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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.

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

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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

  • 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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