Pearl Freier

The FDA approved 20 drugs via the Accelerated Approval pathway in 2024—in 2025 the FDA only approved 9 drugs via accelerated approval said Gottlieb at the CNBC Cures summit focused on rare diseases #CNBCCures #medsky

The FDA's oncology drugs review staff is down to <60 from 100 employees said ex FDA Commissioner Scott Gottlieb ('17-'19) on panel at #CNBCCures conf moderated by Becky Quick.HIgh # of senior reviewers are gone & v difficult to replace. Will probably see a higher # of CRLs in '26 he said #medsky

One Detail About Trump’s Pick for Surgeon General Has Haunted Me for Years. Get Ready. A wellness influencer could soon be writing the warning labels on your vices.

@shanpalus.bsky.social reviews "Flackers" and nails the problem with Casey Means.

slate.com/technology/2...

Novartis's ex president of global drug development & ex CMO Dr. John Tsai has been hired by Japanese pharma Daiichi Sankyo to be Global Head of R&D in April. He was an executive partner at UK-based VC firm Syncona working on early stage biotech after he left Novartis daiichisankyo.us/press-releas...

No word yet if Bhattacharya will also serve as the acting director of FDA's Center for Biologics Evaluation and Research (CBER) & as the acting Chief Medical and Scientific Officer if Prasad resigns from the FDA again: #medsky

A staffing update at CDC & NSF: The NIH Director will reportedly now also be serving as acting CDC Director according to NYT's inside sources. Jim O'Neill, prev acting CDC dir & deputy health secretary, is going to be nominated by Trump to run the NSF. www.nytimes.com/2026/02/18/u... #medsky

The FDA's head of CBER has reportedly been accused of se*xual harassment of FDA employees & retaliation according to tonight's WSJ story. Here's an unlocked link to the story: #medsky www.wsj.com/health/healt...

Attendee at private investor meeting with FDA: Why did the FDA approve leucovorin calcium to treat a condition associated with autism? The largest study to date has been retracted by the journal after several of the authors admitted errors. Makary: The Dow is over $50,000!!! #medsky

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 ⬇️

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

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

83 children died during that measles outbreak.

So he personally admits now that a staffer did not post this without his knowledge

Thanks, I just saw the NYT story and the "non-profit" is also paying for it to air during the Super Bowl

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

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

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-...

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?

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.

Wow, it looks like the ban includes MD Anderson Cancer Center in Houston & many of the medical centers/academic research institutions in Texas. #medsky

For sure, so many things going on last year & this year and it's had a bad effect on the economy as well

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

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...

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.

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-...

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