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

  Top Story 
  • Report: Global spending on APIs reached $113B last year
    The global market for active pharmaceutical ingredients grew from $91 billion in 2008 to $113 billion in 2012, according to the Italian Chemical Pharmaceutical Association. The market grew at an average annual rate of 5.6% compared with a 7.2% average in the previous four years. The slower growth rate was attributed to several factors, including price controls, patent expirations, competition and rising research costs. (3/14) LinkedInFacebookTwitterEmail this Story
  • Device to preserve livers for transplant is used successfully in U.K.
    Two British patients became the first to receive donated livers preserved using an automated perfusion system. The device, being developed by Oxford University researchers, keeps the organ functioning outside the body for longer than 24 hours, maintaining it at body temperature and supplying it with oxygenated red blood cells. Reuters (3/15) LinkedInFacebookTwitterEmail this Story
  Asia Pacific 
  • Anti-infection agents chief cause of adverse drug reactions in China
    Anti-infection medications accounted for approximately 40% of the 1.2 million reported cases of adverse drug reactions in China for 2012, according to the country's State Food and Drug Administration. The agency's report found that 81.6% of ADR cases involved chemical-based medicine, while 17.1% resulted from traditional Chinese medical treatments. Senior SFDA official Yan Min noted that the proportion of adverse reactions due to anti-infection drugs has dropped because of better regulation. (China) (3/14) LinkedInFacebookTwitterEmail this Story
  • Chinese defendants in price-fixing case will appeal ruling, fines
    A Chinese drugmaker, found liable for price fixing by a U.S. federal court last week, has said it will appeal the ruling, which called for $162 million in fines. The North China Pharmaceutical Group and an affiliate were accused of colluding in raising prices for vitamin C exports to the U.S., but the defendants claimed the Chinese government forced them to work together on prices and output. "This verdict shows that companies in China are going to have to play by the same rules as everybody else," said William Isaacson, the attorney for U.S. vitamin C buyers. The Wall Street Journal (3/14) , (China) (3/17) LinkedInFacebookTwitterEmail this Story
  • Drug misuse a concern as new TB treatment faces delay in India
    Despite U.S. approval of bedaquiline drug Sirturo for treating multidrug-resistant tuberculosis, it faces potential delays in India, where the health minister says other research facilities are testing new TB treatments using bedaquiline. Experts are concerned that a culture of misuse that has rendered other drugs increasingly ineffective could do the same for bedaquiline in a country that, along with China, Russia and South Africa, represents 60% of MDR-TB cases in the world. "My biggest concern is you're introducing a brand new TB drug into one of the most unregulated chaotic drug markets you can see anywhere in the world," said Madhukar Pai, founder of the Pai Tuberculosis Research Group at Montreal's McGill University. Business Standard (India) (3/16) LinkedInFacebookTwitterEmail this Story
  North America 
  • FDA generic-drugs chief resigns
    Dr. Greg Geba announced he will resign as director of the FDA's Office of Generic Drugs, just as the FDA has started collecting generic-drug manufacturer user fees. A planned reorganization of the office played a role in his decision, Geba said in a memo. Dr. Janet Woodcock, director of the Center for Drug Evaluation & Research, will temporarily cover Geba's duties. blog (3/14) LinkedInFacebookTwitterEmail this Story
  • 4 FDA drug decisions on the horizon
    The FDA is poised to decide on Biogen Idec's multiple sclerosis drug BG-12 by March 28, while United Therapeutics is set to receive a verdict by March 31 for the lung drug Remodulin. Johnson & Johnson's diabetes drug Invokana and Map Pharmaceuticals' migraine drug Levadex are also set to receive federal decisions by March 31 and April 15, respectively. Investor's Business Daily (3/15) LinkedInFacebookTwitterEmail this Story
  • India, U.K. launch cooperative R&D initiative
    India and the United Kingdom have launched a cooperative R&D effort in several technology areas, including health care and energy, according to a joint announcement by India's Department of Science and Technology and Britain's Technology Strategy Board. The agreement calls for supporting innovation and R&D initiatives by British and Indian businesses and academics over a three-year period. Pharmaceutical Business Review Online (3/15) LinkedInFacebookTwitterEmail this Story
  DIA News 
  • Highlights from DIA's 25th Anniversary EuroMeeting
    Delegates at the EuroMeeting 2013, held in Amsterdam from March 4 to 6, were offered more than 100 sessions across 17 themes and addressed by 300+ speakers from the EMA, the European Commission, the FDA and other national regulatory agencies, academia, industry and patient organizations. The most popular sessions included "Implementation of the New Pharmacovigilance Legislation," the Regulatory Town Hall Meeting and the sell-out "European Landscape on HTA -- The EUnetHTA Joint Action." View a slideshow of pictures from the event. Don't miss next year's EuroMeeting, to be held in Vienna from March 25-27, 2014. LinkedInFacebookTwitterEmail this Story

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