Batu seeks FDA approval to begin trial of cancer vaccine | Bill to boost access to new antibiotics introduced in U.S. | $33M from spending bill will go to fight abuse of pain drugs
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December 12, 2014
FDLI SmartBrief
News for the food and drug law community

Drugs & Biologics
Batu seeks FDA approval to begin trial of cancer vaccine
Batu Biologics submitted an application to the FDA for approval to initiate a Phase I/II study of its polyvalent cancer vaccine ValloVax in patients with advanced lung cancer who failed to respond to chemotherapy. The firm could begin patient dosing by early 2015. San Diego Business Journal (12/11) Share: Email
Bill to boost access to new antibiotics introduced in U.S.
Legislation to streamline the review of antibiotics was introduced by Sens. Orrin Hatch, R-Utah, and Michael Bennet, D-Colo. The Promise for Antibiotics and Therapeutics for Health Act would allow the FDA to expedite approval of antibacterials for "an identifiable, limited patient population upon determining that the drug treats a serious or life-threatening condition and addresses an unmet need." Regulatory Focus (12/11), Modern Healthcare (subscription required)/Vital Signs Blog (12/11), PharmaTimes (U.K.) (12/11) Share: Email
$33M from spending bill will go to fight abuse of pain drugs
Sen. Tom Harkin, D-Iowa, assisted in securing $33 million in the federal spending bill to treat people addicted to prescription pain drugs and to curb abuse. The money will fund the CDC's push against abuse at the state level, widen access to drug treatment programs and buy emergency devices to treat overdoses. The Hill (12/11) Share: Email
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Global Focus
U.S. should support India's drug patent law
Just as the U.S. found a way to support India's right-to-food program, it should seek compromise on India's drug patent regime, Yale Law School associate professors David Singh Grewal and Amy Kapczynski write. The U.S. should stand up to drugmakers and stop pressuring India to change its intellectual property laws, they write. The New York Times (tiered subscription model) (12/11) Share: Email
Abbott wins CE mark approval for Iridica platform
Abbott has earned the CE mark for its Iridica pathogen detection platform, which can determine even infrequent pathogens. The platform, introduced in July under the name Plex-ID, can identify more than 1,000 bacteria, viruses and fungi using only patient samples. GenomeWeb Daily News (free registration) (12/11) Share: Email
Food & Dietary Supplements
Undeclared anchovy prompts recall of Whalen's Seafood & Burger Sauce
Whalen's Seafood & Burger Sauce was pulled by Whalen's Horseradish Products because it includes anchovy not indicated on the label. The affected product, sold online and distributed in New York and Massachusetts, comes in an 8-ounce clear glass bottle with a "sell by" date of July 17, 2015. Food Poisoning Bulletin (12/11) Share: Email
Ore. biotech food labeling proponents admit defeat
Supporters of Oregon's biotech food labeling measure conceded defeat after a judge denied their request to count 4,600 rejected ballots with signature problems. The initiative was defeated by only 812 votes in November, which prompted an automatic recount. Oregon is the fourth state in the Western U.S. to reject biotech food labeling. The Salt Lake Tribune (Utah)/The Associated Press (12/11), USA Today (12/11) Share: Email
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Medical Devices
Defibrillator leads from Medtronic gain premarket approval
The FDA has given premarket approval to Medtronic for new additions to its Attain Performa line of quadripolar cardiac resynchronization therapy defibrillator leads. The additions feature straight and s-shaped leads and work with the firm's Viva Quad XT and Viva Quad S CRT-Ds. (Boston) (12/11) Share: Email
EU approves St. Jude's Quadra Allure MP pacemaker
European regulators have granted CE mark approval to St. Jude's Quadra Allure MP, a cardiac resynchronization therapy pacemaker that features the MultiPoint Pacing technology. The pacemaker, which is undergoing an FDA-approved trial in the U.S., can pace multiple locations on the heart's left section and also operate together with the company's Quartet LV lead. FDAnews (12/11) Share: Email
CDC: Minors can buy e-cigarettes in D.C., 10 states
A CDC study released Thursday found that over 16 million children in 10 states plus the District of Columbia can access electronic cigarettes legally. The federal government does not regulate e-cigarettes, but FDA regulations were proposed in April to prohibit the sale of the devices to people under 18. The CDC said Nevada, Michigan and Texas are among the states that allow e-cigarette sales to minors. Reuters (12/11) Share: Email
FDLI Items
FDLI & BioTech: BioBriefing for the Non-Scientist Conference on Jan. 22!
Join us in Washington, D.C., for FDLI's BioBriefing for the Non-Scientist conference. This is a one-day, fast-paced course giving a high-level overview of the key science concepts required for understanding basic biotechnology applications. Using industry-specific examples, participants will discuss biologic drugs, personalized medicine, and drug discovery and development. Gain an understanding of the fundamental terms and concepts needed to navigate the rapidly changing biotechnology industry. Register today! Share: Email
Volume 4 Issue 11 of the FDLI Policy Forum -- Medical Device Enforcement Actions
Issue 11 of the FDLI Food and Drug Policy Forum, titled "Should FDA Assume Sole Enforcement Responsibility for Alleged Violations of the FDCA? Lessons from Recent Medical Device Enforcement and Qui Tam Cases," focuses on current trends in health care fraud cases, specifically the recent attention on Department of Justice (DOJ) and qui tam cases involving medical device manufacturers. This article, written by Marilyn May, counsel, Philip Desjardins, counsel, and Lauren Haertlein, associate, at Arnold & Porter LLP, states that the FDA should have sole enforcement responsibility for alleged violations under the Food, Drug, and Cosmetic Act (FDCA). The authors recommend that the DOJ re-examine its reliance on suits brought under the False Claims Act and that the FDA should take advantage of its recent reorganization to take enforcement action against medical device manufacturers who fail to comply with the FDCA. Purchase and download our latest article now! Share: Email
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Assistant General Counsel/Senior Corporate CounselGenentechSouth San Francisco, CA
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AttorneyU.S. DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Office of the Chief CounselSilver Spring, MD, MD
Senior Scientist - Cell Engineering GroupPfizerSan Francisco, CA
Director, Litigation & Investigations EMEA Gilead SciencesStockely Park, United Kingdom
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