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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
The Top 10 drugs of 2018, generated at least $6.5 billion. Find out more in our #whitepaper, where our experts discuss the dynamics & marketing of 2018's top selling drugs. #Download the report here bit.ly/2YvGMbI
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/…
Thanks to Dominique Fontanilla @Datamonitor_DF, Laurie Withington @citelineLaurieW, Stephanie Yip @Datamonitor_SY and Pammy Spicer @Datamonitor_PS for joining the podcast!
$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
Zulresso Is Sage’s First Step In Postpartum Depression Treatment bit.ly/2ui04kd #PharmaScrip
Big thanks to Mandy Jackson @ScripMandy and Stephanie Yip @Datamonitor_SY for joining this month's podcast!
Check out the COMPLETELY FREE Informa Pharma Intelligence Podcast! -Bristol-Myers Squibb $BMY and Celgene $CELG merger (1:37) -Selinexor PDUFA for multiple myeloma delayed $KPTI (16:18) -Approval of Spravato $JNJ (28:47) soundcloud.com/dmhcap/0319201…
$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…
jnj.com
Janssen Announces U.S. FDA Approval of SPRAVATOTM (esketamine) CIII Nasal Spray for Adults with...
Janssen Announces U.S. FDA Approval of SPRAVATOTM (esketamine) CIII Nasal Spray for Adults with...
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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