Rezultati pretraživanja
  1. 2. sij

    , a new molecular entity receptor agonist, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

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  2. 15. sij
  3. 10. sij

    FDA panel Qs for smash cut from approvability concerns to possibly expanding the proposed indication. Were trial participants adequately non-responsive to non-opioids? Is a single trial OK? Is liver safety and abuse liability OK? (1/2)

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  4. 23. sij

    FULL ARTICLE: FDA Advisory Committee denies the approval of a new opioid drug due to safety concerns.

  5. 21. sij

    After the AdCom rejected withdrew the NDA

  6. 16. sij

    This week's FDA Adcomm tally: 2 ties, 2 down votes Ties for Durect's (bupivacaine depot) (6-6) + Esteve's tramadol/celecoxib (13-13) Down votes for Nektar's (27-0) + Intellipharmaceutics' (proposed abuse-deterrent oxycodone) (24-2)

  7. 15. sij
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  8. committee rejects , new designed for less abuse

  9. 15. sij

    Nektar won't do those tests and it's not waiting to see what the FDA says. Hours after the panel vote, the company announced it will withdraw its application and stop investment in the drug, . announcement here:

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  10. 15. sij
  11. 14. sij
  12. 14. sij

    The AADPAC/DSARM Committees voted down, 27 - 0.

  13. 14. sij

    advisory committee votes 27-0 against approval of , new opioid molecule designed to give pain relief with slower brain entry and less of a high, largely bc of inadequate safety and efficacy data.

  14. 14. sij

    Welcome to new followers of the Nektar adcomm!

  15. 14. sij

    I really wonder what Dr. Sharon Hertz (the former Director of FDA's pain products review division) is thinking about the adcomm, assuming she's following from outside of FDA. I've gotten so used to her voice at these meetings.

  16. 14. sij

    The must not approve the new , which is closely related to , for treatment of chronic low back pain because the medication is not effective for treating this condition and poses a high risk of being abused

  17. 14. sij
    Odgovor korisniku/ci

    Today is the FDA ad comm, where they review a drug already pushed off for approval (issued a CRL). Do we really need ....another long acting opioid? I’m so glad we spend more $ than other countries to spawn this sort of “drug innovation.” 🙄

  18. 14. sij
    Odgovor korisniku/ci

    Do we really need ? I’m so glad we spend more money on drugs than other countries to spawn this sort of “innovation.” 🙄

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