Stephanie Yip @Datamonitor_SY
Views expressed are my own. Joined March 2017-
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Positive CHMP opinions for $ABBV Rinvoq for #rheumatoidarthritis and $JNJ Spravato for treatment-resistant #depression ema.europa.eu/en/news/meetin…
$RLMD REL-1017(d-methadone) potent efficacy for treatment-resistant #depression. PhII ~9.4-10.4 reduction in MADRS score over placebo is more than double the reduction seen with approved antidepressants and this was achieved in a challenging population relmada.com/news-events/pr…
New Drug Application submitted for investigational #RA treatment in Japan: bit.ly/2AQGaQD.
$GWPH Epidyolex #cannabidiol approved in the EU as an adjunctive therapy for Lennox‑Gastaut syndrome or Dravet syndrome, in conjunction with clobazam, for #epilepsy patients 2 years of age and older ir.gwpharm.com/news-releases/…
FDA approval of $ABBV Rinvoq (upadacitinib) for #rheumatoidarthritis, will be the third JAK inhibitor for RA, launching in late August 2019 news.abbvie.com/news/press-rel… Black box warning for thrombosis as expected in line with other JAK inhibitors accessdata.fda.gov/drugsatfda_doc…
Free downloads of the white paper I wrote on the best-selling drugs of 2018
Nuplazid failed PhIII ENHANCE trial for treatment-resistant #schizophrenia $ACAD to continue pursuit of underserved schizophrenia patients with negative symptoms with PhII ADVANCE trial. See analysis @Biomedtracker biomedtracker.com/EventDetail.cf… PR: ir.acadia-pharm.com/phoenix.zhtml?…
$ALKS to submit #ALKS3831 NDA in Q4 2019 for #schizophrenia and #bipolardisorder PR: phx.corporate-ir.net/phoenix.zhtml?…
$LGND $SAGE Zulresso has launched in the US, exciting as the first and only FDA-approved treatment for #postpartumdepression investor.ligand.com/press-releases…
$GILD $GLPG filgotinib NDA filing for #rheumatoidarthritis expected in 2019, good news that completing PhII MANTA trial isn't a prerequisite gilead.com/news-and-press… …
Positive outcome for $ZGNX Type A meeting with FDA- no additional long-term tox studies required. Expected to file NDA for Fintepla for #dravetsyndrome in Q3 2019, hoping for a 6-month review period zogenixinc.gcs-web.com/news-releases/…
$MYOV relugolix demonstrated placebo-like tolerability in its 1st pivotal trial in uterine fibroids, looking advantageous vs $ABBV's oral GnRH receptor antagonist Orilissa that has hypoestrogenic effects investors.myovant.com/news-releases/… Comment here @Biomedtracker biomedtracker.com/EventDetail.cf…
$ZGNX FDA RTF letter for Fintepla for #Dravetsyndrome may cause 12-15month delay if non-clinical tox studies must be started from scratch and prolonged first-to-market advantage for $GWPH Epidiolex. Full comment on @Biomedtracker biomedtracker.com/EventDetail.cf… PR:zogenixinc.gcs-web.com/news-releases/…
$UTHR Failed BEAT study marks final nail in the coffin for its US development of esuberaprost for pulmonary arterial hypertension- see comment on @Biomedtracker biomedtracker.com/EventDetail.cf… PR here: ir.unither.com/news-releases/…
First-in-class steroidal antidepressant, $SAGE Zulresso, gains unprecedented FDA approval for #postpartumdepression
First-in-class steroidal antidepressant, $SAGE Zulresso, gains unprecedented FDA approval for #postpartumdepression
Big thanks to Mandy Jackson @ScripMandy and Stephanie Yip @Datamonitor_SY for joining this month's podcast!
Big thanks to Mandy Jackson @ScripMandy and Stephanie Yip @Datamonitor_SY for joining this month's podcast!
$AGN rapastinel PhIII treatment-resistant #depression program washout- 3 failed acute trials and a negative interim analysis for the relapse prevention study. $AGN invested in 10 PhIII depression trials for rapastinel and has to decide whether to continue. allergan.com/News/News/Thom…
FDA approval of $JNJ Spravato (intranasal esketamine) marks the first antidepressant with a new mechanism of action in decades and is set to address critical unmet need in the treatment-resistant #depression space jnj.com/janssen-announ…
Global license agreement between $ARNA and $UTHR to develop ralinepag for pulmonary arterial hypertension further extends $UTHR's existing, broad product portfolio in this space ir.unither.com/news-releases/…

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