Alerts

Abbott Receives CE Mark for New Ketone and Glucose Monitor See Product of the Week. Bydureon Recall in Europe For Under-Filled Vials More Info

Sanofi Withdrawing NDA for Lixisenatide  Sanofi announced they are withdrawing their New Drug Application (NDA) for their once-daily GLP-1 lixisenatide from the FDA. The combination of lixisenatide and Lantus® (basal insulin), the investigational LixiLan fixed-ratio product, remains on schedule to enter into phase 3 in the first half of 2014. 

Urine Testing Can Screen for Cognitive Decline  See this week’s Item #2.

Family History Not Obesity Greatest Risk Factor  See this week’s Item #1.

Glucotoxicity Increases Risk of Cancer See this week’s Item #1. 

Warning: Fluoroquinolone Antibiotics Linked to Nerve Damage  The FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated with the serious side effect of peripheral neuropathy. The nerve damage may occur soon after these drugs are taken by mouth or by injection, and may …

GLP-1 Albiglutide Review Time Extended The FDA has extended the review time for GlaxoSmithKline’s (GSK) incretin mimetic once-weekly GLP-1 diabetes treatment albiglutide, delaying the deadline for delivering a verdict on the drug until April 15 next year. 

FDA: Diabetes Test Strip Maker Recalls 62 Million Products  Nova Diabetes Care announced it is initiating a voluntary recall of 21 lots of the Nova Max Glucose Test Strips distributed both in the USA and outside the continental USA. Nova Max® Plus™ Glucose meter kits are included in this recall. …

Congress Re-evaluating Medical Services Pricing System A bipartisan group of legislators has drafted a bill that would reshape the way the nation pays doctors, responding to criticism that the current method of valuing medical procedures misprices payments. The pricing system used by Medicare and most private insurers depends upon assessments …

FDA Approves Repaglinide (Generic Prandin)  FDA gives final approval for the generic form of Novo’s Prandin (repaglinide) to Sun Pharmaceutical Industries.