FDA gives orphan drug designation for investigative uclerative colitis treatment
PHILADELPHIA The Food and Drug Administration has given orphan drug designation to an investigative drug for treating ulcerative colitis in children.
Eurand announced this week that it had received the designation for EUR-1073 (beclomethasone diproprionate). The FDA gives orphan drug designation to drugs that affect fewer than 200,000 people; drugs that receive the designation receive seven years of market exclusivity upon approval.
“We are pleased with the FDA’s decision, and we believe EUR-1073 has the potential to address key unmet medical needs of pediatric patients with ulcerative colitis,” said Gearoid Faherty, Eurand chairman and CEO.
Ulcerative colitis is an inflammatory bowel disease that causes inflammation and ulcers along the inside of the large intestine, causing cramping, bloating, diarrhea, bleeding, fatique, weight loss and frequent bowel movements.
AstraZeneca’s collaboration with biotech co. extended
BERKELEY, Calif. A collaboration between Anglo-Swedish drug maker AstraZeneca and a U.S. biotech will be extended.
Dynavax Technologies Corp. announced Wednesday that it would extend the collaboration, which began in September 2006, until July 2010. Dynavax is eligible to receive up to $136 million in payments, as well as royalties.
Under the collaboration, the two companies are developing medicines for treating chronic obstructive pulmonary disease. The first drug candidate, AZD1419, is expected to enter phase 1 clinical studies in the second half of this year. The companies developed AZD1419 using Dynavax’s proprietary immunostimulatory sequences technology.
HHS launches new federal office to coordinate Recovery Act spending
WASHINGTON Moving quickly to get ahead of a massive federal outlay spawned by the economic stimulus – and assure the orderly distribution of those funds – the Department of Health and Human Services announced the creation of the Office of Recovery Act Coordination.
The new office, HHS announced late Wednesday, “will help ensure the timely, organized and transparent distribution of an estimated $137 billion in Recovery Act Funds,” and will be managed by the massive federal health department. It also could be seen as a bid to pre-empt any potential sniping from political opponents of the Obama Administration – or of the massive economic stimulus plan the White House proposed and signed into law.
“HHS is committed to moving quickly and carefully to distribute Recovery Act funds in an open and transparent manner,” said HHS spokeswoman Jenny Backus. “We have already worked to put more than $3 billion in Recovery Act funds into states, and the new Office of Recovery Act Coordination will enhance and streamline our efforts to get critical resources and potential new job opportunities to the American people during tough times.”
Dennis Williams, a 20-year agency veteran, will lead the new office and serve as HHS’ deputy assistant secretary for Recovery Act coordination.
As of March 11, HHS has distributed $3 billion in Recovery Act funds to support what the agency calls “a variety of policies and programs including Community Health Centers and Medicaid.”