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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.

Genfit claims FDA breakthrough status for liver disease drug

Genfit claims FDA breakthrough status for liver disease drug

Elafibranor up for speedy US review. Genfit’s most advanced liver disease drug elafibranor has today achieved a breakthrough tag from the US FDA following positive data from a phase 2 ... The FDA’s decision to grant elafibranor the Breakthrough

Latest news

  • Second chance for AstraZeneca’s selumetinib with breakthrough designation Second chance for AstraZeneca’s selumetinib with breakthrough designation

    uses. The partners have just announced that the FDA has granted the two companies Breakthrough Therapy Designation (BTD) for selumetinib in a rare paediatric condition.

  • Roche files Venclexta plus Gazyva in CLL Roche files Venclexta plus Gazyva in CLL

    Chemotherapy-free treatment for these previously untreated patients is the new paradigm the competitors are pushing for, with trials showing advances over the standard therapy. ... The combination has already been awarded Breakthrough Therapy Designation

  • Ipsen buys rare disease group Clementia in $1.3bn deal Ipsen buys rare disease group Clementia in $1.3bn deal

    Through this transaction, we will gain scientific expertise, exceptional talent, and a cornerstone ultra-rare disease drug candidate with rare paediatric disease and breakthrough therapy designations, potential US approval in 2020 ... and gene therapy

  • Finch’s microbiota drug for C. diff gets FDA breakthrough status Finch’s microbiota drug for C. diff gets FDA breakthrough status

    Boost for firm as it races rivals in microbiome space. Finch Therapeutics has won a breakthrough designation (BTD) from the FDA for CP101, a drug for serious Clostridium difficile infections based ... The Minnesota-based biotech, which was acquired by

  • Roche submits Kadcyla for FDA Real-Time review Roche submits Kadcyla for FDA Real-Time review

    Roche is taking advantage of this process with Kadcyla, which was first cleared as a therapy for patients with HER2-positive, late-stage metastatic breast cancer who have previously been treated ... Kadcyla was granted Breakthrough Therapy Designation

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Latest Intelligence

  • Drug launches to watch in 2019 Drug launches to watch in 2019

    Analysts say the market could eventually be worth $4.8bn annually. The FDA granted AR101 Fast Track Designation for peanut allergy in September 2014 and Breakthrough Therapy Designation for peanut allergy ... The follow-up, Ultomiris ALXN1210, is a second

  • 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

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