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FDA approval

This page shows the latest FDA approval news and features for those working in and with pharma, biotech and healthcare.

Boehringer’s Corsico to be new GSK drug dev leader

Boehringer’s Corsico to be new GSK drug dev leader

However the company has just received bad news from the FDA, the US regulator refusing to approval a licence extension for its respiratory drug Nucala into COPD, citing i nsufficient efficacy

Latest news

  • FDA awards another non-opioid pain drug breakthrough status FDA awards another non-opioid pain drug breakthrough status

    FDA awards another non-opioid pain drug breakthrough status. Second drug fast-tracked amid addiction epidemic. ... The FDA is prioritising the approval of new non-opioid pain treatments, as part of the US battle against its opioid addiction epidemic.

  • Gilead optimistic about Yescarta deal in UK Gilead optimistic about Yescarta deal in UK

    When NICE gave a rapid ‘no’to Yescarta on 28 August, just one day after it gained EU-wide marketing approval, some commentators concluded England’s cost-effectiveness watchdog was displaying ... Gilead is already in the lead in terms of revenues in

  • FDA rejects GSK’s Nucala for COPD FDA rejects GSK’s Nucala for COPD

    FDA rejects GSK’ s Nucala for COPD. Says evidence that Nucala was effective in preventing COPD exacerbations was insufficient. ... Another potentially strong challenge could come from AZ and Amgen’s tezepelumab, which has just been awarded a

  • FDA rejects GSK’s Nucala for COPD FDA rejects GSK’s Nucala for COPD

    FDA rejects GSK’ s Nucala for COPD. Decision will add to slow growth for respiratory newcomer. ... Another potentially strong challenge could come from AZ and Amgen’s tezepelumab, which has just been awarded a breakthrough designation from the FDA

  • FDA gives Loxo breakthrough tag for second cancer drug FDA gives Loxo breakthrough tag for second cancer drug

    FDA gives Loxo breakthrough tag for second cancer drug. US regulatory body to expect a NDA for LOXO-292 in late 2019. ... approval in the US, with an FDA decision due by 26 November.

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Latest Intelligence

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

    Learning from the failures of Glybera and Strimvelis. When Spark Therapeutic’s Luxturna gained FDA approval last year, it was the first US-approved gene therapy, but Europe was years ahead ... Spark's Luxturna: already approved in the US, expected to

  • Taking a lean and careful approach Taking a lean and careful approach

    His pioneering research culminated in the drug, Trulance, which has received FDA approval and is being used to treat irritable bowel syndrome and chronic constipation. ... Now that our first drug has FDA approval, maybe the pace has slowed a bit, ”he

  • Deal Watch - May 2017 Deal Watch - May 2017

    In December the FDA notified Innocoll that the product should be characterised as a drug-device combination and additional data would be required. ... exit. The CVR payments are linked to FDA approval for various indications and if annual sales exceed

  • Creative marketing and compliance Creative marketing and compliance

    In common with other industries, marketing assets can become siloed into shared drives, email approval chains or other processes. ... relevant authority - for instance, the FDA - for approval before hitting the market, a process that can easily take

  • Pharma deals in September 2015 Pharma deals in September 2015

    Agenus is giving the royalty rights to Oberland Capital in exchange for a $100m loan, (recouping the other $15m if and when the shingles vaccine gets FDA approval) and GSK will ... Amgen's busy month (part 2). Following FDA approval for its novel PCSK9

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Latest appointments

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Latest from PMHub

  • A stumble, but not a fall – what’s next for Opdivo?

    The  immuno-oncology treatment won an accelerated FDA approval for metastatic melanoma in December 2014, and has since proved to be a thriving sensation. ... Rubbing salt into BMS’ s wounds, Merck's  Keytruda snagged a new FDA approval in

  • Immunotherapy in oncology

    To date, Blue Latitude Health have worked with 4 of the 9 immunotherapies currently approved by the FDA, and this article will provide an overview of the area; sharing some of ... approval by the FDA in March 2011.

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