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March 21, 2013
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News on diagnostic and therapeutic innovations and regulatory science

  Top Story 
  Europe 
  • Austerity measures could further shrink French drug market
    Drug sales in France, Europe's second largest market, are expected to decline more than 3% this year as the government continues to reduce health care spending through price cuts and greater use of generics, according to the pharmaceutical intelligence firm IMS Health. By contrast, other mature markets like the United States, Germany and Japan should register slight increases, and growth rates in Brazil and China may exceed 10%. This is the second consecutive year of declines in France. Chicago Tribune (tiered subscription model) (3/19) LinkedInFacebookTwitterEmail this Story
  • Welsh government opens $159M fund for life sciences firms
    The Welsh government has announced the launch of the Wales Life Sciences Investment Fund, which aims to promote job and business growth as well as boost the global profile of the biotech sector in that country. The fund, worth $159 million, is expected to help launch more Welsh medical device and diagnostic companies in the U.K. and international markets. Clinica (subscription required) (3/19) LinkedInFacebookTwitterEmail this Story
  Asia Pacific 
  • India to inspect drug firms for EU, WHO compliance
    India's Drug Controller General plans to begin inspections of drug companies exporting to Europe to ensure that they are meeting requirements set by the World Health Organization for the manufacture of active pharmaceutical ingredients. Once a firm is found compliant with WHO regulations, it will receive a three-year certificate of good manufacturing practices. India exports more than $13 billion in pharmaceutical products annually, of which APIs account for about 40%. The Economic Times (India) (3/20) LinkedInFacebookTwitterEmail this Story
  North America 
 
  • Justices hear arguments about generic-drug liability
    The Supreme Court heard arguments on Tuesday about whether generic-drug makers can be held liable under state law for alleged flaws in the designs of drugs. Justice Antonin Scalia said that if state law takes precedence, it could take complex decisions out of the hands of the FDA and instead juries would have to consider "what the cost-benefit analysis is for a very novel drug that unquestionably has some deleterious effects, but also can save some lives." A decision is anticipated by the end of June. Reuters (3/19) , The Wall Street Journal (3/19) , The New York Times (tiered subscription model) (3/19) LinkedInFacebookTwitterEmail this Story
  • Interim leader named for FDA's generic drug office
    The FDA has appointed Dr. Kathleen Uhl as acting director of the Office of Generic Drugs. "Dr. Uhl brings a wealth of regulatory and medical policy, scientific, and management experience to the position," Center for Drug Evaluation and Research Director Dr. Janet Woodcock wrote in a memo. Uhl previously was senior adviser to Dr. Greg Geba, who stepped down last week. Drug Store News (3/19) , Reuters (3/19) LinkedInFacebookTwitterEmail this Story
  Latin America 
  • Brazil considers new role for pharma, med tech to avoid disruptions
    Brazil's regulatory agency Anvisa has proposed that med tech and pharmaceutical firms be required to take active steps to warn the health care industry and identify alternative sources before halting any drug production that could disrupt critically needed medications. At present, companies are required to give six months' notice before stopping manufacture or withdrawing a product from market. Anvisa has three months to turn the proposal into a draft regulation for formal public comment. Clinica (subscription required) (3/19) LinkedInFacebookTwitterEmail this Story
  Global 
  • Proposed budget hike would increase FDA oversight in China
    A Senate bill that aims to raise the FDA's fiscal 2013 budget to $2.5 billion has gained support from the Alliance for a Stronger FDA, which calls it "strongly favorable" to the agency. The measure, which includes the new user fees for medical devices, drugs and biologics, provides $10 million to allow the FDA to beef up its inspections in China, the agency said. In-PharmaTechnologist.com (3/18) LinkedInFacebookTwitterEmail this Story
  • India alleges big pharma behind charges of counterfeit drugs in Africa
    Western pharmaceutical companies, concerned about competition from lower-cost generics, are behind charges that Indian firms are selling increasing amounts of counterfeit drugs in Africa, said Indian Commerce and Industry Minister Anand Sharma. Nevertheless, officials in Nigeria and Ghana, among other countries, have expressed deep concern that Indian and Chinese firms have flooded their markets with "fake medicines." Daily News (New York) (3/19) LinkedInFacebookTwitterEmail this Story
  DIA News 
  • DCGI to take part in DIA India's 6th Regulatory Conference
      
    The Drug Controller General of India (DCGI) Dr. G. N. Singh will be participating in the 6th Regulatory Conference, to be held in Ahmedabad, Gujarat, from April 5 to 6. Other high-profile attendees include keynote speaker Rajiv Gulati, president of the global pharmaceuticals business at Ranbaxy Laboratories; K. Anand, president of global quality and regulatory affairs at Zydus Cadila; and Rajiv Desai, president of quality at Dishman Pharmaceuticals and Chemicals Ltd. Read more about the insightful sessions. LinkedInFacebookTwitterEmail this Story

  • Share knowledge with global professionals
     
    Professionals and students have the chance to share research at the 5th DIA China Annual Meeting by submitting a poster. The Professional and Student Poster Show is a great opportunity to share knowledge, experience and applications of technology and methodology with professionals from around the world. The meeting will be held at the Beijing International Convention Center from May 12 to 15. Submit your poster before Monday, April 15.
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Quality is not an act, it is a habit."
--Aristotle,
Greek philosopher


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