency states that it needs to deepen its reliance on regulators outside of the U.S. to provide safety and protection to Americans.

47. Abbott Acquires Latin American CFR Pharmaceuticals 5/19/2014

    Abbott announced in a press release that it has agreed to acquire CFR Pharmaceuticals, a Latin American pharmaceutical company. The acquisition positions Abbott in the growing Latin America market and doubles its generic drug presence in that region, which is estimated to bring in $900 million in sales in 2015, with double-digit sales growth expected in the coming years. Abbott expects to tender about $3 billion for CFR, which it says is worth it to instantly become one of the top ten pharmaceutical companies in Latin America.

48. Weekly FDA Enforcement Report For Drugs And Biologics 5/14/14 5/15/2014

    The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for May 14, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Biologics or Drugs, and by Classification.

49. FDA Approves Ibalizumab Manufactured In China By WuXi PharmaTech 5/8/2014

    WuXi PharmaTech announced in a press release that the Food and Drug Administration (FDA) has approved its first batch of Ibalizumab (TMB-355). The company reports that this is the first FDA approval for a sterile biologic product manufactured in China for U.S. clinical trials.

50. WHO Issues Polio Global Health Emergency 5/8/2014

    The World Health Organization (WHO) declared that polio is a global health emergency. WHO says that Syria, Pakistan, Cameroon, Iraq, Afghanistan, and Equatorial Guinea should immediately take aggressive action to stop the spread of polio. Gregory Hartl, WHO spokesman said, “Things are going in the wrong direction and have to get back on track before something terrible happens.”