Michael McCaughan @RPMReportMike
Founding Member, Prevision Policy LLC Business Implications of FDA and CMS Policy; Policy Implications of Biopharma Business previsionpolicy.com Washington DC Joined March 2009-
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Michael McCaughan retweeted
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 insights.citeline.com/pink-sheet/pro…
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Michael McCaughan retweeted
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: bit.ly/4uD6Q0o
Michael McCaughan retweeted
Great read. Midterms still seems like safer bet.
Latest on the post-Makary turmoil across the Food and Drug Administration: cnn.com/2026/05/15/pol…
Not FDA/pharma related but important! youtube.com/watch?v=1iOLe8…
Michael McCaughan retweeted
An argument for the FDA to slow down ... @PharmaPinkSheet @RPMReportMike: Psychedelic Reviews: Why The US FDA May Be Heading For A Bad Trip insights.citeline.com/pink-sheet/pat…
Michael McCaughan retweeted
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 insights.citeline.com/pink-sheet/pro…
Michael McCaughan retweeted
US FDA’s Richard Pazdur: Appreciating An Extraordinary Career — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/4ky4k vist.ly/4ky4m
Gotta believe it already has a 100% inflation rebate.
Michael McCaughan retweeted
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: amazon.com/John-Lewis-Lif…
I would also love to know if the prices quoted for Ozempic and Wegovy are the MFPs (price negotiation) as well as the MFNs....
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?
Michael McCaughan retweeted
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 insights.citeline.com/pink-sheet/pat…
Michael McCaughan retweeted
Worth revisiting the new CDER Director's role in this meeting. via @RPMReportMike insights.citeline.com/pink-sheet/com…
That would be a BFD, but not what FDA is doing here. These CRLs are I believe all already public.
@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? 🤷♂️
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...
I bet @RPMReportMike has thoughts! This is a BFD, though we shall see what we see.
Michael McCaughan retweeted
I bet @RPMReportMike has thoughts! This is a BFD, though we shall see what we see.
News: The FDA plans to publish rejection letters describing why medicines aren't approved that companies have mostly kept hidden until now via @damiangarde + @SamHornblower bloomberg.com/news/articles/…
Michael McCaughan retweeted
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 insights.citeline.com//pink-sheet/pa…
Michael McCaughan retweeted
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 insights.citeline.com//pink-sheet/ag…
Michael McCaughan retweeted
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.
Michael McCaughan retweeted
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? insights.citeline.com//pink-sheet/ag…
Michael McCaughan retweeted
Center director departures @US_FDA used to be relatively rare. Maybe not anymore. From @RPMReportMike and @PharmaPinkSheet: US FDA Center Directors Are Political Now insights.citeline.com//pink-sheet/ag…
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