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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.

Roche’s Tamiflu successor hits the mark in complicated flu

Roche’s Tamiflu successor hits the mark in complicated flu

Roche already has positive data from a phase III trials of baloxavir marboxil in uncomplicated flu, and recently filed for approval with the FDA for that indication, setting up a possible ... Also in its favour is that baloxavir marboxil is already on

Latest news

  • Heron boosted by new data for ‘breakthrough’ pain drug Heron boosted by new data for ‘breakthrough’ pain drug

    Heron Pharma has new data on its combination anaesthetic drug, and a breakthrough designation from the FDA, which suggests it could have an impact on the post-operative pain market. ... The new breakthrough designation adds to an earlier fast-track

  • Another R&D flop for Incyte, but Jakafi keeps delivering Another R&D flop for Incyte, but Jakafi keeps delivering

    that the company could be in a position to file for approval in cholangiocarcinoma next year. ... after a less-than-optimal FDA approval, and data suggesting that myelofibrosis patients treated with Jakafi may be at elevated risk of aggressive lymphomas.

  • Sanofi’s rare blood disorder drug Cablivi set for European approval Sanofi’s rare blood disorder drug Cablivi set for European approval

    Europe looks set to be the first market for the new drug, ahead of the US where it has not yet been submitted for approval, according to Sanofi. ... changes in the EU, according to Jazz, which got FDA approval for the drug last August.

  • Summit plunges after Duchenne disappointment Summit plunges after Duchenne disappointment

    Sarepta's investment in the field has been possible thanks to the FDA’s approval of the first US-approved Duchenne drug, Exondys 51, in 2016, despite controversies over its efficacy. ... The field is marked by the curiosity of the EMA having approved

  • The year of the blockbuster The year of the blockbuster

    Together with the Genzyme unit of Sanofi, Alnylam filed for EU approval that same month. ... effects, which led to FDA approval in December 2017.

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  • 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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Latest appointments

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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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HME are an innovative and technology enabled agency offering our clients over 35+ years of knowledge and expertise in delivering...

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Developing advocacy in the pharmaceutical industry.
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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...
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The modern approach to B2B sales is data-driven, and enabled by digital tools....

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