Pamela Spicer

Analyst | Autoimmune & Inflammation | CNS | Views & opinions expressed are strictly my own

[Mandy Jackson @ScripMandy]

$LLY Floated the idea of some kind of accelerated approval for its injectable donanemab earlier this year but has since backed off of that. Will that change now that $BIIB has been granted accelerated approval for infused antibody Aducanumab based on amyloid-clearing activity?

[Mandy Jackson @ScripMandy]

While we await a decision on $BIIB Aducanumab In Alzheimer’s disease, @PinkSheetSutter took a look at other controversial FDA approvals.

[Pamela Spicer @Datamonitor_PS]

$BMY declares deucravacitinib as first in new TYK2-selective class to differentiate from JAKs #AADVMX2021
https://t.co/0BsM3LWlgX

[Pamela Spicer @Datamonitor_PS]

Aducanumab AdComm panel disagrees with FDA about strong evidence of effectiveness provided by the positive study

[Sue Sutter @PinkSheetSutter]

Alzheimer's Association rep urges approval, says requiring another Ph III trial would delay access to #aducanumab for 4 years; urges panel to weigh the scientific uncertainty against the certainty of what disease will do to millions of people

[Pamela Spicer @Datamonitor_PS]

Aducanumab AdComm open public hearing: patients comment on rapid decline 6-8 months after stopping treatment.

[Pamela Spicer @Datamonitor_PS]

Aducanumab AdComm - In response to Dr. Joel Perlmutter’s question on dose response, @US_FDA confirms there is a sub-set of ENGAGE patients who are inconsistent with EMERGE, and not consistent with what would be expected in a dose-response relationship

[Pamela Spicer @Datamonitor_PS]

FDA AdComm - In replying to to Dr. Chiadi Onyike’s question on differences in placebo response between the aducanumab studies $BIIB said greater decline on CDR in EMERGE played a minor role in explaining differences in EMERGE’s positive outcome vs the negative topline from ENGAGE

[Pamela Spicer @Datamonitor_PS]

$BIIB say only high dose is discordant between aducanumab's ENGAGE/EMERGE in response to Dr. Caleb Alexander's concern about the "extraordinary amount of explaining" about the data

[Sue Sutter @PinkSheetSutter]

Still early on in #aducanumab AdComm, but fair to say biostatistican Scott Emerson, a temporary voting member, is highly skeptical of the efficacy analyses and explanation of differences b/n the two studies ...

[Pamela Spicer @Datamonitor_PS]

$BIIB: amyloid testing for treatment with aducanumab may not necessarily be limited to PET testing as it was in the study

[Pamela Spicer @Datamonitor_PS]

Outlook For Biogen's Aducanumab Brightens Based On FDA Clues https://t.co/GbsjSE8vCL

[Pamela Spicer @Datamonitor_PS]

Nov 6 FDA AdCom briefing documents for $BIIB aducanumab in early #Alzheimer’s released

https://t.co/SnBYszMO56

[Pamela Spicer @Datamonitor_PS]

Limited details, but topline H2H Ph3 suggests $BMY was right to divest Otezla to $AMGN in favor of TYK2i in oral #psoriasis showdown https://t.co/mzHa0nK9As

[Pamela Spicer @Datamonitor_PS]

TRIAD-2, second Phase 3 trial of AVP-786 for agitation in Alzheimer's, fails to meet primary endpoint https://t.co/CMRUXCvID2

[Pamela Spicer @Datamonitor_PS]

$LLY data confirm shorter-term IL-17 > IL-23 in #psoriasis , but what about longer-term results? TBD in 2020
https://t.co/H7WbjiAJjS

[Citeline @Citeline]

Are you ready for our first #twitterchat? First a few house rules:
✅Start your post with Q:
✅Always use the hashtag #AskTheAnalyst
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Follow these & we will be able to see all your questions.
We look forward to chatting with you!

[Citeline @Citeline]

Will you be ready to #AskTheAnalyst on Wednesday, May 1st? We will be hosting our first #Twitterchat next week & our expert analysts are ready & waiting to answer your questions about the #pharma & #medtech industries. See you next week on @pharma_intell #asktheanalyst

[Pamela Spicer @Datamonitor_PS]

AbbVie’s Humira Succession Plan Begins Taking Shape With Skyrizi US Approval https://t.co/OY6qOCjsBz

[Pamela Spicer @Datamonitor_PS]

Taltz Results In Spondyloarthritis Add To Lilly Franchise Hopes https://t.co/5mvG2ZStuw