Teva receives favorable court decision regarding generic Celebrex
JERUSALEM — Teva Pharmaceutical Industries announced on Friday that the U.S. District Court for the Northern District of West Virginia has denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100-, 200- and 400-mg capsules.
On April 17, Teva entered into a settlement agreement with Pfizer related to Teva’s generic version of Celebrex (celecoxib) 50-, 100-, 200- and 400-mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December 2014, or earlier under certain circumstances.
Teva has received tentative approval from the FDA for all strengths. Sales of Celebrex were $2.2 billion in the U.S. according to IMS data as of December 2013.
Sephora offers new 3-D Augmented Reality Mirror in Milan
MILAN, Italy — Beauty retailer Sephora and ModiFace, a global augmented reality virtual makeover technology provider, have launched in Milan a 3-D Augmented Reality Mirror that can simulate cosmetics on a user’s face in real-time and in 3-D.
The new technology, created by ModiFace, tracks the precise location of a user’s facial features and applies eye shadow colors directly on the video feed from a camera. Sephora customers can:
- Try any number of cosmetic colors — instantaneously and virtually — by tapping on a shade palette on the Beauty Mirror screen;
- Preview unique textures of eye shadow including glittery, sparkly and shiny shadow textures; and
- View all eye shadows from different angles as they turn their face from side to side, enabling customers to virtually try out products quickly in a store and to make better informed purchasing decisions.
Originally announced in 2014, the Sephora 3-D Augmented Reality mirror is the result of more than three years of research and development.
“We believe ModiFace’s 3-D Augmented Reality Mirror will be a breakthrough technology for our customers as they virtually try out different eye shadow shades quickly and easily," stated Antonio Ferreira de Almeida, GM, Sephora Italy.
A statement that government needs to take seriously
The Congressional Research Service issued a new report last week that includes an important statement: "Federal policy on PCS [prescription controlled substances] aims to balance the need to limit abuse of PCS with the need to maintain access to PCS for legitimate medical use. The federal government's approach to addressing prescription drug abuse has increasingly relied on coordination across agencies, including both law enforcement and health agencies."
At least two things can be said about that statement. First, it articulates the way things should be. But, second, it probably overstates the degree to which the government is pursuing this dual responsibility.
The Congressional Research Service is a nonpartisan and objective arm of the Library of Congress that analyzes issues for legislators' consideration. Its inclusion of this statement in its report on prescription drug abuse shows progress in telling both sides of this complex issue. However, much more needs to be done to ensure legitimate access to these medications for patients.
That is one of the reasons that this week's "mark-up" — or bill-writing session — by the Health Subcommittee of the House of Representatives Energy and Commerce Committee is so important. The Subcommittee adapted and approved the Ensuring Patient Access and Effective Drug Enforcement Act (H.R. 4709), sponsored by Rep. Tom Marino (R-PA) and Energy and Commerce Committee Vice Chair Marsha Blackburn (R-TN). NACDS affirmed support for the bill, which would establish a framework to foster collaboration among health and enforcement officials on this issue.
The Subcommittee's action represents an important step, among other steps that are needed, to make the Congressional Research Service's statement a reality.
The views expressed here are the author's, and do not necessarily reflect the opinions of DSN.
Steve Anderson is the president and CEO of the National Association of Chain Drug Stores.