Zach Brennan

@ZacharyBrennan

Managing editor for 's Regulatory Focus. Views are mine. zbrennan@raps.org

Washington, DC
raps.org/news-and-artic…
Vrijeme pridruživanja: lipanj 2012.
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  1. prije 1 sat

    Spikes in both NDA & BLA filings in Q1 2020 (vs. 2019)

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  2. proslijedio/la je Tweet
    prije 3 sata

    . OCE's Pazdur at ... We don't set policy on twitter or facebook. If you have an issue "come on down" and talk to us.

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  3. prije 14 sati

    audible laugh on that one.

    “My administration is also taking on big pharmaceutical companies”
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  4. prije 19 sati

    FDA issued an Emergency Use Authorization to authorize the emergency use of CDC's 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel

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  5. prije 23 sata

    Takeda says its rare disease drug won't be available until March 2021 at the earliest. Background on the struggles for those w/hypoparathyroidism:

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  6. 3. velj

    FDA survey of 650 physicians/ on perceptions of drug quality - pretty eye opening

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  7. 3. velj

    the term "non-medical switching" has been used as a fear tactic too. Lots of suggestions that interchangeables are somehow better than biosimilars as well

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  8. 3. velj

    it's an interesting space as so many of the biologic promo materials merely hint at the fact that biosimilars are lesser products or have lot to lot differences (even though it's the same with biologic products) - but have yet to see any FDA untitled/warning letters

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  9. 3. velj

    FDA going after the misinformation in the biologic/biosimilar promotional space (i.e. reference product sponsors should not suggest that fewer indications for a biosim should mean that it's less effective than the ref prod)

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  10. 1. velj

    Might have to break out the Haggadah early this year to see what comes next

    As if we need another world scourge: Desert locusts threaten Africa.
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  11. 31. sij

    $44 million in PRV user fees for FDA, but the agency says PRVs can still shift resources away from public health priorities

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  12. 31. sij

    Axinn's Chad Landmon explains what he thinks will be the biggest impact from the MAPP changes

    Revised MAPP Tightens FDA Scope for Prioritized Generic Drug Applications | Focus
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  13. 31. sij

    should Congress reauthorize the rare pediatric and medical countermeasure PRV programs? New GAO report shows both sides

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  14. proslijedio/la je Tweet
    31. sij

    FDA inspections of medical product facilities located in China probably halted or greatly impacted by new guidance from State Department. Public health actors should consider this when contemplating new facilities and product supply. Will also create large backlog of inspections.

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  15. proslijedio/la je Tweet
    30. sij

    revenues of $568m, of $738m and of $911m in 2019; looks like biosimilars are becoming material to the top line. But for each company it is a portfolio of products and US and Europe.

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  16. 30. sij

    quite a few new interesting guidance docs from CDER coming this year (a couple on individualized antisense oligonucleotides), though this still lingering since 2017: "Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements"

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  17. 30. sij

    Carol Linden, Director of FDA's Office of Regulatory Science and Innovation, to retire at the end of this month after over 40 years in the federal gov. (announcement on LinkedIn)

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  18. proslijedio/la je Tweet
    30. sij

    In the provision that may attract the most attention, HHS says that it will allow states to close their formularies. What that means, in English, is that state Medicaid programs can refuse to cover some FDA-approved drugs if there are other, cheaper drugs available.

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  19. 30. sij

    Beyond the absurdity of granting a co exclusivity for cocaine, FDA does a great job of spelling out why Genus is wrong

    A Tale of Competing Cocaine Drugs: Genus Sues FDA Over its NCE Exclusivity | Focus
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  20. proslijedio/la je Tweet
    29. sij

    And here is a sample of 3 policies we describe and how they alter the Reward Box shape and thus the risk and reward of developing particular types of drugs:

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