Zachary Brennan
@zacharybrennan.bsky.social
Senior editor, Endpoints News
Reposted by Zachary Brennan
Someday I will not have to write about Sarepta Therapeutics and their ineffective drugs that never should have been approved by the FDA in the first place.
This is not that day.
This is not that day.
Sarepta: Enough, For God's Sake
www.science.org
November 5, 2025 at 1:33 PM
Someday I will not have to write about Sarepta Therapeutics and their ineffective drugs that never should have been approved by the FDA in the first place.
This is not that day.
This is not that day.
Reposted by Zachary Brennan
Exactly.
This is explicitly building political favoritism into the FDA review process.
This is explicitly building political favoritism into the FDA review process.
"Despite historically short median review times, the CNPV program proposes to further accelerate the drug-review process."
Then why is this program needed? Oh, I see...
"The CNPV proposal opens the door to conflicts of interest in the relationship between the FDA commissioner and sponsors."
Then why is this program needed? Oh, I see...
"The CNPV proposal opens the door to conflicts of interest in the relationship between the FDA commissioner and sponsors."
The title of this @nejm.org perspective could have been, "Commissioner’s National Priority Voucher Program: The Trumpification of FDA Drug Review."
Another must-read from @portalresearch.org
www.nejm.org/doi/10.1056/...
Another must-read from @portalresearch.org
www.nejm.org/doi/10.1056/...
October 28, 2025 at 5:58 PM
Exactly.
This is explicitly building political favoritism into the FDA review process.
This is explicitly building political favoritism into the FDA review process.
Reposted by Zachary Brennan
I’m pretty sure that this trained medic, whatever else you may think about him, totally knows there’s no such thing as a 650% discount.
Dr Oz: "Drugs for lung diseases are discounted massively. The president highlighted 650%. Significant discounts ... "
October 10, 2025 at 10:05 PM
I’m pretty sure that this trained medic, whatever else you may think about him, totally knows there’s no such thing as a 650% discount.
$AZN will pay you to use their inhalers
An official White House press release announces that an AstaZeneca inhaler will become available at a price discount of 654%.
www.whitehouse.gov/fact-sheets/...
www.whitehouse.gov/fact-sheets/...
October 10, 2025 at 10:44 PM
$AZN will pay you to use their inhalers
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...
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.
endpoints.news
October 6, 2025 at 5:09 PM
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...
Reposted by Zachary Brennan
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...
I spoke with @cnn.com about how chaos there jeopardizes the country. kffhealthnews.org/news/article...
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.
kffhealthnews.org
September 2, 2025 at 12:07 PM
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...
I spoke with @cnn.com about how chaos there jeopardizes the country. kffhealthnews.org/news/article...
Reposted by Zachary Brennan
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...
the web of connections is a bit headspinning...
nam04.safelinks.protection.outlook.com?url=https%3A...
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...
nam04.safelinks.protection.outlook.com
September 2, 2025 at 1:47 PM
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...
the web of connections is a bit headspinning...
nam04.safelinks.protection.outlook.com?url=https%3A...
Reposted by Zachary Brennan
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.
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.
My YouTube channel has like 300 followers and 99% of it is just videos of our medical establishment.
Today, I learned they are trying to censor me, instead of doing their job.
Today, I learned they are trying to censor me, instead of doing their job.
September 2, 2025 at 11:07 AM
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.
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.
Reposted by Zachary Brennan
Endpoints: Kennedy pledges support for mRNA cancer vaccines despite decrying mRNA for Covid
by @zacharybrennan.bsky.social
bit.ly/41ztoTm
by @zacharybrennan.bsky.social
bit.ly/41ztoTm
August 14, 2025 at 9:55 PM
Endpoints: Kennedy pledges support for mRNA cancer vaccines despite decrying mRNA for Covid
by @zacharybrennan.bsky.social
bit.ly/41ztoTm
by @zacharybrennan.bsky.social
bit.ly/41ztoTm
Reposted by Zachary Brennan
This is a crime.
I can’t put it any other way.
I can’t put it any other way.
Pandemic preparedness in the US has been leveled a crippling blow with the cancellation of multiple #BARDA contracts to help develop mRNA vaccines. No other vaccine platform produces vaccine so quickly; without mRNA, Americans will have a long wait for pandemic vax. www.statnews.com/2025/08/05/m...
Health secretary RFK Jr. shuts door on U.S. investment in mRNA vaccine research
Vaccine experts and people steeped in pandemic preparedness expressed horror at the news that RFK Jr. has shut the door in U.S. investment in mRNA vaccine research.
www.statnews.com
August 5, 2025 at 11:09 PM
This is a crime.
I can’t put it any other way.
I can’t put it any other way.
Reposted by Zachary Brennan
Reposted by Zachary Brennan
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.
“Things will be missed, we are going to have a lot less safe drugs,” a former inspector said.
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.
www.propublica.org
July 7, 2025 at 11:00 AM
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.
“Things will be missed, we are going to have a lot less safe drugs,” a former inspector said.
6 (from today). RFK says he made no promises to Cassidy
Bill Cassidy and RFK Jr: A Short Story
1. Cassidy says that RFK Jr. will keep ACIP intact
2. RFK Jr. fires every member of ACIP
3. Cassidy says he will talk to RFK Jr. to ensure RFK Jr. appoints qualified people to ACIP
4. RFK Jr. appoints quacks
5. Cassidy wants to delay ACIP meeting
1. Cassidy says that RFK Jr. will keep ACIP intact
2. RFK Jr. fires every member of ACIP
3. Cassidy says he will talk to RFK Jr. to ensure RFK Jr. appoints qualified people to ACIP
4. RFK Jr. appoints quacks
5. Cassidy wants to delay ACIP meeting
June 24, 2025 at 5:33 PM
6 (from today). RFK says he made no promises to Cassidy
Reposted by Zachary Brennan
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....
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.
www.nejm.org
June 18, 2025 at 10:45 PM
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....
Reposted by Zachary Brennan
New CDC advisers will skip some expected topics and explore a target of antivaccine activists apnews.com/article/acip...
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.
apnews.com
June 18, 2025 at 7:53 PM
New CDC advisers will skip some expected topics and explore a target of antivaccine activists apnews.com/article/acip...
Reposted by Zachary Brennan
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...
(Gift article)
www.nytimes.com/2025/06/18/h...
Regulators Approve a Twice-Yearly Shot to Prevent H.I.V. Infection
www.nytimes.com
June 18, 2025 at 6:35 PM
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...
(Gift article)
www.nytimes.com/2025/06/18/h...
👀
Makary says reason he is doing his CEO forums privately is so CEOs can be honest and don't have to worry about shareholders think. #BIO2025
June 17, 2025 at 7:51 PM
👀
Reposted by Zachary Brennan
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.🧪
It’s clear what’s coming, but we will have to wait to count the dead.🧪
June 11, 2025 at 11:56 PM
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.🧪
It’s clear what’s coming, but we will have to wait to count the dead.🧪
Reposted by Zachary Brennan
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
https://ja.ma/3TepavL
June 9, 2025 at 3:15 PM
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
https://ja.ma/3TepavL
Reposted by Zachary Brennan
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...
www.richmondscientific.com/how-a-discov...
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.
www.richmondscientific.com
June 8, 2025 at 9:09 PM
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...
www.richmondscientific.com/how-a-discov...
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)
RFK Jr's tenure at HHS is shaping up to be one of inconsistent, nonsensical, and dangerous overregulation (see, e.g., vaccines) and underregulation (see, gene and cell therapies)
“President Trump has given us an executive order that says for every regulation that we put in place, we have to get rid of 10." HHS & FDA apparently moving forward with broad deregulatory agenda for cell & gene-based medical interventions. www.fiercebiotech.com/biotech/fda-...
June 9, 2025 at 2:26 AM
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)
Reposted by Zachary Brennan
So it looks like #ACIP will be meeting later this month.
It will be interesting.
🍿
public-inspection.federalregister.gov/2025-10432.pdf
It will be interesting.
🍿
public-inspection.federalregister.gov/2025-10432.pdf
public-inspection.federalregister.gov
June 6, 2025 at 9:41 PM
So it looks like #ACIP will be meeting later this month.
It will be interesting.
🍿
public-inspection.federalregister.gov/2025-10432.pdf
It will be interesting.
🍿
public-inspection.federalregister.gov/2025-10432.pdf
Reposted by Zachary Brennan
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.
June 4, 2025 at 2:16 PM
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.
Reposted by Zachary Brennan
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...
A separate tool, called Elsa, which was rolled out to FDA employees Monday is also having issues.
www.nbcnews.com/health/healt...
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.
www.nbcnews.com
June 3, 2025 at 6:42 PM
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...
A separate tool, called Elsa, which was rolled out to FDA employees Monday is also having issues.
www.nbcnews.com/health/healt...
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...
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.
endpoints.news
June 3, 2025 at 11:27 AM
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...