Eisai receives orphan drug designation for thyroid cancer drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has granted special designation to a drug made by Eisai for treating thyroid cancer.
The drug maker said Thursday that its experimental drug E7080 (lenvatinib) had received orphan drug designation from the FDA for follicular, medullary, anapestic and metastatic or locally advanced papillary thyroid cancer.
The FDA grants the designation under the Orphan Drug Act for products that treat, diagnose or prevent a rare disease or disorder affecting fewer than 200,000 people in the United States. Orphan drug designation entitles a company to tax credits, extended market exclusivity following regulatory approval and other benefits.
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United Therapeutics resubmits application for pulmonary arterial hypertension drug
SILVER SPRING, Md. — The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said Thursday.
The FDA originally declined to approve the drug, treprostinil diolamine extended-release tablets, in a letter submitted to the company in October 2012.
The agency plans to decide whether or not to approve the drug in March of this year, United Therapeutics said.
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Cardinal Health acquires AssuraMed
DUBLIN, Ohio — Cardinal Health on Thursday announced plans to acquire privately held AssuraMed, a provider of medical supplies to patients in the home, for $2.1 billion.
"AssuraMed is a natural extension of the Cardinal Health businesses and of our mission to be essential to care," stated George Barrett, Cardinal chairman and CEO. "The acquisition of this industry leader allows us to serve the growing number of Americans treated in home settings, particularly those patients recovering from acute episodes and those suffering with chronic diseases. This is a platform opportunity for Cardinal Health products and services which will be increasingly important as the delivery of care migrates to more cost-effective settings," he said. "This acquisition further aligns us with key trends including demographic shifts and increased consumerism."
After the transaction is complete, Cardinal Health will supply the home healthcare channel with product lines including ostomy, diabetes, insulin therapy, urological, wound care and incontinence. The company also expects to use this acquisition as a platform to begin offering a variety of its current product offerings in the direct-to-home channel.
With annual sales in calendar year 2012 of approximately $1 billion, which includes the sales of the recently acquired Invacare Supply Group, AssuraMed currently serves more than 1 million patients nationally with more than 30,000 products. The company operates through two separate businesses, Independence Medical and Edgepark Medical Supplies.
In addition to broadening Cardinal Heath’s reach into the home, AssuraMed’s expertise in products for specific disease categories and small parcel logistics will significantly enhance Cardinal Health’s ability to service customers across the broad ambulatory care channel, including care sites such as physician offices and in support of home health agencies, Cardinal Health noted. This will also allow Cardinal Health to provide a solution for integrated delivery network, retail pharmacy and medical equipment provider customers, who are currently delivering services to the home.
The transaction is expected to close by early April 2013.
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Cardiac health basically defines as high range of the hypertension cause such disease therefore it is better to take the intensive care treatment in ccu to control all the matters to find the better health. Healthcare practice management
At what point does it make sense to stop dealing with a wholesaler that is now your competitor?