Analyst | Autoimmune & Inflammation | CNS | Views & opinions expressed are strictly my own
Joined September 2014
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Pamela Spicer retweeted
Pamela Spicer retweeted
While we await a decision on $BIIB Aducanumab In Alzheimer’s disease, @PinkSheetSutter took a look at other controversial FDA approvals.
Will we be adding aducanumab to this list? An interesting Monday read from @PinkSheetSutter: pink.pharmaintelligence.info…
$BMY declares deucravacitinib as first in new TYK2-selective class to differentiate from JAKs #AADVMX2021
s21.q4cdn.com/104148044/file…
Aducanumab AdComm panel disagrees with FDA about strong evidence of effectiveness provided by the positive study
Pamela Spicer retweeted
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
Aducanumab AdComm open public hearing: patients comment on rapid decline 6-8 months after stopping treatment.
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
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
$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
Pamela Spicer retweeted
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 ...
$BIIB: amyloid testing for treatment with aducanumab may not necessarily be limited to PET testing as it was in the study
Outlook For Biogen's Aducanumab Brightens Based On FDA Clues scrip.pharmaintelligence.inf…
Nov 6 FDA AdCom briefing documents for $BIIB aducanumab in early #Alzheimer’s released
fda.gov/advisory-committees/…
Limited details, but topline H2H Ph3 suggests $BMY was right to divest Otezla to $AMGN in favor of TYK2i in oral #psoriasis showdown news.bms.com/news/corporate-…
TRIAD-2, second Phase 3 trial of AVP-786 for agitation in Alzheimer's, fails to meet primary endpoint otsuka.co.jp/en/company/news…
$LLY data confirm shorter-term IL-17 > IL-23 in #psoriasis , but what about longer-term results? TBD in 2020
investor.lilly.com/news-rele…
Pamela Spicer retweeted
Are you ready for our first #twitterchat? First a few house rules:
✅Start your post with Q:
✅Always use the hashtag #AskTheAnalyst
✅Tag @Pharma_Intell in your post
Follow these & we will be able to see all your questions.
We look forward to chatting with you!
Pamela Spicer retweeted
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
AbbVie’s Humira Succession Plan Begins Taking Shape With Skyrizi US Approval scrip.pharmaintelligence.inf…
Taltz Results In Spondyloarthritis Add To Lilly Franchise Hopes scrip.pharmaintelligence.inf…