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Astellas applies for FDA approval of organ transplant drug

BY Alaric DeArment

NORTHBROOK, Ill. — The U.S. subsidiary of Japanese drug maker Astellas is seeking approval from the Food and Drug Administration for a drug to prevent rejection of transplanted organs.

Astellas Pharma US said it applied with the FDA for approval of tacrolimus extended-release capsules to prevent rejection of transplanted kidneys in adults and transplanted livers in men. The drug was approved in Europe in 2007 under the name Advagraf and under the name Graceptor in Japan in 2008; the drug has been approved in 69 countries so far.

"There remains a large, unmet treatment need for transplant recipients who have a difficult time controlling their immunosuppression drug levels with existing products," Astellas global therapeutic area head for transplantation Roy First said. "Astellas believes tacrolimus extended-release capsules, given the efficacy, safety profile and unique dosing schedule, offer a potentially promising treatment option for recipients."


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Cardinal Health initiates Medicare awareness effort in advance of healthcare-reform changes

BY Michael Johnsen

DUBLIN, Ohio — Cardinal Health this week announced that it is kicking off an effort to encourage its retail pharmacy customers to educate their patients about new Medicare benefits and options that will be available under the Patient Protection and Affordable Care Act starting in 2013.

“It’s important for Medicare beneficiaries to fully understand their coverage options, and the new benefits and services that are available to them starting in 2013,” stated Jon Giacomin, president of U.S. Pharmaceutical Distribution for Cardinal Health. “Cardinal Health passionately believes that community pharmacists can play a powerful role in helping patients better manage their health — and in helping patients make more informed decisions about their health care.”

In preparation for the Medicare open enrollment period, which kicks off Oct. 15, the Department of Health and Human Services recently made available an array of materials to educate patients about new Medicare benefits — which include new preventive services, such as mammograms and annual wellness visits, as well as new prescription drug savings options.

Cardinal Health is supporting HHS’s educational campaign by promoting these educational materials among its retail pharmacy customers, including several hundred regional chain pharmacy locations and more than 7,500 independent pharmacies, nationwide.

The company also is hosting a series of webinars for its retail pharmacy customers — aimed at ensuring pharmacists and pharmacy owners are familiar with these free patient educational materials. The webinars also will reinforce the important role community pharmacists can play in ensuring patients are aware of their Medicare coverage options.


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Holiday sales to grow as much as 4%

BY Mike Troy

NEW YORK — Deloitte is forecasting holiday sales will increase between 3.5% and 4% as the economy’s health and the presidential election take center stage among consumers this fall.

Despite some distractions this year, retailers should expect a modest increase in 2012 holiday sales, according to Deloitte’s annual holiday forecast release Tuesday morning.

"Economic headwinds nagging consumers this fall include stubbornly high gasoline prices that continue to creep up and soft housing and job markets," said Carl Steidtmann, Deloitte’s chief economist. "While consumers turned out in the summer to give retailers solid gains for a few months, that pace may be difficult to sustain through the end of the year. Consumers and businesses alike may pause in advance of the election; however, retailers may benefit from a post-election consumer spending boost."

Deloitte’s retail and distribution practice expects total holiday sales to climb to between $920 and $925 billion, representing a 3.5% to 4% increase in November through January holiday sales when compared to last year. While that is a respectable increase, it is below last year’s growth rate of 5.9%.

Additionally, Deloitte forecasts a 15% to 17% increase in nonstore sales, which is primarily attributable to ecommerce. Nearly three-quarters of nonstore sales result from the online channel with additional sales coming from catalogs and interactive TV. 

"Nonstore sales continue to outpace overall growth, but increasingly influence consumers’ experience with the retail store, from trip planning, to in-store product research, and post-purchase reviews and sharing," said Alison Paul, vice chairman, Deloitte LLP and retail & distribution sector leader. "This holiday season, retailers’ most lucrative customers may be the ones they engage across physical and virtual storefronts."

Paul noted that consumers also might consolidate or reduce trips to the store in response to higher gas prices. Conversely, she added, consumers are expected to keep a sharp eye on promotions and pricing, making retailers’ digital connections with consumers before and during each shopping trip even more critical this year. "This year, we anticipate retailers will come to the starting gate with true omni-channel pricing strategies, as opposed to disparate or reactionary strategies of the past," Paul said. "Consumers should see more price transparency across mobile, online and store channels, and retailers will use these same channels to gain insights into their core customers’ behavior. Retailers that interpret and respond to real-time information about shoppers can hit the right notes on pricing and promotions that drive traffic without eroding margins."

Deloitte forecasts that mobile-influenced retail store sales will account for 5.1%, or $36 billion, in retail store sales this year as consumers increase store-related smartphone activity such as product research, price comparison or mobile application use. 

"Retailers that welcome the smartphone shopper in their stores with mobile applications and wi-fi access, rather than fear the showrooming effect, can be better positioned to accelerate their in-store sales this holiday season," Paul said.

The firm’s recent research shows shoppers armed with smartphones are 14% more likely to make a purchase in the store than those who do not use a smartphone as part of their in-store journey.

"The mobile channel is a powerful customer engagement tool, enabling retailers to capture a shopper’s attention at the point-of-purchase, while gleaning valuable information about shopper behavior regardless of the shopper’s location," Paul said.

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