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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.

BMS claims rapid FDA nod for Opdivo plus Yervoy in kidney cancer

BMS claims rapid FDA nod for Opdivo plus Yervoy in kidney cancer

The combination of Opdivo and Yervoy lies at the heart of much of Bristol-Myers Squibb’s ambition in immuno-oncology, and an FDA approval for the pairing in kidney cancer ... BMS notes that Opdivo and Yervoy was given a priority review by the FDA last

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  • Pfizer’s plans for Inlyta go awry with failed adjuvant trial Pfizer’s plans for Inlyta go awry with failed adjuvant trial

    That goal was not achieved”. Pfizer’s drug was a big hit in second-line RCC treatment after its approval in 2012, but failed to transfer that potential to the ... Sutent sales slipped 1% last year to just over $1bn but could suffer as Opdivo and

  • ViiV’s two-drug HIV combo backed by CHMP ViiV’s two-drug HIV combo backed by CHMP

    ViiV’s chief executive Deborah Waterhouse said the approval recommendation “is an important milestone for people living with HIV in Europe [taking] us a step closer to offering the first, ... The CHMP opinion follows approval of Juluca by the FDA

  • AbbVie slumps on trial results for would-be blockbuster Rova-T AbbVie slumps on trial results for would-be blockbuster Rova-T

    Now the company has said it won’t be able to file for accelerated approval after discussions with the FDA about “the magnitude of the effect across multiple parameters”in the

  • Sun Pharma passes milestone with novel psoriasis drug approval Sun Pharma passes milestone with novel psoriasis drug approval

    India’s largest drugmaker Sun Pharmaceutical has picked up its first FDA approval for a novel drug, getting the nod for plaque psoriasis therapy Ilumya. ... Almirall licensed European rights to the drug in July 2016 and filed for the regulatory

  • Seattle Genetics claims key US approval for Adcetris Seattle Genetics claims key US approval for Adcetris

    Seattle Genetics has won FDA approval for Adcetris as a first-line treatment for advanced Hodgkin’s lymphoma, which it believes could help unlock blockbuster sales for the drug in the ... Last November it was granted FDA approval in adult patients with

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Latest Intelligence

  • 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

  • Biosimilars - the same, but different? Biosimilars - the same, but different?

    The FDA's approval was a clear signal of intent and the regulator followed up on Zarxio's approval with the release in May of a flurry of guidance to firm ... Emerging regulatory clarity. Beyond pricing policies, regulatory changes should help more

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  • 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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