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February 7, 2013
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News on diagnostic and therapeutic innovations and regulatory science

  Top Story 
  • GlaxoSmithKline announces release of all clinical trial data
    GlaxoSmithKline announced its intentions to publish all clinical study reports, making it the first drugmaker to do so in an effort to increase data transparency and increase medical breakthroughs. The company said it will release clinical trial data for drugs after they've been approved or discontinued, and eventually it will publish data all the way back to GSK's formation in 2000. The Guardian (London) (2/5) LinkedInFacebookTwitterEmail this Story
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  • U.K. legislator wants stricter transparency requirements
    The lead legislator for the European Parliament's Environment, Public Health and Food Safety Committee said she wants proposed clinical trial legislation to be more stringent and require that drugmakers submit full clinical trials for approval, instead of only summaries. However, her suggestion has met resistance from the pharmaceutical industry, which voiced its concern about the protection of trade secrets under this plan. (2/4) LinkedInFacebookTwitterEmail this Story
  • Assobiomedica: Italy to cut medtech spending by 33% through 2014
    Italy's austerity measures could reduce medical technology spending in the country by about €4.2 billion, or 33%, between 2013 and 2014, according to Assobiomedica. The industry association's figure is significantly more than the government's €3 billion estimate and is based on a study by its Centro Studi (CSA) research group. Clinica (2/4) LinkedInFacebookTwitterEmail this Story
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  Asia Pacific 
  • China expects significant growth in medical device market
    Increasing demand for upgraded medical devices in China will help expand the market, which is expected to surpass Japan as the second largest medtech market in the world within the next seven years and account for a quarter of the world market by 2050, according to consulting firm PharmaLive. Currently, 60% of medical devices in China's health institutions were installed prior to the mid-1980s. (China) (2/5) LinkedInFacebookTwitterEmail this Story
  • Groups join with AIDAN to fight for cost-based pricing in India
    Several organizations are planning on filing affidavits in India's Supreme Court, joining with the All India Drugs Action Network to fight the country's new Pharmaceutical Pricing Policy. The groups are pushing for cost-based pricing in the industry, and their case is expected to be heard by the Supreme Court some time this month. (India) (2/4) LinkedInFacebookTwitterEmail this Story
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  North America 
  • FDA's approval of generic version of Doxil could ease shortage
    The FDA approved the first generic version of the Johnson & Johnson drug Doxil on Monday, which is used to treat multiple myeloma, ovarian cancer and AIDS-related Kaposi's sarcoma. The generic version, which is made by Sun Pharma Global FZE, could help solve a Doxil shortage brought about by quality control problems in the manufacturing process. (2/4) LinkedInFacebookTwitterEmail this Story
  • U.S. Senate will consider "pay for delay" pharma bill
    A bipartisan group of senators reintroduced a bill this week that would bar "pay for delay" pharmaceutical deals in which brand-name drugmakers pay generic drug companies to keep the cheaper drugs from becoming available. "I have long supported efforts to crack down on this behavior and the recent rise in pay-for-delay agreements underscores the need for legislation to help make sure people have access to the drugs they need at a price they can afford," said Sen. Amy Klobuchar, D-Minn. Reuters (2/5) LinkedInFacebookTwitterEmail this Story
  • Researchers call for CONSORT revision due to inconsistent Pfizer data
    Researchers are seeking changes to journal publishing standards after they found that clinical trials reported by Pfizer for the seizure drug gabapentin didn't match up with internal reports of the drug studies. Professor Kay Dickersin of Johns Hopkins' Center for Clinical Trials said her team's findings indicate a need to revise the CONSORT statement, which provides a list of information that must be included when publishing trials. (2/5) LinkedInFacebookTwitterEmail this Story
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  • Developing nations unite to fight drug-resistant TB
    The governments of Brazil, Russia, India, China and South Africa will cooperate to address drug-resistant tuberculosis as well as malaria, mental health conditions and tobacco use. The so-called BRICS nations will share technology and expertise, such as that gained from South Africa's use of a device to identify a type of drug-resistant TB in less than two hours. The Wall Street Journal (2/3) LinkedInFacebookTwitterEmail this Story
  • New Zealand researchers make significant diabetes discovery
    A new mechanism for how glucose stimulates insulin secretion has been uncovered by researchers at New Zealand's University of Auckland. The discovery could explain how a gene called TCF7L2 makes people more susceptible to diabetes and could open the door for the development of new diabetes drugs, as well as new methods of prevention. (China) (2/4) LinkedInFacebookTwitterEmail this Story
  DIA News 
  • Using MRCTs in new drug development
    Multiregional clinical trials (MRCTs) in East Asia, including Japan, China, Korea and Taiwan, are now considered one of the promising key strategic options in new drug development. The 7th Annual Conference for Asian New Drug Development, to be held in Tokyo, Japan, from April 15 to 16, will provide a forum for exchange of opinions among regulatory agencies in East Asia about how increasing MRCT data should be used in new drug applications in the region. Read more. LinkedInFacebookTwitterEmail this Story

  • Dr. Lingshi Tan on the global value of China Annual Meeting
    “The China Annual Meeting helps to enhance communication and collaboration between China and the world,” said China Annual Meeting Program Co-chair Dr Lingshi Tan, vice president, Pfizer worldwide development operations. “This year’s sessions will highlight the latest developments within the pharmaceutical industry in China, explore ideas that will impact global health, and feature open debates among senior professionals, top academics and high-level officials from various fields in medicine development.” Find out more about the event to be held in Beijing from May 12 to 15.
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--Maya Angelou,
American author and poet

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