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February 12, 2013
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News on diagnostic and therapeutic innovations and regulatory science

  Top Story 
  • Cipla to delay purchase of Medpro
    Indian drugmaker Cipla announced it will delay its acquisition of South Africa-based drugmaker Cipla Medpro after valuation issues emerged. India's second-largest drug company had planned on acquiring Medpro for $220 million, which would have allowed the company to enter the $3 billion African drug market. The Economic Times (India) (2/11) LinkedInFacebookTwitterEmail this Story
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  • Complete drug study data should be uploaded on EU's public database
    Drugmakers and researchers should publish comprehensive findings from clinical studies on the public European Union database, writes the Labour Party's Glenis Willmott, a member of the European Parliament. Summaries may be influenced by bias and could inflate drugs' value, Willmott writes. Financial penalties should be used to enforce transparency, Willmott writes. Public Service Europe (2/6) LinkedInFacebookTwitterEmail this Story
  Asia Pacific 
  • Japan loosens stability testing requirements for devices
    Japan will no longer require medtech companies to include stability testing data in order to get approval for devices after a Regulatory Task Force agreed the requirements could be eliminated in most cases. The task force is comprised of the country's Ministry of Health, Labour and Welfare, as well as medical device industry representatives. The move is meant to alleviate the delay in medical device approval in Japan, but certain devices still require the data, including those that contain certain raw materials, biological products and radioactive material. Clinica (subscription required) (2/11) LinkedInFacebookTwitterEmail this Story
  • India implements compensation rules for injury, death in studies
    India's government is making compensation mandatory when clinical trial volunteers are injured or die. Failure to comply could result in a ban or suspension of trials for drug companies and clinical research organizations. Compensation will be decided by an independent committee appointed by the drug controller general of India on a case-to-case basis, according to a government official. The Economic Times (India) (2/7) LinkedInFacebookTwitterEmail this Story
  North America 
  • Guidance for new Alzheimer's treatments unveiled by FDA
    The FDA released a nine-page draft guidance document that recommends ways to develop medicines aimed at treating Alzheimer's disease before the onset of brain damage and memory loss. "This draft guidance is intended to serve as a focus for continued discussions between the FDA and pharmaceutical sponsors, the academic community, advocacy groups, and the public," the FDA Center for Drug Evaluation and Research's Dr. Russell Katz said. The Pharmaceutical Research and Manufacturers of America has identified a lack of noninvasive, validated biomarkers and the nature of the illness itself as reasons behind statistics that show only three drugs have been approved since 1998, while 101 candidates have failed. Modern Healthcare (subscription required) (2/7) , The Hill/RegWatch blog (2/7) , Reuters (2/7) LinkedInFacebookTwitterEmail this Story
  • FDA finds more bogus Avastin in U.S. supply chain
    Counterfeit versions of bevacizumab, which is sold in the U.S. as Genentech's Avastin, have entered the U.S. drug supply chain, according to a warning from the FDA. The bogus drug is labeled as Roche Holding's Altuzan. That drug is not approved for sale in the U.S. Testing found one or more batches of the suspect drug lacked the active ingredient, and the fake products are linked to Medical Device King, Pharmalogical and Taranis Medical. HealthDay News (2/6) , Yahoo/The Associated Press (2/6) LinkedInFacebookTwitterEmail this Story
  • J&J leads ranking of most productive pharmaceutical firms
    Johnson & Johnson topped IDEA Pharma's third annual Productive Innovation Index, which seeks to rank drugmakers by their ability to launch innovative products. J&J's rank can be attributed to the commercialization of prostate cancer treatment Zytiga, or abiraterone, IDEA CEO Mike Rea said. Amgen, last year's No. 1, was second, followed by Roche. Rounding out the top 10 were Merck & Co., Sanofi, Eli Lilly & Co., Novartis, GlaxoSmithKline, Bristol-Myers Squibb and Abbott. PharmaTimes (U.K.) (2/6) , (2/4) LinkedInFacebookTwitterEmail this Story
  DIA News 
  • EMA head Guido Rasi to speak at EuroMeeting
    Guido Rasi, head of the European Medicines Agency (EMA), is just one of the A-list participants set to speak at the EuroMeeting 2013 in Amsterdam, March 4 to 6. Professor Rasi joins more than 300 speakers, moderators and panelists who substantiate the meeting’s claim to being the most important event in the medicines development calendar. Find out about all the high-profile attendees – read the press release and download the Conference Programme. LinkedInFacebookTwitterEmail this Story

  • Drug safety – a global challenge
    The latest global challenges in drug safety will be addressed at the 4th Pharmacovigilance Conference in India from March 8 to 9. Professionals attending this two-day event, to be held in Bangalore, will learn about current global safety reporting requirements for prescription and over-the-counter drugs and discuss new, pragmatic approaches to pharmacovigilance. Read the program highlights. LinkedInFacebookTwitterEmail this Story
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The only man I know who behaves sensibly is my tailor; he takes my measurements anew each time he sees me. ... The rest go on with their old measurements and expect me to fit them."
--George Bernard Shaw,
Irish playwright

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