Teva gains tentative OK for HIV treatment | FDA to expedite review of Avastin plus chemotherapy for ovarian cancer | Puma to seek FDA approval of neratinib for breast cancer after trial success
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July 23, 2014
FDLI SmartBrief
News for the food and drug law community

Drugs & Biologics
Teva gains tentative OK for HIV treatment
Teva Pharmaceutical obtained tentative approval for its abacavir sulfate and lamivudine tablets for the treatment of HIV-1 infection. Drug Store News (7/22) Share: Email
FDA to expedite review of Avastin plus chemotherapy for ovarian cancer
Genentech obtained priority-review status from the FDA for its application to market Avastin, or bevacizumab, in combination with chemotherapy, for the treatment of women with platinum therapy-resistant recurrent ovarian cancer. The designation was granted based on late-stage trial data that showed bevacizumab plus chemotherapy significantly improved progression-free survival compared with chemotherapy alone. Healio (free registration)/HemOnc Today (7/22) Share: Email
Puma to seek FDA approval of neratinib for breast cancer after trial success
Puma Biotechnology plans to submit its investigational breast cancer drug neratinib for FDA review next year after obtaining positive results in a Phase III trial. Data from the trial showed that neratinib was significantly more effective than placebo in improving disease-free survival among women with early-stage HER2-positive breast cancer who already received trastuzumab. Reuters (7/22) Share: Email
FDA meeting to focus on regulations affecting biomarker development
A public meeting will be held by the FDA on Sept. 5 to discuss different approaches that could be used in relation to biomarker development, acceptance and use in the creation of therapeutic products such as biologics. The discussion will highlight various topics such as the challenges to the application of biomarkers in early- and late-stage clinical studies as well as the different best practices to ensure the success of biomarker-based initiatives. Health Industry Washington Watch blog (7/22) Share: Email
Agency updates informed consent guidance for clinical trials
The FDA last week released an updated version of its informed consent guidance for clinical trials that was first issued in 1998. Among the changes in the document is the addition of a section urging studies to inform participants of the trial results. Despite the updates, several issues remain, such as a failure to discuss what should be done if participants lack the ability to consent themselves, including children, unconscious people and those who are mentally ill. MedPage Today (free registration) (7/23) Share: Email
U.S. needs new mechanisms to encourage drug development
Today's drug pipeline is strong but the economics of developing such drugs as the "next antibiotic" are not favorable, and drugmakers are moving toward orphan drugs, or rare disease drugs, said Michael S. Kinch of the University of Washington in St. Louis. The University of Pennsylvania's Patricia Danzon recommends adjusting the current regulatory burden in favor of research into drugs with a wider possible footprint. The New York Times (tiered subscription model) (7/22)
Global Focus
Cuts to vital drug prices are not limited to India
Drugmakers worldwide are being pressed to cut prices as governments target them due to growing concerns over health care costs. India is not the only one to cut prices as countries like the U.S., U.K. and Germany also monitor the prices of life-saving drugs. "Governments have realized that pricing policy of drug companies has no relation to their actual cost, including no relation to research cost," All India Drug Action Network's S. Srinivasan said. "This present pricing model of companies needs to go." The Economic Times (India) (7/22) Share: Email
Comments sought on EU proposal to evaluate nano-based devices
The European Commission has released preliminary guidelines governing the risk assessment of medical devices that use nanomaterials. The commission will accept public comment on the guidelines through Oct. 3. Clinica (subscription required) (7/22) Share: Email
Food & Dietary Supplements
Makers of 5-Hour Energy drink accused of deceptive marketing by 3 states
Lawsuits were filed by Vermont, Washington and Oregon accusing Living Essentials and Innovation Ventures of deceptive advertising of their 5-Hour Energy drink. The states are complaining that the producers used unsubstantiated, misleading or false claims to promote the energy drink. Washington is seeking a $2,000 penalty for every violation against its consumer protection laws, Vermont is seeking $10,000 per violation, while Oregon is seeking $25,000 per violation. (7/22) Share: Email
Medical Devices
St. Jude earns CE mark for next-gen heart ablation device
St. Jude Medical has obtained CE mark approval in Europe for its FlexAbility system, a next-generation catheter with a flexible tip to allow easier targeting of tissue during heart ablation procedures. The newly CE-marked device has been used for the first time to help treat patients with abnormal heart rhythms in France and Portugal. (Boston) (7/22), (7/22) Share: Email
FDLI Items
FDA Regulation of Tobacco Products -- Oct. 21
On Oct. 21, FDLI will host the annual "FDA Regulation of Tobacco Products" conference in Washington, D.C. This meeting will feature discussions on the proposed deeming regulations, post market considerations, tobacco product standards, Modified Risk Tobacco Product applications and enforcement. Join us to hear from keynote speaker Mitch Zeller, director of the Center for Tobacco Products, and other experts in the tobacco community. For more information on this event please contact Liz Stevulak at or register online. Share: Email
Food Safety: FSMA Developments & Enforcement Actions, Sept. 9 -- registration open
Mike Landa, director of the Center for Food Safety and Applied Nutrition at the FDA, keynotes this event at the law offices of Sidley Austin LLP, in Washington, D.C. The conference takes an in-depth look at the proposed rules that have been promulgated by the FDA in the last year to implement the Food Safety Modernization Act and how these rules will affect enforcement in a changing business climate. There will also be a case study on recent food recalls and discussion of how to avoid recalls. Sign up today! Share: Email
Who's Hiring?
Position TitleCompany NameLocation
Director, Corporate Counsel - Regulatory Law RegeneronTarrytown, NY
Food LawyerCargillWayzata, MN
Sr. Regulatory Specialist, Biotech Center of ExpertiseBASF, The Chemical Co.San Diego, CA
Biotechnology/Pharmaceutical Patent AttorneyCoats and Bennett PLLCCary, NC
Click here to view more job listings.
You may delay, but time will not."
-- Benjamin Franklin,
American Founding Father Share: Email
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