Strides Arcolab's HIV medication gets FDA OK | GlycoMimetics' leukemia drug gains FDA orphan drug status | Researchers apply for patent on leukemia drug
May 15, 2015
FDLI SmartBrief
News for the food and drug law community

Drugs & Biologics
Strides Arcolab's HIV medication gets FDA OK
The FDA has granted Strides Arcolab approval for its Lamivudine and Zidovudine tablets for the treatment of patients with HIV infection. The anti-retroviral comes in 150- and 300-milligram strengths. (India)/Press Trust of India (5/15) Share: Email
GlycoMimetics' leukemia drug gains FDA orphan drug status
GlycoMimetics' GMI-1271, a proprietary E-selectin antagonist, has obtained orphan drug status from the FDA as a treatment for acute myeloid leukemia. A Phase I/II trial is underway to assess the drug in patients also being treated with chemotherapy. Healio (free registration)/HemOnc Today (5/14), Seeking Alpha (free registration) (5/14) Share: Email
Researchers apply for patent on leukemia drug
A patent application was submitted by researchers from Sandia National Laboratories, the University of Maryland and the University of Texas MD Anderson Cancer Center in Houston for their drug that can potentially kill acute lymphoblastic leukemia cells and other cancer cells. The drug, which works by depriving cancer cells of the nutrient asparagine, is being tested in mice. (5/14) Share: Email
Warner Chilcott holds settlement talks with government authorities
Actavis' Warner Chilcott business unit is holding settlement talks with the U.S. government over accusations from two of its former sales representatives alleging that the unit offered kickbacks to doctors and made improper product claims. Subpoenas were issued in 2012 by the U.S. Attorney for the District of Massachusetts to Warner Chilcott and some of its sales reps for information about sales and marketing practices, payments, education and employee training. Reuters (5/15) Share: Email
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Food & Dietary Supplements
USDA releases rules on labeling mechanically tenderized beef products
The U.S. Department of Agriculture has completed rules for labeling beef products that were tenderized by piercing them with small blades or needles because the process could cause bacterial contamination. The requirements, which will take effect in May 2016, highlight the need for manufacturers to state on the package that the product is mechanically tenderized and add instructions on how to safely prepare and cook the meat. Food Poisoning Bulletin (5/14) Share: Email
Botulism risk prompts recall of carrot soup
Concerns about possible Clostridium botulinum contamination prompted The Soup Boy and the Canadian Food Inspection Agency to pull the company's carrot soup. The recalled soup is unlabeled and was distributed in 1-liter containers in New Brunswick. Food Poisoning Bulletin (5/14) Share: Email
Medical Devices
Siemens reaches settlement deal in purchasing case
A settlement deal worth about $5.9 million has been reached by Siemens Healthcare with the U.S. government to settle claims that the firm overcharged the Defense Department and Department of Veterans Affairs for medical imaging equipment purchases. The government says the company overcharged when it did not offer the government as large of a discount as it would have given to a commercial or private client buying a comparable product. Siemens makes no admission of wrongdoing or liability under the deal. (free registration) (5/14) Share: Email
CMS drafts coverage of NanoString's breast cancer test
A positive local coverage determination draft was released by the CMS for the Prosigna breast cancer recurrence test developed by NanoString. The draft would allow coverage of the test when used in estrogen receptor-positive post-menopausal patients who have breast cancer that has not affected the lymph nodes or in patients with stage II breast cancer that has affected up to three nodes. The CMS will accept comments from stakeholders on the draft from June 9 to Aug. 24. GenomeWeb Daily News (free registration) (5/14) Share: Email
EU approves infusion catheter from Ablative Solutions
European regulators have granted Ablative Solutions CE mark approval for its Peregrine System Infusion Catheter designed to help patients with hypertension. The firm has started enrolling participants in a European trial to test the device for treating drug-resistant hypertension and plans to launch a U.S. trial for treating hypertension. FDAnews (5/15) Share: Email
Lawmaker urges FDA to finalize Tobacco Control Act regulations
Sen. Richard Blumenthal, D-Conn., has warned the FDA that he will propose legislation if the agency fails to finalize deeming regulations authorized under the Tobacco Control Act by the end of the summer. The act allows the FDA to regulate any tobacco products, including cigarettes, smokeless tobacco, roll-your-own tobacco and electronic cigarettes, that the agency feels should be included under the law. Blumenthal issued the warning after the CDC published a report stating that e-cigarette use tripled among high-school and middle-school students in 2014. The Hill (5/14) Share: Email
FDLI Items
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  • Legal and compliance personnel within pharmaceutical companies
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