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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.

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.

Latest news

  • 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

  • Europe urged to adapt faster to gene therapy challenges Europe urged to adapt faster to gene therapy challenges

    Existing models include conditional reimbursement, such as England’s Cancer Drugs Fund and Scotland’s fund for ultra-orphan drugs. ... Pay-for-performance deals for traditional drugs are also becoming established in Europe and the US, linking price

  • Sobi takes ownership of rare disease drug Gamifant for $518m Sobi takes ownership of rare disease drug Gamifant for $518m

    This gives companies investing in orphan drugs a cost reduction for the application fee for future products and shortens the review period, and can be used or sold on to other

  • Stream on Stream on

    That’s it. The other drugs will have their own Netflix models. ... In other words, we’re not seeing any $1m-per- year therapies or ultra-orphan drugs being made available under these models.

  • Orphan drugs market to soar to $224bn by 2024 Orphan drugs market to soar to $224bn by 2024

    for orphan drugs through to 2024, according to a report by Evaluate Pharma. ... However this bonanza has generated scrutiny of industry prices, and the very favourable incentives for orphan drugs.

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Latest Intelligence

  • Orphan drugs and breakthrough therapies drive Cortellis Drugs to Watch 2019 Orphan drugs and breakthrough therapies drive Cortellis Drugs to Watch 2019

    This year's list contains no cancer drugs. Orphan drugs and breakthrough therapies dominate the list of seven drugs predicted to launch this year and forecast to achieve blockbuster status by ... The third theme is niche versus mass clinical impact. A

  • Launch trends 2019 Launch trends 2019

    A key trend is increasing evidence needs, ie, having greater evidence to ensure reimbursement of high prices, even for orphan drugs. ... 2018 saw the FDA approve a record number of drugs, as well as an increasing number in orphan disease areas.

  • Drug R&D

  • The sound of silence puts the squeeze on generics and biosimilars The sound of silence puts the squeeze on generics and biosimilars

    drugs - from Adalimumab to Rituximab - go off-patent and boost savings across eight European nations to 33.4bn over the next three years. ... What is surprising is that the whole of Europe is deeply concerned about the price of new medicines and how it

  • Europe vs the US: New drug product approvals Europe vs the US: New drug product approvals

    Altogether 39 orphan drugs were approved in the US during 2016 and 14 in the EU (a mix of NME, BLA, NAS or old substances with a new use for an ... We expect the strong overall trend for more orphan drugs submitted to and approved by the FDA and the EMA

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