Zachary Brennan
@zacharybrennan.bsky.social
📤 2089
📥 336
📝 63
Senior editor, Endpoints News
Scoop: FDA confirms it's shaking up its university collaborations this year, under what's known as its CERSI program (5-yr, $50M collabs w/the likes of Hopkins, MD, UCSF-Stanford, Yale-Mayo Clinic) -
endpoints.news/fda-to-rewor...
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FDA to rework 'CERSI' university collaborations, will make funding changes
FDA plans to redesign its Centers for Excellence in Regulatory Science and Innovation program in 2026, affecting partnerships with Johns Hopkins, Yale, Mayo Clinic and others.
https://endpoints.news/fda-to-rework-cersi-university-collaborations-will-make-funding-changes/
2 days ago
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Zachary Brennan
Amy Maxmen, PhD
about 1 month ago
The CDC is an emergency response agency, whether that means responding to a cancer cluster, a measles outbreak, lead poisoning or the next pandemic. I spoke with
@cnn.com
about how chaos there jeopardizes the country.
kffhealthnews.org/news/article...
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Watch: How Concerns of CDC Scientists Over Political Interference Have Grown This Year - KFF Health News
KFF Health News correspondent Amy Maxmen traces the political turmoil at the CDC under President Donald Trump.
https://kffhealthnews.org/news/article/watch-cdc-scientists-political-interference-trump/
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Sarah Karlin-Smith
about 1 month ago
more vertical integration in health care... Cigna invests in Shields Health Solutions a specialty pharmacy company that just acquired the PE firm that just acquired Walgreens... the web of connections is a bit headspinning...
nam04.safelinks.protection.outlook.com?url=https%3A...
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Evernorth Health Services Announces Investment in Shields Health Solutions
Investment Further Enhances Evernorth's Participation in Growing Market for Specialty Medicine BLOOMFIELD, Conn., Sept. 2, 2025 /PRNewswire/ -- Evernorth Health Services ("Evernorth"), a...
https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fnewsroom.thecignagroup.com%2F2025-09-02-Evernorth-Health-Services-Announces-Investment-in-Shields-Health-Solutions&data=05%7C02%7Csarah.karlin-smith%40citeline.com%7C63c9151116a94c505f9b08ddea106adc%7Cfa62df0185e942728434d8b84d55a66d%7C0%7C0%7C638924079320084001%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C40000%7C%7C%7C&sdata=0%2BIC1iGz5pKBpAXu8YfywFSgAQFyAzZbByHcUCFhyjk%3D&reserved=0
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Zachary Brennan
Renee DiResta
about 1 month ago
Vinay Prasad had YouTube censor Jonathan Howard’s channel because he didn’t like how it made him look. A petty act by a vindictive, unqualified hack. And more evidence that these frEe sPeEcH warriors have always been petty censors out to silence criticism that they just can’t cope with.
add a skeleton here at some point
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Greg Folkers
about 2 months ago
Endpoints: Kennedy pledges support for mRNA cancer vaccines despite decrying mRNA for Covid by
@zacharybrennan.bsky.social
bit.ly/41ztoTm
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Zachary Brennan
Derek Lowe
2 months ago
This is a crime. I can’t put it any other way.
add a skeleton here at some point
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Robert Califf
2 months ago
This is ominous.
open.substack.com/pub/pauloffi...
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RFK Jr.’s Plan to Eliminate Vaccines
Think VICP
https://open.substack.com/pub/pauloffit/p/rfk-jrs-plan-to-eliminate-vaccines?r=7bit1&utm_campaign=post&utm_medium=email
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Zachary Brennan
ProPublica
3 months ago
NEW: With deep job cuts at the FDA, inspectors say the ongoing strain could compromise policing an industry spread across more than 90 countries. “Things will be missed, we are going to have a lot less safe drugs,” a former inspector said.
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FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked with rooting out dangerous manufacturing practices.
https://www.propublica.org/article/fda-cuts-drug-factory-inspections?utm_source=bluesky&utm_medium=social&utm_campaign=propublica-bsky&utm_content=7-7
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6 (from today). RFK says he made no promises to Cassidy
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4 months ago
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Zachary Brennan
Jason L. Schwartz
4 months ago
Things are very bad for U.S. vaccination policy these days and are only going to get worse. In
@nejm.org
, I examine the recent news about COVID-19 vaccines and ACIP, what likely lies ahead, and what the medical and public health communities should do to lessen the damage
www.nejm.org/doi/full/10....
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Revised Recommendations for Covid-19 Vaccines — U.S. Vaccination Policy under Threat | NEJM
A series of recent actions by the Trump administration upend the country’s approach to Covid-19 vaccination and may portend a broader shift in the government’s role in protecting the public health.
https://www.nejm.org/doi/full/10.1056/NEJMp2507766
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Zachary Brennan
Mike Stobbe
4 months ago
New CDC advisers will skip some expected topics and explore a target of antivaccine activists
apnews.com/article/acip...
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New CDC advisers will skip some expected topics and explore a target of antivaccine activists
U.S. Health Secretary Robert F. Kennedy Jr.’s new vaccine advisers meet next week. Their agenda suggests they’ll skip some expected topics, including a vote on COVID-19 shots.
https://apnews.com/article/acip-cdc-vaccine-thimerosal-3d27b10be11112a77c6dea86695ec4df?utm_source=twitter&utm_medium=share
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Zachary Brennan
Apoorva Mandavilli
4 months ago
BREAKING: The FDA has approved a twice-yearly injection that provided a near-perfect shield against H.I.V. infection in clinical trials. But the Trump administration has gutted the programs that might have paid for it in low-income countries (Gift article)
www.nytimes.com/2025/06/18/h...
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Regulators Approve a Twice-Yearly Shot to Prevent H.I.V. Infection
https://www.nytimes.com/2025/06/18/health/hiv-fda-lenacapavir.html?unlocked_article_code=1.P08.ZNmq._VIjGpBFawDT&smid=url-share
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4 months ago
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Kai Kupferschmidt
4 months ago
Feeling a lot like I did in early days of the pandemic these days. It is so clear what’s coming: The people that will die because of cuts in global health, because of cuts to research, because of the concerted anti-vaccine push. It’s clear what’s coming, but we will have to wait to count the dead.🧪
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JAMA
4 months ago
Viewpoint: The FDA's non-standard review of Novavax's #COVID19 vaccine raises concerns about regulatory integrity and the influence of political considerations on public health decisions.
https://ja.ma/3TepavL
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Zachary Brennan
Ted Pavlic (he/him/his)
4 months ago
Reminder: Nobel-prize winning PCR (1983), used in basically all genetic tech today, was only possible because of extremophile bacterium discovered in 1964 in Yellowstone funded by a small ~$80k NSF grant with no obvious application at the time.
#science
🧪
www.richmondscientific.com/how-a-discov...
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How a discovery in Yellowstone National Park led to the development of PCR - Richmond Scientific
A discovery in Yellowstone National Park led to the development of PCR, the gold-standard COVID-19 tests used to fight the global pandemic.
https://www.richmondscientific.com/how-a-discovery-in-yellowstone-national-park-led-to-the-renowned-technique-of-dna-amplification-pcr
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the 10 out, 1 in policy is agency-wide, not at all specific to cell/gene therapies and there was no mention at that meeting of deregulating or changing any regs (RFK was talking about adding some, and asking for requests/lists on which to cut)
add a skeleton here at some point
4 months ago
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Zachary Brennan
Helen Branswell 🇨🇦
4 months ago
So it looks like
#ACIP
will be meeting later this month. It will be interesting. 🍿
public-inspection.federalregister.gov/2025-10432.pdf
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https://public-inspection.federalregister.gov/2025-10432.pdf
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Larry Levitt
4 months ago
An increase of 10.9 million uninsured people, plus millions of others who will lose coverage if enhanced ACA premium tax credits expire this year, would reverse much of the gains in insurance coverage from the ACA.
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Berkeley Lovelace Jr.
4 months ago
NEW - A new FDA AI tool that could speed up reviews of medical devices is struggling with simple tasks, like uploading documents, according to two people familiar. A separate tool, called Elsa, which was rolled out to FDA employees Monday is also having issues.
www.nbcnews.com/health/healt...
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FDA’s AI tool for medical devices struggles with simple tasks
On Monday, the agency announced that a separate AI tool, called Elsa, had been rolled out to all FDA employees. Sources say that it also has issues.
https://www.nbcnews.com/health/health-news/fdas-ai-tool-medical-devices-struggles-simple-tasks-rcna210340
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Meet the FDAers who were cut by DOGE but still get paid in full w/benefits as they look for new work (going on month 3 now..)
endpoints.news/laid-off-fda...
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DOGE set today as their last day at FDA. Instead, they're continuing to get full pay and don't work
FDA lawyer and other federal health agency workers remain on paid leave amid Trump administration cuts, awaiting court decisions while searching for new jobs.
https://endpoints.news/laid-off-fda-workers-wait-in-limbo-collecting-pay-and-wondering-whats-next/
4 months ago
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Zachary Brennan
Alexander Tin
4 months ago
For pregnant women, CDC now lists COVID-19 vaccines during pregnancy as "No Guidance/Not Applicable"
www.cdc.gov/vaccines/hcp...
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Zachary Brennan
Mehdi Hasan
4 months ago
This is what happens when you put internet conspiracy theorists in charge of major government departments.
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The MAHA Report Cites Studies That Don’t Exist
The Trump administration’s “Make America Healthy Again” report misinterprets some studies and cites others that don’t exist, according to the listed authors.
https://www.notus.org/health-science/make-america-healthy-again-report-citation-errors
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Sarah Karlin-Smith
4 months ago
If someone has to read halfway through your story before finding out Kennedy's step on COVID vaccination today is not in alignment with the scientific evidence you are doing it wrong.
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Robert Califf
4 months ago
These ACOG views were based on a significant studies. it will be interesting to see if the recommendation against vaccination is based on new evidence or some kind of interpretation of the old evidence.
www.acog.org/news/news-re...
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ACOG Statement on HHS Recommendations Regarding the COVID Vaccine During Pregnancy
ACOG strongly opposes the U.S. Department of Health and Human Services' decision to stop recommending the COVID vaccination during pregnancy, citing clear evidence of its safety and effectiveness in p...
https://www.acog.org/news/news-releases/2025/05/acog-statement-on-hhs-recommendations-regarding-the-covid-vaccine-during-pregnancy
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Zachary Brennan
Larry Levitt
5 months ago
The House reconciliation bill would penalize states to the tune of $92 billion if they use their own funds to provide health care to undocumented immigrants.
www.kff.org/medicaid/iss...
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Zachary Brennan
Carl T. Bergstrom
5 months ago
Goddamn. The dek really says it all.
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Apoorva Mandavilli
5 months ago
Come this fall, only older Americans and those with chronic health problems may be urged to get the Covid shot — assuming the vaccine is available at all.
www.nytimes.com/2025/05/15/h...
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Federal Officials May Limit Recommendations for Covid Vaccine
https://www.nytimes.com/2025/05/15/health/covid-vaccine-recommendations.html?unlocked_article_code=1.HU8.zz1u.upC1rU_45ocb&smid=url-share
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Zachary Brennan
Jonathan Howard
5 months ago
The guy who demanded his predecessors do RCTs and bashes Big Pharma trials is suddenly going to pivot and claim the government has no role in generating evidence, and only Big Pharma trials are reliable.
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This is the equivalent of someone asking where Albany is located and you wrongly guess Vermont, and they say, “No, actually, it’s the United States.”
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5 months ago
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Apoorva Mandavilli
5 months ago
RFK Jr. said multiple times during his house and senate hearings today that no scientists have been fired from federal agencies. Our reporting has shown that hundreds, if not thousands, of scientists have been let go from NIH/CDC/FDA
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ACF falls under HHS…there were quite a few gaffes in this exchange from Alsobrooks too
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5 months ago
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Zachary Brennan
Alondra Nelson
5 months ago
"For me, the answer now lies in refusal, the withdrawal of participation from systems that require dishonesty as the price of belonging." Today I am resigning from the National Science Board and the Library of Congress Scholars Council. I wrote about my decision in TIME.
time.com/7285045/resi...
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Why I’m Resigning from the NSF and Library of Congress
I cannot participate in systems that require dishonesty as the price of belonging.
https://time.com/7285045/resigning-national-science-foundation-library-congress/
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Zachary Brennan
The New York Times
5 months ago
Robert F. Kennedy Jr., the health secretary, posted photos on Sunday of himself and his grandchildren swimming in a contaminated Washington creek where swimming is not allowed because it is used for sewer runoff.
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RFK Jr. Swims in Washington Creek That Flows With Sewage and Bacteria
https://www.nytimes.com/2025/05/12/us/politics/rfk-jr-rock-creek-bacteria.html?smtyp=cur&smid=bsky-nytimes
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Zachary Brennan
Dominic Tyer
5 months ago
After FDA firings, drug reviewers are asked to volunteer for administrative work
endpts.com/after-fda-fi...
#FDA
#pharma
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Exclusive: After FDA firings, drug reviewers are asked to volunteer for administrative work
Leadership in the FDA's Office of New Drugs sent an email to staff Friday afternoon asking if anyone would volunteer to take on more administrative work, following the firing of many of the agency's a...
https://endpts.com/after-fda-firings-drug-reviewers-are-asked-to-volunteer-for-administrative-work/
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Zachary Brennan
Elizabeth Jacobs, PhD
5 months ago
RFK Jr. ordered the NIH’s Integrated Research Facility in Frederick to stop all research on serious infectious diseases yesterday at 5:00 PM. They study pathogens like Ebola there. You may be familiar with it from The Hot Zone.
www.wired.com/story/hhs-ni...
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RFK Jr.'s HHS Orders Lab Studying Deadly Infectious Diseases to Stop Research
NIAID's Integrated Research Facility is one of the few federal facilities charged with studying Ebola. Tuesday afternoon, all of its work was put on indefinite pause by Robert F. Kennedy Jr.'s departm...
https://www.wired.com/story/hhs-niaid-irf-ebola-disease-research-stop/
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A wave of early retirements at OND and elsewhere across CDER recently took effect, following the April staff cuts
t.co/I8lE4ZgtuR
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https://endpts.com/more-fda-staff-leave-following-broad-firings-at-drug-agency/
https://t.co/I8lE4ZgtuR
5 months ago
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Charles Ornstein
5 months ago
“As alleged, Gilead spent tens of millions of dollars on these programs, including over $20 million in speaking fees and millions more in exorbitant meals, alcohol and travel, all in an effort to induce doctors to prescribe Gilead’s HIV drugs and drive up sales.” -DOJ
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U.S. Attorney Announces $202 Million Settlement With Gilead Sciences For Using Speaker Programs To Pay Kickbacks To Doctors To Induce Them To Prescribe Gilead’s Drugs
Jay Clayton, the United States Attorney for the Southern District of New York; Naomi Gruchacz, the Special Agent in Charge of the New York Regional Office of the U.S. Department of Health and Human Se...
https://www.justice.gov/usao-sdny/pr/us-attorney-announces-202-million-settlement-gilead-sciences-using-speaker-programs
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Zachary Brennan
Patti Zettler
5 months ago
Out today in
@jama.com
, me and
@nathancortez.bsky.social
examine how the drastic staffing cuts at FDA run counter to FDA's many statutory obligations and the bargains embodied in user fee provisions - and put public health, innovation, and all of us at risk.
jamanetwork.com/journals/jam...
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The FDA’s Crisis Is Everyone’s Crisis
This Viewpoint discusses the Trump administration’s firings of thousands of US Food and Drug Administration employees and the ramifications of those actions on the agency’s congressionally given publi...
https://jamanetwork.com/journals/jama/article-abstract/2833417
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Derek Lowe
5 months ago
The lasting damage that the Trump administration is doing to US science is barbaric. But more and more of the general public is hearing about it and just how bad it is:
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The Continuing Crisis, Part XIII: Lasting Damage
https://www.science.org/content/blog-post/continuing-crisis-part-xiii-lasting-damage
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Jeremy Berg
5 months ago
Here is the link to the Last Week Tonight with John Oliver about RFK, Jr, public health, and HHS (including NIH)
www.youtube.com/watch?v=8H34...
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RFK Jr. & HHS: Last Week Tonight with John Oliver (HBO)
YouTube video by LastWeekTonight
https://www.youtube.com/watch?v=8H34jcpEsFs
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Jeremy Berg
5 months ago
Here is a link to 60 Minutes NIH segment...
www.cbsnews.com/news/scienti...
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Scientists fear Trump administration cuts to NIH could impact the health of Americans for generations
Former National Institutes of Health Director Dr. Francis Collins, who abruptly left his NIH research lab in February, fears aggressive downsizing could impact Americans' health.
https://www.cbsnews.com/news/scientists-fear-trump-administration-nih-cuts-could-impact-health-60-minutes-transcript/
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Alexander Tin
6 months ago
In interviews, FDA Commissioner Makary has repeatedly claimed no scientists were laid off at his agency We spoke to laid-off scientists in some of FDA's food safety labs that were gutted by layoffs "That just made me so mad," one laid-off scientist told us
www.cbsnews.com/news/fda-hea...
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https://www.cbsnews.com/news/fda-head-falsely-claims-no-scientists-laid-off-as-agency-shutters-food-safety-labs/
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Zachary Brennan
Jared Whitlock
6 months ago
👀 Approvals for drugs aimed at exceptionally rare conditions could be made “on a conditional basis,” Makary said, without a randomized trial. Via
@zacharybrennan.bsky.social
endpts.com/fdas-makary-...
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Makary, in one of first comments on FDA policy, floats new pathway for rare disease drugs
FDA Commissioner Marty Makary announces plans for new conditional approval pathway for rare disease drugs, discusses agency reforms in SiriusXM interview with Megyn Kelly.
https://endpts.com/fdas-makary-floats-new-approval-pathway-for-rare-disease-drugs/
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Zachary Brennan
Anna Brown
6 months ago
While Trump has launched a 232 investigation to tax pharmaceuticals, he's simultaneously issued an executive order to lower US drug prices. See
@zacharybrennan.bsky.social
coverage on this at
@endpts.com
:
endpts.com/trump-pledge...
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Trump pledges his support for a change to the IRA long sought by drugmakers
Trump signs EO on drug pricing, supports PhRMA reforms for Medicare negotiations timeline, calls for Canadian drug imports, and includes 340B program changes for EpiPens and insulin.
https://endpts.com/trump-pledges-support-for-changing-ira-pill-penalty-siding-with-pharma/
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Zachary Brennan
Aaron Rupar
6 months ago
Trump on his plan to impose tariffs on pharmaceuticals: "All I have to do is impose a tariff. The more, the faster the move in. It's very simple -- it's inversely proportional, the higher the tariff, the faster they come."
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donnayoungdc
6 months ago
"I don’t see any possible way" to get the answer by September of what causes
#autism
, Peter Marks, former director of
#FDA's
Center for Biologics Evaluation & Research, told
@facethenation.bsky.social
, calling RFK Jr.'s claim "false hope."
www.cbsnews.com/video/full-i...
#VaccinesSaveLives
#MedSky
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Full interview: Dr. Peter Marks
Watch Margaret Brennan's full interview with Dr. Peter Marks, the former head of FDA's Center for Biologics Evaluation and Research, a portion of which aired on "Face the Nation with Margaret Brennan"...
https://www.cbsnews.com/video/full-interview-dr-peter-marks/
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Max Gelman
6 months ago
FDA commissioner Marty Makary wants to phase out animal testing and replace it with organoids, lab-grown cultures of human cells that can mimic and recreate organs. But the process may take longer than the 3-5 year timeline he proposed. Story w/@scienceboss.bsky.social:
endpts.com/fda-unveils-...
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Makary wants to replace animal testing with organoids. It may take a while
Under the 11-page 'roadmap' outlined Thursday, the goal is for alternative methods to become 'the exception rather than the norm' in the next three to five years.
https://endpts.com/fda-unveils-plan-to-replace-animal-testing-with-organoids/
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Eric Michael Garcia
6 months ago
Or, Mr. Secretary, you can read my book and read how there isn't an autism epidemic and rather, we've seen an increase in autism thanks to better detection and more services.
www.harpercollins.com/products/wer...
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Helen Branswell 🇨🇦
6 months ago
Secretary Kennedy seems to believe that vaccines against respiratory bugs that target a single antigen don't work. People who have studied and designed vaccines beg to differ. With multiple pending
#Covid
vaccines before
#FDA
, this may not bode well.
www.statnews.com/2025/04/10/r...
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Health secretary RFK Jr. declares certain vaccines have ‘never worked,’ flummoxing scientists
Health secretary Robert F. Kennedy Jr. has expressed another unorthodox view on vaccines, declaring that single antigen vaccines, used to prevent Covid and other conditions, do not work.
https://www.statnews.com/2025/04/10/rfk-jr-single-antigen-vaccines-novavax-fda-decision/
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