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FDA grants accelerated approval to Merck’s Keytruda

BY Ryan Chavis

WHITEHOUSE STATION, N.J. — Merck on Thursday announced that the Food and Drug Administration granted accelerated approval to Keytruda (pembrolizumab) for the treatment of patients with advanced melanoma. An improvement in survival or disease-related symptoms hasn't been established yet, but the tumor response rate and durability response prompted the agency to grant accelerated approval, the company said. 
 
Keytruda is the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States, according to the company. The drug consists of a humanized monoclonal antibody that increases the ability for the patient's immune system to fight advanced melanoma. 
 
“Keytruda embodies Merck’s unwavering commitment to pursue breakthrough science to help people who are facing the most challenging diseases,” said Kenneth Frazier, chairman and CEO, Merck. “We are grateful to the people with advanced melanoma who participated in our trials, and the scientific and medical community for the shared effort that has led to the accelerated approval of Keytruda.”
 
Merck plans to make the drug available within one week following the FDA's approval. 
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True Nopal Cactus Water now available at select Costco locations

BY Ryan Chavis

SCOTTSDALE, Ariz. — True Nopal announced that its line of True Nopal Cactus Water will be available in the Los Angeles region and Hawaii CostCo locations beginning in September. The company will sell the water in a four pack of 1-liter Tetra Paks. 
 
"We are thrilled to be working with Costco to get True Nopal into the hands of more consumers.  For many, Costco will provide people with their first taste of True Nopal Cactus water through Costco's sampling program," said Tom Zummo, CEO of True Nopal's parent company True Me Brands. "Costco is a great platform to show consumers who we are.  Our bright-colored packaging will attract consumer's attention and our great taste and nutritional benefits will keep them coming back."
 
Zummo added that the cactus water has enjoyed extraordinary growth, experiencing an expansion to more than 2,500 retailers since the product first appeared on shelves in May 2014. 
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Pharmavite takes comprehensive approach to build VMS business at retail pharmacy

BY Michael Johnsen

NORTHRIDGE, Calif. — Pharmavite at the recent NACDS Total Store Expo unveiled its go-to-market strategy, a cultural transformation and customer focus that emphasizes service and shopper insights. "As part of delivering a consistent message to all of our customers, we've created this customer value proposition," Tim Toll, Pharmavite chief customer officer, told DSN. "There are six pillars in the customer value proposition," he said, on which Pharmavite will build a strong foundation of growth. 
 
First is driving profitable sales growth through a joint business planning process, Toll said. "Really understand [the retailer's] needs of the category [and] set financial targets on sales, profit and cash flow, and engage with them around what are the opportunities that they individually have around [the VMS] category," he said, including pricing, merchandising and distribution. 
 
The second pillar is around innovation. "We're going to be ramping up our innovation over the next couple of years," Toll said. "Our goal is to make sure we are the unequivocal innovation leader in this category," he said. And not just with new products, Pharmavite intends to lead the VMS category in merchandising, packaging and customer marketing, too. "Our hope is over the next few years, as we start to really focus our efforts against innovation, our customers will realize that we're taking a very deep look at what consumer wants are and creating innovations to better meet those needs." 
 
The shopper forms the base for the third pillar, Toll said. "We really want to understand what are the opportunities for each of our retailers based on the shopper needs," Toll said, and seize those opportunities in partnership with the retailer. "The more we can be grounded in what shopper's expectations are, we think we can lead a different type of dialogue with our retailers that will be mutually beneficial."
 
Fourth is Pharmavite's commitment to quality and manufacturing supplements to USP (U.S. Pharmacopeial Convention) standards. "We're working with that organization to broaden our USP certification and also use it as a way to communicate to the consumer," Toll said. "We're working with different retailers to really bring that point home in merchandising on-shelf and on our package in a way that differentiates us."
 
Pillar number five ties the health-and-wellness factor associated with vitamins and supplements to the back bench with pharmacy education. "We believe there is a ton of work that we can do with our retail partners in making that connection and driving a bigger platform around health and wellness, how vitamins can complement different prescriptions that their consumers are taking," Toll said. Pharmavite will be committing a considerable amount of resources against this, he added. "Getting our quality message, our value message and getting our differentiation message to pharmacists so that they are well equipped to answer questions. They're the real advocate for our business and our category."
 
Last but not least, pillar six incorporates supply chain. "As you work with retailers, there are really two avenues," Toll said. "One is demand creation, which is all around the shopper, innovation, profitable volume growth through joint business planning; the next one is through cost savings," he said. "If we can partner with them and really develop goals, not only for standard supply chain metrics like on-time delivery. … We think there are a considerable amount of dollars that are up for grabs both for our retail partners and ourselves." Toll said Pharmavite has been making significant gains in improving in-stock positions and taking out costs. "[It's about] making sure our products are at the right place, at the right time [and] at the right price," he said. "That's starting to produce dividends."
 
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