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breakthrough therapy

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

The year of the blockbuster

The year of the blockbuster

More than half of the projected blockbusters have been granted priority review, breakthrough therapy or fast-track designations  by the US FDA. ... shown in that setting based  on which the US FDA granted Hemlibra breakthrough therapy designation in

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  • Deal Watch March 2017 Deal Watch March 2017

    Sacituzumab govitecan has been awarded breakthrough therapy status by the FDA.

  • 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 ... 245. Athersys/ Healios.

  • Deal Watch November 2015 Deal Watch November 2015

    The deal includes Protopic (tacrolimus) for severe eczema treatment, skin creams Locoid and Locobase and acne therapy Zineryt (erythromycin/zinc acetate). ... DX-2930 is expected to enter phase 3 studies by the end of the year and has received Fast Track,

  • Pharma deals during August 2014 Pharma deals during August 2014

    The prize: the FDA designated “ breakthrough therapy” pirfenidone (Esbriet), an orally active small molecule, anti-fibrotic agent that inhibits the synthesis of both TGF-beta and TNF-alpha. ... Partners to exploit the potential in other areas such as

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  • The Heart of the Matter 7: Reality Dawns

    Similarly, we also leveraged real-world historical comparator data to mazimise a first-to-market opportunity with a breakthrough therapy designation, priority review and orphan drug designation for another rare tumor

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