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fast-track status

This page shows the latest fast-track status news and features for those working in and with pharma, biotech and healthcare.

Alexion adds to pipeline rebuild with $855m Wilson buy

Alexion adds to pipeline rebuild with $855m Wilson buy

The drug has been awarded fast-track status in the US after a positive phase II trial, and is classed as an orphan drug in both the US and EU.

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  • Significant figures Significant figures

    US regulators at the FDA have recognised the treatment’s potential, handing it breakthrough and fast-track status. ... Fast forward to last September and the company’s decision to put ALIS through phase III trials paid off, when it released

  • 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

  • Pharma deals in August 2015 Pharma deals in August 2015

    Baxalta was of course only spun out from its parent company Baxter in July so this bid is fairly fast and the offer was, not surprisingly, met with a lukewarm response. ... Keeping with the option trend, BMS entered into a deal which gives it the right

  • Cubist: Meeting the challenge in antibiotics Cubist: Meeting the challenge in antibiotics

    GSK has even been working with the US government in AMR research, while AstraZeneca is a step ahead having had the antibiotic AZD0914 receive fast track status from the US FDA ... This includes pathogen specific pathways. “ Furthermore what really

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