GPhA heralds FDA hiring milestone
WASHINGTON — The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.
The Generic Pharmaceutical Association heralded the news Thursday. "Making these hiring decisions is an important step to achieve the goal of [the Generic Drug User Fee Amendments] and address the delays that reduce Americans’ access to affordable medicines," GPhA president and CEO Ralph Neas said. "The FDA has a critical task at hand: reducing the backlog in applications for new generic medicines and speeding the average [abbreviated new drug application] approval time."
As DSN reported Wednesday, FDA Center for Drug Evaluation and Research director Janet Woodcock sent a memo to employees announcing that the agency had hired 234 people as part of its GDUFA Human Capital Team, in excess of the 231 it had intended to hire.
Contigo offers new eco-friendly, reusable tumbler
CHICAGO — Contigo, an Ignite USA LLC brand, announced on Thursday a new reusable tumbler with a lid that snaps shut to ensure 100% leak-proof shaking and mixing to prepare on-the-go drinks and shakes.
The AutoClose Shake and Go Tumbler from Contigo features a "trap door" design that snaps shut when the straw is removed. The tumbler is available in 16- and 20-oz. sizes and is constructed of FDA-approved, BPA-free Tritan. The tumbler features a double-wall design, which helps keep beverages colder longer and prevents sweating, or condensation build-up on the outside of the container. The entire tumbler is top-rack dishwasher safe.
"The instant success of individually-packaged flavor enhancers and mix-ins has left on-the-go consumers without the tools they need to really enjoy them," said Todd Starr, VP of marketing and product development for Contigo. "Disposable water bottles add unnecessary cost and waste, but to date they have been the best option. Our new Shake and Go Tumbler finally gives consumers a reusable solution for quickly and conveniently mixing one of these popular drinks without worry of making a mess."
According to a Contigo survey, almost 50% of consumers report using mix-in flavors or water enhancers every week. This can account for a large number of plastic water bottles being discarded, which is bad for the environment. The Shake and Go Tumbler is ideal for the environmentally conscious consumer, the company noted, and provides a safe and mess-free way to mix drinks while on-the-go.
The Contigo Shake and Go Tumbler launched online at GoContigo.com on September 3, 2013 in 16-oz. and 20-oz. designs, with suggested retail prices of $12.99 and $14.99, respectively. It will be available at Target and Meijer in mid-September in a variety of on-trend hues.
Lonza Group launches new immune system booster
BASEL, Switzerland — The Lonza Group recently launched its Alomune daily immune supplements into the U.S. market, backing the product with clinical trials that show the supplement helps improve the body’s natural defenses for optimized immune health.
“Alomune works to naturally power your immune system and to keep it strong and more active,” stated Dan Johnston, brand spokesman.
The active ingredient in Alomune is proprietary ResistAid made with larch arabinogalactan, a natural extract sourced from renewable Minnesota Larch trees. LAG is an excellent source of dietary fiber, the company noted.
LAG also supports the immune system in two different ways — by improving the innate immune response, which is with us from birth; and by improving the adaptive immune response, which is built over time and affected by exposure to various immune challenges presented by the environments that we live in. LAG also helps to support the body’s own friendly bacteria in the digestive tract, which makes up 70% of the immune system.
In a double-blind, placebo-controlled clinical trial involving 204 healthy adults, those taking Alomune were 57% more likely to stay healthy than those taking the placebo, based on a primary immune health outcome. Alomune was awarded the Good Housekeeping Seal upon evaluation by the Good Housekeeping Research Institute.