Brian Shields
79.3K posts
Brian Shields
@MrPug94
Former Army Aviator, USMA grad, Software Entrepreneur, Founder: @kolpulseai
GA Katılım Temmuz 2010
5.1K Takip Edilen4.2K Takipçiler
What companies would you like to see interviewed during #ASCO26 on @BiotechTV?
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Brian Shields retweetledi
💊 Today’s publication by FDA of 71 new & revised guidances for the development of high-quality generic drugs can be a game changer for patients.
Why? Oftentimes, it takes YEARS for generics to emerge even after they can legally be available, because the path can be so unclear or complex.
By fixing that (I obviously haven’t read these documents so it’s impossible to know yet comprehensive they are, but I’m hopeful as I know it’s been in the works for some time), there should be much less time for quality generic drugs to become available. And that often translates into better availability & lower cost.
For many conditions, the best drugs (or close enough to best) are already available as generics - you may not hear about them because companies typically don’t advertise generics!
Over time, this kind of patient-focused regulatory action has the potential to make meaningful improvements in how Americans receive care.
Michael Davis, MD, PhD@FDACDERDirector
Affordable medicines aren't a luxury — they're a necessity. Today's release brings us closer to a marketplace where patients can access the safe, effective, high-quality treatments they need without financial hardship.
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Brian Shields retweetledi
In the wake of the #ASCO26 data drop, we reflect on 20 key phase 3 trials which could make a significant impact. Some of these may make their competitors irrelevant if they change the standard of care:
tinyurl.com/nhz2nchf
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@emilyakopp @maxonwifi Interesting, Replimune CEO Sushil Patel received an award from Melanoma Research Foundation for their “Sponsorship” just a month or so after MRF sent letter to FDA leadership for approval of Replimune’s drug.
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FDA under Trump began with people known for courage during COVID: Marty Makary, Vinay Prasad, Tracy Beth Hoeg. All gone. To be replaced with status quo picks.
Now @maxonwifi reports pharma pressured the White House. They "really were out to get" Makary.
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@adamfeuerstein I think @WSJopinion wants to see the IGNYTE data? Or maybe they don’t even know what that is?
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Hey BioXers who pay attention to cancer: Are there data coming out on May 21 in #ASCO26 abstracts (not late breakers) that you deem must see?
I'm trying to figure out what needs to be covered on May 21 when regular abstracts are posted vs. what can wait for the actual meeting. Thanks.
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Brian Shields retweetledi
So few kept their skills up to date and then get rolled over.
Even fewer figure out where the puck is going and try to get ahead.
But the changes are happening so fast people struggle to keep up.
And I have talked to many people who are very rich about these questions.
The only thing that leads to happiness is to help others.
But humans will try everything else first. :-)
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Brian Shields retweetledi
As it relates to @FDAOncology practice of approving neoadjuvant treatments, the important point is: FDA has never approved a breast cancer drug based solely neoadjuvant results, without documented neo/adjuvant effect on DFS too.
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FDA Oncology@FDAOncology
#FDA approves a treatment for HER2-positive early-stage breast cancer. fda.gov/drugs/resource…
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Brian Shields retweetledi
Historical movement of TOPO1 ADCs to the curative setting. This will be only the first of several more to come in the next years. In breast oncology, and beyond.
FDA Oncology@FDAOncology
#FDA approves a treatment for HER2-positive early-stage breast cancer. fda.gov/drugs/resource…
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Brian Shields retweetledi
My comment on the WSJ blog for this article was rejected! So much for free speech @WSJ
Who will the WSJ shill for next in healthcare?
Real Doc Speaks@realdocspeaks
wsj.com/health/healthc… Another day, another anti-physician article from the Wall Street Journal. I don't see any mention in the article that 60% of NPs graduate from online schools with no oversight of the clinical hours. Medical Students receive 5,000 supervised and standardized clinical hours in Medical School, aren't allowed to practice, and must complete a residency. The author does not list her healthcare credentials in her bio, which instead highlights stories such as the quest to build a better rice cooker. The WSJ should be writing about how self-funded employers should use transparent TPAs and DPC physicians to cut out the majority of the healthcare middlemen. Now that @MartyMakary and @VPrasadMDMPH are out at the FDA, the WSJ had to find another anti physician angle to publish! @KatyTalento @HCLibertyLab @noahkaufmanmd @HeathVeuleman @AtlasMD @mcuban @DutchRojas @mass_marion @DrDiGiorgio @crappiedoc
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Brian Shields retweetledi
Our next step is clearly individualizing therapy based on response. We are making progress! See editorial for DB05 @NEJM and the trial design for @ISPY2trial - and Phergain 2 @myESMO. Biology driven selection is key. @JavierCortesMD @OncoAlert
@AngieDemichele
Dr Amol Akhade@SuyogCancer
Trastuzumab deruxtecan gets @US_FDA approval for NACT and for post NACT residual disease , based upon Destiny breast 011 and 05 trials . Expected approval especially for DB 05 setting . @stolaney1 @ErikaHamilton9 @dr_yakupergun @PTarantinoMD @elmayermd @OncoAlert
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Brian Shields retweetledi
Surprised to discover that Thermo Fisher appears to show a fake western blot for the validation of one of their p53 antibodies. I've added a diagram to show the very similar bands. This does not appear to be one of the "published figures", but their own internal data.
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Brian Shields retweetledi
@foxpaws_onco @hhashmi87 @myelomatips @OncUpdates @End_myeloma @Myeloma_Doc @Bethfaiman @RahulBanerjeeMD @HemOncFellows @GKaurMD @JanakiramMurali @RenoHemonc @BijoyTelivala Financial and time toxicity with IVIG is real. But infection rates decrease significantly with prophylactic IVIG for BCMA BsAbs. Not chasing any number but sticking with IVIG from the get go here. Risk of infections is certainly different with GPRC5D (lower than BCMA)…
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Brian Shields retweetledi
US FDA Approves #atezolizumab for Adjuvant Muscle-Invasive Bladder Cancer With #ctDNA-Guided Treatment based on data from #IMvigor011. This is the first approval in #BladderCancer using ctDNA. A step forward in our field. - businesswire.com/news/home/2026…
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Brian Shields retweetledi
Artificial intelligence and the death of the academic author tandfonline.com/doi/full/10.10… via @itmeded
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Brian Shields retweetledi
100% with Ted on this:
Ted Okon@TedOkonCOA
Let me make this VERY CLEAR: independent community oncology practices don't want #340B discounts, which instead should go to patients in need; not hospitals or practices. We made that very clear in our letter to the @WSJ. @RFKJr_Official @DrOz wsj.com/opinion/expand…
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Brian Shields retweetledi
Bingo!
And who is paying Laura Loomer to attack @SecKennedy? The majority of animal testing is done by Big Pharma & the Chemical Industry, yet Laura Loomer attacks Kennedy relentlessly on this issue.
Has all the markings of a corporate misdirection/disinformation campaign.
Roger Stone@RogerJStoneJr
.@DNIGabbard declassified the Russian Collusion Documents proving it was a hoax, declassified the fake impeachment documents and now she's investigating the integrity of our elections. Why is Laura Loomer attacking Gabbard and who is paying her to do so?
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@RxRegA @SenRonJohnson I think his concerns revolve around whatever the most effective lobbyists prioritize to his staffers.
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I do wonder if @SenRonJohnson has concerns/questions about the unusually swift removal of FDA officials associated with this review (Makary, Prasad, Hoeg), particularly given that it was initiated during their tenure.
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Senator Johnson’s May 11 release does appear to verify that the internal FDA review referenced in Vinay Prasad’s email involved 96 pediatric post-vaccination death reports, with the appendix case narratives ultimately categorizing seven as “probable” or “possible.”
I honestly don’t know enough of the surrounding details/process/timeline to make any broader claims. There are only so many FDA-related rabbit holes one person can go down while also trying to have a life ;)
h/t @OpenVAERS
Screenshot, pg.8: ronjohnson.senate.gov/services/files…
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This is the voice that launched the initial Biopharma media attack on the @fda and @VPrasadMDMPH
Keep this in mind🧐
👇
Laura Loomer@LauraLoomer
As I’ve been saying for a while now, Fauci Holdovers at @NIH and @HHSGov are about to unleash Ebola in America in an effort to undermine President Trump’s second term with another pandemic so they can steal more elections. The @FBI, NIH and HHS have been covering this up since a foreign born virologist named Vincent Munster who worked with Dr. Fauci was recently just caught smuggling Ebola like viruses into the US with his wife and one other colleague. Munster is now under FBI investigation, but he and his wife still remain employed at NIH. Munster and his wife Emmie de Wit work at NIH out of the Rocky Mountain Lab in Montana, and nobody is doing anything about this… Don’t say I didn’t warn you. @POTUS Why are foreign virologists who were caught smuggling deadly pathogens into the US not in prison? How come they haven’t been deported? @NIHDirector_Jay should resign. @TimSheehyMT @RepRyanZinke @DrJBhattacharya @SecKennedy
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@RNAiAnalyst Whatever @US_FDA that @statnews wants. Let @matthewherper choose the next FDA leadership!
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What type of #FDA do you prefer now?
An entirely revamped agency positioned for the AI, preventative medicine future...or putting it back into 'trusted' hands like Pazdur and Marks?
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Brian Shields retweetledi
#ASCO26 is coming soon. Below are the seven GI cancer abstracts that could change the current standard of care if results are positive. Stay tuned.
@ASCO @jgong15 @RevMedicines @SWOG @VanMorrisMD @skopetz @ArndtVogel @GIcancerDoc @ProvSwedish #Daraxonrasib #Pemigatinib #colorectalcancer #HCC #BTC #cholangiocarcinoma #pancreaticcancer #PDAC @curecc
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