Novo becomes second company to discontinue inhaled insulin device
NEW YORK Novo Nordisk has discontinued the development of its experimental inhaled insulin device, the AERx inhaler and, as a result, has taken a hit of $260 million, according to Bloomberg. The company also said the product offered little clinical benefit.
This is the second new insulin product to be discarded in the past year. The first was Pfizer a few months ago, when it stopped manufacturing its new inhaled insulin Exubera, which—when first announced—was thought to be a breakthrough for Pfizer and would help the company deal with the loss of Lipitor once it lost its patent protection. Pfizer lost $2.8 billion to rid itself of Exubera.
According to Mads Krogsgaard Thomsen, Novo’s chief scientific officer, “Pfizer’s decision on Exubera prompted this. We have realized that the trend is for physicians to start treatment with something simple rather than a device that has to be loaded with insulin for each mealtime use.”
Eli Lilly, however, is staying with its development of an inhaled insulin product. Lilly’s AIR inhaled insulin is in the final phase of testing required for U.S. regulatory approval.
FDA to open office in India
KOCHI The Food and Drug Administration is planning on opening an office of its agency in India, in an effort to ensure the quality of the food and drugs being imported by the U.S., according to published reports.
Health and Human Service secretary Michael Leavitt and FDA commissioner Andrew von Eschenbach are in the country presently assessing the manufacturing practices existing at drug and food processing units.
According to Leavitt, he set up the mission because, “there was a serious apprehension among the consumers in this country on the quality of food and drugs being imported.” “We are trying to ensure the quality in the entire system of supply chain, right from the seed to the last outlet from where people buy the goods,” he said.
The U.S. imports about $56 million worth of food and drug products from India.
BioDelivery works on risk management plan for dissolving fentanyl patch
RALEIGH, N.C. BioDelivery Services International is planning on developing a safety plan for its new BEMA fentanyl patch, which the Food and Drug Administration accepted for review last week, according to published reports.
In December, a public health advisory from the FDA was released following reports of life-threatening side effects and even death associated with inappropriate prescriptions or use of the patches. So, to be safe, BioDelivery has developed a Risk Minimization Action Plan, or RiskMap, for its patch, which dissolves in the mouth and is placed on the walls of the cheek, unlike other fentanyl patches, which are placed on the skin and have to be disposed of.
Fentanyl is a narcotic pain medication more powerful than morphine. It has been in use for years. The FDA first issued a public health advisory for fentanyl skin patches in July 2005 following reports of the deaths of some patients.
BioDelivery’s vice president of marketing stated that the company is more confident as to the differences between its patch and other fentanyl patches, and believes the confidence is extended to how the drug is meant to be used and how the drug is delivered in the body.