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January 31, 2013
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News on diagnostic and therapeutic innovations and regulatory science

  Top Story 
  • Glaxo refuses settlement in U.K. Avandia diabetes cases
    Despite settling U.S. lawsuits over claims that the diabetes drug Avandia causes heart attacks and strokes, GlaxoSmithKline has decided to fight similar claims in the U.K. It has become “increasingly difficult in the U.K. to challenge large corporations such as pharmaceutical companies," said Liz Thomas, policy manager at the patient-safety charity Action against Medical Accidents. blog (1/30) LinkedInFacebookTwitterEmail this Story
  • EMA to consider blood clot risks of newer contraceptives
    The European Medicines Agency will review third- and fourth-generation combined oral contraceptives' safety to decide if restricting their use is necessary. The move was requested by France, which wants to limit the newer contraceptives' use due to blood clots. "There is no reason for any woman to stop taking her contraceptive," the EMA said. "If a woman has concerns, she can discuss this with her doctor." Reuters (1/28) , PharmaTimes (U.K.) (1/29) LinkedInFacebookTwitterEmail this Story
  • U.K. drugmakers and physicians call for transparency in financial ties
    A coalition of British physicians and pharmaceutical companies have created a template for disclosing payments and other financial ties between drugmakers and doctors as the U.K. works toward greater transparency. Similar efforts are under way in the U.S. and France. The effort is to find "whether there is, in principle, support for a publicly available, single, searchable system for disclosure of payments," said Richard Thompson, president of the Royal College of Physicians. (1/29) LinkedInFacebookTwitterEmail this Story
  • Drug industry group disputes lowering cost-effectiveness thresholds
    Lowering the current threshold of quality-adjusted life years, or QALYs, for assessing the cost effectiveness of new drugs and medicines would deny such medications to thousands and lead to a decline in U.K. health standards, according to the Association of the British Pharmaceutical Industry. The group was responding to a study by University of York health economists who said the current standard "is not based on evidence" and should be reduced. PharmaTimes (U.K.) (1/30) LinkedInFacebookTwitterEmail this Story
  Asia Pacific 
  • Malaysia issues final regulations for medical devices
    The Malaysian government has published comprehensive regulations for medical devices, covering such areas as registration, licensing, export permits and procedures for appealing decisions. The effective date is July 1, with a two-year transition period for devices already on the market. Clinica (1/29) LinkedInFacebookTwitterEmail this Story
  North America 
  • Few migraine medications for adults are effective in children
    Data from 21 trials of migraine drugs for adults showed that only topiramate and trazodone significantly reduced the frequency of headaches among children and teens who experience regular migraines. Placebos alone yielded good outcomes in children, effectively reducing headaches per month from between five to six to just three, researchers reported in the journal JAMA Pediatrics. Reuters (1/28) LinkedInFacebookTwitterEmail this Story
  • Statins linked with lower mortality risk in study of liver cancer
    Patients with hepatocellular carcinoma who took statins, in combination with local and systemic treatments or surgical resection, had a 30% lower risk of death than non-statin users. Statin users lived for an average of 25.4 months compared with 18.5 for non-users, researchers said. The retrospective, nonrandomized study, which involved 644 patients, was presented at the Gastrointestinal Cancers Symposium. MedPage Today (free registration) (1/27) LinkedInFacebookTwitterEmail this Story
  • Indian drugmakers filed most DMFs in 2012
    Drugmakers from India submitted more drug master files with the FDA than companies from any other nation. The files are required for the third-party sale of drug ingredients in the U.S. Indian drugmakers filed 70 DMFs out of a total 143 in one quarter. Sun Pharmaceutical Industries, Lupin Pharmaceuticals and Dr. Reddy's Laboratories were among the top filers for the year. Business Standard (India) (1/30) LinkedInFacebookTwitterEmail this Story
  DIA News 
  • Worldwide collaboration at China Annual Meeting
    Patient safety and managing risk will be the top themes for discussion as pharmaceutical and health care professionals from around the world meet for the 5th DIA China Annual Meeting 2013. The conference, to be held at the Beijing International Convention Center from May 12-15, brings together professionals within a neutral global platform to share knowledge. Find out more. LinkedInFacebookTwitterEmail this Story
  • 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.

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