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Research may provide insight to cause of birth defects among babies born to diabetic mothers

BY Allison Cerra

NEW YORK — A new study conducted by a team at the Joslin Diabetes Center suggested that a certain enzyme could cause birth defects among babies born to women with diabetes.

The enzyme, known as AMP kinase, could cause babies to be at an increased risk of developing neural tube effects (i.e., such conditions as spinal bifida) and certain heart defects, because it blocks the expression of a gene known as Pax3, which helps the neural tube form.

"The stimulation of a metabolism-sensing enzyme that can regulate specific genes explains how oxidative stress, which is generated throughout the embryo during maternal hyperglycemia, causes malformation of specific embryo structures," said Mary Loeken, who headed the study. "We now know that we must do whatever we can to prevent AMPK from being stimulated."

The results were published Monday in Diabetologia.


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CDC, Walgreens pharmacists on hand for Black Women’s Roundtable event

BY Michael Johnsen

RIVERDALE, Ga. — The Black Women’s Roundtable, part of the National Coalition on Black Civic Participation, will host an event this Saturday that will have representatives from the Centers for Disease Control and Prevention and Walgreens pharmacists on hand to address health issues and administer free flu shots, the group announced Friday.

The event is the Black Women’s Roundtable Healthy Wealthy Wise National Empowerment Tour, which will feature a luncheon with actresses Vivica Fox and Demetria McKinney, Riverdale mayor Evelyn Wynn-Dixon and the first African-American female fire chief, East Point fire chief Rosemary Cloud.

The event is free and open to the public.
 

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Senators urge congressional super committee to support ‘pay-for-delay’ ban

BY Alaric DeArment

WASHINGTON — Two senators are trying to get the Joint Select Committee on Deficit Reduction to take up a bill that would ban so-called "pay-for-delay" patent settlements between brand and generic drug companies, according to published reports.

The Pharma Letter reported that Sens. Herb Kohl, D-Wis., and Chuck Grassley, R-Iowa, had urged the "super committee" to support a bill that would ban settlements that include any form of payment in exchange for holding off launch of a generic drug.

When a generic drug company wants to launch a product ahead of the expiration of the patent covering the branded version, it will file an application with the Food and Drug Administration containing a paragraph IV certification, an assertion that the patent is invalid, unenforceable or won’t be infringed. In response, the brand manufacturer will usually file a patent infringement suit, but many of these suits never go to trial and instead end in a settlement between the two companies.

In what the senators, the Federal Trade Commission and several advocacy groups have called "pay-for-delay" settlements, the generic drug company will agree to not immediately launch its product in exchange for a cash payment or, more often, a pledge by the brand company not to launch an authorized generic — essentially the branded drug marketed under its generic name for a lower price — during the 180 days of market exclusivity in which the generic and branded versions compete directly with one another. Nevertheless, in virtually all cases, generic launch takes place months and sometimes years ahead of patent expiration.

Critics say the deals delay generic launches for too long and thus cost consumers and the federal government billions of dollars, while brand and generic drug companies say the deals are often necessary to ensure the timely launch of a generic. At any rate, waiting until after patent expiration to launch would be against the law.


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