Genzyme provides update on Lemtrada filing with FDA
CAMBRIDGE, Mass. — Genzyme announced it has received a refuse-to-file letter from the Food and Drug Administration in response to the drug maker’s supplemental biologics license application for the approval of Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis.
The agency requested that the company modify the presentation of the data sets to enable the agency to better navigate the application. The FDA has not requested additional data or further studies. Genzyme will work with the FDA over the coming weeks to resubmit the application as soon as possible, the drug maker said.
"We have had constructive dialogue with the FDA, and we are very confident in our ability to address the agency’s request and resubmit rapidly," Genzyme president and CEO David Meeker said.
Genzyme is developing Lemtrada in MS in collaboration with Bayer HealthCare.
Multichannel strategies rise in importance
WHAT IT MEANS AND WHY IT’S IMPORTANT — Do you doubt the importance of having a multichannel strategy to reach shoppers? If so, consider the fact that — for as little 2.5% off — nearly half of your customers will walk out of the store to make their purchase online. How about a 5% discount? Well, that number jumps to 60% of shoppers who will leave.
(THE NEWS: Study: Discounts as low as 2.5% sway shoppers to leave stores, purchase online. For the full story, click here)
That’s according to recent showrooming research from GroupM Next and, as many would likely agree, that’s a pretty darn compelling reason to implement a multichannel strategy.
That’s not the only study that stresses the importance of such a strategy. A recent report from IBM noted a rise in mobile shopping and a dip in social media sales during the second quarter — further evidence supporting the importance of a multichannel approach.
“Shoppers today are shifting from a singular online approach to a multichannel experience that includes both mobile and social media,” Craig Hayman, GM at IBM Industry Solutions, had stated in announcing the study results. “As a result, retailers must be prepared to connect with their customers on all fronts, or lose them to the competition. As we enter the home stretch for the 2012 holiday season, we will continue to watch how CMOs and CIOs tackle these challenges and create social media efforts that deliver value to the customer while driving revenue for the business."
Several retailers are, in fact, heeding the call. For example, earlier this year, Walgreens announced that it would publish a digital edition of its weekly advertising circular offering additional items through Walgreens.com and the company’s mobile applications as a way to complement its “multichannel strategy by finding new and different ways to cater to today’s consumers.”
Clearly, there is mounting evidence that having a multichannel strategy is key, and those retailers that want to effectively reach today’s shoppers are wise not to rest on their laurels.
What do you think is the most effective multichannel strategy for today’s retailers and suppliers?
Mobeam, ProLogic enter strategic partnership to enable digital coupons on mobile devices
SAN FRANCISCO — Mobeam and ProLogic are joining forces to enable the processing of digital coupons on mobile devices.
The partnership will combine Mobeam’s light-based beaming technology and ProLogic’s digital coupon clearing solution to create a completely digitized coupon system for consumers and retailers. Consumers can acquire and digitally redeem coupons, while retailers can digitally process and clear the coupon to complete the transaction loop.
"Real digital coupons — those that can be digitally displayed and redeemed at checkout via a mobile device — hold enormous value for consumers, retailers and the brands offering the coupons," Mobeam CEO Chris Sellers said. "Someday soon, we will look back at the archaic way we used to present, redeem, and process coupons and wonder why it took us so long to go purely digital. This partnership is a giant leap to get us there."
Added ProLogic president and CEO Ross Ely, "ProLogic has always been the retailer’s advocate for coupon clearing and with the rise of mobile technology we are leading the drive towards digital coupon processing as the industry evolves. Mobeam is the perfect complement to ProLogic’s clearing and settlement system, and together these technologies will drive the evolution of the coupon to a purely digital state, which benefits everyone in the retail economy."