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    Asia Regulatory Roundup: TGA Updates Guidance on the Testing of Biological Medicines

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Updates Guidance on the Testing of Biological Medicines   Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on testing biological medicines. Version 2.0 of the guidance features new details on the use of TGA in-house orthogonal testing methods and other changes.   TGA published the first, and until this week only, version of the guid...
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    Mylan Wins FDA Approval for First Advair Generic

    The US Food and Drug Administration (FDA) late Wednesday approved the first generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Generating almost $80 billion in sales since its initial launch, competi...
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    Asia Regulatory Roundup: Australia, Singapore Expand Generic Drug Work-Sharing Trial (12 December 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australia, Singapore Expand Generic Drug Work-Sharing Trial A regulatory consortium featuring Australia and Singapore has expanded its generic medicine work-sharing program. The initiative allows companies to file for approval with multiple agencies, which then perform a coordinated assessment of the application before reaching individual decisions. Agencies in Aust...
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    European Regulatory Roundup: ex-GSK CEO to Chair UK Accelerated Access Collaborative (9 November 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Tasks ex-GSK CEO With Highlighting Drugs Eligible for Accelerated Access Pathway The UK has tasked former GlaxoSmithKline CEO Sir Andrew Witty with highlighting products suitable for its incoming accelerated access pathway (AAP). Products that follow AAP will benefit from support with evidence generation and a more seamless journey to market, features the government ...
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    Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports

    Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes for biologics to be documented in annual reports. The draft guidance notes that under FDA regulations, postapproval changes in the product, production process, quality controls, equipment, facilities or responsible personnel that have a ...
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    Industry Supports FDA Proposal to Create New Office of Patient Affairs

    Industry groups BIO and TransCelerate, as well as companies GlaxoSmithKline and Shire, have offered their support for the creation of a new office at the US Food and Drug Administration (FDA) focused on patient affairs. The idea for the new Office of Patient Affairs (OPA), proposed in March , is part of the agency’s efforts to offer "a single, central entry point to the Agency for the patient community," as well as "triage and navigation services for inbound inquir...
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    FDA Science Board Weighs Plan for 'Cures' Funds

    The US Food and Drug Administration’s (FDA) science board met Tuesday to discuss an agency plan to spend $500 million over nine fiscal years on a variety of topics stipulated by the passage of the 21st Century Cures Act . Last week, FDA released its proposal for how it would spend the funds ahead of Tuesday’s meeting, with the bulk of the funds to be devoted to sections of the law on "Advancing New Drug Therapies" and "Patient Access to Therapies and Information."...
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    Asia Regulatory Roundup: CFDA Releases Draft Guidance on Data Management (18 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Proposes Change to Rare Disease Threshold in Orphan Drug Rethink The Therapeutic Goods Administration (TGA) of Australia is proposing to change its definition of rare diseases as part of an overhaul of its orphan drug regulation. If implemented, the revised regulations will allow drugs that treat more common diseases to qualify for orphan medicine status, but only...
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    FDA Warns GSK’s UK Site for Contamination in API Manufacturing

    The US Food and Drug Administration (FDA) on Wednesday released a warning letter for GlaxoSmithKline’s Worthing, UK-based active pharmaceutical ingredient (API) manufacturing site. The warning letter, dated 30 June, follows an eight-day inspection of the site from 2015 during which FDA uncovered GSK’s failure to prevent cross-contamination from dedicated penicillin manufacturing areas to non-dedicated areas. FDA says it documented findings of penicillin in non...
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    Gavi Commits $27.5m to WHO Malaria Vaccine Candidate’s Pilot Program as More Funds Needed

    The public-private vaccine alliance known as Gavi on Thursday pledged $27.5 million to a pilot project that the World Health Organization is running to introduce a malaria vaccine candidate into sub-Saharan Africa. As part of the project, WHO, GlaxoSmithKline, the developer of the vaccine, and the nonprofit PATH will collaborate to donate doses of the vaccine candidate, known as RTS,S, for use in the WHO pilots. In addition to the Gavi funds, WHO will provide about $17 ...
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    FDA: Explosions at Chinese Chemical Warehouse Contaminated Drugs

    The US Food and Drug Administration (FDA) on Tuesday alerted compounders and drug manufacturers that shipments from Tianjin, China may be at risk of chemical contamination following two massive explosions in August at a chemical warehouse there. The agency has already detected hydrogen cyanide contamination in two shipments of drugs from Tianjin-based Tianjin Tianyao Pharmaceuticals Co., approximately 30 kilometers (18 miles) from the explosion site. The contaminated sh...
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    Why EMA Recommends Medicines for Foreign Use: Article 58 Procedure

    Today, the European Medicines Agency (EMA) recommended the world's first malaria vaccine. However, unlike most of the medicines EMA reviews, the agency's recommendation won't be forwarded to the European Commission for authorization. In fact, EMA's recommendation only applies to regions outside the EU. Instead, the World Health Organization (WHO) and other non-EU regulators will review EMA's recommendation and make a determination on the vaccine's use. Mosquirix The va...