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Breakthrough Therapy Designation

This page shows the latest Breakthrough Therapy Designation news and features for those working in and with pharma, biotech and healthcare.

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

Latest news

  • 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

  • EMA sees approval numbers rise in 2018 EMA sees approval numbers rise in 2018

    Unsurprisingly, cancer drugs were the biggest therapy area in the 2018 roll call, with the regulatory body approving 23 in total, including AstraZeneca’s Imfinzi and Takeda’s Alunbrig. ... Therapy Designation.

  • 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

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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 ... Upadacitinib is already in a phase 3 trial in

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

    There is no question that these products are truly groundbreaking: three have FDA Breakthrough Therapy Designation and two have the similar PRIME designation from the EMA. ... The sickle cell programme has also been named on the FDA’s Regenerative

  • 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

  • Interview: AstraZeneca's Susan Galbraith Interview: AstraZeneca's Susan Galbraith

    What selumetinib does is potentially deliver a new targeted therapy into an area where there aren't any targeted therapies,” says Galbraith. ... This drug has recently received Breakthrough Therapy designation from the US FDA and phase 1 data will be

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