Antifungal drug from Astellas, Basilea gets FDA panel support | Proposed bill would require pharma wrongdoers to fund government medical research | Supreme Court turns away generics risk labeling case
January 23, 2015
FDLI SmartBrief
News for the food and drug law community

Drugs & Biologics
Antifungal drug from Astellas, Basilea gets FDA panel support
A panel of FDA advisers has endorsed the approval of Astellas and Basilea's antifungal drug Cresemba, or isavuconazole, as a treatment for invasive aspergillosis and invasive mucormycosis. A final decision by the FDA is expected by March 8. PharmaTimes (U.K.) (1/22) Share: Email
Proposed bill would require pharma wrongdoers to fund government medical research
Sen. Elizabeth Warren, D-Mass, plans to introduce a bill that would require drugmakers that reached a settlement with the government over their alleged wrongdoings to support research projects at the NIH and the FDA by giving them a portion of their yearly profits for five years. Warren said the bill would only affect large drugmakers generating more than $1 billion in sales from blockbuster drugs. Robert Zirkelbach, Pharmaceutical Research and Manufacturers of America's senior vice president for communications, said the proposal could result in fewer drugs being produced, leading to "devastating consequences for patients and society." St. Louis Post-Dispatch/The Associated Press (1/22) Share: Email
Supreme Court turns away generics risk labeling case
The Supreme Court will not take a case regarding state requirements for generic drugmakers to update labels before reference product labels are updated. The FDA is writing rules that would allow independent updates to generics labels. The Wall Street Journal (tiered subscription model)/Pharmalot blog (1/21) Share: Email
What might Obama's precision medicine initiative look like?
A precision or personalized medicine initiative suggested by President Barack Obama in his State of the Union address might call for better computational tools, smartphones that diagnose disease and advances in tissue-on-a-chip technology, says Lee Hood, who led the development of the automated DNA sequencer. Other focus areas might include research on the consequences of genetic changes, development of gene sequencing standards and improvements in how mutations are identified, says geneticist David Mittelman, chief scientific officer at Tute Genomics. Xconomy/Seattle (1/21) Share: Email
The Key To Positive Cash Flow
Every business is cyclical with cash flow ups and downs. The key is to find a way to keep the cash coming in as predictably as possible. Seem impossible? Well it's not. There are systems and processes that make it easier to collect the cash you've earned so your small business can grow. Learn how these small-business owners set up their businesses for success.

Global FocusSponsored By
Genzyme drug for Gaucher disease wins EU approval
The European Commission has approved Genzyme's oral drug Cerdelga, or eliglustat, as a first-line therapy for certain adults with Gaucher disease. The approval was based on data from a large research program that showed Cerdelga was non-inferior to Cerezyme, an enzyme replacement treatment, and resulted in improvement of several endpoints, including spleen size and hemoglobin levels. PharmaTimes (U.K.) (1/22) Share: Email
Bayer-Janssen's Xarelto approved for nonvalvular AF in Europe
Xarelto, jointly developed by Bayer and Janssen, has been approved in Europe as a treatment for patients with nonvalvular atrial fibrillation who require cardioversion. The label update is based on findings from a trial that showed Xarelto reduced the risk of stroke, transient ischemic attack, peripheral embolism, myocardial infarction and cardiovascular death. (U.K.) (1/21) Share: Email
EMA accepts AstraZeneca's gout drug for review
A marketing application submitted by AstraZeneca for its gout drug lesinurad has been accepted for review by the European Medicines Agency. The drug enhanced treatment when added to xanthine oxidase inhibitor drugs such as allopurinol or febuxostat, according to late-stage trial data. (U.K.) (1/22) Share: Email
The IDC Market Spotlight on Network Automation and Agility
The arrival of virtualization, cloud computing, and mobility has strained data center networks—and IT staff—like never before. This Market Spotlight explains how data center network fabrics provide a foundation for automated provisioning, configuration, and management of network-based services in a new era of IT agility. Download now.

Food & Dietary Supplements
Possible salmonella contamination prompts firm to recall spicy seed mix products
Concerns about salmonella contamination have prompted Freeland Foods to voluntarily pull all Go Raw Brand Organic Spicy Seed Mix packages in the U.S. and Canada. The affected products come with the UPC code 8 59888 0040 0 and "Enjoy Before May 12, 2015 R2" label. (1/22) Share: Email
Medical Devices
FDA OKs collagen bone graft from BioStructures
The FDA has given BioStructures, a Newport Beach, Calif., medtech firm, clearance to market its advanced Silhouette Mineralized Collagen Scaffold Bone Graft. The product, which has a 90% porous matrix, facilitates the delivery of crucial biologic factors such as bone marrow aspirate to stimulate healing. FDAnews (1/22) Share: Email
Attorney general seeks to raise legal smoking age in Wash.
Washington state Attorney General Bob Ferguson has proposed raising the state's legal smoking age to 21, citing studies indicating that young adult brains are significantly more prone to nicotine addiction. Rep. Tina Orwall, D-Des Moines, and other co-sponsors introduced a bill at Ferguson's request. It was referred to the Health Care and Wellness Committee. (1/22) Share: Email
FDLI Items
Today is the last day to save with early bird discounts on Food Week 2015!
This year, FDLI's Food Week will be held Feb. 23-24 at the Renaissance Hotel in downtown Washington, D.C. The event is a unique combination of two advanced conferences, addressing the latest emerging issues in food regulation. The first day will focus on food safety and globalization, while day two will tackle food advertising, labeling and litigation in depth. Be there to network with government officials, members of the private bar, academics, consultants and other key stakeholders in the food industry. Join us for one or both days! Register before tomorrow to take of advantage of early bird pricing! Share: Email
Registration for the 2015 FDLI Annual Conference is now open!
FDLI's Annual Conference is the largest and longest-running legal conference for the food and drug law community. This two-day event includes every regulatory area covered by the FDA and the many stakeholders who are affected by its authority. The 2015 FDLI Annual Conference will cover legal, regulatory, public health policy and economic issues spanning the broad range of the FDA's authority by bringing together experts from the federal government, industry, the private bar, patient and consumer advocates, consulting organizations and academia. Register now to be part of the dialogue with more than 500 prestigious colleagues! Share: Email
Who's Hiring?
Position TitleCompany NameLocation
Assistant General Counsel/Senior Corporate Counsel - Healthcare Law GroupGenentechSouth San Francisco, CA
Director, Corporate CounselRegeneronTarrytown, NY
Senior Counsel – Healthcare Regulatory #29099BRAmgenThousand Oaks, CA
Director, Compliance & Ethics, US OperationsBristol-Myers SquibbPrinceton, NJ
Counsel – Regulatory AffairsRAI Services CompanyWinston Salem, NC
Manager, Educational ProgramsThe Food and Drug Law InstituteWashington, DC, DC
Click here to view more job listings.
There is nothing more deceptive than an obvious fact."
-- Arthur Conan Doyle,
Scottish writer Share: Email
Learn more about FDLI ->About FDLI | Join FDLI | Conferences | Publications
Subscriber Tools
Please contact one of our specialists for advertising opportunities, editorial inquiries, job placements, or any other questions.
Editor:  Lisa Gough
Advertising:  Meryl Harold
  P: 202.407.7828
Jobs Contact:  Elizabeth Stack

Download the SmartBrief App  iTunes / Android
iTunes  Android
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004
© 1999-2015 SmartBrief, Inc.®
Privacy policy |  Legal Information