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    EMA Prioritizes Three New Treatments as Part of its PRIME Scheme

    The European Medicines Agency (EMA) on Wednesday announced that it recently granted eligibility to three new treatments as part of its PRIME scheme, which focuses on medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. The newly added medicines, which are considered priority medicines by EMA, include Cymabay Therapeutics’ MBX-8025 , which is intended to treat Primary Biliary Cholangitis, a ch...
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    EMA Report Emphasizes Need for Coordinating International Regulatory Initiatives

    The European Medicines Agency (EMA) on Thursday released what it says is the first comprehensive overview of international regulatory initiatives, calling attention to the need for greater coordination across international regulatory efforts. EMA says the report was developed on behalf of the International Coalition of Medicines Regulatory Authorities (ICMRA) to "provide a general overview of multi-project initiatives in which multiple regulators were involved." Backgro...
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    UK’s MHRA and Swissmedic Pledge Closer Collaboration

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday announced it will forge closer ties with its Swiss counterpart, Swissmedic, via a Memorandum of Understanding (MoU) signed as part of the 11th Summit of the Heads of Medicines Regulatory Agencies in Interlaken, Switzerland. After months of discussion, both regulators agreed to a shared approach to complex challenges as well as the promotion of each other’s regulatory frameworks, requirements a...
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    EMA Board Signs Off on New Medicines Web Portal

    The European Medicines Agency’s (EMA) management board on Monday announced that it’s given the go-ahead for a new European medicines web portal, which will look to provide wider access to free, reliable and unbiased information on all medicines authorized in the EU. The portal, which will replace EMA’s online interface EudraPharm , will offer updates on everything from clinical trial information to adverse drug events. Background 2010 pharmacovigilance legislation, ...
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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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    Long-Awaited UN Report Calls for Breaking Link Between Drug R&D Costs and Prices

    The United Nations (UN) High-Level Panel on Access to Medicines released its long-awaited report on Wednesday, with recommendations sure to rile up the pharmaceutical industry as it calls for World Trade Organization (WTO) members to no longer link the cost of research and development (R&D) with drug prices, as well as for an increase in the issuance of compulsory licenses and to require the disclosure of pharmaceutical R&D costs. The call for more compulsory license...
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    Data Integrity: New Draft Guidance and Q&A

    The European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on Thursday released new draft guidance and a question and answer document to help ensure that data integrity is maintained during the process of testing, manufacturing, packaging, distributing and monitoring medicines. The 44-page PIC/S draft guidance, known as “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments,” is focused on providing ind...
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    EMA Adds Four New Drugs to PRIME Scheme

    The European Medicines Agency (EMA) has granted four new drugs eligibility to its PRIority MEdicines (PRIME) scheme, bringing the total number of drugs accepted to the program to eight. Like the US Food and Drug Administration's (FDA) breakthrough therapy program, PRIME aims to streamline the development of promising new therapies through earlier scientific advice and increased engagement between EMA and sponsors in order to facilitate an accelerated product assessme...
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    Federal Circuit: Use of a CMO Prior to Filing Drug Patents Does Not Invalidate the Patents

    Pharmaceutical and biotech companies will likely be relieved to hear that the use of a contract manufacturing organization (CMO) cannot cause a drug’s patents to be invalidated under what’s known as the “on sale” bar, according to an opinion released Monday from the US Court of Appeals for the Federal Circuit. The opinion hinges on an important concept linked to the patenting of pharmaceuticals, the use of CMOs and the manufacturing processes necessary to produce pharma...
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    Brexit Conundrum: How Does MHRA Work With EMA Moving Forward

    With the UK deciding by referendum to leave the EU, the vote will have major implications for the regulation of medicines and medical devices across the entire continent. Not only will the European Medicines Agency (EMA) have to uproot its headquarters from London (presumably shifting more than 600 full-time employees), but the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will have to decide if they want to continue conducting drug manufacturing...
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    FDA, International Authorities Shutter Thousands of Illegal Online Drug Stores

    The US Food and Drug Administration (FDA) and other international regulators and law enforcement on Thursday announced the results of a series of actions to combat illegal and counterfeit medicines. For its part, FDA says it requested the closure of 4,402 websites that illegally marketed or sold drugs or other chemical products to US consumers, and issued 53 warning letters to website operators "for offering unapproved and misbranded prescription drug products." FDA's a...
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    FDA Bans Imports From Teva’s Hungary Plant Except Two Drugs in Shortage

    The US Food and Drug Administration (FDA) late last week announced an import alert prohibiting drugs made at the  Gödöllő, Hungary-based manufacturing site from entering the US. However, Teva spokeswoman Denise Bradley told Focus that the ban does not include two drugs that are medically necessary and currently in short supply in the US. Those two drugs are the infection treatment Amikacin and the chemotherapy Bleomycin. “The import alert was issued on May 27 and w...