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February 5, 2013
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News on diagnostic and therapeutic innovations and regulatory science

  Top Story 
  • EU antitrust regulators scrutinize J&J, Novartis units
    The European Commission has taken formal steps to advance an antitrust investigation involving subsidiaries of Johnson & Johnson and Novartis concerning the painkiller fentanyl. "If our preliminary conclusions are confirmed, the Dutch subsidiaries of Johnson & Johnson and Novartis entered into a so-called 'co-promotion' agreement to avoid competing against each other, depriving users of fentanyl in the Netherlands from access to a cheaper pain killer," an EC official said in a statement. Both companies said they acted properly, and they will have the opportunity to examine the EC's files, make comments and seek a hearing. (2/4) , The New York Times (tiered subscription model) (1/31) LinkedInFacebookTwitterEmail this Story
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  • U.K. looks at enforcing its own version of the Sunshine Act
    The U.K. could require medtech and other life sciences organizations to record all payments made to health care professionals in a public register. The measure is similar to the U.S. Sunshine Act, and it aims to crack down on inappropriate business practices. The Ethical Standards in Health and Life Sciences Group, which represents medtech and professional medical organizations, will study how the system would function if it comes to pass. Clinica (subscription required) (2/4) LinkedInFacebookTwitterEmail this Story
  • European Commission urged to develop IT systems for new regs
    The Medicines and Healthcare Regulatory Agency in the U.K. has urged the European Commission to begin creating the new information technology necessary to support new medical device regulations being proposed that would increase information and transparency requirements for registration, clinical trials, vigilance and Unique Device Identification. The regulations have not been adopted yet, but concerns have arisen about the commission's ability to develop IT systems in a timely fashion. Clinica (subscription required) (2/1) LinkedInFacebookTwitterEmail this Story
  Asia Pacific 
  • Exports to U.S. could increase India's pharma companies 20% in 2013
    India's pharmaceutical companies will grow more than 20% this year due in large part to exports to the U.S., according to an India Ratings report. "Of the export markets, Indian pharma will focus on the US market which presents significant opportunities for the next two years for generics, due to patent cliffs and recent changes in health care policies," the report said. IBN Live (India) (2/3) LinkedInFacebookTwitterEmail this Story
  • South Korea's top drugmaker under tax investigation
    South Korea's biggest drugmaker, Dong-A Pharmaceutical, is under investigation by the country's National Tax Service over allegations that the company created slush funds and evaded taxes. Dong-A officials said the probe was a normal investigation similar to one conducted in 2007, which resulted in the company paying $34.7 million in back taxes. Yonhap News Agency (South Korea) (2/1) LinkedInFacebookTwitterEmail this Story
  North America 
  • Agency releases final Sunshine Act rule
    The CMS on Friday released the final rule for the Physician Payments Sunshine Act, requiring drug and device companies to gather information on gifts, payments and other value transfers provided to doctors and teaching hospitals starting Aug. 1. The rule also requires manufacturers and group purchasing organizations to report ownership and investment interests by physicians. Modern Healthcare (subscription required) (2/1) LinkedInFacebookTwitterEmail this Story
  • Combo-drug-makers petition FDA on exclusivity period
    Ferring Pharmaceuticals and Gilead Sciences have petitioned the FDA to change how market exclusivity is granted for combination drugs. The agency grants five years' exclusivity if all active compounds in a combination drug are new and three years' exclusivity otherwise. The drugmakers say combination drugs are the same as new drugs and should be treated accordingly. Blog (1/31) LinkedInFacebookTwitterEmail this Story
  • Groups react to lobbying of states over biosimilars
    The Generic Pharmaceutical Association and the Pharmaceutical Care Management Association opposed efforts to lobby states for restrictions on biosimilars before the FDA has established a pathway for their approval. PhRMA has said that patient safety should be the top priority and that "given the limits of current scientific knowledge and for reasons of patient safety, we cannot envision a biosimilar product or class of products for which comparative clinical studies would be unnecessary for approval." PharmaTimes (U.K.) (2/4) LinkedInFacebookTwitterEmail this Story
  Latin America 
  • Puerto Rico could extend medical device tax
    The 4% medical device tax in Puerto Rico that was supposed to decrease until it hit 1% in 2016 is the focus of government officials who want to extend the tax at 4% through 2017. Medical devices represent 13% of manufacturing in Puerto Rico, a commonwealth of the U.S. (Boston) (2/1) LinkedInFacebookTwitterEmail this Story
  DIA News 
  • Staying strong in regulation
    Remaining competitive in the world market despite ever-evolving regulation is the hot topic at the 6th Regulatory Conference in India, to be held in Ahmedabad, Gujarat, from April 5 to 6. The two-day conference, titled, "India, the Upcoming Economy: Encouraging Enforcement of Regulations," will bring together the region’s best talent in the pharmaceutical world to understand what the challenges are and how to face them. Read more. LinkedInFacebookTwitterEmail this Story

  • GCP Hot Topics: A EuroMeeting tradition
    The Good Clinical Practice (GCP) Hot Topics session, which brings together regulators, industry and contract research organization (CRO) professionals, and academics who want to get first-hand information on the newest trends, has become a EuroMeeting tradition. This year’s session, to be held on March 5 during the three-day conference in Amsterdam, will highlight the impact of evolutions in technology on the conduct and quality management of clinical trials. Download the conference program. LinkedInFacebookTwitterEmail this Story
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