Andrew G.

13.3K posts

Andrew G.

Andrew G.

@BioDueDiligence

Personal account of professional scientific skeptic and biotech enthusiast. Founder of BiotechDueDiligence.

Washington DC metro Katılım Ocak 2011
446 Takip Edilen12.2K Takipçiler
Andrew G.
Andrew G.@BioDueDiligence·
@tylermilliken_ Of course he pinch hit for one of the only other ones that gets hits
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Tyler Milliken
Tyler Milliken@tylermilliken_·
Ceddanne Rafaela is now rocking a 111 wRC+. Didn't see much power to start the season, but now he's clicking on that front too. If he can consistently tap into that HR power with his BB% and Chase% continuing to trend in the right direction, we're cooking.
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Clark H
Clark H@Clarksterh·
Company appears to have adjusted the data after unblinding and database lock (presumably wo telling the FDA, bc they wld have rejected it). Interesting question is how the FDA discovered it.
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The most dangerous number in medicine is not a bad p-value. It is a rescued p-value. FDA says Tavneos’ pivotal AAV trial went from p=0.1025 to p=0.0132 after post-unblinding readjudication. Now CDER proposes withdrawal. This is a trial-integrity earthquake. #MedTwitter

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Andrew G.
Andrew G.@BioDueDiligence·
RT @AppleHelix: Wow this is really interesting case. Sezaby is phenobarbital sodium. Phenobarbital has been used for over 100 years. There…
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Andrew G. retweetledi
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I'm sad to learn that J. Craig Venter, a key figure in modern genomics and an inveterate troublemaker, passed away. Craig was very important to the study of human genetics and the biotechnology industry. He also had an impact on my career. The pitch that led @michaelnoer to hire
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Woke up to a text from a former Red Sox player who summed up Saturday's moves: 'It's like shitting your pants and changing your shirt.'
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Jared Carrabis
Jared Carrabis@Jared_Carrabis·
The Orioles hit so many home runs off the Red Sox tonight that they ran out of fireworks in Baltimore. This is a real tweet.
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I'm so excited for @Mykalt45. Congrats!
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Andrew G.
Andrew G.@BioDueDiligence·
@chrissyfarr Congrats! I would have thought my podcast consumption was fairly routine (car commute, dog walks, winding down in bed), but I guess not because none of that translates to a time where I have any interest in a video version
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Sarah Karlin-Smith
Sarah Karlin-Smith@SarahKarlin·
This is one of the more interesting FDA-industry revolving door items I've seen via @AlecGaffney @Filmoreorless ex-CDRH Director JEFF SHUREN, Deputy Director DOUG KELLY and Chief Scientist RUSTY SEGAN, are starting a new medtech venture capital fund White Oak 66 Capital
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Andrew G.
Andrew G.@BioDueDiligence·
RT @michaelFhurley: You’ve heard of turning two but betcha haven’t heard of turning zero
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Yuval Cohen
Yuval Cohen@CEOCorbus·
The idea that you can take phase 1 and 2 China data to FDA and use it to get approval to start a phase 3 is simply not true. It’s not even partially incorrect. It is completely and utterly false. Comically so. And if one’s analysis of what the advantage China has in drug discovery and development is to come up with a false explanation, good luck catching up.
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Congrats to Denali for their FDA Approval of AVLAYAH! Fun bit of biotech history. The bi-specific shuttle technology used in Avlayah came from F-star, a European biotech we helped seed in 2006 (thx Regina Hodits). They were advancing a bi-specific mAb format for a range of
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Andrew G.
Andrew G.@BioDueDiligence·
@Jared_Carrabis Maybe to shit on Marcelo a little more while Durbin and Story screw up defensively
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Alexander Gaffney
Alexander Gaffney@AlecGaffney·
FDA is officially looking to hire a new Director of its Center for Biologics Evaluation and Research (CBER), and now you can see the full list of qualifications. Would replace the outgoing director, Vinay Prasad, who is leaving at the end of April. The agency is also looking for a second Deputy Director of CBER : (usajobs.gov/job/860827200) We haven't yet seen FDA post about hiring a new Chief Scientific/Medical Officer, which is the other position held by Prasad.
U.S. FDA@US_FDA

Are you ready to shape the future of public health at the highest levels? The FDA is seeking an exceptional executive leader to serve as the Center Director for CBER—a role at the forefront of regulating life-saving biological products, vaccines, and emerging therapies. This is an opportunity to protect and advance public health on a national scale. You'll work on cutting-edge science, shape critical regulatory policy, and lead a team dedicated to ensuring the safety and effectiveness of biological products that save lives. Apply by April 3, 2026. #FDAJobs usajobs.gov/job/862056100?…

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Alexander Gaffney
Alexander Gaffney@AlecGaffney·
FDA kind of buried this news earlier, but it's planning to hold a public hearing in June to solicit feedback about its Commissioner's National Priority Voucher program. Going to be a popular meeting, I'm sure. fda.gov/news-events/pr…
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Andrew G. retweetledi
STAT
STAT@statnews·
STAT FDA reporter @LizzyLaw_ asks HHS chief counselor Chris Klomp about the turnover at the FDA. Klomp: “When I see turnover in any organization — could be the FDA, it could be another — it's worrisome…” #STATBreakthrough
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On the results of preclinical biotech programs that received the largest upfront cash payments from '10-'15: "High upfronts were a signal that someone felt urgency to act, not that the program was more likely to succeed."
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