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.

If genomic interpretation can become more widely availablw in minutes like below, it could help clinicians make more informed decisions at point of care: identifyinging drug metabolism differences, avoiding serious toxicities, selecting therapies & matching patients 2 clinical trials #medsky #biosky

Pearl Freier@pearlf.bsky.social · last mo.

Stanford genetics & biomedical data sci prof & dept of medicine chair used Claude 2 analyze his genome. What took 9 mos & 30 ppl in '09—took 30 min, 400K tokens & cost $5 in '26. Used 180 word prompt. Fable was downgraded to Opus 4.8 due to "security" www.linkedin.com/feed/update/... #medsky #biosky

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

Pearl Freier@pearlf.bsky.social · 5mo ago

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

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

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 The largest study to date has been retracted by the journal after several of the authors admitted errors.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

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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 ⬇️

Caitlin Rivers@cmyeaton.bsky.social · 6mo ago

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...

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 ⬇️

Christina Jewett@by-cjewett.bsky.social · 6mo ago

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...