Randi Hernandez

@RandiMHernandez

Oncology editor at Cancer Therapy Advisor (). Tweets are my own.

cancertherapyadvisor.com
Vrijeme pridruživanja: srpanj 2016.
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  1. prije 8 sati

    This is SO good.

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  2. prije 10 sati

    This is many mothers who have both a c-section and another kid at home--these moms are essentially alone, even if there is a spouse (bc spouse is with other kid).

    (2) Really struck me how hard it is to go thru the system alone. When I was being discharged, nurse turned to my husband, "Oh! the pharmacy closes in 10 minutes, she needs her antibiotics. Run!" He booked it and just made it. At that point I could not walk unassisted...
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  3. prije 10 sati

    Btw, it IS hypothetically possible a biosimilar performs better than a reference product, and it could be a clinically meaningful difference. See this piece on reference product drift:

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  4. prije 11 sati

    Suggestions "...that the biosimilar is less safe or less effective than the reference product in that indication because licensure for that indication was based in part on extrapolation also would be misleading." [Biosims are coming for ALL your brand-product indications!]

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  5. prije 11 sati

    Though this example below is in competing brands (not biosimilars), this kind of study on AEs is happening. Like in mRCC, where an INVESTIGATIONAL agent (in US) was found to have a superior safety profile across TKIs in a lit review(!)

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  6. prije 11 sati

    ^^^^^this sounds like "pregaming" to me. And something the FDA likely anticipates happening...

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  7. prije 11 sati

    "...suggestions that a biosimilar product is superior to its [ref] product based on a difference that is not clinically meaningful between the rates of occurrence of a particular adverse reaction from a study that supported a demonstration of biosimilarity...would be misleading."

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  8. prije 11 sati

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  9. prije 11 sati

    "...if a [biosim] product is licensed for fewer than all conditions of use for which the reference product is licensed, the [biosim's] FDA-approved labeling generally contains the data and information from the reference product’s FDA-approved labeling that is relevant..."

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  10. prije 11 sati

    WOWWW! (I hope they hired more people for this initiative because FTC seems like it needs help, tbh)

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  11. proslijedio/la je Tweet
    1. velj

    Among many important details from excellent article today, this one on the backlog of testing in China. Also believed that they are rationing testing to only highly probable cases, so most of the milder cases are likely being missed.

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  12. prije 16 sati

    Whoa

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  13. prije 17 sati

    Also, another observation from that ACS report: "....continued increase in incidence of melanoma coinciding with the continued decrease in mortality from melanoma." (screening)

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  14. prije 17 sati

    Reminder on those "falling" mortality rates: "...FDA approval doesn't immediately translate to real-world adoption." IT WASN'T THE THERAPIES IN MOST CASES, PEOPLE!

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  15. 31. sij

    "...decision to administer for compassionate use was based on the case patient’s worsening clinical status, [RCTs] are needed to determine the safety and efficacy of remdesivir and any other investigational agents for...2019-nCoV infection."

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  16. proslijedio/la je Tweet
    31. sij

    “Metrics put unnecessary pressure on pharmacy staff to fill prescriptions as fast as possible, resulting in errors,” one pharmacist wrote.

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  17. 31. sij

    A reason why, from ASCO GI:

    "We do not expect new trials with pegilodecakin."
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  18. 30. sij

    "...the transfection of the cells was the important aspect of this work," said Christian Ottensmeier, MD, PhD

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  19. 30. sij

    And, an announcement on a related trial using peripheral blood mononuclear cells also targeting HPV-positive solid tumors (SQZ-PBMC-HPV): the first dose was administered to a patient in a phase 1 trial.

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  20. 30. sij

    A look at antigen-presenting cells in oncology (in solid tumors, to start)--a concept to watch in ! Article by with mentions of

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