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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.

Heron boosted by new data for ‘breakthrough’ pain drug

Heron boosted by new data for ‘breakthrough’ pain drug

The new breakthrough designation adds to an earlier fast-track status for HTX-011 from the FDA, setting up a possible approval in the first half of 2019.

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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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EY Life Sciences

Our global reach Against a backdrop of regulatory, digital, financial and global transformation, Life Sciences companies are finding integration and...

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Developing advocacy in the pharmaceutical industry.
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GDPR and events. What does the pharma industry need to know?
Many people in the pharma industry still aren’t following the rules set out by the GDPR when it comes to running events and attending tradeshows. But with eye-watering fines for...
Digital trends in B2B sales - how far behind is Pharma?
The modern approach to B2B sales is data-driven, and enabled by digital tools....

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