PHARMACY

ImClone, Bristol-Myers Squibb file FDA application for expanded use of Erbitux

BY Alaric DeArment

NEW YORK ImClone Systems and Bristol-Myers Squibb have submitted an application to the Food and Drug Administration seeking approval for an additional use of the drug Erbitux, the two companies announced Monday.

The drug makers hope to broaden the use of Erbitux (cetuximab) to include first-line treatment of patients with advanced non-small cell lung cancer in combination with platinum-based chemotherapy (cisplatin/vinorelbine). The FDA will notify ImClone whether it has accepted the application for review in February.

 

“This submission reflects our continued efforts to maximize the potential of Erbitux by broadening its approved uses to include new indications such as non-small cell lung cancer, a disease for which there are few impactful treatments and for which less than one-in-five advanced-stage patients currently receive biologic-based combination therapy in the first-line setting,” ImClone executive vice president and chief medical officer Eric Rowinsky said in a statement.

The two companies collaborated to develop Erbitux, and Bristol owns a 16.6 percent share of ImClone. Indianapolis-based Eli Lilly and Co. recently acquired the New York-based biotech company, beating out a lower acquisition bid by Bristol.

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Healthcare affordability, availability are Americans’ top concerns

BY Jenna Duncan

WASHINGTON A Gallup Poll released Monday shows reported that more people are most concerned about the rising costs and possible limits to access of health care than they are worried about the effects of life-threatening conditions such as AIDS, cancer, diabetes, heart disease and obesity.

Of 1,000 people surveyed representing different sexes, ages and social groups, 55 percent said that availability and affordability of health care was the “the most urgent health problem” the nation has to deal with. Just 2 percent cited diabetes, AIDS and heart disease, while 11 percent cited cancer and 12 percent obesity. The Gallup Poll was taken between the dates of Nov. 11 and Nov. 13. A margin of error was reported at 3 percent.

Reports said that the nation’s total healthcare spending in 2007 was more than $2.3 trillion. That figure represents about 16 percent of the nation’s total domestic product and the National Coalition on Health Care has said that the total is expected to climb almost 7 percent by the end of the year.

The Census Bureau has reported that nearly 50 million Americans are currently without health insurance.

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CDC, Families Fighting Flu remind communities Tuesday is Children’s Influenza Vaccination Day

BY Antoinette Alexander

WASHINGTON The Centers for Disease Control and Prevention, Families Fighting Flu members and other public health organizations are partnering to commemorate Children’s Influenza Vaccination Day on Dec. 9, in an effort to remind parents to get children vaccinated.

The non-profit Families Fighting Flu organization was established for the children who die each year due to the influenza virus, and is made up of families and healthcare practitioners dedicated to educating people about the severity of influenza and the importance of vaccinating children against the flu every year.

“The willingness of the members of Families Fighting Flu to speak openly about their loss and the importance of vaccinating children is both courageous and selfless, and I thank them for helping to spread the word about this important issue,” said Dr. Julie Gerberding, director of the CDC.

Yearly flu vaccination should begin as soon as the vaccine is available and continue throughout the flu season. The CDC recommends that children aged 6 months up to 19 years of age get vaccinated against the flu. The CDC also recommends that those in close contact with children younger than 5 years of age, such as family members and caregivers, get a flu vaccine each year. In addition, people who live with or are in close contact with a child of any age with a chronic health problem, such as asthma, diabetes or other conditions, should get a flu vaccine.

Each year, an average of 20,000 children younger than 5 years old are hospitalized in the United States because of flu-related complications. As many as 1-in-5 children younger than 5 years old may have to see the doctor, visit the emergency room or other urgent care for treatment for flu. And about 100 children, on average, die from flu-related complications.

“Losing my infant son, Ian, to the flu has been an unbearable heartbreak, but he is the reason I want parents to know how important it is to protect their infants, especially those who are too young for vaccination, by getting themselves, their family members and every caregiver vaccinated against the flu,” said Julie Moise, a board member of Families Fighting Flu.

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