WHO draft plan: $430M needed to contain worst Ebola outbreak on record | FDA approves Iroko's low-dose Zorvolex for osteoarthritis pain | Insys' brain-cancer candidate wins orphan status from FDA
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August 26, 2014
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News for the food and drug law community

Drugs & Biologics
WHO draft plan: $430M needed to contain worst Ebola outbreak on record
A draft document from the World Health Organization says ending the Ebola outbreak will take more than $430 million, more than half of which would go toward medical care, referral centers and isolation. Support would include in-kind contributions as well as funding from the private sector, development banks and governments. Bloomberg Businessweek (8/25) Share: Email
FDA approves Iroko's low-dose Zorvolex for osteoarthritis pain
Iroko Pharmaceuticals has won the FDA's approval to market a low-dose version of Zorvolex, or diclofenac, as a treatment for osteoarthritis pain. The submicron formulation is already being sold as a treatment for mild to moderate acute pain. MedPage Today (free registration) (8/25) Share: Email
Insys' brain-cancer candidate wins orphan status from FDA
Insys Therapeutics' pharmaceutical cannabidiol secured orphan-drug designation from the FDA as a treatment for glioblastoma multiforme. The designation would give Insys seven years of marketing exclusivity once the drug is approved for this indication. Yahoo/The Associated Press (8/25) Share: Email
Alkermes seeks FDA approval of injectable version of Abilify
Alkermes has filed an application with the FDA for approval to market a long-acting, injectable version of Abilify, or aripiprazole, as a treatment for schizophrenia. The injectable reformulation is intended to be taken once a month. American City Business Journals/Boston/BioFlash blog/Mass High Tech (8/25) Share: Email
Lawsuits accuse drugmakers of aggressively marketing painkillers
Five drugmakers aggressively marketed prescription opioid painkillers, leading to an epidemic of abuse and addiction and millions of dollars in costs to taxpayers, according to lawsuits filed by the city of Chicago and by Orange and Santa Clara counties in California. Chicago argues that opioid abuse and overdose led to some 1,100 emergency room visits in 2009, along with millions of dollars in prescription claims. The lawsuits allege that drugmakers encouraged physicians to prescribe painkillers for treating acute pain from surgery, injury or cancer while understating the risk of addiction. The New York Times (tiered subscription model) (8/25) Share: Email
Global Focus
India gains access to $6B drug market in Argentina
India has been added to the list of nations that can supply drugs to Argentina, giving Indian drugmakers access to a $6 billion market. "Our companies can supply generic drugs at nearly half the price of Argentina's locally made drugs," said PV Appaji of the Indian Pharmaceuticals Export Promotion Council. Other experts warned that it could take several years to secure product registrations and several years after that for Indian companies to see a profit. The Economic Times (India) (8/25) Share: Email
Food & Dietary Supplements
FDA: No proof diet supplements can cure concussions
The FDA said on Monday that claims that some dietary supplements can treat concussions is not backed by science, nor is there evidence enough to prove the efficacy or safety of such products. "We're very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready," FDA National Health Fraud Coordinator Gary Coody said. The FDA has sent warning letters to several companies that market supplements making these claims. LiveScience.com (8/25) Share: Email
Medical Devices
Medtronic gains FDA approval for personalized pacemaker
The FDA has granted Medtronic approval to market its Viva CRT-P system for use in treating patients with heart failure or atrioventricular block. The cardiac resynchronization therapy-pacemaker alters its pacing parameters according to a patient's cardiac rhythms using proprietary software. MassDevice.com (Boston) (8/25) Share: Email
FDA clears 2 blood glucose monitors from Nipro
The FDA has cleared Nipro Diagnostics to market its True Metrix Pro and True Metrix self-monitoring blood glucose systems, which could be available commercially in the fourth quarter. The company said the devices use meal tags and allow patients to link blood glucose readings with noteworthy events to help them make improved decisions about diabetes management. The Miami Herald (tiered subscription model) (8/25), Drug Store News (8/25) Share: Email
More nonsmoking teens use e-cigarettes, CDC finds
Data from the National Youth Tobacco Surveys for 2011-2013 showed that more than 263,000 teens who had never smoked before reported using an electronic cigarette in 2013, up threefold from 79,000 in 2011. Among the respondents who tried e-cigarettes, 43.9% of them said they plan to try a conventional cigarette in the following year, CDC researchers reported in the journal Nicotine & Tobacco Research. Reuters (8/25), The Washington Post (tiered subscription model)/To Your Health blog (8/25) Share: Email
FDLI Items
First-ever Introduction to Tobacco conference, Oct. 20
This introductory course is your one-stop resource for the basics of tobacco law and regulation. This course is also an excellent refresher for seasoned professionals. Our faculty will provide unbiased and practical information on the Tobacco Control Act, the FDA's approach to regulating tobacco products, substantial equivalence, harm reduction efforts, and the regulation of e-cigarettes, cigars and smokeless tobacco. All attendees will receive a complimentary copy of the Primer on Tobacco Regulation. Register today! Share: Email
IFSH symposium on Rapid Methods in Food Safety Microbiology, Sept. 18
Early bird registration is now open for the symposium on Rapid Methods in Food Safety Microbiology. The symposium is co-organized by IFSH and the U WI FRI and will be held Sept. 18 at the Chicago Marriott Southwest at Burr Ridge, Burr Ridge, Ill. Get program information and register. Please contact Armand Paradis, director of business development, IFSH, for further information at aparadi2@iit.edu. Share: Email
Who's Hiring?
Position TitleCompany NameLocation
Senior Counsel, Regulatory (FDA)CareFusionSan Diego , CA
Assistant General Counsel - Pharmaceutical R&DGlaxoSmithKlineMultiple Locations, United States
Assistant General Counsel, RegulatoryCardinal HealthWaukegan, IL
Sr Manager, Business ConductGilead SciencesFoster City, CA
Counsel II, Legal (Anti-corruption) Gilead SciencesFoster City, CA
Associate Director, Regulatory Affairs - Promotional ReviewNovo NordiskPrinceton, NJ
Senior or Principal ConsultantPAREXEL InternationalNationwide, United States
Program Coordinator/Lecturer for the Regulatory Science programJohns Hopkins UniversityWashington, DC
Click here to view more job listings.
Without leaps of imagination, or dreaming, we lose the excitement of possibilities. Dreaming, after all, is a form of planning."
-- Gloria Steinem,
American journalist and political activist Share: Email
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