Ferring signs global agreement to commercialise novel gene therapy for bladder cancer patients

3 May 2018 - The US FDA has granted fast track and breakthrough therapy designations to rAd-IFN/Syn3. ...

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Gottlieb pushes back against criticism of ‘breakthrough’ designation

4 May 2018 - FDA Commissioner Scott Gottlieb defended his agency’s “breakthrough therapy” program, which speeds review of drugs that ...

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The breakthrough therapy designation for promising cancer drugs is good for patients

27 April 2018 - One exciting component of the FDA Safety and Innovation Act was the creation of the breakthrough ...

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FDA grants breakthrough therapy designation to Omeros’ MASP-2 inhibitor OMS721 for the treatment of high-risk haematopoietic stem cell transplant-associated thrombotic microangiopathy

26 April 2018 - Discussions on-going with FDA and European regulators for expedited approval. ...

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Efficacy, safety, and regulatory approval of FDA–designated breakthrough and non-breakthrough cancer medicines

24 April 2018 - The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. ...

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Synthetic Biologics provides update on development of SYN-004 (ribaxamase), for the prevention of C. difficile infection

23 April 2018 - Synthetic Biologics today announced that it has preliminary agreement from the U.S. FDA on a proposed ...

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Pfizer granted FDA breakthrough therapy designation for Trumenba (meningococcal Group B vaccine) for the prevention of invasive meningococcal B disease in children aged 1 to 9 years

23 April 2018 - Pfizer today announced that Trumenba (meningococcal Group B vaccine) received breakthrough therapy designation from the U.S. FDA ...

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FDA grants breakthrough therapy designation for Roche’s Hemlibra in haemophilia A without inhibitors

17 April 2018 - Designation based on phase III HAVEN 3 study demonstrating Hemlibra prophylaxis significantly reduced bleeds compared to no ...

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Breakthrough-therapy designation — an FDA perspective

12 April 2018 - Recent medical advances, such as targeted therapies for specific tumour genomic defects, checkpoint inhibitors for cancers, and ...

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The FDA breakthrough-drug designation — four years of experience

12 April 2018 - In 2012, Congress created the breakthrough-therapy designation to expedite the testing and approval by the FDA of ...

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Seattle Genetics and Astellas receive FDA breakthrough therapy designation for enfortumab vedotin in locally advanced or metastatic urothelial cancer

26 March 2018 - Seattle Genetics and Astellas Pharma today announced that the U.S. FDA has granted breakthrough therapy designation ...

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Funding breakthrough therapies: a systematic review and recommendation

17 March 2018 - Advanced therapy medicinal products are innovative therapies likely associated with high prices.  ...

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Janssen announces U.S. FDA breakthrough therapy designation for erdafitinib in the treatment of metastatic urothelial cancer

15 March 2018 - Erdafitinib, an oral pan-fibroblast growth factor receptor tyrosine kinase inhibitor, shows promise as the first targeted agent ...

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Lumasiran granted breakthrough therapy designation by the United States FDA

12 March 2018 - Alnylam Pharmaceuticals announced today that Sanofi Genzyme has declined its opt-in for the development and commercialisation ...

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Proteostasis Therapeutics announces FDA grants breakthrough therapy designation for PTI-428 in cystic fibrosis

12 March 2018 - Designation granted for PTI-428 for the treatment of CF patients based on the results from a recent ...

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