Here's a run down of some of our stories on $BIIB's Aduhelm approval for Alzheimer's (and then I'll try to stop tweeting about this for a bit :)

@brendasandburg on the unexpectedly BROAD label that doesn't align with trial population.

pink.pharmaintelligence.informa.com/PS144439/Bioge…
@brendasandburg .@PinkSheetSutter looks at the implications of FDA approving the drug via the accelerated approval pathway, including what it means for future FDA decisions.

pink.pharmaintelligence.informa.com/PS144437/Aduca…
@brendasandburg @PinkSheetSutter .@ScripMandy goes into more detail on the other drugs in Alzheimer's space that could benefit from the decision to used amyloid-beta as a surrogate.

scrip.pharmaintelligence.informa.com/SC144494/Aduhe…
@brendasandburg @PinkSheetSutter @ScripMandy .@dgingery has some interesting info on key meetings with FDA that took place after the advisory committee that may have influenced the decision -- including one with patient advocates. pink.pharmaintelligence.informa.com/PS144438/Patie…

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More from @SarahKarlin

10 Jun
#FDA's vaccine advisory committee about to discuss COVID-19 vax approvals and emergency use authorizations in children. Key thing will be whether they think EUAs are OK for younger children.

pink.pharmaintelligence.informa.com/PS144444/US-FD…
FDA's Dorian Fink emphasizes they are asking the committee to focus on safety for this panel (agency feels confident with their established efficacy process).
CDC now presenting some data on inital safety surveillance of use of $PFE vaccine in adolescents.

also on myocarditis and pericarditis w/ mrna vaccines.
Read 20 tweets
9 Jun
About to watch @realrickpazdur on @statnews #ASCO21 recap.

Pazdur is one of thoe FDA voices that silences the room when he pipes up. When he speaks, you listen.
@realrickpazdur @statnews .@realrickpazdur: People want to put regulations that don’t exist on us. For exmaple, we have to demonstrate that drug is safe and effective not that it is better than what we approved yesterday.
@realrickpazdur @statnews .@realrickpazdur: People must undersatnd we have to move on from the traditional overall survival endpoint to meet patients needs. #ASCO21
Read 23 tweets
1 Mar
CDC's ACIP now talking about what data would be needed to inform delaying the 2nd dose of mRNA vaccines or single dose of mRNA vaccine for individuals w/ prioir confirmed SARs-coV-2 infection.
Sanchez - said have to go with what the RCTs showed us for timing of 2nd dose.

for single dose for peope w/ past infection -- he thinks need more data but could see this being a possibility down the line.
Talbot - says we don't need more data re single-dose of mRNA for people w/ confirmed infection - seems to think we could pivot now.
Read 7 tweets
1 Mar
I'm watching the second day of CDC's ACIP meeting today. This meeting if focused more broadly on COVID-19 vaccines than yesterday's.
ACIP going to discuss possibility of delaying 2nd dose of mRNA vaccines as well as whether people who already had COVID-19 only need 1 dose. $BNTX $PFE $MRNA
CDC's Dooling says in Phase I/2 trials neutralizing antibodies did not show large increases until after 2nd dose of mRNA vaccines.
Read 5 tweets
5 Feb
screams into the abyss becuase people just don't get it!!!

.@NateSilver538 please please please please please call some people who understand the FDA and vaccine review.
@NateSilver538 1. the US needs to stop pretending that vaccines are our ONLY tool. There are many and we need to do a lot better job using the other ones while the vaccine deveolpment does its thing.
@NateSilver538 2. I don't think people appreciate how much data FDA is going to pour through and how understaffed and overworked they are.

again read @KatherineEban's piece which will break your heart about the toll this pandemic has taken on some of its reviewers.
Read 7 tweets

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