Idiopathic pulmonary fibrosis drugs from Roche, Boehringer win FDA approval | FDA to expedite review of Eisai's lenvatinib for thyroid cancer | AbbVie to reconsider $54B merger with Shire
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October 16, 2014
FDLI SmartBrief
News for the food and drug law community

Drugs & Biologics
Idiopathic pulmonary fibrosis drugs from Roche, Boehringer win FDA approval
The FDA has approved Roche's Esbriet, or pirfenidone, and Boehringer Ingelheim's Ofev, or nintedanib, as treatments for idiopathic pulmonary fibrosis. Esbriet and Ofev are the first drugs approved for the lung disease in the U.S. Reuters (10/15) Share: Email
FDA to expedite review of Eisai's lenvatinib for thyroid cancer
Eisai obtained priority-review status from the FDA for its application to market lenvatinib for the treatment of progressive radioiodine-refractory differentiated thyroid cancer. A decision is expected by April 14. The drug is also under clinical development for non-small-cell lung cancer, hepatocellular cancer and other forms of solid tumors. PharmaTimes (U.K.) (10/15) Share: Email
AbbVie to reconsider $54B merger with Shire
AbbVie said its board of directors will meet next week to discuss whether it should go ahead with its planned $54 billion merger deal with Shire amid the U.S. government's efforts to block tax inversions. Shire said AbbVie should continue the deal, adding that its own board will meet to discuss the situation. The Irish firm said it will get a break fee of $1.64 billion if AbbVie decides to cancel the merger. PharmaTimes (U.K.) (10/15) Share: Email
Efforts to develop tools to determine value of drugs gain traction
The push to develop systematic tools to gauge the value of medical treatments is gaining momentum because existing methods are not sufficient to manage specialty drugs, panelists said at a meeting sponsored by the Academy of Managed Care Pharmacy Foundation. The CMS is seeking innovative management tools, including value-based insurance design. Forbes (10/15) Share: Email
Industry groups call for changes to FDA's biologic exclusivity guidelines
Changes are needed in the FDA's draft guidance on determining biologic products' exclusivity periods, drug and biotechnology groups said in recent comments. The Pharmaceutical Research and Manufacturers of America advised the FDA to commit to making prompt decisions on all requests, give advice as early as possible on a proposed product's eligibility and accept requests before the submission of biologics license applications. The Biotechnology Industry Organization noted that some recommendations in the guidelines as well as the entire process are "needlessly complicated, unnecessarily burdensome on both sponsors and FDA, and lack sufficient clarity on important issues." Bloomberg BNA (free content) (10/15) Share: Email
First human trials of new Ebola vaccine underway in Md.
Tests of a vaccine developed by Canada's Public Health Agency began this week at the Walter Reed Army Institute of Research in Maryland. Another vaccine is being developed by GlaxoSmithKline. Other promising potential therapies include blood transfusions from survivors, antiviral drugs, antibody drugs and treatments that could stop the virus from reproducing. USA Today (10/15) Share: Email
Global Focus
Forum seeks comments on problematic-device reporting proposal
A document issued by the International Medical Device Regulators Forum outlines the group's proposal to modify its process for exchanging data on serious public health threats tied to medical devices sold in its member countries. The proposal, which outlines information such as the criteria for determining when data should be shared, how it should be shared and the requirements for participating in the exchange program, is up for comment through Dec. 8. Clinica (subscription required) (10/14) Share: Email
Food & Dietary Supplements
Firm pulls Italian-style wedding soup due to undeclared soy, egg
Undeclared soy and egg prompted Fresh Food Manufacturing to recall Giant Eagle Market District Italian Style Wedding Soup. The affected product, made on Oct. 9 with the establishment number EST. 40211, was sold in Pennsylvania, Ohio and Maryland in 24-ounce cups. Food Poisoning Bulletin (10/15) Share: Email
Undeclared almonds prompt recall of carrot crisps in Canada
Okanagan Rawsome and the Canadian Food Inspection Agency recalled Afke's Chia-Hemp Carrot Crisps as the item includes almonds not declared on the label. The affected product, sold in British Columbia and Alberta, comes in 180-gram packs with the UPC number 6 27843 06693 4. Food Poisoning Bulletin (10/15) Share: Email
Medical Devices
FDA clears HPIV test from Quidel
The FDA has given Quidel 510(k) clearance to market its Lyra Parainfluenza Assay. The real-time polymerase chain reaction based test examines nasopharyngeal and nasal swab samples to identify the presence of human parainfluenza virus types 1, 2, or 3 viral RNA. GenomeWeb Daily News (free registration) (10/15) Share: Email
FDLI Items
FDLI Brussels Conference: Do you know what you can and cannot say about your product today?
Join us at our conference, Europe v. U.S. Food, Drug, Device & Tobacco Regulation & Policy: Emerging Issues and Comparative Analysis, in Brussels, Belgium on Nov. 13-14 to witness our panel on "Advertising and Promotion: What Can You Really Say About Your Product?" Learn about the policies and guidelines that are being established on both sides of the pond and how to manage them in your own business. Four prominent experts will be talking over these issues, and you won't want to miss this fascinating discussion. Register now! Share: Email
Only 4 days until Emerging Issues and New Frontiers for FDA Regulation, Oct. 20
FDLI and Harvard are partnering to put together an academic symposium on cutting-edge legal and regulatory issues facing the FDA: "Emerging Issues and New Frontiers for FDA Regulation: An FDLI Symposium, in Cooperation with Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics." Leading academics will present their research on mobile health, stem cells, personalized medicine and other novel medical product issues, as well as food regulation. View the agenda and register now. Share: Email
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Counsel I – Clinical Contracts Gilead SciencesFoster City, CA
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Associate - Food and Drug Keller and Heckman LLPWashington, DC
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