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  • Regulatory NewsRegulatory News

    WHO Adopts Weakened Resolution on Drug Price Transparency

    The World Health Organization (WHO) on Tuesday adopted a resolution to urge countries to publicly share the net prices of health products and the costs of clinical trials. The resolution, adopted after three weeks of negotiations, also calls on United Nations member countries to better facilitate the public reporting of patent status information and marketing approval status of health products, as well as to improve national capacities for open and collaborative researc...
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    BIO Targets Compulsory Licensing, Regulatory Reforms Across Various Countries

    Following the release of PhRMA’s Special 301 Report urging the Office of the US Trade Representative to better protect American pharma companies’ intellectual property in foreign countries, BIO has released its own report this week, with an eye toward compulsory licensing and regulatory data protection. Similar to PhRMA, BIO singles out Malaysia as a “Priority Foreign Country” following the issuance of a compulsory license in 2017 to make generic versions of Gilead’s he...
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    Challenges Providing Pharmaceutical Products to Syrian Refugees

    This article discusses the difficulties encountered by medical personnel working with refugees in Syria and delivering pharmaceutical products. It describes relevant regulatory policy and guidance for drug procurement and quality. Introduction Providing healthcare aid to civilians during war and crisis is a complicated task. The Syrian war has impacted the healthcare system inside Syria and the neighboring countries. Large and small humanitarian organizations have wor...
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    Doctors Without Borders Appeals Exclusive License Granted to Sanofi for Zika Vaccine

    Doctors Without Borders (MSF) on Friday appealed the US Department of Defense’s decision to grant an exclusive, royalty-bearing license to Sanofi Pasteur for patents to a Zika vaccine developed with US government funds. "MSF objects to the granting of an exclusive patent license on a U.S. government-funded invention to a single pharmaceutical company as well as to the lack of conditions to ensure the vaccine will be appropriately developed and made available and ...
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    Doctors Without Borders Objects to Sanofi Receiving an Exclusive License for a Zika Vaccine

    Doctors Without Borders (MSF) on Monday objected to the US government’s granting of an exclusive patent license to Sanofi Pasteur for a developing Zika vaccine, though Sanofi fired back on Tuesday explaining the risks of developing such a vaccine. According to a Federal Register notice from 9 December, the Department of the Army of the US Department of Defense intends to grant an exclusive, royalty-bearing, revocable license on a patent entitled, ‘‘Zika Virus Vaccine an...
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    Doctors Without Borders: Asian Trade Deal Could Restrict Access to Affordable Generics

    The Regional Comprehensive Economic Partnership (RCEP) trade agreement is kicking off another round of negotiations on Sunday in Australia and Doctors Without Borders (MSF) is raising concerns about the tougher intellectual property rights that could restrict access to affordable generic drugs for many in Indonesia, Thailand, Myanmar, Cambodia and Laos. The Regional Comprehensive Economic Partnership (RCEP) is a proposed free trade agreement (FTA) between the ten member...
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    MSF: Access to New TB Medicines Falters Despite Conditional Approvals

    Doctors without Borders (MSF) released a new report on Monday offering details on how the first new drugs in nearly half a century were conditionally approved to treat tuberculosis (TB),  though only 2% of the roughly 150,000 who could benefit from these treatments have access to them. The report comes as the World Health Organization (WHO) reports that only half of notified multi-drug-resistant tuberculosis (MDR-TB) patients were successfully treated and cured in 2014 ...
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    WHO Calls for New Antivenom Treatments as Supplies Dwindle

    The World Health Organization (WHO) on Friday announced it's actively searching for new snake bite treatments as supplies of the most effective anti-venom treatment are due to run out in 2016. Companies can now apply, with no submission fees, to have new treatments assessed by WHO beginning in March. About five million people are bitten by snakes every year, causing upward of 125,000 deaths and leaving 400,000 people permanently disabled or disfigured, according to the W...
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    Health Advocacy Groups Call for Changes to Priority Review Voucher Program

    A group of health advocacy organizations are calling on the Senate Committee on Health, Education, Labor and Pensions (HELP) to tighten requirements for obtaining priority review vouchers for drugs for tropical diseases. In a letter addressed to HELP Committee Chairman Lamar Alexander (R-TN) on Tuesday, seven organizations including Médecins Sans Frontières (MSF), Drugs for Neglected Diseases Initiative (DNDi), Center for Global Health Policy, TB Alliance, Treatment Acti...
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    TPP, WTO Deals Reveal Strength of Pharma Industry’s Negotiating Power

    After five years of negotiations, the release of the final text of the long-awaited trade deal, known as the Trans-Pacific Partnership (TPP), on Thursday, as well as concessions made to the US in the WTO’s TRIPS (trade-related aspects of intellectual property rights) deal announced Friday both offer new insight into the strength of the pharmaceutical industry’s lobbying and negotiating powers. TPP Early last month, a number of questions emerged over a sticking point ...
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    Final TPP Agreement Draws Ire from Both Sides over Biologics Exclusivity

    Pharmaceutical industry groups and nonprofits expressed disappointment Monday over a compromise in the Trans-Pacific Partnership (TPP) on biologics data exclusivity. The deal, which has previously stumbled over the issue of biologics data exclusivity, would either provide eight years of exclusivity to biologic drugs, or provide five years of exclusivity, plus up to three more years under a regulatory framework for the 12 countries in the trade bloc, which includes the ...
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    Public Health Groups Propose Global Drug Innovation Fund

    Two health advocacy groups, Médecins Sans Frontières (MSF) and the Drugs for Neglected Diseases initiative (DNDi) are urging public health authorities to create a global fund to tackle what they call "deadly gaps in innovation." Citing the rising threat of antimicrobial resistance (AMR), emerging infectious diseases and neglected tropical diseases (NTDs), the two organizations say the pharmaceutical industry is failing to address certain public health challenges. Back...