The FDA has cleared Bayer and Johnson & Johnson’s anticoagulant Xarelto for use in hospitalised, acutely ill medical patients at risk of serious blood clots. The approval came as a result of data from the MAGELLAN and MARINER trials of Xarelto (rivaroxaban), which showed that the drug could be safely used to prevent venous thromboembolism
Associate Director, Medical WritingRegulatory ProfessionalsHertfordshire, UK
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Regulatory Professionals is one of the fastest growing global integrated regulatory outsourcing providers with a network of 20,000 pharmaceutical professionals globally. Working exclusively within the regulatory functions of Pharmaceutical, Biotechnology, Medical Device, Consumer health / OTC and Diagnostics industries.
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Regulatory Professionals were delighted to exhibit again at the TOPRA symposium, the biggest event in the organisation’s history for a few years, drawing over 650 delegates and exhibitors. With representation across industry from pharmaceutical, veterinary medicines and medical device sectors, plus patient groups, charities, healthcare professions, and more. The presentations and sessions were hugely insightful
FDA has issued a complete response letter for the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate); Paul Jeng, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers his perspective: “In an attempt to close the gap with chief chronic obstructive pulmonary disease (COPD) rival GlaxoSmithKline (GSK), AstraZeneca pushed to file an