FDA panel recommends approval of Shire’s Firazyr
DUBLIN — A Food and Drug Administration expert panel has recommended approval of a drug made by Shire for a rare immune system disorder, the drug maker said.
Shire said the FDA’s Pulmonary-Allergy Drugs Advisory Committee recommended approval of Firazyr (icatibant) for treating acute hereditary angioedema attacks in adults. The committee also voted 11-1 to recommend approval of self-administration of the drug by patients.
HAE is a genetic and potentially fatal immune system disorder that causes swelling of the face and airways and result in airway blockage.
The FDA is not obligated to follow the recommendations made by advisory committees, but generally considers them when deciding whether or not to grant approval to a drug.
Mylan’s generic Entocort EC to enter market
PITTSBURGH — A generic drug made by Mylan for Crohn’s disease does not infringe on the patent for the branded drug, a federal court ruled Thursday.
Mylan said the U.S. District Court for the District of Delaware ruled that Mylan’s regulatory approval application for budesonide capsules in the 3-mg strength does not violate the patent for the branded drug, AstraZeneca’s Entocort EC.
The Food and Drug Administration approved Mylan’s product last month, and the company said it plans to launch immediately. Budesonide capsules in the 3-mg strength had sales of about $350 million for the 12 months ended in March, according to IMS Health.
BMS donates grants to help African-American women fight Type 2 diabetes
NEW YORK — The charitable arm of Bristol-Myers Squibb has awarded five grants totaling $1.5 million to organizations that encourage African-American women with Type 2 diabetes to better manage their disease.
The Bristol-Myers Squibb Foundation said it has awarded funds to the University of Virginia, East Carolina University, Whittier Street Health Center of Boston, Black Women’s Health Imperative of Washington, D.C., and the United Neighborhood Health Services in Nashville, Tenn., as part of the drug maker’s Together on Diabetes initiative, which is designed to improve health outcomes among Type 2 diabetics living in the United States. Each organization has received $300,000, two-year grants for their efforts to empower African-American women, while also leveraging their standing as leaders in their families and communities to influence the health of those around them, BMS Foundation said.
“African-American women represent one of the country’s highest risk groups for developing and suffering the impact of Type 2 diabetes,” Bristol-Myers Squibb CEO Lamberto Andreotti said. “With these grants specifically focused on African-American women, Together on Diabetes is supporting innovative efforts to make self management programs work for African American women in the context of their lives.”