Sandoz, Momenta gain FDA approval for generic multiple sclerosis drug | FDA fast-tracks steatohepatitis drug from MediciNova | Hepatitis C drug from AbbVie wins priority review status in Japan

April 17, 2015
FDLI SmartBrief
News for the food and drug law community

Drugs & Biologics
Sandoz, Momenta gain FDA approval for generic multiple sclerosis drug
Sandoz's and Momenta Pharmaceuticals' Glatopa, the first generic version of multiple sclerosis drug Copaxone from Teva Pharmaceutical, received approval from the FDA. Prescriptions for Copaxone can be switched with Glatopa because the generic will carry the label "substitutable," according to Momenta. Plans to launch the drug were not disclosed. Reuters (4/16) Share: Email
FDA fast-tracks steatohepatitis drug from MediciNova
The FDA has granted fast-track designation to MediciNova's MN-001, or tipelukast, as a treatment for nonalcoholic steatohepatitis with fibrosis. The agency also gave MediciNova approval to conduct a midstage trial of the drug. San Diego Business Journal (4/16) Share: Email
Hepatitis C drug from AbbVie wins priority review status in Japan
Japan's Ministry of Health, Labour and Welfare has granted priority review to AbbVie's investigational paritaprevir/ritonavir and ombitasvir combination therapy for use in patients with genotype 1 chronic hepatitis C. The priority designation was based on findings of the late-stage GIFT-I trial. PharmaTimes (U.K.) (4/16) Share: Email
Pat Croce Reveals His Insights for Acting on Your Passion
If you're ready to "get your butt off the couch and get into the game of life," it's time to get inspired by this successful entrepreneur and leadership expert. Read the featured article.

Global FocusSponsored By
EU approves HIV-1 assay from Cepheid
The Xpert HIV-1 Qual, a qualitative HIV-1 test developed by Cepheid for early diagnosis in infants and individuals who are at high risk of HIV, has received the CE-IVD mark from European regulators. The assay, which runs on the company's GeneXpert technology, can detect HIV-1 total nucleic acid in whole blood or dried blood spots. GenomeWeb Daily News (free registration) (4/16) Share: Email
Combating Identity Theft in a Mobile, Social World
Mobile connectivity threats extend from consumers to the business environment. But who is really responsible for securing sensitive information? Smart business leaders are becoming proactive on the matter. Learn how to get protected in this white paper. Download the white paper now.

Food & Dietary Supplements
Undeclared cashews prompt recall of Cleveland Crops kale chips
Packages of Cleveland Crops Chili Cheezy Kale Chips were pulled by Solutions at Work because they may include raw cashews not indicated in the label. The recalled products come in 2-ounce pouches with the UPC number 58736 00504. Food Poisoning Bulletin (4/16) Share: Email
Pine nuts pulled by Hannaford over salmonella risk
Potential salmonella contamination prompted Hannaford Supermarkets and Superior Nut and Candy to recall packages of pine nuts. The affected products bear the UPC number 72543920016 and come in 4-ounce packages. Food Poisoning Bulletin (4/16) Share: Email
Listeria risk causes raw cream recall, Wash. dairy closure
Spanish Sonrise Dairy was closed after the Washington State Department of Agriculture discovered potential listeria contamination in its raw cream. Recalled products from the Yacolt, Wash.-based dairy, including raw cow milk, goat milk and cream, have expiration dates between April 16 and 21. Food Poisoning Bulletin (4/16) Share: Email
Medical Devices
CAS Medical Systems gains expanded FDA approval for oximeter
The FDA has granted CAS Medical Systems expanded labeling approval for its Fore-Sight Elite tissue oximeter to include neonatal and pediatric patients. The Branford, Conn., company intends to release the product for those patient groups in the third or fourth quarter. The device continuously and noninvasively measures the absolute oxygenation of cerebral tissue. FDAnews (4/16) Share: Email
Cervical cancer test from Cancer Genetics lands conditional OK in N.Y.
The New York State Department of Health has given Cancer Genetics conditional licensure to expand its push for wider use of its FISH-based HPV-Associated Cancer Test in cervical cancer patients. The device, which is already approved in the U.S. as a laboratory-developed test, can identify patients with higher disease progression risk. GenomeWeb Daily News (free registration) (4/16) Share: Email
U.S. sees more teens using electronic cigarettes
The use of electronic cigarettes tripled among middle- and high-school students from 2013 to 2014, CDC researchers wrote in the Morbidity and Mortality Weekly Report. The increase marked the first time e-cigarettes exceeded the popularity of other tobacco products among teens. HealthDay News (4/16) Share: Email
FDLI Items
Intro to Drug Law and Regulation Course -- Registration now open!
FDLI's Introduction to Drug Law and Regulation courses provide an overview of drug and biologics law and regulation. Here is who typically attends and benefits from these courses: Regulatory and clinical affairs, research and development, quality control, marketing and management professionals in the pharmaceuticals industry, new drug application reviewers, associates working in law firms with a food and drug law practice and other legal professionals interested in issues surrounding drugs and biologics, and legal and compliance personnel within pharmaceutical companies.
Register now to attend this two-day introductory course on May 28-29 in Washington, D.C.
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Food Fight: An examination of recent trends in food litigation and where we go from here
This special issue brings together a series of short reflections on the significance of increasing litigation around food. These reflections emerged from ideas sparked by a conference hosted by the UCLA Resnick Program in conjunction with the Litigation Section of the State Bar of California, which sought to examine expanding food litigation in the broader context of "food systems" thinking. The limitations of the current regulatory system for addressing emerging consumer concerns and the realities of the modern food system are scrutinized, and the authors argue that the continued growth of litigation merits serious attention from all stakeholders. Learn more about which topics are addressed and download this issue to stay informed. Share: Email
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Senior Paralegal - Research & Development, and Medical
Associate - Food and Drug
Vice President of Regulatory Affairs
Junior to Mid-Level FDA Associate
MORGAN LEWIS - Washington, DC
The only way to deal with an unfree world is to become so absolutely free that your very existence is an act of rebellion."
-- Albert Camus,
writer and philosopher Share: Email
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