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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.

EMA sees approval numbers rise in 2018

EMA sees approval numbers rise in 2018

The FDA’s faster approval rate is based on its sustained efforts to identify promising innovative drugs earlier, and work more closely with developers, via pathways such as the FDA Breakthrough ... Therapy Designation.

Latest news

  • Novartis gets breakthrough tag from FDA for sickle cell drug Novartis gets breakthrough tag from FDA for sickle cell drug

    Latest pipeline therapy for painful blood disorder. A monthly antibody drug to treat sickle cell disease, developed by Novartis, has won a coveted breakthrough designation from the FDA as it heads ... Novartis is hoping to file for approval of the

  • Lilly adds to pharma M&A run with $8bn Loxo buy-out Lilly adds to pharma M&A run with $8bn Loxo buy-out

    Loxo also has a promising pipeline, which includes LOXO-292, an oral RET inhibitor being studied across multiple tumour types,   and which was recently granted FDA Breakthrough Therapy designation,   and could

  • Chugai gains FDA breakthrough status for rare CNS treatment Chugai gains FDA breakthrough status for rare CNS treatment

    Adds to company's BTD roll-call. The FDA has granted Breakthrough Therapy Designation to Chugai’s satralizumab, a treatment currently in phase 3 for the rare CNS disorders neuromyelitis optica ... Chugai is part of the Roche group, and the announcement

  • FDA green lights BMS’ multiple myeloma combo FDA green lights BMS’ multiple myeloma combo

    Speedy approval follows a breakthrough designation. Bristol-Myers Squibb and AbbVie have gained a rapid FDA approval to broaden the use of multiple myeloma treatment Empliciti as part of new combined ... Now, after a breakthrough designation, BMS has

  • AZ and Clovis PARP inhibitors show their mettle at ESMO AZ and Clovis PARP inhibitors show their mettle at ESMO

    Rubraca picked up a breakthrough designation from the FDA in prostate cancer earlier this year, and has said it hopes to be in a position to file for approval in the

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

    Bluebird’s four breakthrough candidates. In addition to the two LentiGlobin-based treatments, the company also has its Lenti-D product for patients with cerebral adrenoleukodystrophy (CALD), a rare, serious and ... There is no question that these

  • 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.

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