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drug approval

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

Pfizer’s plans for Inlyta go awry with failed adjuvant trial

Pfizer’s plans for Inlyta go awry with failed adjuvant trial

That goal was not achieved”. Pfizer’s drug was a big hit in second-line RCC treatment after its approval in 2012, but failed to transfer that potential to the ... The story can be seen in the sales figures, with the drug peaking at $430m in 2015.

Latest news

  • AbbVie’s upadacitinib aces phase III trial AbbVie’s upadacitinib aces phase III trial

    AbbVie’ s upadacitinib aces phase III trial. Arthritis drug outperformed both placebo and Humira in the study. ... Analysts said the lack of VTEs in the latest study reduced the risk in the upadacitinib programme and raises the drug’s chances of

  • Novartis buys gene therapy firm AveXis for $8.7bn Novartis buys gene therapy firm AveXis for $8.7bn

    Last year, Biogen secured approval for the first drug treatment for SMA, a progressive, debilitating muscle-wasting disease that affects about 23, 500 patients worldwide. ... some big sellers like cancer drug Afinitor and Gilenya for multiple sclerosis

  • First blood to Roche in Hemlibra patent fight with Shire First blood to Roche in Hemlibra patent fight with Shire

    Roche’s defence of its haemophilia drug Hemlibra against a patent infringement challenge by Shire has been buoyed by a Japanese ruling. ... Approval of the drug came after a protracted battle with Shire which - along with allegations of patent

  • AZ finally gets EU nod for Veltassa rival Lokelma AZ finally gets EU nod for Veltassa rival Lokelma

    delaying approval and giving Vifor time to consolidate its position in the market. ... The European approval finally puts AZ on course to make a return from its $2.7bn purchase of Lokelma’s originator ZS Pharma in 2015, when the drug had already been

  • Sun Pharma passes milestone with novel psoriasis drug approval Sun Pharma passes milestone with novel psoriasis drug approval

    Sun Pharma passes milestone with novel psoriasis drug approval. Ilumya will treat adults with a moderate-to-severe form of the skin condition. ... Almirall licensed European rights to the drug in July 2016 and filed for the regulatory approval with the

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Latest Intelligence

  • The rise of real-world evidence The rise of real-world evidence

    Using real-world evidence. RWE has distinct applications pre- and post-approval. Before a drug comes to market, sponsors use the resource to evaluate unmet needs, identify subpopulations of patients and ... Once a therapy wins approval, companies turn to

  • Finding the patient voice Finding the patient voice

    probability of the drug getting approval. ... Mr Whitley went on to volunteer at an NGO, working with pharma companies to make drug trials simpler for patients.

  • A catalyst for change A catalyst for change

    This was considered a significant step in the internationalisation of the Chinese drug approval process. ... The Policy was a groundbreaking comprehensive instrument that targeted several key issues and fundamentally restructured the entire drug approval

  • The gold standard of scientific evidence The gold standard of scientific evidence

    In addition, securing regulatory approval for a drug can take decades. ... In short, RWE presents a fantastic opportunity to accelerate drug approval, monitor treatment safety and appropriately price medications.

  • Transforming Access to Medicines Through Patient-Centric Solutions Transforming Access to Medicines Through Patient-Centric Solutions

    To do this Inceptua Medicines Access and patient group, HAEi, in association with PMGroup, will host a free webinar on Thursday 14th December that will cover both the pre-approval access ... to medicines and the importance of putting patients at the

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Latest appointments

  • Anthony Zook resigns as Vivus CEO Anthony Zook resigns as Vivus CEO

    shareholders became unhappy with the way Vivus handled the launch of its obesity drug Qsymia (phentermine/ topiramat). ... Pharmaceuticals. Vivus also failed in a bid to win approval for the drug in Europe.

  • CytomX makes senior changes following Pfizer deal CytomX makes senior changes following Pfizer deal

    During his time at Affymax, Dr Polu headed several areas, including clinical sciences, clinical operations and drug safety/pharmacovigilance. ... He was also one of the key figures behind the development and approval of Affymax' first drug Omontys

  • Kite Pharma appoints Zelboraf scientist as CMO Kite Pharma appoints Zelboraf scientist as CMO

    At Plexxikon, he also led the filing of eight investigational New Drug Applications in cancer. ... Dr Nolop's vast experience in drug development from conception to approval will be instrumental to advancing Kite's eACT products through multi-center

  • Sweden’s Tomas Salmonson to chair EMA’s CHMP Sweden’s Tomas Salmonson to chair EMA’s CHMP

    Commenting on his election Salmonson said: “ The regulation of medicines has become much more proactive over the past few years, and we must embrace the tools we have to shape drug ... development pre- and post-approval, for example by providing

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Latest from PMHub

  • Pharma and free medicines: a different perspective

    The drug is used in combination with another breast cancer drug, letrozole, which belongs to a different drug class called aromatase inhibitors. ... Recently, there has been increasing discussion about the use of progression-free survival as a clinically

  • NEW FROM GOWER

    NEW FROM GOWER. Arthur G. Cook's second edition of Forecasting for the Pharmaceutical Industry is now available. Arthur G. Cook's eagerly awaited second edition of Forecasting for the Pharmaceutical Industry is here! The book is a definitive guide

  • Can rare diseases be a viable option for the pharma industry?

    Market research with many of the industry leaders involved with the development of orphan drugs has indicated the main influential drivers to pursuing an orphan drug approval as the reasons shown ... In an environment where a successful Health Technology

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