Sue Sutter
@PinkSheetSutter
Followers
3K
Following
401
Media
9
Statuses
7K
Senior Editor, Citeline's Pink Sheet, covering US FDA drug and biologic regulation and approvals. Views are my own. @PharmaPinkSheet
Washington, DC
Joined June 2010
RT @ScripMandy: The media is not equating Elevidys in DMD with SRP-9004 for LGMD as $SRPT suggests. We all realize these two gene therapies….
0
1
0
RT @ScripMandy: $SRPT The FDA asked Sarepta to stop shipping Elevidys and the company refused. It’s hard to see what is gained by digging i….
fda.gov
FDA is announcing today it has placed Elevidys and certain Sarepta investigational gene therapy clinical trials for limb girdle muscular dystrophy on clinical hold due to new safety concerns that the...
0
3
0
RT @margaretbarthel: Today I'm thinking about this: when Hurricane Helene devastated Appalachia last year, my public radio colleagues in No….
0
29
0
US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much
insights.citeline.com
Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry...
1
0
1
At $GSK Blenrep ODAC, @US_FDA designated federal officer reads new statement advising industry rep not to engage in "unseemly advocacy," mentions non-voting status at least half dozen times.
0
4
5
RT @FTC: FTC takes action against telemedicine firm NextMed over charges it used misleading prices, fake reviews, and deceptive weight loss….
ftc.gov
The operators of telemedicine company Southern Health Solutions, Inc., doing business as Next Medical and NextMed, have agreed to settle the Federal Trade Commission’s charges that they used decept
0
11
0
RT @RPMReportMike: Best I can tell, these letters are already public as part of drug approval packages previously posted by FDA. So, maybe….
0
1
0
#ACIP will create new workgroups to look at cumulative childhood vaccine and adolescent vaccine schedules and vaccines that have not been subject to review in several years, such as hep B at birth.
2
3
5
And we're underway at ACIP - member roster finally posted, 7 voting members total, 1 less than RFK initially annoucned. Michael Ross not listed as a member.
Get ready for day 1 of the two-day @CDCgov ACIP mtg with a @PharmaPinkSheet story on how changes in recommendations could impact insurance coverage for vaccines: ACIP ‘Pivot’ May Mean Variable US Coverage For New Vaccines, Higher Copays
0
2
4
RT @SarahKarlin: Senate HELP schedules hearing for cdc director nominee Monarez on day 1 of what should be a very unique ACIP….
0
3
0
"Resource constraints" - @US_FDA Commissioner Martin Makary has repeatedly said the proverbial trains are running on time at the agency despite the personnel losses. Evidence suggests otherwise.
$KALV KalVista Pharmaceuticals Announces FDA Will Not Meet PDUFA Goal Date for Sebetralstat NDA for Hereditary Angioedema Due to FDA Resource Constraints.
0
0
3
RT @matthewherper: Pfizer CEO: HHS claims of ‘concealed safety concerns’ on mRNA vaccines are ‘completely inaccurate’ .
cnn.com
Pharmaceutical rivals don’t often come to each other’s defense. But after the US Department of Health and Human Services terminated a contract with drugmaker Moderna to develop an mRNA bird flu...
0
2
0
RT @elwasson: BUDGET: White House releases full Appendix for agency budget proposals to allow appropriations process to start https://t.co….
0
33
0
RT @bylenasun: NEW: CDC, which makes vaccine recs, is blindsided as RFK Jr. changes covid-19 vax recs for kids + pregnant women. CDC found….
washingtonpost.com
Agency officials were not aware that the HHS secretary was going to change the recommended vaccine schedule.
0
54
0
Ironic, given that @US_FDA Commissioner Martin Makary and #CBER Director Vinay Prasad announced their new framework for COVID vaccine approvals in an @NEJM editorial last week.
RFK Jr. threatens to bar government scientists from publishing in leading medical journals, including @NEJM @JAMA_current and @TheLancet via @politico.
1
4
6
RT @jeremyfaust: Who is running the CDC? . Why is that person not there? . You've got Marty (FDA) and Jay (NIH) with RFK Jr. But nobody f….
0
372
0