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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.

BioMarin eyes 2019 FDA filing for haemophilia A gene therapy

BioMarin eyes 2019 FDA filing for haemophilia A gene therapy

BioMarin eyes 2019 FDA filing for haemophilia A gene therapy. Valrox study revealed a 97% reduction in mean annual bleed rates. ... We are meeting with the FDA regularly, consistent with [valrox’] status as a breakthrough therapy, and our most recent

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  • AstraZeneca: building a new ‘open innovation’ pharma company AstraZeneca: building a new ‘open innovation’ pharma company

    Lastly, AZ has also gained three Breakthrough Therapy Designations (including two Orphan Drug Designations) and six additional Priority Review Designations.

  • Bluebird Bio: on the cusp of a gene therapy revolution Bluebird Bio: on the cusp of a gene therapy revolution

    build the infrastructure required to administer the therapy safely and efficiently to patients across the continent. ... There is no question that these products are truly groundbreaking: three have FDA Breakthrough Therapy Designation and two have the

  • 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.

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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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VCCP Health

We’re the challenger agency for challenger brands. Brands with a point to prove. Rx, OTC and wellness brands run by...

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World Pancreatic Cancer Day 2018: Combating misconceptions in pancreatic cancer
Patients diagnosed with pancreatic cancer face a dismal prognosis, with the disease having the lowest survival rate of all major cancers. In spite of this, pancreatic cancer research is chronically...
World Diabetes Day: Interaction and impact of diabetes on mental health
For World Diabetes Day on the 14th November 2018, Nisha Shahrukh - Medical Writer at Mednet Group has written an article depicting the impact diabetes has on mental health. Including...
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Innovation in merger control and the impact on the pharmaceutical sector
Is focusing on pipeline products enough to assess regulatory risks?...

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