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January 24, 2013
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News on diagnostic and therapeutic innovations and regulatory science

  Top Story 
  • India's Supreme Court mulls challenge to generic-friendly patent law
    The Indian Supreme Court is weighing the importance of protecting pharmaceutical innovation and providing affordable access to drugs after the country's generic-friendly patent law was challenged by a drugmaker's appeal concerning a cancer treatment. "The whole case is about encouraging generics and the central role they have had in treating deadly diseases," said Patricia Kahn of Medecins Sans Frontieres. Representatives of the pharmaceutical industry disagree, saying patents protect innovation and invention. Scienceline (1/22) LinkedInFacebookTwitterEmail this Story
  • Spain hit with doubled VAT on medtech
    The Court of Justice of the European Union ruled that Spain must apply a 21% value added tax to nearly all medical devices, twice the current rate of 10%. The change will add about $1.33 billion a year to the cost of medtech supplies and reduce public access, said an industry group. Clinica (1/21) LinkedInFacebookTwitterEmail this Story
  • Cost cutting in Greece may cause contraction in medtech market
    Greece’s efforts to cut state spending are expected to affect the medtech market. Among measures cited in a report by the EU reviewing the country’s economic adjustment program were diagnosis-related groups, device reference pricing and a move to centralized tenders. Clinica (1/23) LinkedInFacebookTwitterEmail this Story
  • Other News
  Asia Pacific 
  • WHO designates Chinese institute as Collaborating Center
    The Institute for Biological Product Control of the National Institutes for Food and Drug Control in China has been designated a World Health Organization Collaborating Center for standardizing and evaluating biological products. The designation is the first in a developing country and the seventh in the world. The institute will help develop international standards and regulatory practices for vaccines and other biological products. (China) (1/18) LinkedInFacebookTwitterEmail this Story
  North America 
  • Canadian guidance covers use of foreign data in drug reviews
    Health Canada unveiled a draft guidance regarding the use of data from similar foreign regulatory agencies such as the European Medicines Agency and the FDA. "The Use of Foreign Reviews by Health Canada" covers abbreviated and supplemental new drug submissions, periodic safety update reports, medical device licenses, risk management plans, drug identification number applications and notifiable changes. The guidance aims to establish a framework for more consistent use of foreign reviews in Canada's approval of health products. Financial Post (Canada)/Legal Post blog (1/21) LinkedInFacebookTwitterEmail this Story
  • Institutes collaborate on translational research
    The Scripps Research Institute, Canada's Centre for Drug Research and Development, the Lead Discovery Center in Germany, Belgium's Centre for Drug Design and Discovery, and Cancer Research Technology and MRC Technology in the U.K. are partnering on a translational research effort dubbed The Global Alliance of Leading Drug and Discovery and Development Centres. The partners intend to harness their alliances with biopharmaceutical companies to improve best practices and develop standards and metrics to translate research into new therapies more quickly. Genetic Engineering & Biotechnology News (1/21) , GenomeWeb Daily News (free registration) (1/21) LinkedInFacebookTwitterEmail this Story
  • Treaty omits thimerosal vaccines from effort to curb mercury
    Vaccines containing the ethylmercury preservative thimerosal are exempted from the Minamata Convention's global treaty to limit mercury in the environment. The American Academy of Pediatrics and other groups support thimerosal vaccines, which enable children's access to multidose vaccines in areas without refrigeration. The Washington Times (1/19) LinkedInFacebookTwitterEmail this Story
  DIA News 
  • Wayne L. Pines on the latest in pharmaceutical marketing
    It’s not getting any easier to comply with all the regulatory and legal requirements that apply to marketing pharmaceuticals and medical devices. Wayne L. Pines, president, regulatory services and healthcare at APCO Worldwide, Inc., highlights key recent FDA enforcement actions to be discussed at the Marketing Pharmaceuticals Workshop next month: “The recent letters that OPDP issued regarding press materials are certain to be of great interest. In particular, the letter that dealt with a ‘pitch’ letter was very interesting and should engender questions.” Read more. LinkedInFacebookTwitterEmail this Story
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