Pearl Freier
@pearlf.bsky.social
From Boston, MA. I'm @pearlf on the other blue-colored place. Founder of Cambridge BioPartners, Inc. I post mostly healthcare-related and biotech-related news items.
The same problem for schizophrenia or bipolar disorder or any disease that HHS Secretary Kennedy believes can be treated or cured by a keto diet or "Real Food" or whatever he says. What was FDA's basis for approving leucovorin for autism? #medsky ⬇️
This is troubling for multiple reasons, but one big one is companies won’t want to invest in R&D and clinical trials if they don’t think they can get a fair regulatory review—which is at the end of a long and extremely expensive process.
www.nytimes.com/2026/02/10/h...
www.nytimes.com/2026/02/10/h...
F.D.A. Refuses to Review Moderna Flu Vaccine
www.nytimes.com
February 11, 2026 at 1:06 AM
The same problem for schizophrenia or bipolar disorder or any disease that HHS Secretary Kennedy believes can be treated or cured by a keto diet or "Real Food" or whatever he says. What was FDA's basis for approving leucovorin for autism? #medsky ⬇️
Moderna's seasonal investigational influenza vaccine, mRNA-1010, has been submitted & accepted for review in EU, Canada & Australia. Kennedy's FDA now officially refuses to review the vaccine. "Refusal to review the submission is inconsistent with feedback at pre-Phase 3 & pre-submission" #medsky ⬇️
NEW: The F.D.A. refused to accept an application from Moderna for its mRNA flu vaccine.
Its reason: The agency did not think Moderna compared the new vaccine to one of the best flu shots available. The company spent $750M+ on a 41,000 person study.
www.nytimes.com/2026/02/10/h...
Its reason: The agency did not think Moderna compared the new vaccine to one of the best flu shots available. The company spent $750M+ on a 41,000 person study.
www.nytimes.com/2026/02/10/h...
F.D.A. Refuses to Review Moderna Flu Vaccine
www.nytimes.com
February 11, 2026 at 12:31 AM
Moderna's seasonal investigational influenza vaccine, mRNA-1010, has been submitted & accepted for review in EU, Canada & Australia. Kennedy's FDA now officially refuses to review the vaccine. "Refusal to review the submission is inconsistent with feedback at pre-Phase 3 & pre-submission" #medsky ⬇️
The AI chatbots for medical advice study by Oxford Internet Research Institute researchers cites research on obsolete models that were released nearly 2 yrs ago (2 in 4/24 & 1 in 5/24). The paper wasn't published in an academic journal until 2/9/26. They couldn't publish it in 2024? #medsky
February 10, 2026 at 12:37 AM
The AI chatbots for medical advice study by Oxford Internet Research Institute researchers cites research on obsolete models that were released nearly 2 yrs ago (2 in 4/24 & 1 in 5/24). The paper wasn't published in an academic journal until 2/9/26. They couldn't publish it in 2024? #medsky
I saw that a patient with a PhD in nursing science & work experience in AI posted this on Linked In re: AI scribe her PCP used for annual physical. I left out company's name & similar has likely happened elsewhere. Check the AI-generated notes in your medical record (if you can get access) #medsky
February 9, 2026 at 4:41 AM
I saw that a patient with a PhD in nursing science & work experience in AI posted this on Linked In re: AI scribe her PCP used for annual physical. I left out company's name & similar has likely happened elsewhere. Check the AI-generated notes in your medical record (if you can get access) #medsky
The largest study to date of leucovorin’s effectiveness for treating autism traits was retracted because of data inconsistencies & statistical issues, according to a notice posted by the European Journal of Pediatrics. From @thetransmitter.bsky.social: www.thetransmitter.org/spectrum/lar... #medsky
February 7, 2026 at 7:26 PM
The largest study to date of leucovorin’s effectiveness for treating autism traits was retracted because of data inconsistencies & statistical issues, according to a notice posted by the European Journal of Pediatrics. From @thetransmitter.bsky.social: www.thetransmitter.org/spectrum/lar... #medsky
Reposted by Pearl Freier
83 children died during that measles outbreak.
The Guardian and the AP: Newly revealed emails undermine RFK Jr testimony about 2019 Samoa trip ahead of measles outbreak
Kennedy later said the purpose of his trip had nothing to do with vaccines. US embassy and UN staff at the time said otherwise, emails show www.theguardian.com/us-news/2026...
Kennedy later said the purpose of his trip had nothing to do with vaccines. US embassy and UN staff at the time said otherwise, emails show www.theguardian.com/us-news/2026...
Newly revealed emails undermine RFK Jr testimony about 2019 Samoa trip ahead of measles outbreak
Kennedy later said the purpose of his trip had nothing to do with vaccines. US embassy and UN staff at the time said otherwise, emails show
www.theguardian.com
February 7, 2026 at 12:49 AM
83 children died during that measles outbreak.
Reposted by Pearl Freier
So he personally admits now that a staffer did not post this without his knowledge
Trump doubles down on his racist video: I looked at the first part and it was really about voter fraud... Then I gave it to the people. Generally, they look at the whole thing, but I guess somebody didn't.
February 7, 2026 at 12:48 AM
So he personally admits now that a staffer did not post this without his knowledge
More layoffs at the NIH including new cuts at ARPA-H. Congress approved the funding again including an increase but the layoffs continue. HHS spokesperson didn't reveal the # of employees that were fired or encouraged to resign. "radical transparency" www.fiercebiotech.com/biotech/fier... #medsky
February 6, 2026 at 1:14 AM
More layoffs at the NIH including new cuts at ARPA-H. Congress approved the funding again including an increase but the layoffs continue. HHS spokesperson didn't reveal the # of employees that were fired or encouraged to resign. "radical transparency" www.fiercebiotech.com/biotech/fier... #medsky
Reposted by Pearl Freier
Really wild to see this termed as a "rival" situation because Novo is a pharma company that actually developed and manufactures the drug in question for highly regulated distribution to the public and Hims & Hers is a uhhhh telehealth company selling unauthorized gray market versions of Novo's drug
Novo Nordisk rival Hims & Hers launches cheaper weight-loss pill ft.trib.al/DBF61eT
Novo Nordisk rival Hims & Hers launches cheaper weight-loss pill
US telehealth group will sell product for $49 a month, a third that of its Danish competitor
ft.trib.al
February 5, 2026 at 4:53 PM
Really wild to see this termed as a "rival" situation because Novo is a pharma company that actually developed and manufactures the drug in question for highly regulated distribution to the public and Hims & Hers is a uhhhh telehealth company selling unauthorized gray market versions of Novo's drug
A very interesting story about why an FDA-approved gene editing therapy for sickle cell disease in 12/23 has only treated ~60 patients across US, Europe & MENA & some of the reasons are in the story below. Great explanation of the process involved #biosky #medsky
Vertex’s #$VRTX CRISPR cure for sickle cell has been slow to launch, reaching just 60 patients in 2 years.
Doctors told STAT there's been a surprising culprit: They often can't collect enough cells to make the therapy
www.statnews.com/2026/02/05/v...
Doctors told STAT there's been a surprising culprit: They often can't collect enough cells to make the therapy
www.statnews.com/2026/02/05/v...
Vertex’s CRISPR treatment for sickle cell disease hits unexpected roadblock
Vertex is running out of time to establish Casgevy as a transformative treatment for sickle cell.
www.statnews.com
February 5, 2026 at 6:44 PM
Below is the lead front page story of today's print edition of Wall St Journal. The secondary headline or subhead in 2/4 online edition is "Levies on imports were supposed to bring back a golden age of U.S. manufacturing. They haven’t worked, so far." An unlocked link: www.wsj.com/economy/u-s-...
February 4, 2026 at 9:23 PM
Below is the lead front page story of today's print edition of Wall St Journal. The secondary headline or subhead in 2/4 online edition is "Levies on imports were supposed to bring back a golden age of U.S. manufacturing. They haven’t worked, so far." An unlocked link: www.wsj.com/economy/u-s-...
Reposted by Pearl Freier
This is a targeted attack on science media.
Bhattacharya has slammed science media for what he calls biased coverage, but how are our readers — the global scientific community — supposed to understand his new agency priorities if we can't even get in the door?
Bhattacharya has slammed science media for what he calls biased coverage, but how are our readers — the global scientific community — supposed to understand his new agency priorities if we can't even get in the door?
January 30, 2026 at 6:08 PM
This is a targeted attack on science media.
Bhattacharya has slammed science media for what he calls biased coverage, but how are our readers — the global scientific community — supposed to understand his new agency priorities if we can't even get in the door?
Bhattacharya has slammed science media for what he calls biased coverage, but how are our readers — the global scientific community — supposed to understand his new agency priorities if we can't even get in the door?
Reposted by Pearl Freier
I'm at the Willard Hotel where I've been denied entry and kicked out of the Reclaiming Science event with NIH director Bhattacharya & other top agency leaders.
@jocelynkaiser.bsky.social and I registered for the event months ago yet were told capacity was full, even as they let in dozens of others.
@jocelynkaiser.bsky.social and I registered for the event months ago yet were told capacity was full, even as they let in dozens of others.
January 30, 2026 at 6:07 PM
I'm at the Willard Hotel where I've been denied entry and kicked out of the Reclaiming Science event with NIH director Bhattacharya & other top agency leaders.
@jocelynkaiser.bsky.social and I registered for the event months ago yet were told capacity was full, even as they let in dozens of others.
@jocelynkaiser.bsky.social and I registered for the event months ago yet were told capacity was full, even as they let in dozens of others.
Wow, it looks like the ban includes MD Anderson Cancer Center in Houston & many of the medical centers/academic research institutions in Texas. #medsky
January 27, 2026 at 8:54 PM
Wow, it looks like the ban includes MD Anderson Cancer Center in Houston & many of the medical centers/academic research institutions in Texas. #medsky
Former FIFA president Sepp Blatter on Monday suggested he supports fans boycotting World Cup matches in the US this year due to security concerns. Seeing US federal agents execute a US citizen on the street doesn't bode well for tourism from other countries www.theguardian.com/football/202...
Sepp Blatter suggests fans should not travel to US for World Cup
The ex-Fifa boss showed his support of a Swiss lawyer who called for a boycott of the tournament due to security concerns in the US
www.theguardian.com
January 26, 2026 at 6:48 PM
Former FIFA president Sepp Blatter on Monday suggested he supports fans boycotting World Cup matches in the US this year due to security concerns. Seeing US federal agents execute a US citizen on the street doesn't bode well for tourism from other countries www.theguardian.com/football/202...
Reposted by Pearl Freier
Moderna curbing investments in vaccine trials due to US backlash, CEO tells Bloomberg TV reut.rs/3NBzBtS
Moderna curbing investments in vaccine trials due to US backlash, CEO tells Bloomberg TV
Moderna does not plan to invest in new late-stage vaccine trials because of growing opposition to immunizations from U.S. officials, CEO Stephane Bancel said in an interview with Bloomberg TV on Thursday.
reut.rs
January 22, 2026 at 9:25 PM
Moderna curbing investments in vaccine trials due to US backlash, CEO tells Bloomberg TV reut.rs/3NBzBtS
Some advice for US from Novartis/R. Gal on being more competitive w/China on clinical trials: "Form a recognition system for hospitals which excel in trial leadership using objective measures (e.g. # of trials, patients recruited)" & "Establish guidelines on appropriate costs of trial participation"
Novartis Chief Strategy Officer wrote the US is at "risk of losing its edge" in clinical trials to China. He explains China's advantages incl hospitals: "They're gradually standardizing contracts, driven primarily by national policies, to speed up clinical trials" www.linkedin.com/pulse/early-...
January 26, 2026 at 6:18 PM
Some advice for US from Novartis/R. Gal on being more competitive w/China on clinical trials: "Form a recognition system for hospitals which excel in trial leadership using objective measures (e.g. # of trials, patients recruited)" & "Establish guidelines on appropriate costs of trial participation"
Novartis Chief Strategy Officer wrote the US is at "risk of losing its edge" in clinical trials to China. He explains China's advantages incl hospitals: "They're gradually standardizing contracts, driven primarily by national policies, to speed up clinical trials" www.linkedin.com/pulse/early-...
January 26, 2026 at 6:16 PM
Novartis Chief Strategy Officer wrote the US is at "risk of losing its edge" in clinical trials to China. He explains China's advantages incl hospitals: "They're gradually standardizing contracts, driven primarily by national policies, to speed up clinical trials" www.linkedin.com/pulse/early-...
FDA issued a draft guidance on potential use of minimal residual disease (MRD) & complete response to support accelerated approval of drugs to treat multiple myeloma #mmsm. It was on FDA's agenda in '25 but was delayed by new FDA leaders h/t Fierce Biotech www.fiercebiotech.com/biotech/fda-...
January 22, 2026 at 12:42 PM
FDA issued a draft guidance on potential use of minimal residual disease (MRD) & complete response to support accelerated approval of drugs to treat multiple myeloma #mmsm. It was on FDA's agenda in '25 but was delayed by new FDA leaders h/t Fierce Biotech www.fiercebiotech.com/biotech/fda-...
What drug developers need to know re: the FDA's new draft guidance for use of Bayesian methodology in clinical trials of drugs & biological products—by Yuan Ji, professor of biostats at U Chicago. Linked In post below incl where Bayesian methods are being used currently. #biosky #medsky
What drug developers need to know re: the FDA's new draft guidance for use of Bayesian methodology in clinical trials of drugs & biological products--by Yuan Ji, professor of biostats at U Chicago. Linked In post incl where Bayesian methods r being used currently
www.linkedin.com/pulse/practi...
www.linkedin.com/pulse/practi...
January 20, 2026 at 1:51 PM
CNBC interviewed UBS CEO this morning & one of the topics was the White House's battles with the banking community including the threats made against JPM's Jamie Dimon. Here's the short CNBC video: www.youtube.com/watch?v=qcXx...
UBS CEO Sergio Ermotti on market volatility: Don't see any path of normalization in the future
YouTube video by CNBC Television
www.youtube.com
January 20, 2026 at 1:50 PM
CNBC interviewed UBS CEO this morning & one of the topics was the White House's battles with the banking community including the threats made against JPM's Jamie Dimon. Here's the short CNBC video: www.youtube.com/watch?v=qcXx...
What drug developers need to know re: the FDA's new draft guidance for use of Bayesian methodology in clinical trials of drugs & biological products--by Yuan Ji, professor of biostats at U Chicago. Linked In post incl where Bayesian methods r being used currently
www.linkedin.com/pulse/practi...
www.linkedin.com/pulse/practi...
January 19, 2026 at 11:57 PM
What drug developers need to know re: the FDA's new draft guidance for use of Bayesian methodology in clinical trials of drugs & biological products--by Yuan Ji, professor of biostats at U Chicago. Linked In post incl where Bayesian methods r being used currently
www.linkedin.com/pulse/practi...
www.linkedin.com/pulse/practi...
The termination of $2B in grants by HHS Secretary Kennedy has now been reversed 24 hrs after they were announced during #JPM26 #JPM2026 yesterday. Bulwark confirmed Roll Call's reporting that HHS's decision has now been reversed h/t @samsteindc.bsky.social www.thebulwark.com/p/trump-take... #medsky
January 15, 2026 at 5:08 AM
The termination of $2B in grants by HHS Secretary Kennedy has now been reversed 24 hrs after they were announced during #JPM26 #JPM2026 yesterday. Bulwark confirmed Roll Call's reporting that HHS's decision has now been reversed h/t @samsteindc.bsky.social www.thebulwark.com/p/trump-take... #medsky
MIT's MAESTRO study is looking for a few more #LongCovid male participants in the 18-28 yrs & 56-65 yrs brackets. See below screenshots for more info on Long Covid research study from posts by @immunofever.bsky.social & talresearchgroup.mit.edu/mitmaestro #medsky
January 15, 2026 at 4:37 AM
MIT's MAESTRO study is looking for a few more #LongCovid male participants in the 18-28 yrs & 56-65 yrs brackets. See below screenshots for more info on Long Covid research study from posts by @immunofever.bsky.social & talresearchgroup.mit.edu/mitmaestro #medsky
Dr. Oz & CDC's acting dir left the #JPM26 conf/SF for Minnesota. They posed for photos today in MN in between meetings h/t @ddiamond.bsky.social. CDC's acting dir is also Deputy Sec of HHS. He was appointed by RFK to replace Senate-confirmed Dr. Susan Monarez who left the CDC #medsky
January 15, 2026 at 4:26 AM
Dr. Oz & CDC's acting dir left the #JPM26 conf/SF for Minnesota. They posed for photos today in MN in between meetings h/t @ddiamond.bsky.social. CDC's acting dir is also Deputy Sec of HHS. He was appointed by RFK to replace Senate-confirmed Dr. Susan Monarez who left the CDC #medsky