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FDA grants approval to Ruconest

BY Ryan Chavis

SILVER SPRING, Md. — The Food and Drug Administration on Thursday announced the approval of Ruconest, a recombinant C1-Esterase inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema.

Hereditary angioedema is caused by an insufficient amount of a plasma protein called C1-esterase inhibitor. The condition affects 6,000 to 10,000 people in the United States. People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract or airway, the agency said. The attacks may occur spontaenously or can be triggered by stress, surgey or infection. Swelling of the airway has the potenial to be fatal without immediate treatment.

“Hereditary angioedema is a rare and potentially life-threatening disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approval provides an important treatment option for these patients.”

Ruconest received orphan-drug status from the FDA. The drug is manufactured by Pharming Group NV, Leiden, the Netherlands, and will be distributed in the United States by Santarus Inc., a subsidiary of Salix Pharmaceuticals.

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Lindt celebrates themed chocolate shop

BY Ryan Chavis

INTERLAKEN and KILCHBERG, Switzerland — Lindt and Sprüngli earlier this week celebrated the official opening of Lindt Swiss Chocolate Heaven at the Jungfraujoch “Top of Europe,” which is situated 3,454 meters above sea level. The themed chocolate shop offers a variety of Lindt chocolate and the nearby Master Chocolatiers parlor gives visitors an inside look into how the chocolate is made.

“With the themed chocolate shop at the Jungfraujoch, we have positioned our brand at a lofty height. Our aim is to introduce tourists from abroad to our Lindt chocolate up there,” said Ernst Tanner, CEO and chairman of the board of Lindt and Sprüngli.

On hand to celebrate the official opening were tennis champion Roger Federer and American ski racer Lindsey Vonn, who played a tennis match on the Aletsch Glacier against the picturesque backdrop of the Alps.
 

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Justice Department charges FedEx with illegally distributing pharmaceuticals without a prescription

BY Michael Johnsen

SILVER SPRING, Md. — FedEx on Thursday was indicted as a co-conspirator for illegally distributing pharmaceuticals sourced from a pair of rogue online pharmacies. 
 
FedEx denied the charges outright. "FedEx is innocent of the charges brought today by the Department of Justice. We will plead not guilty. We will defend against this attack on the integrity and good name of FedEx and its employees," the company stated. "We want to be clear what’s at stake here: the government is suggesting that FedEx assume criminal responsibility for the legality of the contents of the millions of packages that we pick up and deliver every day. We are a transportation company – we are not law enforcement. We have no interest in violating the privacy of our customers. We continue to stand ready and willing to support and assist law enforcement. We cannot, however, do the job of law enforcement ourselves."
 
The U.S. Attorney for the Northern District of California on Thursday formally charged the FedEx Corp. with conspiring with two separate but related online pharmacy organizations to distribute controlled substances and prescription drugs to U.S. consumers without requiring their customers to have a valid prescription, as required by the Federal Food, Drug, and Cosmetic Act. Agents from FDA’s Office of Criminal Investigations worked closely with the U.S. Drug Enforcement Administration, which led this investigation, and the U.S. Attorney’s Office to prevent these organizations from distributing drugs ordered illegally through the internet.
 
According to the indictment, as of July 2004, FedEx employees had identified over 200 accounts that were associated with online pharmacies. By September of 2010, the list had increased to over 600 online pharmacy accounts. According to published reports, FedEx had special accounting procedures in place for these online pharmacy accounts in the event that they were to be shut down and unable to satisfy balances owed to FedEx. 
 
"The credit policy, circulated to FedEx directors on July 6, 2006, and included in the indictment, explained the policy's rationale: 'Many of these companies operate outside federal and state regulations over the sale of controlled drugs. … Drugs purchased from these sites may be diluted or counterfeit. Several sites have been shut down by the government without warning or simply disappeared, leaving large balances owing to FedEx,'" USA Today reported
 
"Illegal internet pharmacies rely on overnight couriers to facilitate the illegal distribution of prescription drugs," the FDA released in a statement. "The FDA is hopeful that today’s actions will continue to reinforce the message that the public’s health takes priority over a company’s profits. The FDA also commends its DEA colleagues for their strong lead in helping protect the public’s health."
 

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