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    WHO Officials Offer Opposition to Value-Based Drug Pricing

    World Health Organization (WHO) officials told press in a briefing on Thursday that the agency has serious reservations with value-based pharmaceutical pricing. "What’s the value of life? This structure is good for luxury goods because you have a choice…if I’m sick with cancer, what’s the choice? We think value-based pricing is not feasible for products that are indispensable," Dr. Marie-Paule Kieny, assistant director-general of health systems and innovation at WH...
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    WHO to Begin Cancer Biosimilar Prequalification Pilot This Fall

    The World Health Organization (WHO) on Thursday announced it will invite biosimilar makers to participate in a pilot program to prequalify biosimilars of two top selling biologics this September in an effort bring lower cost versions of the products to low- and middle-income countries. The two cancer treatments—Roche's Rituxan (rituximab) and Herceptin (trastuzumab)—make the top ten list for highest grossing drugs worldwide and cost in the tens of thousands of dollars pe...
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    EMA-FDA QbD Pilot Program Led to Further Harmonization

    The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further hamornization of concepts introduced through the International Council for Harmonisation (ICH). Background The joint pilot program, initially launched in March 2011 for three years, was extended for two more years in 2014 to facilitate further harmonization of per...
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    BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products

    Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations. Background Under what’s known as the pre-request for designation (pre-RFD) program, sponsors can ask FDA how their product will be classified (drug, device, biological product or combination product), and which of the agency's three review centers will be responsible for reviewing and reg...
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    CMS Drops Medicare Part B Drug Payment Pilot

    The Centers for Medicare and Medicaid Services (CMS) late Thursday decided to abandon a pilot plan that aimed to lower Medicare pharmaceutical spending. The Part B Drug Payment Model , first unveiled in March, would have tested whether alternative drug payment designs will lead to a reduction in Medicare expenditures. CMS said in a statement on Friday to Focus : "After considering comments, CMS will not finalize the Medicare Part B Drug Payment Model during this Adm...
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    WHO Prequalifies First Hepatitis C Diagnostic

    The World Health Organization (WHO) on Monday announced it has prequalified its first hepatitis C virus (HCV) rapid diagnostic test, which will help diagnose HCV in low- and middle-income countries and potentially improve access to treatment. The prequalification of South Korea-based Standard Diagnostics’ point-of-care diagnostic, called SD BIOLINE HCV, comes as an increasing number of people in low- and middle-income countries are now gaining access to hepatitis C cure...
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    WHO: New Emergencies Program Faces $200M Funding Gap

    As part of its overall financing dialogue, the World Health Organization (WHO) gave an update on its newly formed Health Emergencies Programme (WHE), which the agency says is currently facing a $200 million funding gap. "For this biennium, we face a double challenge. You have asked us to do more, especially through the health emergencies programme," said WHO Director Margaret Chan in her opening remarks at the 2016 WHO financing dialogue in Geneva on Monday. According t...
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    WHO Seeks API Manufacturers for Prequalification Program

    The World Health Organization (WHO) has released an invitation to active pharmaceutical ingredient (API) manufacturers as part of an effort to increase access to and the affordability of care and treatment of HIV/AIDS, hepatitis B and C, tuberculosis, malaria, neglected tropical diseases, influenza, diarrhea and support reproductive health. WHO invites manufacturers of selected APIs to submit Expressions of Interest (EOIs) for API evaluation and says the ultimate aim of...
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    WHO to Add $20m in Industry Fees to Keep Prequalification Program Sustainable

    The World Health Organization (WHO), industry groups and other partners on Friday announced a new financing arrangement that will add $20 million annually in new industry fees to ensure the financial sustainability and quality of WHO’s prequalification program. The new fees will also include the setting (and public disclosure) of quantitative performance targets. Indicators and performance targets will relate to review time for full assessment, review time for abbreviate...
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    Congress Signs Off on Short-Term Extension to Rare Pediatric PRV Program

    The House late Tuesday followed its Senate counterparts and sent to President Barack Obama a re-authorization of the rare pediatric disease priority review voucher (PRV) program that will last through the end of December. A spokeswoman for Sen. Bob Casey (D-PA), a sponsor of the bill, told Focus that between now and 30 December, Congress will discuss ways to amend the program and extend it again. “Our policy changes are in S. 1878, which is headed to the president, so...
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    FDA’s CBER to Forge Stronger Ties With WHO

    The US Food and Drug Administration (FDA) on Tuesday announced it’s forging a cooperative agreement with the World Health Organization (WHO) to support further regulatory systems strengthening, development of new norms and standards and research to advance global access to safe and effective biologics that meet international standards. FDA's Center for Biologics Evaluation and Research (CBER) anticipates providing up to $2 million in FY 2016 to support the project, as w...
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    WHO Releases Draft Medical Device Regulatory Framework

    The World Health Organization (WHO) is seeking input on its newly developed regulatory framework for medical devices and in vitro diagnostics (IVDs). The framework, which establishes a common global model for regulating devices and IVDs and provides countries with a two-phased path to implementation, was released for public comment in May. WHO began its work developing the framework in 2015 after the World Health Assembly (WHA) adopted Resolution WHA67.20 ,...