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legal action

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

Leadiant gets FDA OK for bubble boy disease drug

Leadiant gets FDA OK for bubble boy disease drug

A non-profit health advocacy group in the Netherlands has launched legal action against the Italian drugmaker (formerly Sigma-Tau), accusing it of hiking the price of chenodeoxycholic acid (CDCA)

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  • ABPI bid to overturn NICE’s budget impact rules fails ABPI bid to overturn NICE’s budget impact rules fails

    The Association of the British Pharmaceutical Industry (ABPI) has been fighting a legal action to try to overturn NICE’s introduction of a £20m cost ceiling for new drugs that have ... NHS England said in a statement that the High Court “has

  • New EU and US approvals for Humira biosimilars New EU and US approvals for Humira biosimilars

    AbbVie is claiming patent protection for Humira in the US out to 2022 and has already taken legal action to try to keep both Amjevita and Cyltezo off the market. ... Thus far, Amgen has opted not to launch its biosimilar 'at-risk' but is waiting to see

  • UK pharma launches legal challenge to NICE plans UK pharma launches legal challenge to NICE plans

    Applies for judicial review of budget impact test. The ABPI is taking legal action to try and block NICE’s forthcoming additional access hurdle for high-cost medicines. ... However, the ABPI’s action doesn’t appear to have unanimous industry backing

  • Endo faces industry-first FDA call to pull its opioid painkiller Endo faces industry-first FDA call to pull its opioid painkiller

    This action will protect the public from further potential abuse of this product,” she added. ... However if the firm doesn’t comply the regulatory agency can take legal action to force it to do so.

  • Activists torpedo Immunomedics deal with Seattle Genetics Activists torpedo Immunomedics deal with Seattle Genetics

    In the face of a legal challenge launched by activist investor group venBio, Immunomedics has now said it will abandon the licensing deal agreed in February - which included a $250m upfront ... The settlement also reimburses venBio for legal expenses

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  • Article: The Colombia Conundrum

    Challenges. For treatments that fall outside of these schemes, there is an alternative route patients can go down to attempt to access them: legal action, via ‘recobros’. Given ‘right to healthcare’

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