@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 The largest study to date has been retracted by the journal after several of the authors admitted errors.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

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

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 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

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...

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

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 <month later #medsky

It looks like the FDA's post for cervical cancer awareness month wasn't authorized to mention FDA-approved HPV vaccines as a cancer prevention strategy or to link to a page about vaccines. The FDA's parent agency, HHS, oversees FDA's communications now #medsky

An update below on Long Covid #medsky

Boston announced yesterday that 2 children have died of the flu & these are the 1st reported flu-related pediatric deaths in Boston since 2013. www.cidrap.umn.edu/influenza-ge... #medsky

Since Makary/FDA Commissioner mentioned investors as 1 of his priorities, the new FDA should disclose which investors will be benefiting from the increase in the number of meningitis, RSV, cervical cancer & hepatitis cases & hospitalizations due to the vaccine changes announced yesterday #medsky

"FDA Commissioner Marty Makary indicated that 1 of the agency’s priorities is fostering an environment that’s good for investors, & that FDA regulation needs to move 'at Silicon Valley speed.' The FDA's digital health policy changes were announced at the CES conference #CES2026 today: #medsky

A response below from Pennsylvania's governor @governor.pa.gov to HHS Secretary Kennedy's strategy to increase meningitis & cervical cancer cases in the US: #medsky

Parents of kids who get RSV, meningitis, hepatitis A or B, hospitalized for flu in 2026 & beyond (or other diseases on the list) might be able to sue HHS Secretary Kennedy & the administration according to this from law professor @doritreiss.bsky.social www.theguardian.com/society/2026... #medsky

Make Meningitis Great Again #medsky

A majority of US children will be losing access to FDA-approved vaccines against meningitis, hepatitis A & B, RSV & more due to unilateral changes made by new federal health officials today. They're also changing HPV vaccine recommendations from 2 shots to 1. www.statnews.com/2026/01/05/c... #medsky

Once again, I implore media outlets to stop saying these are CDC decisions. These are changes being made unilaterally by RFK Jr. against the expert advice of CDC scientists. I note that RFK Jr. no longer recommends flu vaccine for kids in the midst of a horrible influenza year.

Comments below on why a PhD-level education in science could be more important in a world with LLMs, rather than less. In response to: "the frontier models are already as intelligent as the average grad student, if not more. The gap widens by the day. The purpose of a PhD needs to be reevaluated."

Canadian officials are correct, and it’s truly a tragedy.

Comments below on why a PhD-level education in science could be more important in a world with LLMs, rather than less. In response to: "the frontier models are already as intelligent as the average grad student, if not more. The gap widens by the day. The purpose of a PhD needs to be reevaluated."

Top 5 stem cell good news stories of 2025 ipscell.com/2025/12/top-... Duchenne, diabetes, vision loss, and more #stemcells #stemcell

Sarah Cooper posted a new video—"How to MRI"

Biogen's Qalsody (tofersen) was the first gene-based therapy for ALS that received FDA approval (accelerated approval in '23) & the first ALS treatment based on a biomarker. Mutations in the SOD1 gene impact approx 2% of ALS patients but it's a breakthrough in targeting genetic causes of ALS

"new data on the long-term use of tofersen suggest that over about 3 years of treatment, roughly 1/4 of participants in 1 study group experienced stabilization of symptoms & even functional improvement in grip strength & respiratory function." Mutations in SOD1 gene impact approx 2% of ALS patients

"Stopping disease progression & making improvements over 3 to 5 years is unheard of in this type of ALS,” said 1st author Tim Miller WashU Neurology professor & co-dir of the ALS Center. Tofersen shows benefits compared with what we expect to see for these participants, with 25% of participants 1/n

Biogen's ALS gene therapy received accelerated FDA approval in '23 4 rare form of ALS in adults w/mutations in SOD1 gene. Follow up from Ph 3 trial published in 12/22 JAMA Neurology said drug not only delays disease progression & helps patients regain lost function medicine.washu.edu/news/new-als...