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March 18, 2013
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  Today's Top Story 
  • Sequestration threatens faster FDA reviews, Hamburg says
    Across-the-board sequestration cuts could hurt the FDA's efforts to accelerate new drug reviews, said FDA Commissioner Dr. Margaret Hamburg during MassBio's annual meeting. Hamburg said she hopes Congress will allow the agency to put user fees paid by drugmakers toward its operating expenses. Boston Herald (3/15) LinkedInFacebookTwitterEmail this Story
FDA's Draft Guidance Changes Game in Early Alzheimer's
Last month, the FDA's Center for Drug Evaluation and Research issued a draft guidance on the development of drugs in early stage Alzheimer's disease (AD). Intended as a conversation starter, the draft lays out a potential approach to select subjects with early AD and those at risk of developing the disease for enrollment into clinical trials. Find out the details.

  Health Care & Policy 
  • "Design defect" suit threatens FDA review process
    The "design defect" theory behind a lawsuit against generic-drug-maker Mutual Pharmaceutical could result in a wave of lawsuits second-guessing the approval of any drug, former FDA Deputy Commissioner Dr. Scott Gottlieb writes. "The theory would allow state juries to relitigate the risk-benefit analysis that is at the very core of the FDA's authority to approve prescription drugs," he writes. Politico (Washington, D.C.) (3/17) LinkedInFacebookTwitterEmail this Story
  • Mayo will test BrainStorm's stem cell treatment for ALS
    The Mayo Clinic will carry out a clinical study of BrainStorm Cell Therapeutics' NurOwn, an experimental adult stem cell therapy for amyotrophic lateral sclerosis. Minnesota's Mayo is the third U.S. center to agree to test BrainStorm's stem cell treatment, joining Massachusetts General and the University of Massachusetts. Patient enrollment could begin this year. Reuters (3/18) LinkedInFacebookTwitterEmail this Story
Clinical Management Toolkit from MasterControl
Effective management of a clinical study must incorporate not only all the activities and records that comprise a study, but the capacity to efficiently and rapidly assess status and development shifts at any given time. Download the toolkit.
  Company & Financial News 
  • Calif. diabetes monitoring device firm hopes to raise $1.7M
    Epinex Diagnostics is seeking to obtain as much as $1.7 million in a private placement after receiving $318,000 from investors. The Tustin, Calif.-based company is working on a glycated albumin-based test that can be used to monitor glycemic control in type 2 diabetes patients over an intermediate period. (3/14) LinkedInFacebookTwitterEmail this Story
  Food & Agriculture 
  • Firms ally to enhance soybean germplasm
    Bayer CropScience and Nature Source Genetics entered a five-year collaboration centered on the prebreeding and improvement of soybean germplasm. The partnership gives Bayer "access to new and valuable sources of genetic diversity in soybeans, which we can incorporate into our already robust breeding program to further expand and improve the products we offer growers worldwide," said Mike Gilbert, head of global breeding and trait development for Bayer. American City Business Journals/Raleigh/Durham, N.C./Triangle BizBlog (3/15) LinkedInFacebookTwitterEmail this Story
  Hot Topics 

Top five news stories selected by BIO SmartBrief readers in the past week.

  • Results based on number of times each story was clicked by readers.
  Industrial & Environmental 
  • Report: Global biofuel production grew in 2012
    Despite the challenges last year, global production of biofuels grew from 27.9 billion gallons to 31.4 billion gallons, according to a report from Clean Edge. "2012 was a year of extreme uncertainty for clean energy markets, as venture investors pulled back and high-profile bankruptcies became a partisan wedge in the presidential election, all while climate disruptions brought clean tech back into the limelight," said Ron Pernick, Clean Edge managing director. (3/14) LinkedInFacebookTwitterEmail this Story
  News from BIO 
  • Are you taking full advantage of your membership?
    BIO's cost-savings program, BIO Business Solutions, is helping 2,700 companies nationwide save on the cost of essential products and services. Members of BIO and 43 state and regional biotech associations are eligible to receive preferential pricing and other benefits at no additional cost beyond their membership dues. VWR International, FedEx, Office Depot and Business Wire are just a few of the industry leading providers that offer special pricing through this members-only program. Learn more or enroll here. LinkedInFacebookTwitterEmail this Story
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American journalist and essayist

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