Michael McCaughan

Founding Member, Prevision Policy LLC Business Implications of FDA and CMS Policy; Policy Implications of Biopharma Business

[Derrick @dgingery]

Along with these, what controversial product does @RPMReportMike suggest get an advisory committee meeting in @PharmaPinkSheet? US FDA Advisory Committees Revisit Makary Controversies: Mflusiva And Tzield https://t.co/dSGDuVsTFa

[BrainStorm @BrainstormCell]

We are honored to welcome @PeterPitts, former @US_FDA Associate Commissioner, to BrainStorm's Board of Directors. His expertise will help support our mission to advance NurOwn® for people living with ALS. #NurOwn #Biotech #FDA #ALS
Read more: https://t.co/2xnHjmCaeQ

[Ramsey Baghdadi @Ramsey_Baghdadi]

Great read. Midterms still seems like safer bet.

[Michael McCaughan @RPMReportMike]

Not FDA/pharma related but important! https://t.co/kdUyfBBhIR

[Derrick @dgingery]

An argument for the FDA to slow down ... @PharmaPinkSheet @RPMReportMike: Psychedelic Reviews: Why The US FDA May Be Heading For A Bad Trip https://t.co/aussg2Scvt

[Derrick @dgingery]

When will be see the impact of the upheaval? Six months? A year? Never? An interesting question ... @PharmaPinkSheet @RPMReportMike: A Strong Year For US FDA Approvals, But Warning Lights Flashing https://t.co/u9v6M2ipXQ

[Pink Sheet, Citeline Regulatory @PharmaPinkSheet]

US FDA’s Richard Pazdur: Appreciating An Extraordinary Career — Click image below to read more! || #PinkSheet | Start your free trial today: https://t.co/PHlaDA3woU https://t.co/iGACcBZvb2

[Michael McCaughan @RPMReportMike]

Gotta believe it already has a 100% inflation rebate.

[Zach Brennan @ZacharyBrennan]

$BMY to provide Eliquis to Medicaid for free

[David Greenberg @republicofspin]

Named one of Amazon's best books of 2024, JOHN LEWIS is out in paperback and it makes a good Hanukkah/Xmas/Kwanzaa gift! Hardcover also on steep discount at Amazon. Happy to sign copies for you (just email me). LINK here: https://t.co/fFNXsB1xjB

[Michael McCaughan @RPMReportMike]

I would also love to know if the prices quoted for Ozempic and Wegovy are the MFPs (price negotiation) as well as the MFNs....

[Ian Spatz @rockcreekpolicy]

Questions on GLP-1 coverage in Medicare and Medicaid: (1) will there be coverage conditions (e.g., comorbidities)? (2) Will Part D plans have to cover? (3) Will plans be able to negotiate further price concessions? (4) When would coverage begin? (5) Will states have to cover?

[Derrick @dgingery]

The two very different applications potentially getting the first @US_FDA decisions through the CNPV pathway. A @PharmaPinkSheet story from @RPMReportMike: Sanofi, Disc Will Be First To Test US FDA’s CNPV Pathway https://t.co/vWkeEnLjeY

[Sarah Karlin-Smith @SarahKarlin]

Worth revisiting the new CDER Director's role in this meeting. via @RPMReportMike
https://t.co/ez6DJUOang

[Michael McCaughan @RPMReportMike]

That would be a BFD, but not what FDA is doing here. These CRLs are I believe all already public.

[Joe Gitchell @jgitchell]

@RPMReportMike But ... I'm understanding this as release of CRLs before an approval, so not part of an SBA.

For example, if I wanted to know what really happened with the @kenvue @Haleon_health @nicorette Quickmist mouth spray (+ve AdComm vote in 2019), could an FDA document tell me?

🤷‍♂️

[Michael McCaughan @RPMReportMike]

Best I can tell, these letters are already public as part of drug approval packages previously posted by FDA. So, maybe not such a BFD...

[Joe Gitchell @jgitchell]

I bet @RPMReportMike has thoughts!

This is a BFD, though we shall see what we see.

[Joe Gitchell @jgitchell]

I bet @RPMReportMike has thoughts!

This is a BFD, though we shall see what we see.

[Derrick @dgingery]

Interesting that this is happening in the absence of more agency detail on the program ... @PharmaPinkSheet @RPMReportMike: US FDA ‘Commissioner’s Voucher’ As Public Relations Tool https://t.co/y3DjIwM2wT

[Derrick @dgingery]

To say last week was "busy" for the @US_FDA press corps. is an understatement ... @PharmaPinkSheet @RPMReportMike: US FDA Meeting Drought Ends … With A Vengeance https://t.co/UiOJs8kqfA

[David Greenberg @republicofspin]

Very proud and humbled to have JOHN LEWIS: A LIFE chosen as a finalist for the Pulitzer Prize in Biography. It was a privilege to write the life of this remarkable man, and it's been a joy to watch so many appreciative readers draw sustenance and hope from his story.

[Derrick @dgingery]

Despite saying @US_FDA should be apolitical, the agency has done some seemingly political things since the new commissioner's arrival, @RPMReportMike reports for @PharmaPinkSheet: Political Influence And The US FDA: A New Era? https://t.co/dGTurXhKZH

[Derrick @dgingery]

Center director departures @US_FDA used to be relatively rare. Maybe not anymore. From @RPMReportMike and @PharmaPinkSheet: US FDA Center Directors Are Political Now https://t.co/bO5j1jUrXq