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February 19, 2013
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News on diagnostic and therapeutic innovations and regulatory science

  Top Story 
Eliminate TMF Inadequacies in Your Clinical Trials
To comply with regulatory requirements pertinent to clinical trials, every organization engaged in a clinical trial must manage and maintain all trial-related content, documents, and data in a manner that not only supports the claims to the safety and efficacy of a product, but that also serves as evidence the trial was conducted in a compliant manner. Download the whitepaper.
  • Europe anticipates spike in applications for advanced therapies
    Despite past concern over whether new regulations were slowing the growth of advanced therapy medical products, the European Medicines Agency foresees a substantial increase in applications for such advanced treatments in the next five to 10 years, based on the robust R&D pipeline, the agency reports. The agency also said it would focus this year on increasing awareness of the certification procedure for advanced medical therapy products. Clinica (2/15) LinkedInFacebookTwitterEmail this Story
  Asia Pacific 
  • Researchers report progress with experimental dengue vaccine
    Researchers at the International Centre for Genetic Engineering and Biotechnology in New Delhi said they are making strides with a vaccine for the dengue virus, which is being developed with technology used to make hepatitis B vaccine. Preclinical tests showed the vaccine addressed all four dengue virus strains, researchers said. Human trials are estimated to be at least five years away. Deutsche Welle (Germany) (2/14) LinkedInFacebookTwitterEmail this Story
  • Japanese drugmakers eye collaboration with Indian drug companies
    Representatives of Japanese drug companies attending a trade meeting in New Delhi expressed their willingness to collaborate with Indian pharma companies in such areas as marketing, research and product development. "We are looking for long-term partnerships with Indian companies," said Hamano International President Shoichiro Hamano. The Economic Times (India) (2/13) LinkedInFacebookTwitterEmail this Story
  North America 
  • Prescription drug costs rise 3.6%
    Figures from the Bureau of Economic Analysis show that prescription drug costs increased 3.6% last year, rising faster than inflation and other health care costs. Prices of branded treatments are driving the increase and offsetting rising use of generic drugs. USA Today (2/13) LinkedInFacebookTwitterEmail this Story
  • FDA accelerates review of ViiV's HIV/AIDS drug dolutegravir
    ViiV Healthcare, a joint venture of GlaxoSmithKline, Pfizer and Shionogi, obtained priority-review status from the FDA for its investigational daily HIV/AIDS treatment dolutegravir. The drug is an integrase inhibitor that keeps HIV out of cells. The FDA is set to decide on the drug's approval by Aug. 17. Yahoo/Reuters (2/16) LinkedInFacebookTwitterEmail this Story
  • Australia reviews patent lengths in face of "patent cliff"
    The expiration of a large number of drug patents in the next five years -- the so-called "patent cliff" -- could strip an estimated $148 billion in revenue from the world's top drug companies. Australia, which lets drug patents expire after 20 years, is reviewing its laws to see if the time frame provides a reasonable balance between innovation and competition. In its comments to the Australian government, GlaxoSmithKline advocated enhanced patent protection, as well as manufacturing and clinical research incentives, to "encourage future investment in Australia and improve Australian patients' access to new health technologies." WA Today (Australia) (2/16) LinkedInFacebookTwitterEmail this Story
  DIA News 
  • United in diversity
    Europe is a diverse region with a variety of challenges to face in health care. The EMA Roundtable at the EuroMeeting 2013, titled, “Scientific Committees United in Diversity,” will highlight how the EU Scientific Committees come together and interact at the European Medicines Agency to foster scientific excellence in the evaluation and supervision of medicines for the benefit of public health, while being enriched by the EU’s many different cultures and traditions. The session, chaired by Hans-Georg Eichler, senior medical officer at the EMA, will be held on March 6 during the three-day conference in Amsterdam. Download the conference program. LinkedInFacebookTwitterEmail this Story

  • An opportunity to share research
    Regulators have thrown the spotlight on drug classes and therapeutic areas associated with cardiovascular toxicity. New regulations have been introduced in some major regulatory jurisdictions to assess and mitigate such adverse cardiac drug effects. This and other key topics in cardiac safety will be discussed at the 4th Cardiac Safety Workshop in Tokyo from July 11 to 12. Submit your abstract before Feb. 28.
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You will become as small as your controlling desire; as great as your dominant aspiration."
--James Allen,
British author

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