E-cigarette maker welcomes FDA challenge
MIAMI Despite the ongoing battle between the Food and Drug Administration and electronic cigarette makers, one manufacturer welcomes the challenge as a chance to present its product as a healthier alternative to traditional tobacco.
Green Smoke said it has created an electronic cigarette designed to simulate the smoking experience without carcinogenics. Instead, it emits an odorless vapor of mostly steam, with ingredients like nicotine, water, propylene glycol (an additive used in cake mixes) and others. The nicotine also is available in different strengths.
The company also added that the price for the electronic cigarettes are more cost-efficient than regular tobacco products, with cigarette starter kits ranging from $109 to $270. The starter kits include nicotine cartridges, rechargeable cigarette batteries, home charger and more.
WHO: H1N1 to be included in next year’s seasonal flu vaccine
GENEVA During a press conference held Thursday, the World Health Organization updated the status of the novel H1N1 pandemic and announced that the novel H1N1 influenza vaccine would be incorporated into next season’s seasonal flu vaccine.
The triumvirate vaccine will include protection against the novel H1N1 virus, an H3N2 strain and a type-B virus.
“What the scientists said was that in the past year, the overwhelming number of influenza viruses that were isolated around the world were the pandemic H1N1 virus,” Keiji Fukuda, special adviser to the WHO’s director-general for pandemic influenza, told reporters. “The experts believe based on this information that these viruses will continue to be one of the dominant viruses in wide circulation in the coming fall and winter season in the northern hemisphere.”
However, substituting the pandemic H1N1 virus in place of last year’s seasonal H1N1 inoculation does not suggest that the novel H1N1 pandemic has concluded its course, Fukuda warned. “The recommendation to put the pandemic virus in the upcoming vaccine really means that this has been a dominant virus. And it is expected that it will continue to be a significant virus, circulating around the world as we head into the winter or the coming winter in 2010 and 2011.”
WHO will be convening its Emergency Committee under the International Health Regulations Feb. 23, Fukuda added, noting that the meeting will be both to review the overall epidemiologic and virologic situation, and to provide some guidance to WHO as to whether we can consider ourselves in “the so-called post-peak period.”
The post-peak period is a transition period in which WHO continues to expect to see pandemic activity occur at different levels in different parts of the world, but that the worst has come to pass, Fukuda said. WHO will not be removing the “pandemic” status, however, Fukuda added. “The practical effect of indicating that we are in a post-peak period is really to give a broad signal to the world that even though we may continue to see pandemic activity that we expect that we are transitioning more towards a normal level.”
The highest levels of pandemic activity currently are occurring in parts of Eastern Europe, some parts of Northern Africa and parts of Asia.
PositiveID acquires Easy Check Medical Diagnostics
DELRAY BEACH, Fla. PositiveID on Wednesday acquired the intellectual property rights and assets of Easy Check Medical Diagnostics in an effort to expand its portfolio of noninvasive glucose-level testing products and diabetes management tools under development.
“Existing solutions in diabetes care are painful and have mediocre compliance rates,” stated Scott Silverman, PositiveID chairman and CEO. “With our current portfolio of products under development, we are hopeful we can improve diabetics’ lives while helping them manage their healthy glucose levels, thereby decreasing the risk of diabetes-related complications and reducing medical costs.”
Easy Check presently has two primary products under development: the Easy Check breath glucose detection system and the iGlucose wireless communication device.
The Easy Check breath glucose test is a non-invasive glucose detection system that measures acetone levels in a patient’s exhaled breath. The association between acetone levels in the breath and glucose is well documented, the company noted, but previous data on the acetone/glucose correlation has been insufficient for reliable statistics. Easy Check’s breath glucose detection system combines a proprietary chemical mixture of natrium nitroprussid with breath exhalate, which is intended to create a new molecular compound that can be measured with its patent-pending technology. This product, if approved by the Food and Drug Administration, could eliminate a patient’s need to prick his or her finger multiple times per day to get a blood sugar reading.
Easy Check’s other product under development, its iGlucose system, uses wireless SMS messaging to automatically communicate a diabetic’s glucose readings to the iGlucose online database. iGlucose is intended to provide next-generation, real-time data to improve diabetes management and help ensure patient compliance, data accuracy and insurance reimbursement. In addition, PositiveID believes that the iGlucose wireless communication device is the first to address the Medicare requirement for durable medical equipment manufacturers and pharmacies to maintain glucose level logs and records for the millions of high-frequency diabetes patients.