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?
State of the Union address draws mixed responses from drug industry
WASHINGTON — Some people liked President Barack Obama’s State of the Union address Tuesday night, and some people didn’t, and the response from the drug industry was no less mixed.
The Generic Pharmaceutical Association called for measures to lower healthcare costs, including ensuring that generic pharmaceuticals and biosimilars reach patients’ hands quickly and also avoiding measures intended to provide savings that the GPhA said would raise prescription drug costs, though the grow didn’t specify what those measures were.
"While many factors driving health costs, such as an aging population, are inevitable, others are not," GPhA president and CEO Ralph Neas said. "We know that policies that encourage generic and biosimilar utilization hold the promise of saving tens of billions over the next decades."
Meanwhile, the Pharmaceutical Research and Manufacturers of America, which lobbies on behalf of brand drug makers, criticized what it called the Obama administration’s plans to "upend" Medicare Part D by imposing price controls on it.
"The facts about Part D are simple and do not support this radical proposal," PhRMA SVP Matthew Bennett said. "Part D succeeds for seniors and taxpayers because it’s built on effective competition and the savings negotiated by large, powerful plans — the same plans used by private employers and insurers — on behalf of seniors and taxpayers."
Still, PhRMA praised Obama’s expression of support for industry research.
"In his speech tonight, the president recognized the enormous human and economic value of biomedical research, and the extraordinary importance of developing new medicines," Bennett said, noting that the drug sector has one of the most intensive focuses on research and development and accounts for 20% of R&D funding, the single largest share in the country, according to the National Science Foundation.
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