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orphan drugs

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

GSK’s Benlysta given orphan drug status by FDA for systemic sclerosis

GSK’s Benlysta given orphan drug status by FDA for systemic sclerosis

GSK’s Benlysta (belimumab) has been given Orphan Drug Designation (ODD) by the US Food and Drug Administration for the potential treatment of systemic sclerosis (SSc), the company announced. ... The antibody will now benefit from the incentives given

Latest news

  • The Holy Grail of healthcare pricing The Holy Grail of healthcare pricing

    Drugs with an orphan designation as the only FDA-approved indication. That’s quite a list of exclusions. ... No drug with an orphan designation or less than $200m in Medicare spending can be subject to price reductions.

  • PMEA 2020: continuing to recognise excellence in improving patient outcomes PMEA 2020: continuing to recognise excellence in improving patient outcomes

    Excellence in Rare Diseases and Orphan Drugs categories. ... with support from Learner Adams Bones Ltd. 8. Excellence in Rare Diseases and Orphan Drugs.

  • Building a brighter future for rare disease patients Building a brighter future for rare disease patients

    Before 1983 only thirty-eight orphan drugs gained regulatory approval while by 2014 that figure had reached 468 designations covering 373 drugs. ... The calibre of the shortlist in the Excellence in Rare Diseases, and Orphan Drugs category at the PMEA

  • AstraZeneca buys FDA priority review voucher from Sobi AstraZeneca buys FDA priority review voucher from Sobi

    The FDA’s PRV is used as an incentive for companies to invest in orphan drugs, by promising a cost reduction for the application fee for future products and a ... hundreds of millions for the most promising drugs.

  • The most annoying ‘F’ word in healthcare The most annoying ‘F’ word in healthcare

    We know that some of the largest employers in the US participate in these plans and we also know that fail first policies are being applied to the coverage of drugs ... In other words, these policies are not reserved for the orphan disease drugs or the

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Latest appointments

  • New hires at Crescendo, Healx and Galecto New hires at Crescendo, Healx and Galecto

    Prior to joining Healx, he worked as CMO at Aparito and as therapeutic area head of orphan drugs at Mereo BioPharma. ... Before that, he lead global R&D at Almirall, which involved 500 staff and the development and approval of several new drugs in a

  • New hires at FibroGen, Saniona and Turbine New hires at FibroGen, Saniona and Turbine

    He has extensive experience of the regulatory, access, commercial and financial environment for developing orphan drugs in the US – a region which is directly relevant to Saniona’s next phase of ... The first members of the SAB bring 70 years of

  • Orchard Therapeutics appoints Mark Rothera as CEO Orchard Therapeutics appoints Mark Rothera as CEO

    market, and launching several orphan drugs.

  • XenoGesis appoints business development consultant XenoGesis appoints business development consultant

    business.”. Currently, Mogle serves as chief executive officer of RareMoon Consulting, a non-clinical development and regulatory affairs consulting firm specialising in orphan drugs she co-founded earlier this year. ... She has previously held

  • Hansa Medical strengthens management team Hansa Medical strengthens management team

    In his new role, van Troostwijk will be responsible for overseeing the firm's commercial assessments of its lead project IdeS, an orphan drug in development for organ rejection. ... IdeS.”. Van Troostwijk brings over 20 years of sales and marketing

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