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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.

EMA sees approval numbers rise in 2018

EMA sees approval numbers rise in 2018

From these, 21 were orphan medicines (exactly 50%) and three were advanced therapy medicinal products – Novartis’ Kymriah and Gilead/Kite’s Yescarta CAR-T therapies, plus Spark’s Luxturna, co-marketed ... Unsurprisingly, cancer drugs were the

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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 ... therapy treatments

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China’s clinical trial shake-up
As many of the obstacles to running clinical trials in China fall away, the country is proving to be a better research location...
Alzheimer’s disease – is Europe prepared if a breakthrough treatment becomes available?
Healthcare leaders in the European Union should begin preparing for a breakthrough now...
The UK’s new five-year pricing agreement
Pharma has agreed to capped growth again - in exchange for uptake promises...