Derrick

An Indiana Hoosiers fan, news junkie, health care journalist @PharmaPinkSheet, @IUBloomington alum, and soon a novelist. Opinions are my own.

[Derrick @dgingery]

Some believe the "bridge" program in Medicare will not be much of a bridge to anything ... @PharmaPinkSheet: Medicare Obesity Drug Coverage Unlikely To Lapse After 2027, Lilly’s Ricks Says https://t.co/3PyNcELlmg

[Derrick @dgingery]

(2/2) The second story in the @PharmaPinkSheet's Hepcludex package from @PinkSheetSutter is a chronology of the major events throughout the review, including @GileadSciences' attempt to gain a Tropical Disease PRV: https://t.co/QTxjNewoc9

[Derrick @dgingery]

(1/2) The first package of stories from @PinkSheetSutter's deep dive into the review of the @GileadSciences' Hepcludex is here. This story explores how unmet need overruled use errors in product administration ... @PharmaPinkSheet: https://t.co/w1ayDlBKL0

[Derrick @dgingery]

A closer look at the new @FDA inspections agreement and policy, known as ConOps. New language on remote assessments and MRAs included ... @PharmaPinkSheet: US FDA’s Inspection Decisions Now May Hinge On Remote Assessments, Foreign Reports https://t.co/61W4S1PFop

[Derrick @dgingery]

Start your lobbying now. Sen. Cassidy says he's undecided on @FDA commissioner nominee Heidi Overton.

[U.S. Senator Bill Cassidy, M.D. @SenBillCassidy]

Over the last several months, I have had several frank conversations with both Dr. Overton and Mr. O’Neill about their visions, roles, and the lack of trust that exists due to broken promises and irresponsible decisions from other officials within the Administration. I appreciate their ongoing candid conversations. While I remain undecided on both of their nominations and am aware that other Republican members of the Committee are undecided as well, the Committee is moving forward with noticing their markup in the hopes of resolving their path forward one way or another this Congress.

[Derrick @dgingery]

Buckle up ... Senate HELP scheduled a vote on Heidi Overton's nomination for @FDA commissioner for Nov. 18: https://t.co/Q6woMS0rnn

[Derrick @dgingery]

Mark your calendars for a big lame-duck session vote ... @PharmaPinkSheet @MaaishaO @PinkSheetSutter: Senate Committee To Vote On US FDA Commissioner Nominee Before Dem Takeover https://t.co/CloXWcGOmt

[Derrick @dgingery]

Getting around data use agreements will be important if sponsors want the @FDA to use RWE for regulatory decision-making ... @PharmaPinkSheet: US FDA Seeking Ideas To Avoid Data Use Problems When RWE Included In Application Reviews https://t.co/oSjoDwvOYe

[Derrick @dgingery]

The competition to get into the program is tight! I wonder how they all found partners to help write the INDs? @PharmaPinkSheet @PinkSheetSutter: Operation TrialBlazer: US FDA’s Expedited IND Pilot Draws 100+ Applications https://t.co/wGM7LSpK8r

[Derrick @dgingery]

If you manufacture cell and gene therapies, you're on notice ... @PharmaPinkSheet @RPMReportMike: US FDA Reorg Will Help Address ‘Surge’ In Cell, Gene Therapy Facility Inspections https://t.co/6kMW7XNBBh

[Derrick @dgingery]

For some reason, I suspect this is not over yet ... @PharmaPinkSheet: WuXi AppTec Removed From 1260H List, For Now https://t.co/K37GyH6YBU

[Maaisha Osman @MaaishaO]

Senate Committee To Vote On US FDA Commissioner Nominee Before Dem Takeover https://t.co/FYdwkGgVXa

[Derrick @dgingery]

For your GLP-1 radar ... @PharmaPinkSheet: GLP-1 Class Warning On Rare Eye Condition Driven By US FDA Meta-Analysis, Sentinel Study https://t.co/osvE2H6Qlm

[Derrick @dgingery]

Interesting ... @PharmaPinkSheet: US FDA Probes Tumor Risk With Novartis’ Zolgensma And Itvisma After Gene Integration Reports https://t.co/5kzf9OUhwt

[Derrick @dgingery]

For your gene therapy radar ... @PharmaPinkSheet: US FDA Defines Risk-Based Potency Approach To Cell and Gene Therapy https://t.co/LwyGH9Jfe5

[Derrick @dgingery]

The latest detail on FDA hiring and departures. One of my @PharmaPinkSheet stories with graphics! US FDA Biologics Center Joins Hiring Binge, Posts First Net Gain Since Pre-Trump Administration https://t.co/iOGZ1uVy8a

[Derrick @dgingery]

More from the Medicare price negotiation final rule from @PharmaPinkSheet's @MaaishaO: One-time treatments count as a year's worth ... CMS Retains ‘Value Of 12’ For One-Time Therapies In Medicare Price Negotiation Despite Pushback https://t.co/YKph6GgaZG

[Derrick @dgingery]

You can ask for more @FDA ad/promo advisory comments after an initial round to add clarity, @PharmaPinkSheet @PinkSheetSutter reports ... Ad/Promo: Multiple US FDA Advisory Comment Requests OK, But Know Their Limits https://t.co/WXELXMHKm8

[Derrick @dgingery]

Agree with this assessment

[Alexander Gaffney @AlecGaffney]

https://t.co/NQfIZP9f94

This is going to have reverberations throughout government.

[Derrick @dgingery]

Industry is looking forward to the new Congress already ... @PharmaPinkSheet: MFN Revisions, Codification Unlikely In Divided US Government, Pfizer’s Bourla Suggests https://t.co/ev7VnOIGM3