'This is a policy of death by technicality.'
Since the start of 2025, the FDA has refused approval for rare disease therapies at least 23 times. The topic took center stage during today's Senate hearing, with one witness testifying that engaging with regulators was “like talking to a brick wall.”
For anyone else who suffers from hyposmia (you've got a bad sniffer), this Cyrano phase 2 win is super interesting. Only in patients with smell loss after viral infection, but cool nonetheless and heading into phase 3 next!
I'm excited to launch a new series highlighting the vibrant, diverse communities that make up biopharma. This week, I spoke with the Biotech CEO Sisterhood founders about sponsorship amid political headwinds, allyship and how 'women are kicking ass.' www.fiercebiotech.com/biotech/buil...
BREAKING: @lizzylawrence.bsky.social reports that CBER director Vinay Prasad overruled career #FDA staff and unilaterally decided to refusal to accept #Moderna 's #flu vaccine submission. www.statnews.com/2026/02/11/m...
For people who don't follow the FDA closely: this is insane. Like my jaw hit the floor when I saw this. The FDA is flat out refusing to even consider Moderna's application for a new flu vaccine? The federal health apparatus is fully compromised by anti-vax conspiracy. THIS IS NUTS! BAD
NIH Director Jay Bhattacharya, M.D., Ph.D., spent yesterday's Senate hearing dancing around direct answers—like whether the agency will continue to terminate grants or not—except when it came to vaccines and their false association to autism.
www.fiercebiotech.com/biotech/nih-...
A brain tumor has prompted the FDA to place clinical holds on two Regenxbio gene therapies, including a candidate that is less than two weeks away from an approval decision. $RGNX www.fiercebiotech.com/biotech/fda-...
Went to my local library this morning to do a bit of research for my current book project and my goodness such a life-affirming space! There was an adult being taught to read on the next table, children enjoying story time, countless people taking out books. So grateful for our libraries ❤️
The Minnesota civil resistance campaign has been remarkably successful:
- The GOP governor candidate dropped out
- Numerous DOJ officials resigned
- GOP members of Congress are speaking out; business feels pressure
- Noem has been relieved of operational responsibility
The campaign is winning.
Just like in Trump's first term, the NIH has banned the use of fetal tissue from abortions in research--more fully this time. The move "will likely delay discoveries and delivery of therapeutics to patients in need" 🧪 my story (and yes, of course this connects to vaccines):
Asked about government cuts to vaccine research, the new director of ARPA-H said new tech may one day render the "vaccine debate" a thing of the past 🤔 a very interesting conversation with Dr. Alicia Jackson, my latest:
Biogen could have stripped HI-Bio for parts when it bought the biotech for $1.15 billion last year--instead, it used the California company as a foundation to build a brand new, immunology-focused West Coast Hub. I've got the details here! 🧪💊
Cuts to NIH grants have disrupted at least 383 clinical trials, with infectious disease research hit especially hard. A stark example of the real-world repercussions of Trump and co.'s health policy 🧪 my latest:
Biotechs beware: you're in for a scare.
Had a blast writing this year's edition of the Biotech Graveyard, a terrifying Fierce Biotech tradition where we honor the ghosts of biotechs past and also allude to the 1958 novelty song "The Purple People Eater." Give it a read--if you dare!
About 30 years after their discovery, Nobel-winning regulatory T cells are on the cusp of becoming new medicines; and as one of this year's laureates told me, they have the potential to become a "universal drug" 🧪 my deep dive into Tregs:
When it comes to China tariffs and limiting licenses to innovation from the country, Nkarta CEO Paul Hastings is urging the Trump administration to “let that one go."
Read more from my interview here ⬇️
The FDA has handed out its first national priority vouchers, positioning 9 companies to complete the approval process in one to two months. www.fiercebiotech.com/biotech/fda-...
An extremely common drug used to treat diabetes was able to soothe brain inflammation in female mice with multiple sclerosis, suggesting it could be a ready treatment option for a vexing disease that disproportionally affects people with female sex chromosomes 🧪 my story:
The most complicated story I've ever worked on has dropped.
It's long and worth the read.
I go deep into the world of alternative funding programs & how they're harming patient access to timely prescriptions:
www.fiercehealthcare.com/payers/new-w...
Emerging from the darkness of this era will require us to acknowledge that the previous status quo, including many institutions that may have served us well in another era, have been failing for my entire lifetime.
An ICE agent throws a tear gas canister at protesters at East 105th Street and South Avenue N in East Side. Photo Credit: Anthony Vazquez/Sun-Times
Federal immigration enforcement agents detain a protester during a skirmish at East 105th Street and South Avenue N in East Side. Photo Credit: Anthony Vazquez/Sun-Times
A U.S. Immigration and Customs Enforcement agent points a crowd control weapon at a protester Tuesday at East 105th Street and South Avenue N in the East Side neighborhood. Photo Credit: Anthony Vazquez/Sun-Times
A Chicago Police Department officer washes his face after being exposed to tear gas during a protest at East 105th Street and South Avenue N in East Side. Photo Credit: Anthony Vazquez/Sun-Times
Greg Bovino, Kristi Noem, and DHS need to answer for their unchecked attacks on Chicago residents.
ICE is an out-of-control danger to our peaceful communities.
The images from the Sun-Times today speak for themselves.
The 2025 Nobel Prize in Physiology or Medicine is here and it's a doozy: the discovery of regulatory T cells! I woke up at 2am to write this story so if you see any typos, no you didn't:
If the university is found in violation of civil rights laws, a "debarment" would prohibit the university from business relations with any federal agency for a specified timeframe. www.fiercebiotech.com/biotech/hhs-...
To understand how budget cuts could impact the NIH, economists looked to the past--and their alternate history revealed how Trump-level defunding would have undercut breakthrough new medicines of the 21st century 🧪 my story:
After a tumultuous journey filled with delays and rejection, the FDA has approved Stealth BioTherapeutics’ treatment for the ultrarare disease Barth syndrome, marking the peptide as the first therapy for the condition.
NIH-sponsored research was the basis of all 356 new drug approvals between 2010 and 2019, according to a new AAMC report.
Here, I take a look at the states most impacted by NIH research cuts, plus the domino effects on clinical trials, the economy and public health.
Vaccines work. Period.
The problem with allowing guns everywhere is that no one is safe anywhere.
Had a blast visiting the Knight Cancer Institute in Portland to talk about their record-setting $2 billion gift from Nike founder Phil Knight, and how they plan to use the cash to become a household name in cancer research and care. Check it out, and enjoy the photo quality from my ancient iPhone!
