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orphan medicines

This page shows the latest orphan medicines news and features for those working in and with pharma, biotech and healthcare.

Shionogi and F2G partner to develop antifungal treatment olorofim

Shionogi and F2G partner to develop antifungal treatment olorofim

It also covers azole-resistant strains, coccidioidomycosis and scedosporiosis (including lomentosporiosis). The treatment has already been granted orphan drug status by the European Medicines Agency (EMA) and orphan drug status, Qualified

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  • Biopharma and orphan drugs Biopharma and orphan drugs

    The success is clear: before the Regulation was introduced, only eight orphan-like medicines were available for patients. ... diseases. “In the area of orphan medicines, as the patient population is very small, the opportunities for the companies

  • Shoring up the framework Shoring up the framework

    Consequently pharmaceutical companies that hold marketing authorisations for centrally authorised medicines will be required to take certain steps. ... Marketing authorisation holders for medicines, including orphan drugs, must be established in the EU

  • Brexit: Implications for the pharma industry Brexit: Implications for the pharma industry

    Similarly, orphan drug designations currently need to be held by an EU-based entity. ... If the UK ends up outside the EEA, it may, like other non-EEA countries, put in place reduced assessment processes for products categorised as orphan drugs by the

  • A rare talent A rare talent

    Shire’s Sebastian Stachowiak on dealing with change and working for a fit-for-purpose orphan drug environment. ... The latter, says Sebastian, is “a very good first step, in terms of recognising that there is a difference when it comes to

  • Market access improvements in Turkey Market access improvements in Turkey

    Almost the entire pharmaceutical market is made up of prescription medicines (93.8%) with 87% reimbursed. ... While welcoming the promise of a slight acceleration of review time with high priority medicines, industry is disappointed that orphan drugs and

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