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January 22, 2013
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News on diagnostic and therapeutic innovations and regulatory science

  Top Story 
  • NICE report calls for public release of clinical trial data
    Drugmakers should open their information to the public, including trial data from drugs that have been reviewed and made available for clinical use, said a report issued by the Health Committee at the U.K.’s National Institute for Health and Clinical Excellence. “The committee believes there should be both a professional and legal obligation to ensure that all regulators, including NICE, have access to all the available research data about the efficacy and safety of pharmaceutical products,” the report said. (1/18) LinkedInFacebookTwitterEmail this Story
7 keys: Put real-world evidence into action
Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
  • Europe issues draft guidance on cross-contamination thresholds
    Cross-contamination thresholds should be identified when more than one drug is made in the same production facility, the European Medicines Agency said in a draft guidance. Companies should know the threshold of toxicological concern or the permitted daily exposure by evaluating the available data from patient trials and laboratory tests. Treatments such as cytotoxic and highly active drugs, hormones and antibiotics must be produced separately. (1/16) LinkedInFacebookTwitterEmail this Story
  • Russia urges rapid compliance with new medtech registration rules
    Russia’s regulatory authority Roszdravnadzor is urging medical device and in vitro diagnostic suppliers to comply quickly with new product registration provisions enacted at the end of 2012. Companies with outstanding applications already submitted must observe the new rules, and existing registration certificates with an unlimited validity period will expire at the end of 2013 and must be re-registered. Clinica (1/17) LinkedInFacebookTwitterEmail this Story
  Asia Pacific 
  • China issues new incentives for reporting food and drug issues
    China’s State Food and Drug Administration announced rewards of up to $48,000 per case for whistle-blowers who bring food and drug issues to the agency's attention. The rewards are intended to "encourage the public to report illegal activities so as to determine, control and eliminate potential safety risks concerning food and medicine," according to the SFDA. (China) (1/15) LinkedInFacebookTwitterEmail this Story
  • Drug regulator in India orders clinical trials of generics
    The Drug Controller General of India, which regulates the country's pharmaceuticals, has asked drugmakers to conduct clinical trials of all generic drugs and seek approval within 18 months. The move is in response to abuse of legal loopholes that enabled some companies to bypass DGCI and sell drugs with dangerous side effects, many of which are banned abroad. BioSpectrum Asia (1/21) LinkedInFacebookTwitterEmail this Story
  • Australia wants to conduct its own assessments of higher-risk devices
    Australia wants to add implantable devices and surgically invasive devices intended for long-term use to the list of products requiring a mandatory application audit by the country’s Therapeutic Goods Administration. The TGA also wants to allow Australian manufacturers of low-risk medical devices to use a European conformity assessment instead of requiring TGA scrutiny. Clinica (1/17) LinkedInFacebookTwitterEmail this Story
  North America 
  • Vaccine makers are updating flu-fighting tactics
    In response to early and widespread flu cases in the U.S., vaccine makers are making significant treatment updates for next year’s flu season. Three major drug companies are preparing vaccines that will address four different strains of the virus, and Protein Sciences gained FDA approval last week for a faster vaccine production process. Bloomberg (1/17) LinkedInFacebookTwitterEmail this Story
  • Report: Drugmakers need new ways to fill clinical trials
    While about 89% of clinical trials meet their enrollment goals, 48% of trial sites miss enrollment and timeline goals, according to the Tufts Center for the Study of Drug Development. About 90% of drugmakers and research organizations use conventional methods such as physician referrals and mass media advertising to enroll participants, and only about 14% use social media, online data mining and electronic health records to recruit participants. "The emergence of open innovation models, where scientists worldwide openly share knowledge, and novel partnerships and alliances hold significant promise to transform the nature, pace, and cost of new drug development," said Kenneth Kaitin, the center's research director. blog (1/15) , PharmaTimes (U.K.) (1/17) LinkedInFacebookTwitterEmail this Story
  • Drugmakers focus on rare diseases, genetic targets
    More than 5,400 drug candidates are being tested in patients, including many for rare diseases and disorders for which no new drugs have been introduced in 10 or more years, according to a report sponsored by Pharmaceutical Research and Manufacturers of America. Hundreds of drugs being studied target genetic variations or are based on genes or cloned antibodies. Yahoo/The Associated Press (1/16) LinkedInFacebookTwitterEmail this Story
  • Researchers inch toward a vaccine for Alzheimer's disease
    Researchers at Université Laval and GlaxoSmithKline are reporting success in using monophosphoryl lipid A to stimulate the nervous system's immune response to Alzheimer's disease in mice. Weekly injections of MPL over 12 weeks eliminated up to 80% of brain plaques and improved the mice's cognitive function, researchers say. GSK has used the molecule as a vaccine adjuvant for years. Salon (1/16) LinkedInFacebookTwitterEmail this Story
  DIA News 
  • Monitoring medicines’ safety the hot topic at EuroMeeting
    Amsterdam will play host to more than 3,000 professionals involved in the development of medicines from more than 50 countries at the DIA’s 25th Annual EuroMeeting from March 4 to 6. Find out more about the 110 sessions focusing on new legislation for monitoring medicines’ safety and better public health protection. LinkedInFacebookTwitterEmail this Story
  • Worldwide collaboration at China Annual Meeting
    "The China Annual Meeting is an innovative event that helps to enhance communication and collaboration between China and the world," said Dr. Ling Su, DIA Board President. "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 debate by senior professionals." Read more. LinkedInFacebookTwitterEmail this Story
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Give me six hours to chop down a tree and I will spend the first four sharpening the axe."
--Abraham Lincoln,
16th U.S. president

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