Sue Sutter

Senior Editor, Citeline's Pink Sheet, covering US FDA drug and biologic regulation and approvals. Views are my own. @PharmaPinkSheet

[Sue Sutter @PinkSheetSutter]

@statnews My sympathies to the folks at STAT on the loss of your colleague, friend, and a superb health care journalist.

[Sue Sutter @PinkSheetSutter]

@maxonwifi Very sad to hear this. She was an icon in the health journalism world, especially for her coverage of flu, Covid and Ebola. My sympathies to her STAT colleagues.

[Sue Sutter @PinkSheetSutter]

US FDA’s Davis, Mikhail Gain Permanent CDER, CBER Director Positions https://t.co/4D4bIDzn0l

[Derrick @dgingery]

For those keeping track ... Capt. Sarah Meyer of the CDC is no longer listed as a member of the @FDA Vaccines and Related Biological Products Advisory Committee. Her term was set to expire in 2028.

[Brian Reid @brianreid]

Good catch by Cathy Kelly and Pink on this. BridgeBio didn't note the orphan drug exception in their release, but they appended it to the 8-K. Hmmm.

I'm curious what other companies have that orphan provision baked in.

[Mandy Jackson @ScripMandy]

Notable that none of these companies involved in today’s MFN deals with the Trump administration are members of the Midsized Biotech Alliance of America, formed to lobby on behalf of mid-sized drug makers on policy issues like MFN. https://t.co/iMT1map2Gd

[Alexander Gaffney @AlecGaffney]

@adamfeuerstein @NedPagliarulo I'm surprised the Senate doesn't have a café called "Strong Concerns," what with how often legislators have them and swallow them anyways.

[Maaisha Osman @MaaishaO]

NEW: Outgoing Georgia Congressman Buddy Carter Eyed For FDA Commissioner https://t.co/DgTNLT6tHj

[Derrick @dgingery]

The PDUFA VIII commitment letter is posted! Enjoy ... (but if you have been reading the @PharmaPinkSheet you already know a lot of what's in it): https://t.co/iyOPfusc4M

[Helen Branswell 🇨🇦 @HelenBranswell]

#CDC's new director clearly has been sworn in. Erica Schwartz is now listed on CDC's website as the director. First big challenge for Schwartz: how she responds to this week's executive order on reducing recommended childhood vaccines & the call to break up MMR vax. https://t.co/lQBeVCy6dH

[Max Bayer @maxonwifi]

We may not get a better MAHA split screen this admin.

AM: Popular GRAS reforms
PM: Unpopular MMR vaccine change, autism claims

[Sue Sutter @PinkSheetSutter]

Today's @US_FDA "bulletin" on Lipfendra approval mentions CNPV program FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol

[Sue Sutter @PinkSheetSutter]

@PRVWatch @AlecGaffney @NedPagliarulo https://t.co/MRXVcBFdfm

[Sue Sutter @PinkSheetSutter]

@dgingery @US_FDA @PharmaPinkSheet Thanks!

[Sue Sutter @PinkSheetSutter]

@PRVWatch @AlecGaffney @NedPagliarulo Image not rendering but story is on the $MRK voucher

[Sue Sutter @PinkSheetSutter]

@PRVWatch @AlecGaffney @NedPagliarulo https://t.co/MRXVcBFdfm

[Sue Sutter @PinkSheetSutter]

SCOOP: @US_FDA once again posting complete response letters for unapproved drugs/biologics after temporary pause in April https://t.co/9d22zDIq87

[Sue Sutter @PinkSheetSutter]

HHS Considering US FDA Reorganization With Medical Products Chief Overseeing Centers https://t.co/8nGxvX8Ow4

[PRV Watch @PRVWatch]

Sanofi $SNY receives approval for Tzield (teplizumab) to treat pediatric stage 3 T1D. Sanofi was awarded a Commissioner's National Priority Voucher for this indication but its unclear if this approval was still under the CNPV program as the decision has been delayed for months.

[Sue Sutter @PinkSheetSutter]

And say hi to me in White Oak 😀

[Derrick @dgingery]

Going to @US_FDA's public mtg on the NPV program today? Make sure to check out the @PharmaPinkSheet preview stories from @MaaishaO: https://t.co/hGlX3r3V7H

[Sue Sutter @PinkSheetSutter]

SCOOP: $AMGN Fights @US_FDA On Tavneos Withdrawal Over Efficacy, Data Integrity Concerns https://t.co/rdaY0OD8Wo