September 2009

  • Vivus Inc said that obese patients treated for a year with its experimental drug Qnexa lost, on average, 14.7 percent of their body weight.
  • The FDA has approved four H1N1 vaccines, made by CSL, AstraZeneca, Novartis and Sanofi-Aventis, that will be distributed in the next four weeks as part of the US’ swine flu preparation.
  • In 25 years most biotechs will be virtual, according to a director of preclinical CRO L2D.
  • FDA notified healthcare professionals of a Class I recall of Pedi-Cap End-Tidal CO2 Detector (Pedi-Cap and Pedi-Cap 6), because the device may increase the resistance of the flow of air into the lungs, resulting in ineffective ventilation.
  • FDA requires a boxed warning for Promethazine stating, it should neither be administered into an artery nor administered under the skin because of the risk of severe tissue injury.
  • The USFDA has approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia.
  • USFDA has issued final guidance on Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects.
  • Now Duke Abdominal Assessment Scale radiographic score can predict surgical intervention in infants and neonates with suspected necrotizing enterocolitis.
  • New WHO Criteria May Qualify More Flu Viruses as Pandemic Strains reducing the risk for a false alarm, according to an editorial reported online in the BMJ Nov 2009.
  • FDA has approved first-line use of incretin-mimetic exenatide with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus with warning of cautious use in patients with kidney dysfunction after 78 postmarketing reports of kidney dysfunction (including acute renal failure and insufficiency), received between April 2005 and October 2008, in 6.6 million users.
  • Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic (mycophenolate mofetil) use.
  • FDA Grants Delcath Orphan-Drug Designation for Doxorubicin.
  • DCGI revised timeline for approvals, efforts on for speedy disposal of pending cases.
  • Biolog System identifies bacterium causing contamination in kidney dialysis clinic
  • GOLD Stage II trial data shows tiotropium improves lung function in COPD patients.
  • Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested addition in PI.