FDA fast-tracks Agios' experimental leukemia drug | Genentech-Roche's Avastin wins FDA nod for cervical cancer | B. Braun's parenteral nutrition emulsion gains FDA nod
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August 15, 2014
FDLI SmartBrief
News for the food and drug law community

Drugs & Biologics
FDA fast-tracks Agios' experimental leukemia drug
Agios Pharmaceuticals' AG-221, an experimental drug for the treatment of acute myelogenous leukemia with an isocitrate dehydrogenase-2 mutation, has been given fast-track designation by the FDA. The approval was based on positive preliminary data from a Phase I trial in patients with advanced hematologic malignancies. The company intends to test the drug against IDH2-mutant–positive AML and other IDH2-mutant-positive hematologic malignancies throughout the rest of this year. Pharmaceutical Business Review Online (8/14), Healio (free registration)/HemOnc Today (8/14), The Boston Globe (tiered subscription model) (8/13) Share: Email
Genentech-Roche's Avastin wins FDA nod for cervical cancer
Genentech and Roche Holding obtained the FDA's approval to market Avastin, or bevacizumab, as a treatment for recurrent, persistent or late-stage cervical cancer. The drug is to be given with paclitaxel in combination with cisplatin or topotecan. Avastin is already cleared for the treatment of four types of cancer. Medscape (free registration) (8/14) Share: Email
B. Braun's parenteral nutrition emulsion gains FDA nod
B. Braun Medical received federal approval for its Nutrilipid 20% intravenous emulsion to be used as parenteral nutrition for adults and children. The new treatment could help ease a two-year supply shortage of such products. Pharmaceutical Business Review Online (8/14) Share: Email
Fake Ebola treatments are being sold online, FDA warns
Consumers were alerted Thursday by the FDA about the online sale of fake Ebola drugs, vaccines and supplements, and the agency said that it has yet to approve any product to treat the disease. "Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection," the FDA said. "Individuals promoting these unapproved and fraudulent products must take immediate action to correct or remove these claims or face potential FDA action." Reuters (8/14), The Hill (8/14) Share: Email
FDA meeting to address drug development for female sexual dysfunction
A two-day workshop has been scheduled by FDA officials for October to talk about the development of sexual dysfunction treatments for women. The agency has been criticized for the lack of approvals for treatments to help women with sexual problems. The Wall Street Journal (tiered subscription model)/Pharmalot blog (8/14) Share: Email
Thurm gets HHS senior counselor appointment
HHS Secretary Sylvia Mathews Burwell has named Kevin Thurm senior counselor for the department. Thurm will collaborate with senior HHS staff on strategic programs, policy changes and external affairs management. BeckersHospitalReview.com (8/14) Share: Email
Food & Dietary Supplements
Ground oregano recalled by McCormick due to salmonella risk
Potential salmonella contamination prompted McCormick to pull 1,032 cases of its ground oregano in 0.75-ounce bottles. The affected product, with UPC number 0 523561 6 and item number 900356, was distributed in 41 states from April 4 to Aug. 5 and was also shipped outside the U.S. The Baltimore Sun (8/14), American City Business Journals/Baltimore (8/14), Food Poisoning Bulletin (8/14) Share: Email
Undeclared milk prompts recall of seaweed crackers in Canada
Pan Asia Food and the Canadian Food Inspection Agency pulled Wang Korepab-Seaweed crackers in Korean characters as they include milk not declared on the label. The affected product, sold in Quebec, Ontario and possibly nationwide, comes in 56-gram packs with the UPC number 8 801117 268206. Food Poisoning Bulletin (8/14) Share: Email
Medical Devices
FDA offers guidelines on device ID rule, de novo review process
The FDA has released its final guidelines on how small firms may satisfy the unique device identifier rules, including information related to the appearance of UDIs, rule exceptions and record-keeping standards. The agency also issued a draft document meant to guide companies when submitting Class III medical devices under the agency's de novo review program. MassDevice.com (Boston) (8/14) Share: Email
Synar program continues to keep underage tobacco sales in check
For eight consecutive years, all states have managed to meet the goals under the Synar Amendment program to curb the sale of tobacco products to minors, the Substance Abuse and Mental Health Services Administration said. However, the report showed that the national average rate of tobacco sales to minors increased from 9.1% in 2012 to 9.6% last year. HealthDay News (8/14) Share: Email
FDLI Items
Pharmaceutical Drug Law & Regulation — An FDLI Webinar in partnership with USP, Sept. 10 and on-demand
FDLI and the United States Pharmacopeial Convention (USP) have partnered to bring you "Current Issues: Pharmaceutical Drug Laws and Regulations Addressed by Food and Drug Administration (FDA)." This two-hour webinar, taught by subject-matter expert Areta Kupchyk, partner at Nixon Peabody, will walk you through social media related to drug marketing, off-label concerns and pharmacy compounding. The webinar will initially be offered Sept. 10, but then will be available on-demand through the USP website. For more information, contact Davina Rosen Marano at dsr@fdli.org. Share: Email
Register for early-bird rates for the 30th Anniversary of the Hatch-Waxman Amendments conference, Sept. 18
This year marks the 30th anniversary of the Hatch-Waxman amendments, which were enacted to promote generics while keeping financial incentives for research and development for brand manufacturers. Join us for this timely one-day conference that explores why the Act was passed, where we are right now in terms of FDA and industry developments, and what's on the horizon in terms of ongoing brand-generic issues Speakers from Capitol Hill, the FDA, the private bar and industry will provide practical insights on the impact of the Hatch-Waxman Amendments, controversial issues currently facing generic drug manufacturers and their counsel, and the status of the implementation of the Biosimilars Price Competition and Innovation Act (BPCIA). Register by Aug. 18 and receive early-bird rates. Share: Email
Who's Hiring?
Position TitleCompany NameLocation
Assistant General Counsel, RegulatoryCardinal HealthWaukegan, IL
Associate Director, Regulatory Affairs - Promotional ReviewNovo NordiskPrinceton, NJ
Senior or Principal ConsultantPAREXEL InternationalNationwide, United States
Food LawyerCargillWayzata, MN
Sr. Regulatory Specialist, Biotech Center of ExpertiseBASF, The Chemical Co.San Diego, CA
Director, Corporate Counsel - Regulatory Law RegeneronTarrytown, NY
Program Coordinator/Lecturer for the Regulatory Science programJohns Hopkins UniversityWashington, DC
Click here to view more job listings.
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-- G.K. Chesterton,
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