| February 5, 2013 | News for the food and drug law community |
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| Drugs & Biologics |  |  |
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- Zealand-Sanofi diabetes drug wins go-ahead in Europe
Sanofi and Zealand Pharma obtained approval from the European Commision to market the drug Lyxumia, or lixisenatide, for treatment of diabetes. The prandial GLP-1 receptor agonist will be used with oral glucose-lowering treatments and/or basal insulin to control blood sugar levels. PharmaTimes (U.K.)
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- FDA rejects Hemispherx's Ampligen as treatment for CFS
The FDA didn't approve Hemispherx Biopharma's application for its candidate chronic fatigue syndrome drug Ampligen. The drugmaker will seek an "end-of-review" meeting with regulators and could file a formal appeal. Hemispherx said the agency requested data analyses, the completion of nonclinical trials and at least one more study involving patients. Reuters
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- Some CME payments exempt from Sunshine Act disclosure
Drugmakers and medical-device makers will not be required under the Sunshine Act to disclose payments to speakers at continuing medical education events who they did not select or pay directly. The decision to exempt indirect speaker payments is "good common sense," says Coalition for Healthcare Communication executive director John Kamp. Pharmalot.com/Pharma Blog
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| Food & Dietary Supplements | | |
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- Rule widens FDA power to keep unsafe food from market
The FDA introduced a final rule that allows the agency the ability to keep adulterated or mislabeled food from being sold. "The agency can keep the products out of the marketplace for a maximum of 30 days while the agency determines whether to take further enforcement action, such as seizure," the FDA said. FoodSafetyNews.com
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| Medical Devices | | |
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- FDA OKs MRI device as companion Dx for iron overload drug
Resonance Health has received the FDA's OK for its FerriScan R2-MRI system to be sold as a companion diagnostic for Novartis drug Exjade, which is used to treat iron overload in patients suffering from genetic blood disorders. The device is intended to help pinpoint which patients with nontransfusion-dependent thalassemia would best benefit from the drug. AuntMinnie.com (free registration)
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| Tobacco | | |
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- FDA doing too little with its power to regulate tobacco
 Last year, a report found, the FDA slowed the march of new regulations for tobacco. The agency says it was consolidating enforcement of regulations added since the signing of the Tobacco Control Act. It's time for more progress from the agency, as well as from Congress and states, according to this editorial. The Washington Post
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| FDLI Items | | |
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2013 conference calendar announced -- speak, register & save the dates!
There are plenty of speaking opportunities available for this year's FDLI conferences. Please email our development team if you are interested in participating or have any session/program ideas. FDLI members routinely receive at least a 20% discount on FDLI conferences, webinars and publications. Upcoming programs include:
- Pharmacy Compounding: An FDLI Dialogue | Feb. 12 | Washington, D.C., or via teleconference
- Medical Device Compliance, Regulation and Litigation Conference | March 4 | Washington, D.C.
- Introduction to Drug Law and Regulation | April 3-4 | Washington, D.C.
- Introduction to Medical Device Law and Regulation | April 3-4 | Washington, D.C.
- FDLI Annual Conference | April 23-24 | Washington, D.C.
- FDLI International Conference | June 10-11 | Beijing
- Advertising & Promotion Conference | Sept. 16-17 | Washington, D.C.
- Food Advertising: Claims, Litigations and Strategies | Oct. 8 | Washington, D.C.
- FDA Regulation of Tobacco Products | Oct. 17 | Washington, D.C.
- Enforcement, Litigation and Compliance | Dec. 10-11 | Washington, D.C.
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