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breakthrough designation

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

AZ bags key lung cancer approval for Imfinzi

AZ bags key lung cancer approval for Imfinzi

The FDA granted the drug a breakthrough designation in non-metastatic NSCLC last July.

Latest news

  • Roche’s autism drug scores FDA breakthrough status Roche’s autism drug scores FDA breakthrough status

    A drug that may improve social interaction and communication in people with autism spectrum disorder (ASD) has been granted Breakthrough Therapy Designation by the US Food and Drug Administration. ... The FDA’s designation bucks the regulator’s usual

  • Shire’s Maribavir wins US breakthrough therapy designation Shire’s Maribavir wins US breakthrough therapy designation

    Shire’ s Maribavir wins US breakthrough therapy designation. It's based on phase II data for the transplant infection treatment. ... therapies, and I’m proud of the innovation and hard work that made this breakthrough designation therapy milestone a

  • Novartis’ Promacta receives US breakthrough therapy designation Novartis’ Promacta receives US breakthrough therapy designation

    Novartis’ Promacta receives US breakthrough therapy designation. Regulatory filings of the rare blood disorder treatment are expected this year. ... Known as Revolade in most countries outside the US, Promacta gained its breakthrough therapy

  • Seattle Genetics' Adcetris earns FDA priority review status Seattle Genetics' Adcetris earns FDA priority review status

    Seattle Genetics' Adcetris earns FDA priority review status. The win follows a breakthrough designation from the US regulator last year. ... The priority review status follows a breakthrough therapy designation, which was granted by the US regulators

  • Novartis bags new breakthrough status for Kisqali in breast cancer Novartis bags new breakthrough status for Kisqali in breast cancer

    Novartis bags new breakthrough status for Kisqali in breast cancer. The Swiss pharma group’s treatment will rival Lilly’s Verzenio and Pfizer’s Ibrance if approved. ... The US FDA has awarded Novartis’Kisqali breakthrough designation (BTD) in the

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Latest Intelligence

  • Deal Watch February 2017 Deal Watch February 2017

    IMMU-132 has FDA Breakthrough Therapy designation for the treatment of patients with TNBC who have failed prior therapies for metastatic disease and also has Fast Track status and orphan designation

  • Deal Watch January 2016 Deal Watch January 2016

    32, 000. Seres Therapeutics/ Nestle Health Science. Collaboration. Rights to market products including SER 262 (p1 for Clostridium difficile), 287, 301 and 109 (SER 109 has breakthrough therapy designation); includes $120m

  • Creating a 21st century life sciences ecosystem Creating a 21st century life sciences ecosystem

    Part of the scheme involves a new 'promising innovative medicine' designation - similar to the FDA's breakthrough designation - the first of which have started to be awarded.

  • Pharma deals during October 2014 Pharma deals during October 2014

    Imbruvica was one of the first products to gain approval via the breakthrough designation pathway and has European approval for use in mantle cell leukaemia and chronic lymphocytic leukaemia.

  • Interview: AstraZeneca's Susan Galbraith Interview: AstraZeneca's Susan Galbraith

    This drug has recently received Breakthrough Therapy designation from the US FDA and phase 1 data will be presented at ASCO in June.

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Latest from PMHub

  • The Heart of the Matter 7: Reality Dawns

    At Amgen, our CfOR infrastructure has helped us use RWE to achieve orphan drug designation. ... Similarly, we also leveraged real-world historical comparator data to mazimise a first-to-market opportunity with a breakthrough therapy designation, priority

  • The Heart of the Matter 7: Reality Dawns

    At Amgen, our CfOR infrastructure has helped us use RWE to achieve orphan drug designation. ... Similarly, we also leveraged real-world historical comparator data to mazimise a first-to-market opportunity with a breakthrough therapy designation, priority

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