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

  Top Story 
  • British pharma asks for delay in pricing system
    A group of British drug wholesalers, concerned about supply chain issues, asked for a one-month grace period before the introduction of a new value-based pricing system. The new program will replace a 55-year-old system that allowed the industry to set its own prices -- under a cap -- and negotiate every five years. PharmaTimes (U.K.) (3/1) LinkedInFacebookTwitterEmail this Story
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  • Drug makers halt shipments to Greece
    More than 50 pharmaceutical manufacturers have withheld shipments to Greece, creating shortages of drugs including antibiotics, antipsychotics and drugs used to treat arthritis, cancer and high cholesterol. “Companies are ceasing these supplies because Greece is not profitable for them and they are worried that their products will be exported by traders to other richer countries,” said Yannis Tountas, president of the National Organisation for Medicines. Drugmakers point to the country's pricing system as the cause of at least some of the shortages. (2/28) LinkedInFacebookTwitterEmail this Story
  • Europe supports push to cure rare conditions
    The European Commission will spend about $187 million on 26 research projects on rare diseases, involving research teams from 29 countries. The goal is to discover effective treatments for metabolic, immune and cardiovascular disorders, among others. PharmaTimes (U.K.) (3/1) LinkedInFacebookTwitterEmail this Story
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  Asia Pacific 
  • China plans food and drug regulatory agency
    China is set to create a new, ministerial-level agency to regulate food and drugs, similar to the U.S. Food and Drug Administration, that will also be responsible for law enforcement, barring last-minute changes. The country is responding to recent food safety scandals including tainted baby formula that sickened 300,000 infants. Currently, as many as 13 different government agencies are responsible for food and drug supervision. South China Morning Post (Hong Kong) (free registration) (3/4) LinkedInFacebookTwitterEmail this Story
  North America 
  • FDA to scrutinize 30 compounders in 2 months
    The FDA plans to inspect around 30 drug compounders in the next two months amid heightened efforts following a deadly meningitis outbreak tied to compounded drugs. The pharmacies mainly produce sterile drugs for health care providers across the country, FDA spokeswoman Erica Jefferson said. Bloomberg Businessweek (3/1) LinkedInFacebookTwitterEmail this Story
  Latin America 
  • Brazil to allow foreign inspection of med-tech import licenses
    Brazil has expanded the role of its regulatory agency Anvisa to enable overseas inspections of med tech importers. The move is in response to criticism of the lengthy delays in license approvals experienced by as many as 5,000 domestic and 2,500 foreign firms. Clinica (3/4) LinkedInFacebookTwitterEmail this Story
  • UN agencies urge deal to keep drugs accessible to world's poor
    Two United Nations agencies are urging extension of an exemption for least-developed countries on patent protection to ensure that HIV/AIDS and other lifesaving drugs remain affordable for the poor. "If this transition period is not extended, then LDCs will be expected to comply with TRIPS obligations, and they simply do not have resources to do so," said Aziz ur Rehman of Doctors Without Borders. "In the area of pharmaceuticals, it will lead to massive patenting of drugs resulting in higher prices and erosion of generic competition." Development Newswire blog (3/1) LinkedInFacebookTwitterEmail this Story
  DIA News 

  • Dr. Koshia on what to expect from India’s 6th Regulatory Conference
    “DIA India’s 6th Regulatory Conference will focus on the challenge of keeping the Indian pharmaceutical industry competitive in the world market despite ever-evolving regulation,” said Program Co-Chair Dr. Hemant Koshia, food and drug commissioner of Gujarat. “Attendees will discuss current issues in the regulatory field, deliberate how to be prepared to face up to these complexities by learning from the past, and decide proactive measures that could be taken by the industry.” The event will be held in Ahmedabad, Gujarat from April 5 to 6. Read more. LinkedInFacebookTwitterEmail this Story
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The man who insists upon seeing with perfect clearness before he decides, never decides. Accept life, and you must accept regret."
--Henri Frédéric Amiel,
Swiss philosopher, poet and critic

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